Therapeutic Relativity Sheets - 1 April 2014

Therapeutic Relativity Sheets - 1 April 2014

Note: Recent additions are italicised.

Section 100 Items    Effective Date:  04/14

1. Interferon Alfa-2A and interferon Alfa-2B are considered equivalent.

2. Lenograstim was accepted for listing as being equivalent to filgrastim on a microgram to microgram basis.

3. The protease inhibitors, saquinavir, indinavir and ritonavir are priced on the basis of same cost per day at recommended doses.

4. Lamivudine, for use in the treatment of HIV infection, was accepted on the basis of acceptable cost-effectiveness compared to zidovudine.

5. Stavudine was accepted on the basis of cost minimisation compared to zidovudine,

6. Zidovudine is considered more effective than zalcitabine and of similar effectiveness to didanosine.

7. The price of zidovudine syrup is the same per mg as the capsule presentation based on the advice from PBAC that the syrup offered no advantage over the capsule.

8. Azithromycin tablet 600mg for use in MAC prophylaxis was accepted as being more effective and (at that time) of lower cost compared to rifabutin (1.2g weekly compared to 300mg daily).

9. Tacrolimus has been listed on the basis of acceptable cost-effectiveness compared to cyclosporin.  For use in kidney transplant recipients, a lower price was negotiated than had originally been agreed for use in liver transplant recipients.  The actual listed price is a weighted price across the two uses.  Also refer to L04 – Immunosuppressive agents.

10. Cidofovir infusion was recommended on a cost minimisation basis compared to ganciclovir infusion taking account of drug and administration costs.

11. Saquinavir soft gelatin capsule 200 mg (Fortovase®) was presented and accepted on the basis that twelve capsules would replace nine capsules of saquinavir mesylate 200 mg (base) (Invirase®).

12. Ritonavir oral solution was accepted on the basis of same price per mg as for the capsule presentation.

13. Stavudine powder for oral suspension was presented at the same price per mg of drug as for stavudine capsule 15 mg.

14. Abacavir sulfate was recommended for listing on the basis of cost minimisation compared to other nucleoside reverse transcriptase inhibitors e.g. lamivudine, at recommended doses. 

15. Foscarnet was presented as having comparable efficacy with ganciclovir and with the overall costs of therapy, including the costs of reconstitution (where ganciclovir is treated as a cytotoxic), being similar (foscarnet was slightly more costly).

16. Efavirenz was recommended for listing on the basis of cost minimisation compared to other non-nucleoside reverse transcriptase inhibitors e.g. nevirapine, at recommended doses.  Special pricing arrangements apply.

17. Lamivudine oral solution 5mg per mL, 240mL is priced on a mg to mg basis with the 100mg lamivudine tablet (both for the treatment of hepatitis B).

18. Octreotide acetate modified release injections (Sandostatin LAR®) for intramuscular administration (usually once four-weekly) were recommended on a cost minimisation basis compared to octreotide acetate ‘plain’ injections administered subcutaneously (usually two-three times daily).

19. For use in the treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy, 90mg of pamidronate every three weeks was accepted as provided similar benefits to 3.2g daily of sodium clodronate.

20. Dysport® brand of botulinum toxin type A neurotoxin injection was accepted for listing for the treatment of spasmodic torticollis and treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients. Listing was on the basis that three Ipsen units of Dysport are similar to one unit of Botox® brand of botulinum toxin type A neurotoxin.  Special pricing arrangements apply.

21. All the different brands of somatropin are considered equivalent on a per mg basis.  Price charged by the suppliers per mg of somatropin is identical regardless of the delivery method and/or price quoted in the Schedule of Pharmaceutical Benefits.

22. The fixed combination tablet (Trizivir®) containing abacavir sulfate with lamivudine and zidovudine was listed on a basis of cost minimisation compared to individual components.

23. Darbepoetin alfa was accepted for listing on a cost minimisation basis with 37.5 μg darbepoetin alfa weekly being of similar safety and efficacy to 7275.9 units of epoetin alfa weekly.

24. Amprenavir was listed on the basis of the same cost per 30 days supply as for the other listed protease inhibitors.

25. Lanreotide acetate injection was listed on the basis that a 30mg injection every 11.7 days is equivalent to octreotide acetate modified release injection 20mg (base) every 28 days.

26. The fixed combination formulation of lopinavir with ritonavir (Kaletra®) was listed on the basis of advantage over single protease inhibitor therapy.

27. Zoledronic acid injection 4 mg (Zometa®) was listed on the basis of acceptable cost-effectiveness compared to disodium pamidronate injection 90 mg in the treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy.  Zoledronic acid injection 4 mg was listed on a cost minimisation basis compared to disodium pamidronate injection 90 mg (drug plus administration costs) for use in multiple myeloma and bone metastases from breast cancer, and listed at the same price as this for use in the treatment of bone metastases from prostate cancer.  The actual listed price (from 1 November 2003) is a weighted price across indications according to its predicted use.  Special pricing arrangements apply.

28. Peginterferon alfa-2a and ribavirin  (Pegasys RBV®) for use in hepatitis C patients who have had no prior interferon therapy, was recommended on the basis of acceptable cost-effectiveness compared to plain (non-pegylated) interferon alfa therapy. 

29. Peginterferon alfa-2a (Pegasys®) was recommended for listing for use in hepatitis B patients. Special pricing arrangements apply. 

30. Tenofovir disoproxil fumarate tablet 300mg, for use in combination with other anti-retroviral drugs in patients who have failed current regimens, was recommended for listing on the basis of acceptable cost-effectiveness.  For use as first line therapy, the drug was recommended on the basis of cost minimisation compared to stavudine and zidovudine at recommended dosages.  The final price was weighted to account for the predicted use between the two settings.

31. Valganciclovir has been listed on the basis of cost minimisation compared to ganciclovir. Its initial listing for cytomegalovirus retinitis was on the basis of total cost of therapy with intravenous ganciclovir 10mg/kg/day induction for three weeks plus oral ganciclovir 3g per day for one week equals oral valganciclovir 1.8g per day. Its listing for prophylaxis of cytomegalovirus infection and disease was on the basis of valganciclovir 900 mg per day equals ganciclovir 3 g per day (oral).

32. Pegfilgrastim injection 6mg was recommended for listing on a cost minimisation basis compared to filgrastim with 6mg being considered equivalent to filgrastim injection 5ug/kg/day for 11.25 days.

33. Crinone®, progesterone prolonged release vaginal gel 90mg per dose, was recommended for listing on a cost minimisation basis compared to human chorionic gonadotrophin and to progesterone pessary 200mg per dose.  The Pricing Authority agreed to pricing based on relativity with progesterone pessary.

34. Pegasys-RBV® was recommended on the basis of similar safety and effectiveness to and thus on a cost minimisation basis to ribavirin and peginterferon alfa-2b (Pegatron®). 

35. Infliximab in rheumatoid arthritis was recommended for listing on a cost minimisation basis compared with etanercept (including the infusion administration costs for infliximab) at a dose of 3 mg/kg. Special pricing arrangements apply

36. Infliximab was recommended for the treatment of severe acute psoriatic arthritis on a cost minimisation basis versus etanercept.  The equi-effective doses are infliximab 5 mg/kg given for 7.25 infusions in total compared with etanercept 25 mg twice per week given for one year.  Also refer to L04 – Immunosuppressive Agents.

37. Somatuline Autogel®, lanreotide acetate prolonged release injection, for the treatment of acromegaly, was recommended on the basis that 93.3 mg every 28 days is of similar safety and efficacy to octreotide acetate long acting formulation (Sandostatin LAR®) 20 mg every 28 days.  Subsequently it was recommended for the treatment of carcinoid tumour with the same dosage relativity (i.e, lanreotide autogel:octreotide LAR = 4.67: 1).

38. Bosentan was recommended for listing on the basis of acceptable cost-effectiveness.

39. Sirolimus was recommended for listing on the basis that it is no worse than tacrolimus in respect to effectiveness and toxicity.  The (non-head-to-head) clinical data suggested average daily doses of approximately 6.4 mg for sirolimus and 12.8 mg for tacrolimus.  Also refer to L04 – Immunosuppressive agents.

40. Fosamprenavir calcium was recommended for listing on a cost minimisation basis compared to nelfinavir - 1.4 g of fosamprenavir plus 200 mg ritonavir daily = 2.25 g nelfinavir daily. 

41. Atazanavir sulfate was recommended for listing on a cost minimisation basis (1) for use in protease inhibitor treatment-naïve patients, 400 mg daily = nelfinavir 750 mg three times daily; and (2) for use in protease inhibitor treatment-3experienced patients, 300 mg plus 100 mg ritonavir daily = lopinavir 400 mg plus ritonavir 100 mg twice daily.  Pricing was based on weighting according to the predicted use between the two patient groups.

42. Iloprost was recommended for listing on a cost minimisation basis compared with bosentan, with the equi-effective doses being iloprost 2.5-5 micrograms nebulised 6-9 times per day, giving a mean of 7.5 x 20 micrograms (i.e. 7.5 x one ampoule) consumed per day, and bosentan 125 mg taken twice daily.  Special pricing arrangements apply.

43. Emtricitabine 200 mg daily was recommended for listing on the basis of cost minimisation versus 150 mg lamivudine twice daily.

44. Everolimus was recommended on a cost minimisation basis compared to sirolimus (kidney) and mycophenolate mofetil (heart) with equi-effective doses of everolimus 2.15 mg per day = sirolimus 6.4 mg per day and everolimus 1.3 mg per day = mycophenolate mofetil 2.72 g per day.  The dose and cost of concomitant immunosuppressive agents were taken into account in the analysis.  Also refer to L04 – Immunosuppressive agents.

45. Buprenorphine with naloxone fixed dose combination was granted a price increase in 2010 on the basis of a PBAC recommendation that it is superior in terms of comparative effectiveness and safety over buprenorphine alone, based on the evidence of reduced diversion and abuse potential, and represents acceptable cost effectiveness at the increased price requested.

46. The fixed combination tablet of abacavir with lamivudine (Kivexa®) was recommended on a cost minimisation basis compared with the individual components.

47. Epoprostenol sodium was recommended on a cost minimisation basis compared to bosentan.  The equi-effective doses are epoprostenol, commencing at an average dose of 11.9 ng/kg per min over the first three months of treatment and escalating linearly in steps to an average dose of 27.2 ng/kg/min at 3 years, and bosentan 125 mg twice a day.

48. Entecavir tablet 1 mg, Baraclude® was recommended for the treatment of chronic hepatitis B infection in lamivudine resistant patients on a cost minimisation basis compared to adefovir with entecavir 1 mg for 48 weeks considered of equivalent effectiveness to adefovir 10 mg for 48 weeks.

49. Entecavir tablet 500 microgram, Baraclude® was recommended on a cost-effectiveness basis compared with lamivudine 100 mg. 

50. Cyclosporin (Neoral®) 10 mg capsule and 100 mg/mL oral solution was recommended to be priced independently of other strengths and formulations of cyclosporin, on the basis that the presentations are marketed as service items for a small group of patients for whom there is a clinical need for fine dose titration of cyclosporin.   Also refer to ATC L04 – Immunosuppressive Agents.

51. Deferasirox was recommended on a cost-effectiveness basis.  Special pricing arrangements apply.

52. Etanercept (Enbrel®) was recommended on a cost-effectiveness basis for use in severe active juvenile chronic arthritis.  Also refer to L04 – Immunosuppressive Agents.

53. Trastuzumab (Herceptin®) was recommended for listing on a cost-effectiveness basis in the treatment for HER2 positive early breast cancer.  Special pricing arrangements apply.

54. Tipranavir (Aptivus®) was recommended on the basis of acceptable cost-effectiveness compared to alternative protease inhibitors (ritonavir, amprenavir, indinavir, lopinavir and saquinavir).  Special pricing arrangements apply.

55. Rituximab (Mabthera®) was recommended for listing, in combination with methotrexate, on a cost minimisation basis compared to etanercept and adalimumab for severe active rheumatoid arthritis.  The equi-effective doses are rituximab 1000 mg on Days 1 and 15 being equivalent to etanercept 25 mg twice weekly = adalimumab 40 mg once every second week. Special pricing arrangements apply.

56. Thalidomide (Thalomid®) was recommended on acceptable cost-effectiveness basis compared to salvage treatments and a standard chemotherapy regimen in the treatment of multiple myeloma.

57. Infliximab was recommended on cost-effectiveness basis compared to efalizumab and etanercept in the treatment of severe chronic plaque psoriasis. Special pricing arrangements apply to etanercept.  For etanercept also refer to ATC L04 – Immunosuppressive Agents.

58. Infliximab was recommended on a cost-effectiveness basis compared to standard therapy in the treatment of severe Crohn disease (paediatric).  Special pricing arrangements apply.

59. Recombinant choriogonadotropin alfa, Ovidrel® 250 mcg was recommended on a cost minimisation basis compared to hCG, Pregnyl®.   The Pricing Authority agreed to pricing based on relativity with 10,000 units of Pregnyl®. 

60. Sildenafil citrate was recommended for listing on a cost minimisation basis with bosentan for the treatment of primary pulmonary hypertension or pulmonary hypertension association with connective tissue disease in patients categorised as WHO functional class III. The equi-effective doses are sildenafil 20 mg three times daily and bosentan 62.5 mg twice daily for 4 weeks followed by a maintenance dose of 125 mg twice daily.

61. Abatacept was recommended for listing on the PBS for the treatment, in combination with methotrexate, of adults with severe active rheumatoid arthritis (RA) who have failed prior DMARD therapy on a cost minimisation basis compared with infliximab in the treatment of rheumatoid arthritis.  The PBAC recommended that the equi-effective doses were abatacept 10mg/kg administered on days 1, 15, 29 and then every 28 days, and infliximab 3mg/kg administered on days 1, 15, 43 and then every 56 days. Special pricing arrangements apply.

62. Ibandronic acid was recommended for listing on a cost minimisation basis against disodium pamidronate with the equi-effective doses being ibandronic acid 6 mg IV and pamidronate 90 mg IV.

63. Sevelamer was recommended on a cost-effectiveness basis compared to calcium carbonate in the treatment of hyperphosphataemia.  Special pricing arrangements apply. Also refer to ATC V03 – All Other Therapeutic Products.

64. Dysport® was recommended on a cost-effectiveness basis for the treatment of moderate to severe spasticity of the upper limbs in adults following a stroke. Special pricing arrangements apply.

65. Adalimumab (Humira®) was recommended for the treatment of patients with moderate to severe Crohn disease on a cost-minimisation basis compared with infliximab at an equi-effective dose of adalimumab 160 mg at week 0 and 80 mg week 2, then 40 mg fortnightly thereafter and infliximab 5 mg/kg (weeks 0,  2 and 6 then every 8 weeks thereafter).  Special pricing arrangements apply.

66. Natalizumab (Tysabri®) was recommended for listing for relapsing-remitting multiple sclerosis in adults on a cost-effectiveness basis compared with interferon beta-1b.  Special pricing arrangements apply.

67. Lanthanum carbonate was recommended for listing on a cost minimisation basis compared to sevelamer. The equi-effective average daily doses were estimated as 1936 mg for lanthanum and 5231 mg for sevelamer based on a dose relativity of 2.7. Special pricing arrangements apply. Also refer to ATC V03 – All Other Therapeutic Products.

68. Ambrisentan (Volibris®) was recommended for listing on a cost minimisation basis to bosentan, the equi-effective doses are ambrisentan 5 mg daily and bosentan 125 mg twice daily.

69. Tenofovir disproxil fumarate was recommended for extension to listing to include chronic hepatitis B in nucleoside analogue naïve patients on a cost minimisation basis to entecavir 0.5 mg and on a cost minimisation basis with adefovir 10 mg.The equi-effective doses are entecavir 0.5 mg once daily and tenofovir 300 mg for long term therapy for treatment experienced patients.

70. Lenalidomide was recommended for listing for the treatment of patients with relapsed/refractory multiple myeloma for which thalidomide therapy has failed or in whom there is severe intolerance/ toxicity to thalidomide on a cost minimisation basis with bortezomib with the equi-effective doses to be based on 6 cycles of bortezomib.  Special pricing  arrangements apply.

71. The combination tablet containing tenofovir with emtricitabine and efavirenz was recommended on a cost-minimisation basis compared with the corresponding strengths of the individual components given concomitantly.

72. The PBAC recommended that the cost per day for the Erythropoeisis Stimulating Agents (ESAs) should be the same, taking into account the different settings of use.  Methoxy-polyethylene glycol-epoetin beta (MPGE) was recommended for listing on a cost- minimisation basis compared with darbepoetin alfa. The equi-effective doses were estimated as MPGE 29.29 mcg per week and darbepoetin 40.49 mcg per week.

73. The PBAC recommended that darunavir co-administered with ritonavir be listed on a  cost-minimisation basis compared with lopinavir with ritonavir (Kaletra®).  The equi- effective doses are darunavir 600 mg twice daily in combination with ritonavir 100 mg  twice daily and lopinavir 400 mg with ritonavir 100 mg twice daily.  Special pricing arrangements apply.

74. Tocilizumab (Actemra®) was recommended for listing as monotherapy for the treatment of severe active rheumatoid arthritis on a cost-minimisation basis compared to etanercept.  The equi-effective doses are tocilizumab 8 mg/kg every four weeks and etanercept 50 mg weekly and including the costs associated with different modes of administration.  Special pricing arrangements apply.

75. Epoetin beta was recommended for listing on a cost-minimisation basis compared to epoetin alfa, on a unit per unit basis.

76. Adalimumab (Humira®) was recommended for listing for severe active polyarticular course juvenile idiopathic arthritis on a cost-minimisation basis compared to etanercept. The equi-effective doses are adalimumab: 15 kg to <30 kg 20 mg and ≥ 30 kg 40 mg SC every other week compared with etanercept: 0.4 mg/kg up to 25 mg SC twice weekly. Also refer to ATC  L04 – Immunosuppressive Agents.

77. Tacrolimus (Prograf XL ®) prolonged release capsules was recommended for listing for patients with organ or tissue transplants on a cost-minimisation basis with immediate release  tacrolimus (Prograf ®) on a mg:mg basis at the same price per mg.  Also refer to ATC L04 –  Immunosuppressive Agents.

78. Ganirelix was recommended for listing for use in IVF/GIFT at the price comprised of twice the cost of narafelin acetate on the PBS for the treatment of endometriosis plus the cost offset of a reduction in incidence of severe ovarian hyperstimulation syndrome (OHSS) with gonadotrophin releasing hormone (GnRH) analogue antagonists compared to GnRH analogue agonists.

79. Epoetin lambda was recommended for listing on a cost-minimisation basis with epoetin alfa.

80. Cetrorelix was recommended for listing for use in IVF/GIFT on a cost-minimisation basis compared with ganirelix.   The equi-effective doses are cetrorelix 250 micrograms and ganirelix 250 micrograms.

81. Romiplostim was recommended for listing on a cost-effectiveness basis compared to placebo.  Special pricing arrangements apply.

82. Levodopa with carbidopa intestinal gel was recommended on the basis of a cost-effectiveness compared with standard medical management including deep brain stimulation. Special pricing arrangements apply

83. Omalizumab was recommended for listing on a cost effectiveness basis compared to placebo.

84. Eltrombopag was recommended for listing on the basis of cost effectiveness (less effective and less expensive) compared with romiplostim for patients with chronic immune (idiopathic) thrombocytopenia purpura. Special pricing arrangements apply.

85. Darunavir 400 mg was recommended for listing on the basis that darunavir 800 mg with ritonavir 100 mg daily is non-inferior to darunavir 600 mg with ritonavir 100 mg twice daily.

86. Nafarelin for use in IVF/GIFT was recommended for listing on a cost-minimisation basis with ganirelix,with the price of the nafarelin to not include the cost offset awarded to ganirelix and cetrorelix for a reduction in incidence of OHSS.

87. Etravirine 200 mg was recommended for listing for the treatment of HIV infection at an equivalent price to the current 100 mg strength on a mg to mg basis.

88. Darunavir 600 mg was recommended for listing for the treatment of HIV infection at the same price as 2 x darunavir 300 mg tablets.

89. Rilpivirine was recommended for listing on a cost-minimisation basis with efavirenz. The equi-effective doses are rilpivirine 25 mg daily and efavirenz 600 mg daily, both over 96 weeks.

90. Nevirapine 400 mg extended release tablets were recommended for listing on a cost-minimisation basis compared with the nevirapine 200 mg immediate release tablets.

91. Tadalafil was recommended for listing for the treatment of WHO functional Class III pulmonary arterial hypertension and pulmonary arterial hypertension secondary to connective tissue disease on a cost-minimisation basis compared with sildenafil.  The equi-effective doses are tadalafil 40 mg (2 x 20 mg once daily) and sildenafil 60 mg (20 mg three times a day).

92. Clostridium botulinum type A toxin-haemagglutinin complex lyophilised powder for I.M. injection (Dysport®) was recommended for listing for blepharospasm or hemifacial spasm in adults on a cost-minimisation basis with botulinum toxin type A (Botox®) with 4 units of Dysport being equivalent to 1 unit of Botox.

93. Tocilizumab was recommended for listing for treatment of severe active systemic juvenile idiopathic arthritis in patients under 18 years of age on a cost-minimisation basis compared with etanercept and adalimumab.  The equi-effective doses are estimated to be tocilizumab: <30kg 12mg/kg and ≥30kg 8mg/kg IV every 2 weeks compared with etanercept: 0.4mg/kg up to 25mg SC twice weekly and adalimumab 24mg/m2 SC second weekly.  Special pricing arrangements apply.

94. Tenofovir disoproxil fumarate with emtricitabine and rilpivirine fixed dose combination was recommended for listing on a cost-minimisation basis compared with tenofovir disoproxil fumarate with emtricitabine and efavirenz fixed dose combination. The doses of tenofovir disoproxil fumarate and emtricitabine in both combinations were the same at the time of listing. The equi-effective doses of rilpivirine and efavirenz are 25mg/day and 600 mg/day, respectively.

95. Etanercept was recommended for listing for severe chronic plaque psoriasis in patients under 18 years of age on the basis of acceptable cost-effectiveness compared to placebo in the context of high clinical need. Special pricing arrangements apply.

96. Mannitol was recommended for listing for the treatment of cystic fibrosis on a cost- minimisation basis against a mixed comparator of 70% dornase alfa and 30% hypertonic saline. 

97. Boceprevir was recommended for listing for chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin on the basis of acceptable cost effectiveness over peginterferon with ribavirin.  Special pricing arrangements apply.

98. Telaprevir was recommended for listing for chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin at the same price for a course of treatment of boceprevir in combination with peginterferon and ribavirin.  Special pricing arrangements apply.

99. Raltegravir chewable tablet was recommended for treatment, in combination with other antiretroviral agents, of human immunodeficiency virus (HIV-1) infection in treatment experienced patients from 2 years of age on a cost-minimisation basis with nevirapine suspension. The chewable tablet has a price premium over the plain tablet.

100. Botulinum toxin type A was recommended for an extension to listing to include treatment of severe primary axillary hyperhidrosis on a cost-effectiveness basis over placebo. Special pricing arrangements apply.

101. Botulinum toxin type A was recommended for an extension to listing to include the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients with multiple sclerosis, spinal cord injury or adult spina bifida, on the basis of acceptable cost-effectiveness compared to best supportive care. Special pricing arrangements apply.

102. Darunavir 800 mg was recommended for listing for the treatment of HIV infection at the same price as 2 x darunavir 400 mg tablets.

103. Botulinum toxin type A was recommended for an extension to listing to include the treatment of urinary incontinence due to idiopathic overactive bladder on a cost-effectiveness basis compared to best supportive care.  Special pricing arrangements apply. 

104. Dolutegravir was recommended for listing for the treatment of HIV infection in combination with other anti-retrovirals on a cost-minimisation basis with raltegravir.  The equi-effective doses are dolutegravir 50 mg once a day and raltegravir 400 mg twice a day. 

105. Tocilizumab was recommended for listing for the treatment of active polyarticular course juvenile idiopathic arthritis (JIA) as a single-agent or in combination with methotrexate, on a cost-minimisation basis compared with etanercept and adalimumab. 
The equi-effective doses are:

  • tocilizumab: 10 mg/kg of body weight for patients less than 30 kg and 8 mg/kg for patients more than 30 kg, IV administration every 4 weeks, 16 week cycles compared with
  • adalimumab: 20 mg for patients with body weight between 15 kg to less than 30 kg and 40 mg for patients with body weight 30 kg or more fortnightly as a SC injection, 16 week cycles compared with
  • etanercept: 0.4 mg/kg up to 25 mg sub-cutaneously twice weekly 0.4 mg/kg (up to a maximum of 25 mg) twice weekly, subcutaneously, 16 week cycles.

106. Infliximab was recommended for extension to listing to include the treatment of acute severe ulcerative colitis on a cost-minimisation basis compared with cyclosporin, with cost-offsets for hospitalisation, drug administration and monitoring.  The equi-effective doses are infliximab: 3 infusions at days 0, 14 and 42 of 5 mg/kg and cyclosporin: 7 days intravenously 2 mg/kg followed by 90 days of oral 4 mg/kg.

 

ATC A01 – Stomatological Preparations    Effective Date:  06/11  

There are currently no therapeutic relativities for this group.

ATC A02 – Antacids, Drugs for Treatment of Peptic Ulcer and Flatulence    Effective Date:  04/06  

1.    The listed antacids, both tablets and liquids, have historically been listed at the same price.

2.    The sodium alginate-calcium carbonate-sodium bicarbonate product was accepted for listing as having a small advantage over the plain antacid liquids.

3.    From listing up until the removal of the authority on H2 receptor antagonists, misoprostol was priced the same, or very near to, ranitidine.  From October 1995 it has been reviewed as a stand-alone item.

4.    Omeprazole is recognised by the PBAC as having advantages over the H2-receptor antagonists.

5.    Lansoprazole was listed on the basis of equivalence to omeprazole, 30mg = 20mg.

6.    Pantoprazole was listed on the basis that 40mg is of similar safety and efficacy to 20mg omeprazole and 20mg is of similar safety and efficacy to 10mg omeprazole and 15mg lansoprazole.

7.    Omeprazole magnesium was recommended for listing on the basis of equivalence with omeprazole base.

8.    Rabeprazole sodium was recommended for listing on a cost minimisation basis compared to omeprazole/omeprazole magnesium, 10mg = 10mg and 20mg = 20mg.

9.    Esomeprazole magnesium trihydrate was recommended for listing on the basis that 20mg esomeprazole was equivalent to 20mg omeprazole in terms of effectiveness and safety in the maintenance of healed severe refractory ulcerating oesophagitis and that 40mg was more effective than 20mg omeprazole in healing of severe refractory ulcerating oesophagitis.

10.    In the treatment of gastric ulcer, esomeprazole magnesium trihydrate was recommended on a cost minimisation basis compared with omeprazole.  The equi-effective doses are esomeprazole 20 mg daily for 4 to 8 weeks and omeprazole 20 mg daily for 4 to 8 weeks.

11.    Nexium Hp7® (esomeprazole magnesium, clarithromycin and amoxycillin for seven days) was recommended on a cost minimisation basis compared to Klacid Hp 7® and Losec Hp 7® (omeprazole/omeprazole magnesium, clarithromycin and amoxycillin for seven days).

ATC A03 – Antispasmodic and Anti-Cholinergic Agents and Propulsives    Effective Date:  08/95  

1.    Domperidone and metoclopramide are considered clinically equivalent and until the Minimum Pricing Policy the drugs were priced the same.

ATC A04 – Antiemetics and Antinauseants    Effective Date:  05/13

1.    Tropisetron capsules were accepted for listing with the advice that 5mg tropisetron daily is of similar safety and efficacy to 8mg ondansetron twice daily in the treatment of chemotherapy induced nausea and vomiting.  Ondansetron has a small premium due to its approval for use subsequent to radiotherapy and use in children.

2.    Tropisetron I.V. has been accepted as being equivalent to ondansetron I.V. in the ratio 5mg = 8mg.

3.    Dolasetron was listed on a cost minimisation basis - 100mg dolasetron I.V. = 8mg ondansetron I.V. and 200mg dolasetron orally = 16mg ondansetron.

4.    Ondansetron syrup 4mg/5mL was listed on the basis of equivalence to ondansetron 4mg tablet.

5.    Ondansetron wafers and tablets are considered clinically equivalent.

6.    Granisetron, for use following radiotherapy and chemotherapy, was accepted for listing on the basis that 2 mg is no worse than 16 mg of ondansetron orally and that 3 mg is no worse than 8 mg of ondansetron parenterally.

7.    Palonosetron injection was recommended for listing on a cost-minimisation basis compared with intravenous ondansetron. The PBAC also recommended a small price advantage for palonosetron. The equi-effective doses are palonosetron 250 micrograms and 12 mg intravenous ondansetron.

8.    Aprepitant 165 mg capsule was recommended for listing as a single dose oral regimen on the basis of similar efficacy and safety compared with aprepitant 3-day dose regimen.

ATC A05 – Bile and Liver Therapy    Effective Date:  06/11

There are currently no therapeutic relativities for this group.

ATC A06 - Laxatives    Effective Date:  08/10

1.    Bisacodyl suppositories and Docusate with bisacodyl suppositories have traditionally been the same price.  Docusate with bisacodyl suppositories has been deleted from the Schedule.

2.    Bisalax® (Bisacodyl) micro-enema and Microlax® (both 5mL volume) are used in the treatment of constipation and for evacuation prior to endoscopy.  Since listing they have been considered as alternatives.

3.    Macrogol 3350 sachets of 13.125g of powder plus electrolytes (Movicol®) was recommended for listing on the basis of acceptable cost-effectiveness compared with lactulose 3.34g per 5mL mixture.

4.    Macrogol 3350, powder for solution, 510 g (Osmolax®) was recommended for listing on a cost minimisation basis compared with Movicol®. The equi-effective doses are 17g of macrogol 3350 ((Osmolax®) and one sachet of macrogol 3350, 13.125 g with electrolytes (Movicol®).

ATC A07 – Antidiarrheals, Intestinal Antiinflammatory/Antifective Agents    Effective Date:  02/14

1.    Loperamide capsule 2mg has a similar dosage to diphenoxylate with atropine (2501P) tablet although it is in a pack of 12 rather that 20.  Nevertheless, historically the two items have been priced similarly.

2.    Olsalazine and mesalazine are listed for the same conditions and are seen as alternatives.  The dosage for olsalazine is 8 capsules per day for treatment and 4 for maintenance.  For mesalazine the dose is 6 tablets and 3 tablets respectively.

3.    Sulfasalazine enteric coated tablet 500mg was accepted on listing as deserving a 10% premium over the plain 500mg tablet.

4.    Mesalazine granules were recommended on the basis of same price per mg compared to mesalazine tablet.

5.    Mesalazine enemas 2g and 4g were recommended for listing on the basis of acceptable cost-effectiveness compared with prednisolone sodium phosphate enema 20mg.

6.    Listing of the 1 g in 100 mL mesalazine enema was on the basis of similar safety and efficacy compared to the 2 g in 60 mL mesalazine enema.

7.    Listing of the 1 g mesalazine suppository was on the basis of similar safety and efficacy to hydrocortisone foam at a dose of 356 mg per day.

8.    Mesalazine rectal foam, 1g per applicator, was listed on the basis of same price for two applicators as for each 2 g enema.

9.    Balsalazide sodium was recommended on a cost minimisation basis compared to mesalazine with the dosage relativities of 6.75 g balsalazide = 2.4 g mesalazine in acute treatment and 4.5 g = 1.5 g for maintenance. The ratio of use between acute and maintenance was accepted as 17%:83%.

10.    Mesalazine tablet 1.2 g prolonged release was recommended for listing for the treatment of ulcerative colitis where hypersensitivity to sulfonamides or intolerance to sulfasalazine exists on a cost minimisation basis with Salofalk® and Pentasa® brands of mesalazine at the same price per mg of mesalazine.

11.    Rifaximin was recommended for listing for the prevention of hepatic encephalopathy on a cost-effectiveness basis compared to existing treatments.  Special pricing arrangements apply.

12.    Budesonide foam enema was recommended for listing for the treatment of ulcerative colitis on a cost-minimisation basis with prednisolone enema.  The equi-effective doses are budesonide 2 mg and prednisolone 20 mg.

ATC A09 – Digestives, including Enzymes    Effective Date:  03/01  

1.    Creon® 10,000 units of lipase activity, has been accepted as being equivalent to Cotazyme-S Forte® 10,000 units of lipase activity.

2.    Creon Forte® 25,000 units of lipase activity were listed with a price double that of Creon 10,000 units.

3.    Panzytrat®  brand of pancrelipase was recommended for listing on the basis of cost minimisation compared to Creon Forte®.

ATC A10 – Drugs used in Diabetes    Effective Date:  03/14

1.    Prior to the removal of porcine insulin, all types of insulin from the same animal source (i.e beef, porcine or human) were at the same price.  Due to the use of bovine insulin being low compared to human insulin, prices up to those for human insulin have been granted, despite the fact that the human variety is considered superior.

2.    The cartridge insulins have been accepted as deserving a 15% premium over the vial presentation.

3.    Glibenclamide and Gliclazide are similar drugs and were originally considered as alternatives.  However, following the presentation of detailed clinical and cost-effectiveness data in 2001, gliclazide was demonstrated to cause less hypoglycaemia than glibenclamide and the premium over glibenclamide was accepted as representing acceptable cost-effectiveness.  Glibenclamide and glipizide are similar drugs and on the advice of the PBAC are considered to provide similar safety and efficacy.

4.    Insulin Lispro was accepted for listing on the basis of advantage (taken directly before a meal) over short acting insulin.

5.    The insulin lispro-insulin lispro protamine combination insulin product was listed on the basis that it deserves a premium similar to that for plain insulin lispro compared to regular human insulin.

6.    Insulin aspart was accepted on a cost minimisation basis compared with insulin lispro (unit for unit).

7.    Glimepiride was recommended on a cost minimisation basis compared with sulfonylureas , the equi-effective doses being:

           1mg glimepiride:  80mg gliclazide
           2mg glimepiride:  160mg gliclazide
           3mg glimepiride:  240mg gliclazide
           4mg glimepiride:  320g gliclazide

           Pricing could be compared on an average treatment cost basis.

8.    Gliclazide modified release tablet 30 mg was recommended on a cost minimisation basis compared to gliclazide immediate release tablet 80 mg.

9.    Rosiglitazone maleate (for use in combination with either metformin or a sulphonylurea in type 2 diabetic patients whose blood glucose concentrations are inadequately controlled despite diet, exercise and maximal tolerated doses of metformin or sulfonylureas and in whom combination therapy with metformin plus a sulfonylurea is contraindicated or not tolerated) was recommended for listing on a cost minimisation basis with  8 mg rosiglitazone accepted as being similar in effectiveness and safety to 88 units insulin (including the non-drug cost offsets incurred with the use of insulin).

10.    Pioglitazone hydrochloride was recommended for listing on a cost minimisation basis compared with rosiglitazone maleate with the equi-effective doses being 30 mg pioglitazone daily and 8 mg rosiglitazone daily.   Special pricing arrangements apply to both pioglitazone and rosiglitazone.

11.    The combination products of metformin with glibenclamide, Glucovance®, were listed on the basis of cost minimisation versus the sum of the components.

12.    Metformin extended release tablet 500 mg (Diabex XR®) was listed on a cost minimisation basis compared with the immediate release metformin hydrochloride tablet 500 mg, on a mg per mg basis.

13.    Rosiglitazone maleate with metformin hydrochloride tablet, Avandamet®, was recommended for listing on a cost minimisation basis against the individual components.  The equi-effective doses were rosiglitazone 4 mg plus metformin 500 mg fixed dose combination tablet compared to rosiglitazone 4 mg and metformin 500 mg administered separately.

14.    Insulin detemir was listed on a cost minimisation basis, unit for unit, compared with insulin glargine.   Special pricing arrangements apply to both, insulin detemir and insulin glargine.
   
15.    Insulin glulisine was recommended for listing on a cost minimisation basis compared to insulin lispro with the equi-effective doses being 1 unit of insulin glulisine = 1 unit of insulin lispro.

16.    Sitagliptin (Januvia®) was recommended for listing on a cost-minimisation basis compared to rosiglitazone with the equi-effective doses being sitagliptin 100 mg daily and rosiglitazone 8 mg daily.  Special pricing arrangements apply.

17.    Sitagliptin with metformin was recommended for listing on a cost minimisation basis compared with the individual components.

18.    Gliclazide modified release tablet 60 mg was recommended on a cost-minimisation basis compared with the 30 mg modified release tablet with the equi-effective doses being one 60 mg modified release tablet and two 30 mg modified release tablets.

19.    Vildagliptin (Galvus®) was recommended for listing in combination with metformin or a sulfonylurea on a cost-minimisation basis with sitagliptin. The equi-effective doses in the setting of combination usage with metformin are vildagliptin 50 mg twice daily, sitagliptin 100 mg daily, pioglitazone 30 mg daily, and rosiglitazone 8 mg daily. The equi-effective doses in the combination usage with sulfonylurea are vildagliptin 50 mg once daily, sitagliptin 100 mg daily, pioglitazone 30 mg daily, and rosiglitazone 8 mg daily.

20.    Exenatide (Byetta®) was recommended for listing on the basis of a proportion between rosiglitazone and insulin glargine. The equi-effective doses are exenatide 10 micrograms twice daily equivalent to rosiglitazone 8 mg daily and exenatide 9.07 micrograms twice daily is equivalent to insulin glargine 24.93 IU per day for triple therapy and exenatide 9.35 micrograms twice daily is equivalent to insulin glargine 27.30 IU per day for dual therapy. Special pricing arrangements apply.

21.    Vildagliptin with metformin was recommended on a cost-minimisation basis compared with the corresponding strengths of the constituent components given concomitantly, with a further price reduction to account for the cost of liver function testing.

22.    Saxagliptin 5 mg tablet was recommended for listing on a cost minimization basis with  sitagliptin with the equi-effective doses of saxagliptin 5 mg/day and sitagliptin 100 mg/day.

23.   Linagliptin was recommended for listing on a cost-minimisation basis compared with sitagliptin.  The equi-effective doses are estimated as linagliptin 5 mg daily and sitagliptin 100 mg daily.

24.   Sitagliptin with simvastatin (Juvicor®) was recommended on a cost-minimisation basis compared with the corresponding strengths of sitagliptin and simvastatin given concomitantly.  Also refer to C10 – Lipid Modifying Agents.

25.    Alogliptin was recommended for listing on a cost-minimisation basis compared with sitagliptin.  The equi-effective doses are alogliptin 25 mg daily and sitagliptin 100 mg daily. 

26.    Canagliflozin was recommended for listing in the third line setting on a cost-minimisation basis compared with sitagliptin.  The equi-effective doses are canagliflozin 300 mg daily and sitagliptin 100 mg daily. Special pricing arrangements apply.

27.    Dapagliflozin was recommended for listing in the third line setting on a cost-minimisation basis compared with sitagliptin.  The equi-effective doses are dapagliflozin 10 mg daily and sitagliptin 100 mg daily. Special pricing arrangements apply.

28.      Alogliptin with metformin was recommended for listing on a cost-minimisation basis compared to the individual components given concomitantly. 

29.    Linagliptin with metformin was recommended for listing on a cost minimisation basis compared with the individual components.  

30.     Saxaglitptin with metformin was recommended for listing on a cost minimisation basis compared with the individual components.

ATC A11 – Vitamins    Effective Date:  06/11

There are currently no therapeutic relativities for this group.

ATC A12 – Mineral Supplements Diabetes    Effective Date:  08/95  

1.    For pricing purposes potassium chloride preparations are considered equivalent.

ATC A14 – Anabolic Agents for Systemic Use    Effective Date:  06/11

There are currently no therapeutic relativities for this group.

ATC B01 – Antithrombotic Agents    Effective Date:  09/13

1.    The Clinical data indicate a dosage relativity between enoxaparin and dalteparin of between 1mg:100 units and 1mg:125 units.

2.    Clopidogrel was listed on the basis of cost minimisation compared to dipyridamole plus aspirin in stroke and of acceptable cost-effectiveness compared to placebo in myocardial infarction.  The final price is based on a weighting of use across indications. Special pricing arrangements apply.

3.    The dipyridamole plus aspirin fixed combination capsule (Asasantin SR®) was listed on the basis that the combination product was of similar safety and efficacy to the individual drugs taken concomitantly.

4.    Tenecteplase was recommended for listing on the basis of cost minimisation versus reteplase, with 44.6mg of tenecteplase (based on the ratio of usage between the 40mg and 50mg strengths) being equivalent to 20 units of reteplase.

5.    Eptifibatide was recommended for listing on a cost minimisation basis that two IV boluses of 180 mcg/kg followed by a continuous infusion at 2.0 mcg/kg/minute for up to 18.3 hours is no worse than abciximab at a dose of one IV bolus of 0.25 mg/kg followed by a continuous infusion at 0.125 mcg/kg/minute for 12 hours.

6.    Bivalirudin was recommended on a cost minimisation basis compared to abciximab and eptifibatide with the equi-effective doses being bivalirudin 0.75mg/kg bolus IV followed by 1.75mg/kg/hr infusion for the duration of the procedure (plus provisional GP IIb/IIIa inhibitor in 7.2% of patients) and heparin 65U/kg bolus followed by further dose if low aPTT and abciximab 0.25mg/kg IV bolus followed by 0.215 mcg/kg/min for 12 hours OR eptifibatide acetate 180mcg/kg IV bolus followed by 2.0mcg/kg/min for 18 hours.

7.    Clopidogrel with aspirin was recommended on a cost- minimisation basis compared with clopidogrel alone.

8.    Rivaroxaban was recommended for listing for the prevention of venous thromboembolism in adult patients undergoing elective total replacement of the hip or knee on the basis of uncertain but overall acceptable cost-effectiveness compared with enoxaparin.  Special pricing arrangements apply.

9.    Prasugrel was recommended for listing on the basis of acceptable cost effectiveness compared with clopidogrel.  Special pricing arrangements apply.

10.    Dabigatran was recommended for listing on a cost minimisation basis compared with enoxaparin.  The equi-effective doses are dabigatran 220 mg is equivalent to enoxaparin 40 mg.

11.    Dalteparin for the management of symptomatic venous thromboembolism in a patient with a solid tumour(s) was recommended on a cost-minimisation basis compared with enoxaparin.  The equi-effective doses were considered to be dalteparin 200 IU/kg daily for 1 month, then 150 IU/kg (max 18,000 IU) daily for 5 months, equivalent to enoxaparin 1.5 mg/kg daily for entire treatment course of 6 months.

12.    Apixaban was recommended for listing on a cost minimisation basis compared with rivaroxaban for the prevention of venous thromboembolism in patients undergoing hip or knee replacement. The equi-effective doses are apixaban 2.5mg twice daily and rivaroxaban 10mg daily.

13.    Ticagrelor for use in acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin, was recommended on the basis of acceptable cost-effectiveness compared with clopidogrel in combination with aspirin.

14.    Rivaroxaban was recommended for acute symptomatic deep vein thrombosis without symptomatic pulmonary embolism, and for the prevention of recurrent venous thromboembolism.  The recommendation was on a cost minimisation basis compared with enoxaparin and warfarin with a cost offset for the additional INR tests associated with warfarin treatment. The equi-effective doses for 6 months treatment are rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg once daily for 6 months being equivalent to enoxaparin 1 mg/kg twice daily for 8.7 days for 34% of patients or enoxaparin 1.5 mg/kg once daily for 8.7 days for 66% of patients, both followed by warfarin 5 mg daily for 6 months. Special pricing arrangements apply.

15.    Rivaroxaban was recommended for listing for acute symptomatic pulmonary embolism and prevention of recurrent venous thromboembolism on a cost minimisation basis with enoxaparin 80 mg twice daily followed by INR adjusted warfarin, at the same treatment cost for enoxaparin twice daily followed by INR adjusted warfarin.

16.    Rivaroxaban was recommended for prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation on a cost-effectiveness basis compared with warfarin. Special pricing arrangements apply.

17.    Apixaban was recommended for listing on a cost minimisation basis compared with  rivaroxaban for the prevention of stroke or systemic embolism in non-valvular atrial fibrillation with the equi-effective dose based on the doses in the trials. Special pricing arrangements apply.

18.    Dabigatran was recommended for listing on a cost minimisation basis compared with rivaroxaban for the prevention of stroke or systemic embolism in non-valvular atrial fibrillation with the equi-effective dose based on the doses in the trials. Special pricing arrangements apply.

ATC B02 – Antihemorrhagics    Effective Date: 05/13

1.   Hydroxocobalamin (as acetate), 1 mg in 1 mL injection, was recommended for listing on a cost-minimisation basis with hydroxocobalamin (as chloride) injection 1 mg, for use in pernicious anaemia and other proven vitamin B12 deficiencies.

ATC B03 – Antianemic Preparations    Effective Date: 09/11

There are currently no therapeutic relativities for this group.

ATC B05 – Blood Substitutes and Perfusion Solutions    Effective Date:  01/10

1.    Succinylated gelatin IV infusion was recommended for listing on a cost minimisation basis compared with polygeline IV infusion.

2.    Hydroxyethyl starch was recommended for listing on a cost-minimisation basis with succinylated gelatin on a bag for bag basis.

ATC B06 – Other Haematological Agents    Effective Date:  10/12

1.    Icatibant was recommended for listing on a cost effectiveness basis compared to placebo as proxy for best supportive care.

ATC C01 – Cardiac Therapy    Effective Date:  12/13 

1.    The transdermal patches of glyceryl trinitrate which release the drug at the same rate are considered equivalent.

2.    Glyceryl trinitrate patches releasing 15mg per 24 hours have been accepted at prices the same as those for the same products releasing 10mg per 24 hours.

3.    Nicorandil was accepted for listing on the basis that 20mg twice daily has similar efficacy to diltiazem 180mg daily.

4.    Ivabradine was recommended for the treatment of symptomatic systolic chronic heart failure (NYHA classes II or III) on a cost-effectiveness basis compared to placebo.

ATC C02 - Antihypertensives    Effective Date:  08/06  

1.    Moxonidine was recommended on a cost minimisation basis compared to clonidine when used as add-on therapy for the treatment of hypertension.  The equi-effective doses are moxonidine 0.380 mg per day and clonidine 0.357 mg per day.

ATC C03 - Diuretics    Effective Date:  08/10 

1.    Hydrochlorothiazide with amiloride 50mg-5mg is more potent than hydrochlorothiazide with triamterene 25mg-50mg (although the latter has enjoyed the premium).

2.    Indapamide was accepted for listing with a considerable premium over the other unrestricted diuretics used for hypertension. The relativity with hydrochlorothiazide was reviewed by the PBAC in March 2001. Although the PBAC found any advantage for indapamide to be marginal, the PBPA decided that the current premium over hydrochlorothiazide could remain (but would not be increased).

3.    The sustained release tablet formulation of indapamide hemihydrate was listed on the basis that it would be the same price as for the 2.5 mg immediate release tablet.

ATC C04 – Peripheral Vasodilators    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC C07 – Beta Blocking Agenda    Effective Date:  05/13 

Note:
The pricing of the beta blocking agents has been based on the times of listing and it is historical, rather than being based on PBAC advice (except for 2. below).

Historically the basis for pricing has been:

1.    Propranolol 40mg and oxprenolol 40mg are considered comparable.

2.    Pindolol 5mg is considered comparable but has a premium over 1.

3.    Atenolol 50mg and metoprolol 50mg are considered comparable but with a premium over 2.

4.    Labetalol 100mg has always had a premium over 3.

5.    Bisoprolol fumarate was recommended on the basis of cost minimisation compared to carvedilol with the equivalent doses being 7.4mg bisoprolol = 37mg carvedilol.

6.    Metoprolol succinate controlled release tablets (Toprol-XL) were recommended on a cost minimisation basis compared to carvedilol (138 mg = 37 mg) and bisoprolol (138 mg = 7.4 mg).

7.    Nebivolol was recommended on a cost minimisation basis compared with carvedilol, bisoprolol and metoprolol. The equi-effective doses are estimated as nebivolol 7.59mg and carvedilol 37mg, and by extension, bisoprolol 7.4mg, metoprolol 138mg.

8.    Atenolol oral solution, 50 mg in 10 mL, was recommended for listing with a price premium over the tablet form.

ATC C08 – Calcium Channel Blockers    Effective Date:  12/13

1.    Since the listing of the nifedipine and diltiazem as single daily dosage formulations, the pricing of nifedipine, felodipine, amlodipine and diltiazem has been compared on an average treatment cost basis.

2.    The sustained release verapamil products were recommended for listing with the advice that they have no therapeutic advantage over the equivalent dose in non-sustained release formulations.  e.g. 240mg sustained release has no advantage over 3 x 80mg plain.

3.    Lercanidipine hydrochloride was recommended for listing on the basis of equivalence to other dihydropyridine calcium channel blockers, with 20 mg lercanidipine providing similar safety and efficacy to 10 mg amlodipine besylate.

4.    Amlodipine besylate with atorvastatin calcium tablet, Caduet®, was recommended on a cost minimisation basis compared with the corresponding strengths of the amlodipine and atorvastatin components.  Also refer to ATC C10 - Lipid Modifying Agents.

5.    Ramipril with felodipine (Triasyn®) was recommended for listing on a cost minimisation basis compared to the corresponding strengths of the ramipril and felodipine components given concomitantly.  Also refer to ATC C09 – Agents Acting on the Renin-Angiotensin System.

6.    Amlodipine maleate was recommended listing on a cost minimisation basis compared with amlodipine besylate at comparable strengths (ie 5 mg of amlodipine base provided as the maleate salt is equivalent to 5mg of amlodipine as the besylate salt) and on the basis of TGA endorsement of data demonstrating bioequivalence of the maleate salt to the currently listed besylate salt.

7.    Trandolapril with verapamil hydrochloride was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of the trandolapril and verapamil hydrochloride sustained release constituents. Also refer to ATC C09 - Agents Acting on the Renin-Angiotensin System

8.    Amlodipine with valsartan was recommended for listing on a cost-minimisation basis compared with its constituent components, amlodipine and valsartan at equivalent doses. Also refer to ATC C09 - Agents Acting on the Renin-Angiotensin System.

9.    Perindopril with amlodipine was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of its constituent components, perindopril (erbumine/arginine) and amlodipine given concomitantly.  Also refer to ATC C09 - Agents Acting on the Renin-Angiotensin System.

10.    Amlodipine with valsartan and hydrochlorothiazide was recommended for listing on a cost-minimisation basis compared with the constituent components at equivalent doses.  Also refer to ATC C09 - Agents Acting on the Renin-Angiotensin System.

11.    Olmesartan with amlodipine was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of the constituent components, amlodipine and olmesartan given concomitantly.  Also refer to ATC C09 - Agents Acting on the Renin-Angiotensin System.

12.    Amlodipine with hydrochlorothiazide and olmesartan was recommended on a cost-minimisation basis compared to the individual components given concomitantly.  Also refer to ATC C09 - Agents Acting on the Renin-Angiotensin System.

ATC C09 – Agents Acting on the Renin-Angiotensin System    Effective Date:  12/13

1.    The listed ACE inhibitors are all considered to be of similar safety and efficacy and are priced on an average-daily-dose comparison. 

2.    The angiotensin II antagonist, irbesartan, was accepted for listing on the basis of similar safety and efficacy in the treatment of hypertension compared to enalapril, with the equivalent doses being 132mg irbesartan to 17mg enalapril.

3.    Candesartan was recommended for listing on the basis of equivalence to irbesartan (8mg = 75mg) and enalapril (8mg = 10mg).

4.    Telmisartan was recommended by the PBAC on the basis of cost minimisation compared to irbesartan (62 mg = 123.9 mg and 96.8 mg = 229.5 mg). Listing as a restricted benefit was accomplished by pricing being based on a comparison with enalapril on a weighted average monthly treatment cost basis.

5.    Eprosartan mesylate was recommended on a cost minimisation basis compared to enalapril maleate.  The equi-effective doses from the trials were 702mg for eprosartan and 20.6mg for enalapril.  Listing was effected on the understanding that pricing would be reviewed on a weighted average monthly treatment cost basis.

6.    Monoplus®, the combination tablets containing fosinopril sodium plus hydrochlorothiazide, was recommended on the basis that the fixed combinations were of similar safety and efficacy to the individual drugs taken concomitantly.

7.    The combination tablets containing irbesartan plus hydrochlorothiazide (Avapro HCT® and Karvezide®), were recommended on the basis that the fixed combinations were of similar safety and efficacy to the individual drugs taken concomitantly.

8.    Coversyl Plus®, the combination tablets containing perindopril erbumine 4mg plus indapamide hemihydrate 1.25mg. was recommended on a cost minimisation basis compared with perindopril erbumine 4mg and indapamide hemihydrate 2.5mg.

9.    The combination tablet containing enalapril maleate 20mg plus hydrochlorothiazide 6mg was recommended on a cost minimisation basis compared with enalapril maleate 20mg and hydrochlorothiazide 12.5mg as individual items.

10.    The combination tablet of candesartan 16mg plus hydrochlorothiazide 12.5mg was recommended for listing on a cost minimisation basis compared to the individual components.

11.    The fixed combination of quinapril hydrochloride plus hydrochlorothiazide was recommended on the basis that the price to pharmacist would be no greater than the sum of the individual components.
 
12.    The combination tablet of eprosartan mesylate 600mg (base) plus hydrochlorothiazide 12.5mg was recommended for listing on a cost minimisation basis compared to the individual components.

13.    The combination of telmisartan plus hydrochlorothiazide was recommended for listing on a cost minimisation basis compared to the individual components.

14.    The ramipril titration pack was accepted for listing with pricing being based on the sum of the cost of the individual components.

15.    Captopril oral solution is restricted to use in patients unable to take solid dose forms of ACE inhibitors. In this setting it was recommended on the basis of acceptable cost-effectiveness and is thus excluded from the WAMTC review of the ACE inhibitors.

16.    Olmesartan was recommended on a cost minimisation basis compared to irbesartan for use in hypertension.

17.    Olmesartan with hydrochlorothiazide was recommended for listing on a cost minimisation basis compared to the corresponding strengths of the hydrochlorothiazide and Olmesartan components given concomitantly. 

18.    Ramipril with felodipine (Triasyn®) was recommended for listing on a cost minimisation basis compared to the corresponding strengths of the ramipril and felodipine components given concomitantly.  Also refer to ATC C08 – Calcium Channel Blockers.

19.    Lercanidipine with enalapril was recommended for listing in accordance with the combination guidelines, on a cost minimisation basis compared with its constituent components, lercanidipine and enalapril, the equi-effective doses being lercanidipine with enalapril 10/10 or 10/20 daily and lercanidipine 10 mg in combination with enalapril 10 mg or 20 mg daily over duration of therapy.

20.    Trandolapril with verapamil hydrochloride was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of the trandolapril and verapamil hydrochloride sustained release constituents. Also refer to ATC C08 – Calcium Channel Blockers.

21.    Valsartan was recommended on a cost-minimisation basis compared with irbesartan and that the equi-effective doses are valsartan 160 mg and irbesartan 150 mg.

22.    Amlodipine with valsartan was recommended for listing on a cost-minimisation basis compared with its constituent components, amlodipine and valsartan at equivalent doses. Also refer to ATC C08 – Calcium Channel Blockers.

23.    Valsartan with hydrochlorothiazide was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of the hydrochlorothiazide and valsartan components given concomitantly.

24.    Perindopril with amlodipine was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of its constituent components, perindopril (erbumine/arginine) and amlodipine given concomitantly.  Also refer to ATC C08 – Calcium Channel Blockers.

25.    Amlodipine with valsartan and hydrochlorothiazide was recommended for listing on a cost-minimisation basis compared with the constituent components at equivalent doses. Also refer to ATC C08 – Calcium Channel Blockers.

26.    Olmesartan with amlodipine was recommended for listing on a cost-minimisation basis compared with the corresponding strengths of the constituent components, amlodipine and olmesartan given concomitantly. Also refer to ATC C08 – Calcium Channel Blockers.

27.    Telmisartan with amlodipine was recommended for listing on a cost minimisation basis compared to the individual components.

28.    Losartan was recommended for listing on a cost-minimisation basis compared with irbesartan.  The equi-effective doses are losartan 100 mg and irbesartan 280 mg.

29.    Amlodipine with hydrochlorothiazide and olmesartan was recommended on a cost-minimisation basis compared to the individual components given concomitantly.  Also refer to C08 – Calcium Channel Blockers.

ATC C10 – Lipid Modifying Agents    Effective Date:  12/13

1.    Cholestyramine sachets and colestipol sachets have historically been priced the same on a per-sachet basis.

2.    The PBAC has agreed to the listing of simvastatin with a 10% premium over cholestyramine at a dosage comparison of 13 mg simvastatin versus 3 sachets of cholestyramine.

3.    Pravastatin sodium has been recommended for listing on the basis of clinical equivalence to simvastatin on a mg to mg basis.  PBAC was agreeable to comparison of the two drugs on an average daily dosage basis.

4.    Fluvastatin sodium was recommended for listing with the advice that pricing be based on the drug's ability to reduce LDL cholesterol compared to simvastatin (approximately 22% for fluvastatin 20mg compared to 30% for simvastatin 10mg and approximately 25% for fluvastatin 40mg compared to 40% for simvastatin 20mg).

5.    Fenofibrate was recommended for listing on a cost minimisation basis compared to gemfibrozil with 160 mg fenofibrate (tablet formulation)  = 1.2 g gemfibrozil. 

6.    Ezetimibe tablet 10 mg, for use in patients unable to take a statin, was recommended for listing on the basis of cost minimisation versus cholestyramine (10 mg daily = 17.2 g daily). For use as add-on therapy to a statin, the drug was recommended on the basis of acceptable cost-effectiveness compared with placebo. The agreed price was based on 50% use for each of the two indications.

7.    Atorvastatin was initially recommended for listing on the basis of cost minimisation, with the equi-effective doses being 10mg atorvastatin = 20mg simvastatin.  Subsequently, the drug was included in the HMG CoA reductase inhibitor therapeutic group and pricing has been reviewed on a weighted average monthly treatment cost basis.  In July 2005, following the presentation of further data, the PBAC advised that:
•    Atorvastatin is more effective than simvastatin in lowering LDL-cholesterol (LDL-C).
•    The relative price differential modelled in the current submission’s cost-effectiveness analysis is acceptable.
•    Any further price change in simvastatin should not result in any increase in this price relativity.
•    The only basis for judging whether the price relativity could be further increased would be an incremental cost-effectiveness analysis based on major cardiovascular events measured directly in randomised trials rather than based on predictions modelled from surrogate outcomes.

In line with the PBAC’s advice in July and November 2005, atorvastatin has been removed from both the statin WAMTC and TGP groups.  However, its pricing remains linked to that of simvastatin.
 
8.    Ezetimibe with simvastatin (Vytorin®) was recommended on a cost minimisation basis compared to the sum of the corresponding strengths of the individual components in patients with coronary heart disease, patients with diabetes mellitus and patients with homozygous familial hypercholesterolemia.  The price for the simvastatin component of the combination tablet will be maintained at the same price as that of simvastatin. 

9.    Rosuvastatin calcium was recommended on a cost minimisation basis compared to atorvastatin, with the ratio of equi-effective doses being rosuvastatin to atorvastatin 1:3.

10.    Amlodipine besylate with atorvastatin calcium tablet, Caduet®, was recommended on a cost minimisation basis compared with the corresponding strengths of the amlodipine and atorvastatin components.  Also refer to ATC C08 – Calcium Channel Blockers.

11.    Sitagliptin with simvastatin (Juvicor®) was recommended on a cost-minimisation basis compared with the corresponding strengths of sitagliptin and simvastatin given concomitantly.  Also refer to A10 – Drugs used in Diabetes.

12.    Atorvastatin and ezetimibe composite pack was recommended for listing on a cost-minimisation basis with the corresponding doses of the components given concomitantly.

ATC D01 – Antifungals for Dermatological Use    Effective Date:  07/08  

1.    Terbinafine cream, for the treatment of a fungal or yeast infection in an Aboriginal or Torres Strait Islander person, was recommended on a cost-minimisation basis with miconazole cream.

ATC D05 - Antipsoriatics    Effective Date:  04/14

1.    Calcipotriol ointment was accepted as being more effective (relative improvement of 12.9%) than betamethasone dipropionate 0.05% (although the incremental cost-effectiveness was high).

2.    Calcipotriol scalp lotion was recommended on a cost minimisation basis against calcipotriol cream, with the equi-effective doses considered to be 1 mL of 0.005% scalp lotion is equivalent to 1 g of 0.005% cream.

3.    Calcipotriol with betamethasone was recommended for listing on a cost-minimisation basis compared with the individual components.

4.    Clobetasol propionate shampoo was recommended for the treatment of moderate to severe scalp psoriasis on a cost-minimisation basis with DBET.  The equi-effective doses are CP shampoo 9.2 g and DBET gel 2.7 g.

ATC D06 – Antibiotics and Chemotherapeutics for Dermatological Use    Effective Date:  12/07  

1.    There are currently no therapeutic relativities for this group.

ATC D07 – Corticosteroids, Dermatological Preparations    Effective Date:  08/11

1.    The weaker strength, 100g packs of the different items are considered clinically equivalent and priced the same.

2.    The higher strength, 15g packs, until recently (see 3), have also always been at the same price.

3.    Based on data presented to the PBAC (1990) it has been accepted that betamethasone dipropionate 0.05% (15g pack) has a modest advantage over the alternative products.

4.    Mometasone applied once daily has been accepted as being of similar safety and efficacy to betamethasone diproprionate applied twice daily. 

5.    Methylprednisolone aceponate 0.1% topical preparations were accepted on the basis of cost minimisation compared to mometasone furoate 0.1% topical preparations.

ATC D10 – Anti-Acne Preparations    Effective Date: 04/12

1.    Adapalene with benzoyl peroxide was recommended on the basis of a cost-effectiveness ratio compared with placebo

ATC D11 – Other Dermatological Preparations    Effective Date:  07/13 

1.    Pimecrolimus was recommended on a cost-effectiveness basis compared to topical corticosteroids (TCS) and vehicle cream in patients with facial or eyelid dermatitis.

2.    Imiquimod was recommended on a cost-effectiveness basis compared to placebo in the treatment of basal cell carcinoma in immunocompetent patients

3.    Imiquimod cream, 2 g multi-use pump, was recommended under the same listing conditions as the currently listed single use sachets.

ATC G02 – Other Gynecologicals    Effective Date:  08/03  

1.    Cabergoline was accepted for listing on the basis of acceptable cost-effectiveness compared to bromocriptine **.

2.    Quinagolide was recommended on a cost minimisation basis compared to cabergoline with the equi-effective doses being 143 mcg quinagolide daily (1.001 mg weekly) = 1.23 mg cabergoline weekly.

    ** Needs to be considered with: Group N04 - ANTI-PARKINSON DRUGS   
          (bromocriptine mesylate).

ATC G03 – Sex Hormones and Modulators of the Genital System    Effective Date:  08/13

1.    Despite different active ingredients, strengths and formulations of combinations, all oral contraceptives have been considered of similar utility and thus equivalent for pricing purposes.

2.    The lower strengths of the oral formulations of oestradiol valerate, oestrogens-conjugated, piperazine oestrone sulphate and oestriol (when it was PBS listed) are considered as alternatives as are the higher strengths of the first three drugs.

3.    Testosterone esters injection 250mg and testosterone enanthate injection 250mg are considered to be approximately equivalent. 

4.    Testosterone implants were listed on the basis that 600mg every four months was similar to 250mg testosterone injection every two weeks.  Testosterone transdermal patch was recommended on a cost minimisation basis compared with testosterone undecanoate capsule.  The equi-effective doses are two patches 12.2mg per day and 6 capsules testosterone undecanoate 40mg per day.

5.    For use in endometriosis, goserelin was accepted as being of similar safety and efficacy compared to danazol 200mg three times daily ***.

6.    Nafarelin nasal spray was accepted for listing with the advice that 400 mcg Nafarelin per day is equivalent to 200mg Danazol three times daily.

7.    Gestrinone was recommended for listing on the basis that 2.5mg twice weekly is of similar safety and efficacy to Danazol 200mg three times daily.
   
8.    Testogel®, testosterone transdermal gel 50 mg per 5 g sachet, was listed on a cost minimisation basis versus testosterone transdermal patch releasing 5 mg per day.

9.    Climara® oestradiol patch applied once weekly has been accepted as being equivalent to Estraderm®,  Dermestril® and Estradot® patches applied twice weekly.

10.    Estraderm MX® oestradiol patches were listed on a cost minimisation basis compared to “plain” Estraderm® oestradiol patches.
 
11.    The recombinant follicle stimulating hormone products, follitropin alfa and follitropin beta, are accepted as being equivalent on a per unit basis.

12.    Oestradiol tablet 2mg was accepted as being equivalent to oestradiol valerate 2mg and conjugated oestrogens 625 microgram.

13.    Sandrena® oestradiol transdermal gel was accepted as equivalent to oestradiol patches releasing 50 micrograms oestradiol every 24 hours at appropriate dosages.

14.    Estalis continuous® and Estalis sequi® were accepted as being equivalent with Estracombi®.  All are patches containing oestradiol and norethisterone acetate.

15.    Etonogestrel subcutaneous implant 68mg was recommended for listing on the basis that the overall cost associated with one implant every three years was similar to medroxyprogesterone acetate injection 150mg every three months plus costs associated with 12 doctor’s visits over 3 years.

16.    Mirena®, levonorgestrel intrauterine drug delivery system releasing approximately 20 micrograms every 24 hours, was initially recommended for contraception on a cost minimisation basis compared to Implanon®, etonogestrel implant 68 mg, noting that Mirena® has an effective life of five years and Implanon® three years. Subsequently, the PBAC accepted that Implanon® is acceptable in a broader setting than for Mirena® and pricing is based on Implanon® for three years being similar to Mirena® for five years.

17.    Reandron 1000®, testosterone undecanoate intramuscular injection was recommended on a cost minimisation basis compared to testosterone implant with the equi-effective doses being testosterone intramuscular injection 1000 mg every 12 weeks and testosterone implant (600 mg) every 4 months.

18.    Levonorgestrel (Mirena®) was recommended for listing for the treatment of menorrhagia on a cost minimisation basis compared to hysterectomy and on the basis of overall savings per patient on average over a five year period, where hysterectomy had not been undertaken during that time period.  Price to pharmacist is based on the weighted price across the two indications (menorrhagia and contraception).

19.    Axiron®, testosterone transdermal solution was recommended on a cost-minimisation basis compared with testosterone gel.  The equi-effective doses are 70 mg testosterone solution and 50 mg testosterone gel.

20.    Levonorgestrel 100 micrograms with ethinyloestradiol 20 micrograms (Femme-Tab ED®) was recommended on a cost-minimisation basis with levonorgestrel 150 micrograms with ethinyloestradiol 30 micrograms.  The equi-effective doses are one tablet of levonorgestrel 100 micrograms with ethinyloestradiol 20 micrograms to one tablet of levonorgestrel 150 micrograms with ethinyloestradiol 30 micrograms.

21.    Mifepristone tablet 200 mg and Misoprostol tablet 200 mcg were recommended for termination of an intra-uterine pregnancy on the basis of non-inferior effectiveness compared to surgical termination of pregnacy.

      ***   Need to compare danazol with goserelin
      (GROUP L02 - ENDOCRINE THERAPY),and nafarelin
      (GROUP H01 - PITUITARY, HYPOTHALAMIC HORMONES AND ANALOGUES.)

ATC G04 - Urologicals    Effective Date:  10/12

1.    For pricing purposes trimethoprim with sulphamethoxazole tablet 160mg - 800mg has generally been compared with amoxycillin 250mg. (Both used as first line antibiotics).

2.    Oxybutynin hydrochloride was listed on the basis that it deserved a small premium over propantheline bromide and on the basis of comparative studies which found 15mg oxybutynin compares to 90mg propantheline. Special pricing arrangements apply.

3.    Oxybutynin transdermal patches was recommended for listing for treatment of detrusor overactivity in a patient who cannot tolerate oral oxybutynin, or who cannot swallow oral oxybutynin on the basis of acceptable cost effectiveness over placebo. Special pricing arrangements apply.

4.    Dutasteride (Avodart®) was recommended for listing on the basis of acceptable cost- effectiveness compared with alfa-antagonist alone. Special pricing arrangements apply.

5.    Dutasteride (0.5mg) with tamsulosin (0.4mg) fixed dose combination (FDC) was recommended for listing on a cost minimisation basis compared with co-administered dutasteride and prazosin. The equi-effective doses are (i) dutasteride 0.5 mg with tamsulosin 0.4 mg FDC and (ii) dutasteride 0.5 mg one daily with prazosin 2 mg twice daily.

ATC H01 – Pitutary, Hypothalamic Hormones and Analogues    Effective Date:  10/12 

1.    Desmopressin acetate nasal spray was accepted for listing with a small premium over the 'rhinyle' formulation.

2.    Nafarelin nasal spray was accepted for listing with the advice that 400 mcg nafarelin per day is equivalent to 200mg danazol three times daily **.

3.    The tablet formulation of desmopressin acetate was recommended for listing on a cost minimisation basis with 12 microgram from the tablet equivalent to 1 microgram from the nasal spray.

4.    Desmopressin wafers for primary nocturnal enuresis was recommended for listing on a cost minimisation basis with desmopressin tablets the equi-effective doses being desmopressin 120 µg sublingual wafer being equivalent to desmopressin 200 µg tablet.       
 

5.    Human menopausal gonadotrophin (hMG) powder for injection was recommended for listing for use in IVF/GIFT on a cost-minimisation basis with follitropin alfa.  The equi-effective doses are hMG 1.01 I.U to follitropin alfa 1.00 I.U.


      ** Needs to be compared to GROUP N04 - ANTI-PARKINSON DRUGS

ATC H02 – Corticosteroids for Systemic Use    Effective Date:  02/98  

1.    The approximate relativities in relation to their anti-inflammatory effects are:

Cortisone 25
Hydrocortisone 20
Prednisolone 5
Prednisone 5
Triamcinolone 4
Methylprednisolone 4
Dexamethasone 0.75
Betamethasone 0.75
Fludrocortisone 0.05


2.    For the oral products this means the approximate relativities are:

increasing strengths --->

Cortisone 5 25
Hydrocortisone 4 20
Prednisolone 1 5 25
Prednisone 1 5 25
Dexamethasone 0.5 4
Fludrocortisone 0.1


3.    Despite the relativities in 1 and 2, cortisone tablets and hydrocortisone tablets have been priced individually on the basis of PBAC advice that they should remain available.

4.    Betamethasone acetate with betamethasone sodium phosphate injection and triamcinolone acetonide injection are listed for similar indications and are taken as alternative.

ATC H03 – Thyroid Therpy    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC H04 – Pancreatic Hormones    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC H05 – Calcium Homeostasis    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC J01 – Antibacterials for Systemic Use    Effective Date:  04/14

1.    Doxycycline and minocycline are similar tetracyclines and when used for acute infection, may be considered clinically equivalent (in appropriate dosages).

2.    In relation to the use of minocycline in acne the PBAC has accepted that it has similar efficacy to other tetracyclines.  However, listing of the 50mg tablet was accepted at a price relative to the 100mg minocycline capsule.

3.    Phenoxymethylpenicillin was the first widely used oral penicillin and was, historically, the cheapest of the penicillins.  However, since October 1995 the pricing has been allowed to increase to the same level as amoxycillin.

4.    Ampicillin has a wider antimicrobial activity than phenoxymethylpenicillin and until the PBPA meeting in October 1995 enjoyed a premium over that drug.  Prior to the minimum pricing policy it was priced under the amoxycillin price (see 5 below).

5.    Amoxycillin is similar in activity to ampicillin but is better absorbed orally and was initially listed with a premium over ampicillin (i.e. until the generic pricing policy and the Minimum Pricing Policy).

6.    Amoxycillin with clavulanic acid was accepted by the PBAC as being a 'significant advance' over amoxycillin and thus has always attracted a 'significant' premium over plain amoxycillin. 

7.    Amoxycillin powder for paediatric drops has been compared relative to amoxycillin powder for syrup 125 mg per 5ml. 

8.    Cephalexin is a first generation cephalosporin.  It has a different spectrum of activity to amoxycillin but, as far as the PBAC is concerned, as used in general clinical practice, it is used in the same way and for pricing purposes should be considered as clinically equivalent to amoxycillin. 

9.    The PBAC has accepted that, in general, cefaclor capsule 750mg daily has similar efficacy to amoxycillin 750mg in combination with clavulanic acid daily.  However, in relation to a specific use, in lower respiratory tract infection, the PBAC has accepted that cefaclor capsule 750mg is approximately clinically equivalent to amoxycillin 1.5g in combination with clavulanic acid daily.

10.    Since listing, ceftriaxone has been accepted as being approximately 3 times the potency of cefotaxime.  This ratio was confirmed by the PBAC in 1991.

11.    Cefotetan was initially accepted for listing by the PBAC with the advice that it had similar clinical use to ceftriaxone (at 2 g cefotetan daily = 1 g ceftriaxone daily). At the PBAC meeting in June 2003, the Committee accepted that ceftriaxone was no longer the appropriate comparator. Cost-effectiveness was accepted based on the prices applying at that time.
 
12.    For pricing purposes trimethoprim with sulphamethoxazole tablet 160mg - 800mg has generally been compared with amoxycillin 250mg.  (Both used as first line antibiotics).

13.    Eryc 250mg has been accepted as being clinically equivalent to erythromycin ethyl succinate 400mg.

14.    Roxithromycin was recommended for listing by the PBAC with the advice that 150mg roxithromycin twice daily offers a small advantage compared to erythromycin 500mg four times daily.

15.    Dicloxacillin was accepted for listing on the basis of cost minimisation (same price) compared to flucloxacillin.

16.    Cefuroxime was listed on the basis of cost minimisation compared to cefaclor with pricing based on 14 x 250 mg tablets being the same as 10 x 375 mg cefaclor.

17.    Clarithromycin tablet 250mg was recommended for listing as an unrestricted benefit on the basis of pack per pack compared to roxithromycin tablet 150mg i.e. five days of roxithromycin (at 150mg twice daily) = seven days of clarithromycin (at 250mg twice daily).  The actual price is based on a weighting between use as an unrestricted benefit and use for the treatment of MAC (Section 100).

18.    Cefepime was initially listed on the basis that it deserved a small premium over ceftriaxone (at 4 g cefepime daily = 2 g ceftriaxone daily).  At the PBAC meeting in June 2003, the Committee accepted that ceftriaxone was no longer the appropriate comparator. Cost-effectiveness was accepted based on the prices applying at that time.

19.    Amoxycillin tablet 1g was recommended for listing on the basis that 1g twice daily provides similar safety and efficacy to 500mg three times daily

20.    Moxifloxacin (available only on the RPBS) was recommended for listing on the basis of cost minimisation compared to IV ceftriaxone plus IV erythromycin plus oral roxithromycin where 20% of therapy was administered in an ICU setting and 80% in a hospital ward setting.

21.    Tobramycin solution for inhalation was recommended for listing on the basis of an acceptable cost effectiveness compared with placebo. Special pricing arrangements apply.

22.    Cefuroxime granules for oral suspension was recommended on the basis of clinical need for the paediatric population and acceptable cost-effectiveness.

23.    Tobramycin powder for inhalation was recommended for listing for the treatment of Pseudomonas aeruginosa infection in a patient aged 6 years or older with cystic fibrosis, with a price premium over tobramycin solution for inhalation.

ATC J02 – Antimycotics for Systemic Use    Effective Date:  09/11  

1.    Itraconazole has been accepted as being as effective, safer and less expensive than amphotericin B injection in the treatment of aspergillosis, sporotrichosis and histoplasmosis.

2.    In the treatment of candidiasis, itraconazole has been accepted as being of similar safety and efficacy to fluconazole 200mg and less costly (200mg itraconazole daily versus fluconazole 200mg daily).

3.    Voriconazole was recommended on a cost-effectiveness basis compared to oral itraconazole.

4.    Posaconazole was recommended on a cost-effectiveness basis compared to a suite of salvage therapies.

5.    Fluconazole powder for oral suspension was recommended for listing with a price premium over the solid dose form of fluconazole.

ATC J04 – Antimycobacterials    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC J05 – Antivirals for Systemic Use    Effective Date:  05/08  

1.    Famciclovir, for use in herpes zoster, was accepted for listing on the basis that famciclovir 250mg three times daily is of similar safety and efficacy to aciclovir 800mg five times daily.

2.    Famciclovir 125 mg for use in the intermittent treatment of genital herpes was accepted as being equivalent to aciclovir with the relative dosages being 125 mg twice daily and 200mg five times daily (both for five days). 

3.    For suppressive treatment of recurrent genital herpes (as opposed to intermittent therapy), famciclovir 250mg twice daily was accepted as being similar to aciclovir 200mg three times daily.  With this listing the pricing of famciclovir has been based on weighted pricing across the different indications.

4.    Valaciclovir, (for herpes zoster), was accepted for listing with the advice that the incremental cost-effectiveness compared to aciclovir was acceptable.

5.    In the treatment of genital herpes, valaciclovir was accepted on the basis of equivalence to aciclovir: 500mg twice daily = 200mg five times daily for initial episodes and intermittent treatment of recurrent episodes; 500 mg daily = 200 mg three times daily for the prevention of recurrent attacks in immunocompetent patients with less than ten attacks per year; and 1 g daily = 200 mg three times daily in immunocompetent patients with more than ten attacks per year and immunocompromised patients.  Pricing is based on use in all genital herpes indications and in herpes zoster.

6.    Famciclovir was recommended for listing on a cost minimisation basis compared to aciclovir for the suppressive therapy of moderate to severe recurrent oral or labial herpes in patients with HIV infection or other opportunistic infections or AIDS defining tumours.  The equi-effective doses famciclovir 500 mg twice daily and aciclovir 800 mg four times daily.

7.    The PBAC recommended an increase in tablet strength from 125 mg to 250 mg for famciclovir tablet and a decrease in the maximum quantity from 40 to 20, in line with the recent change to the dosage for the episodic treatment of genital herpes approved by the TGA, which replaces the current 5-day dosage regimen with a 2-day regimen.

ATC J07 – Vaccines    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC L01 – Antineoplastic Agents    Effective Date:  03/14

1.    Cladribine was recommended for listing on the understanding that it is both more effective and of better cost-effectiveness than interferon alfa.

2.    Idarubicin capsules were listed with prices based on the comparison 10mg I.V. equals 25mg orally (capsules are 40% bioavailable).

3.    For use in breast cancer, docetaxel was accepted on a cost minimisation basis compared to paclitaxel, 75 mg per m2 docetaxel compared to 175 mg per m2 paclitaxel.  For advanced metastatic ovarian cancer, the cost minimisation dosage relativity accepted was 100mg per m2 compares to 175mg per m2 paclitaxel.  For use in non-small cell lung cancer the drug was accepted by the PBAC as being no worse than cisplatin plus vindesine.  In this indication pricing was based on the drug and administration costs for other drugs which had previously been accepted as being similar to cisplatin plus vindesine, namely gemcitabine and vinorelbine.  The final price is based on the weighted use across indications.  Special pricing arrangements apply to docetaxel.

4.    Etoposide phosphate injection 113.6mg was accepted on the basis of equivalence to etoposide base 100mg.

5.    Vinorelbine was accepted on the basis of similar safety and efficacy compared to paclitaxel in advanced breast cancer and to gemcitabine in locally advanced or metastatic non-small cell lung.

6.    For use in the treatment of non-small cell lung cancer, paclitaxel was accepted on a cost minimisation basis compared to gemcitabine and docetaxel.

7.    Irinotecan, for use in colorectal cancer after failure of fluorouracil-based therapy, was listed on the basis that it provided a significant improvement in efficacy compared to best supportive care and fluorouracil-based therapy, and for first line use in colorectal cancer, listing was recommended on a cost minimisation basis compared to oxaliplatin

8.    For use in colorectal cancer after failure of fluorouracil-based therapy, oxaliplatin was listed on a cost minimisation basis compared to irinotecan.  Its listing as first line therapy for colorectal cancer in combination with fluorouracil was recommended on the basis of acceptable cost-effectiveness compared to fluorouracil alone.  Its listing as adjuvant therapy for stage 3 (Dukes C) colon cancer, in combination with fluorouracil and folinic acid, was recommended on the basis of acceptable cost-effectiveness compared with fluorouracil/folinic acid based therapy.

9.    Pegylated liposomal doxorubicin hydrochloride (Caelyx®) was initially listed, for use in AIDS-related Kaposi’s sarcoma, on the basis of acceptable cost-effectiveness (applying the ‘rule of rescue’). For use in the treatment of ovarian cancer, the drug was recommended on a cost minimisation basis compared to topotecan; and for use as monotherapy in breast cancer it was recommended on a cost minimisation basis (drug plus administration costs) versus vinorelbine.

10.    Pemetrexed for non-small cell lung cancer was recommended for listing on the basis of cost minimisation compared to docetaxel. The costs accepted were those due to the drug, pre-medication and drug administration.

11.    Cladribine (Litak®) was recommended for listing on the basis of cost minimisation compared to the currently listed cladribine product (Leustatin®).

12.    Gemcitabine (Gemzar®) was recommended for listing on the basis of acceptable cost-effectiveness for non-small cell lung cancer, pancreatic cancer and bladder cancer. However, in relation to the extension to include treatment of advanced breast cancer, this was on the basis of cost minimisation of gemcitabine + paclitaxel versus capecitabine + docetaxel.  In epithelial ovarian cancer, gemcitabine when used in combination with carboplatin was recommended on a cost minimisation basis versus paclitaxel in combination with carboplatin.  The equi-effective doses are gemcitabine 1.6 g on Days 1 and 8 plus carboplatin 400 mg on Day 1 for six 21-day cycles versus paclitaxel 280 mg on Day 1 plus carboplatin 500 mg on Day 1 for six 21-day cycles.

13.    Carmustine implants were recommended for listing on a cost minimisation basis with one pack of eight carmustine 7.7 mg implants being equivalent to a course of temozolomide capsules.  The temozolomide costs were based on a weighted average dose and included the costs of tests and prophylactic medicines associated with the use of temozolomide.

14.    Capecitabine for adjuvant treatment in Stage III colon cancer was recommended on a cost minimisation basis compared to 5-fluorouracil plus leucovorin in terms of disease free survival.  The price calculations included the cost off-sets which had previously been accepted by the PBAC, in particular the costs of specialist visits for each episode of intravenous administration of 5-fluorouracil/leucovorin which were most substantial.

15.    Vinorelbine tartrate capsules were recommended for listing on a cost minimisation basis versus intravenously administered vinorelbine.  The equi-effective doses are one 3-week cycle at 60mg/m2 and two 3-week cycles at 80mg/m2 for oral vinorelbine and three 3-week cycles at 30mg/m2 for intravenous vinorelbine.     

16.    Dasatinib was recommended for listing on a cost-effectiveness basis compared to imatinib.  The price of dasatinib should be calculated such that 140 mg of dasatinib is no greater than the price for 670 mg of imatinib.  Special pricing arrangements apply.

17.    Imatinib (Glivec®) was recommended for listing on a cost-effectiveness basis in the treatment of chronic myeloid leukaemia and in the treatment of acute lymphoblastic leukaemia (ALL).  Special pricing arrangements apply.

18.    Bortezomib was recommended for listing on a cost-effectiveness basis compared to salvage treatments in the treatment of multiple myeloma.   Special pricing arrangements apply.

19.    Docetaxel was recommended on an acceptable incremental cost-effectiveness basis in the treatment of prostate carcinoma.  Special pricing arrangements apply.

20.    Nilotinib was recommended for listing for the treatment of chronic and accelerated phase Philadelphia positive chronic myeloid leukaemia in patients who have failed imatinib on a cost-minimisation basis compared with dasatinib.  The equi-effective doses are nilotinib 792.1 mg equivalent to 111 mg dasatinib.

21.    Fludarabine was recommended for listing for the treatment of B-cell chronic lymphocytic leukaemia on a cost-effectiveness basis against the main comparator, chlorambucil.  Special pricing arrangements apply.

22.    Nab-paclitaxel was recommended for listing for metastatic breast cancer after failure of prior therapy which includes an anthracycline on a cost-minimisation per mg basis to ensure no wastage. The equi-effective doses are 260 mg/m2 of nab-paclitaxel and 175 mg m2 of paclitaxel.

23.    Dasatinib tablet 100 mg was recommended as an addition to the currently listed 20 mg, 50 mg and 70 mg strengths on the basis of price parity with 2 x 50 mg tablets.  The availability of the 100 mg tablet is expected to reduce the pill burden (1 x 100 mg instead of 2 x 50 mg).

24.    Cetuximab was recommended for listing on a cost-effectiveness basis compared with best supportive care.

25.   Imatinib was recommended for listing for adjuvant treatment following complete resection of Primary GatroIntestinal Stromal Tumour (GIST) on the basis of an acceptable cost-effectiveness ratio compared with placebo.

26.   Dasatinib and nilotinib were recommended for lisitng for the first-line treatment of chronic phase Philadelphia positive chronic myeloid leukaemia on a cost-minimisation basis compared with imatinib 400 mg.  The equi-effective doses are estimated to be dasatinib 93.88 mg and imatinib 395.77 mg; nilotinib 553.9 mg and imatinib 423 mg.

27.   Pazopanib was recommended for listing for the treatment of renal cell carcinoma on a cost-minimisation basis compared with sunitinib with PBAC noting that some considerations previously relevant to sunitinib do not apply to pazopanib.  The equi-effective doses are 1 mg sunitinib to 24 mg pazopanib.  Special pricing arrangements apply.

28.     Cabazitaxel was recommended for listing for the treatment of metastatic carcinoma of the prostate on a cost-effectiveness basis compared to mitozantrone.

29.     Ipilimumab was recommended for the treatment of unresectable Stage III or Stage IV malignant melanoma on a cost-effectiveness basis compared to best supportive care. Special pricing arrangements apply.

30.        Sunitinib was recommended for an extension for listing to include the initial and continuing treatment of metastatic, unresectable, well-differentiated malignant pancreatic neuroendocrine tumour on a cost-effectiveness basis compared to best supportive care.  Special pricing arrangements apply.

31.        Everolimus was recommended for the treatment of visceral manifestations of tuberous sclerosis complex on a cost-effectiveness basis compared to best supportive care.  Special pricing arrangements apply.

32.        Dabrafenib was recommended for the treatment of patients with BRAF V600 mutation positive advanced (unresectable stage III) or metastatic (stage IV) melanoma on a cost-effectiveness basis compared to existing treatments.  Special pricing arrangements apply.

33.        Imatinib was recommended for an increase in the maximum duration of adjuvant treatment of primary gastrointestinal stromal tumour (GIST) from 1 year to 3 years, on a cost-effectiveness basis compared to imatinib treatment for 1 year.

34.     Erlotinib was recommended for listing to include initial and continuing first-line treatment, as monotherapy, of locally advanced (stage IIIB) or metastatic (stage IV) non-squamous or not otherwise specified (NOS) non-small cell lung cancer in patients with evidence of activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material, who do not have progressive disease.  The recommendation was done on a cost-effectiveness basis compared with platinum-based doublet chemotherapy.  .

35.    Gefitinib was recommended for listing, as monotherapy, for the treatment of locally advanced (stage IIIB) or metastatic (stage IV) non-squamous or not otherwise specified (NOS) non-small cell lung cancer in patients with evidence of activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material, who do not have progressive disease.  The recommendation was done on a cost minimisation basis compared with erlotinib, with equi-effective doses of gefitinib 250 mg daily and erlotinib 150 mg daily.

36.     Pazopanib was recommended for an extension for listing to include the initial and continuing treatment of advanced (unresectable and/or metastatic) soft tissue sarcoma.  The recommendation was done on a cost-effectiveness basis when compared to a mixed comparator of 50% best supportive care and 50% Ifosfamide/MESNA.  Special pricing arrangements apply.

37.    Panitumumab was recommended for listing for the treatment of K-RAS wild-type metastatic colorectal cancer on a cost-minimisation basis with cetuximab.  The equi-effective doses are panitumumab 6 mg/kg every two weeks and cetuximab 250 mg/m2 weekly, following an initial loading dose of 400 mg/m2.  Special pricing arrangements apply. 

ATC L02 – Endocrine Therapy    Effective Date:  08/13

1.    For use in endometriosis, goserelin was accepted as being of similar safety and efficacy compared to danazol 200mg three times daily **.

       ** Compare danazol with goserelin (GROUP G03 - SEX HORMONES AND
                    MODULATORS OF THE GENITAL SYSTEM)

2.    Bicalutamide 50mg daily was accepted on a cost minimisation basis compared to flutamide 250mg three times daily.

3.    Nilutamide was accepted on the basis of a cost minimisation analysis, 150mg nilutamide daily compared to flutamide 250mg three times daily.

4.    When used in the treatment of prostate cancer, goserelin and leuprorelin are seen as equivalent eg. 10.8mg goserelin = 22.5mg leuprorelin (each provides 3 months' therapy).

5.    Toremifene citrate was accepted for listing on the basis that toremifene 60mg daily is no worse than tamoxifen 20mg or 40mg daily.

6.    Letrozole 2.5mg daily, for use where the drug will compete with tamoxifen (advanced breast cancer in post-menopausal women) was recommended on the basis of acceptable cost-effectiveness compared with tamoxifen.  In the adjuvant treatment of early breast cancer, letrozole 2.5 mg was recommended on a cost minimisation basis.  The equi-effective doses are letrozole 2.5 mg and anastrozole 1 mg. 

7.    Anastrozole, for the treatment of advanced breast cancer in post-menopausal women, was recommended on a cost minimisation basis compared to letrozole with the equi-effectives doses being 1 mg anastrozole daily = letrozole 2.5 mg daily.  In July 2005, anastrozole was recommended for the treatment of early breast cancer in post-menopausal women on the basis of acceptable cost-effectiveness compared with tamoxifen; this means that anastrozole is now approved for use in all hormone dependent breast cancer in post menopausal women.

8.    In the treatment of advanced breast cancer, exemestane tablet 25mg was recommended for listing on the basis of similar safety and efficacy to 1mg anastrozole and 2.5mg letrozole.  In the adjuvant treatment of early breast cancer, exemestane 25 mg was recommended on a cost-effectiveness basis compared to tamoxifen.  However, the PBAC advised the PBPA that the pricing of the aromatase inhibitors should remain linked overall.

9.    Eligard® brand of leuprorelin acetate suspension for subcutaneous injection was listed on the basis of cost minimisation compared to Lucrin® brand of leuprorelin acetate implant.

10.    Goserelin acetate with Bicalutamide (ZoloCos CP®) was recommended for listing on a cost minimisation basis compared with the corresponding strengths of the constituents.

11.    Triptorelin 6-month sustained release (Diphereline ®) was recommended for listing on a cost-minimisation basis with leuprorelin acetate (Eligard 6 month®).

12.   Degarelix powder for injection (Firmagon®) was recommended for listing on a cost-minimisation basis compared with leuprorelin acetate 7.5 mg powder for I.M. injection. The equi-effective doses are for maintenance therapy (Days 28 onwards) degarelix 80mg monthly and leuprorelin 7.5mg monthly, and for initiation therapy (Days 0 to 28) degarelix 240mg and leuprorelin 7.5mg, in combination with bicalutamide (50mg) daily for 11% patients.

13.  Abiraterone 250 mg was recommended for listing on a cost-minimisation basis compared with cabazitaxel and a cost-effectiveness basis when compared with best supportive care. 

ATC L03 – Immunomodulating Agents    Effective Date:  05/11  

1.    Interferon alfa-2a and interferon alfa-2b have been accepted as being equivalent on a unit to unit basis.

2.    Interferon beta-1a was presented on a cost minimisation basis compared to interferon beta-1b with the PBAC accepting that the drugs are of similar efficacy but that beta-1a causes less injection site reactions and flu-like symptoms.

3.    Glatiramer was accepted for listing on a basis of cost minimisation compared to interferon beta-1a and interferon beta-1b.

4.    Rebif® brand of interferon beta-1a was recommended on a cost minimisation basis compared to Avonex® and Betaferon®.

ATC L04 – Immunosuppressive Agents    Effective Date:  12/13

1.    Adalimumab (Humira®) for use in rheumatoid arthritis was recommended for listing on the cost minimisation basis versus etanercept (Enbrel®) with the equi-effective doses being 40 mg adalimumab every second week = 25 mg etanercept twice weekly.  Special pricing arrangements apply to both adalimumab and etanercept for rheumatoid arthritis.  For etanercept, also refer to Section 100 Items.

2.    Etanercept (Enbrel®) for use in the treatment of ankylosing spondylitis was recommended on a cost minimisation basis versus infliximab. Also refer to Section 100 Items.

3.    Adalimumab (Humira®) for use in the treatment of severe acute psoriatic arthritis and ankylosing spondylitis was recommended on a cost minimisation basis versus etanercept.  The equi-effective doses are adalimumab 40 mg every second week compared with etanercept 25 mg twice per week. For etanercept, also refer to Section 100 Items.

4.    Tacrolimus has been listed on the basis of acceptable cost- effectiveness compared to cyclosporin.  For use in kidney transplant recipients, a lower price was negotiated than had originally been agreed for use in liver transplant recipients.  The actual listed price is a weighted price across the two uses.  Also refer to Section 100 items.

5.    Sirolimus was recommended for listing on the basis that it is no worse than tacrolimus in respect to effectiveness and toxicity.  The (non-head-to-head) clinical data suggested average daily doses of approximately 6.4 mg for sirolimus and 12.8 mg for tacrolimus.  Also refer to Section 100 items.

6.    Everolimus was recommended on a cost minimisation basis compared to sirolimus (kidney) and mycophenolate mofetil (heart) with equi-effective doses of everolimus 2.15 mg per day = sirolimus 6.4 mg per day and everolimus 1.3 mg per day = mycophenolate mofetil 2.72 g per day.  The dose and cost of concomitant immunosuppressive agents were taken into account in the analysis.  Also refer to Section 100 items.

7.    Cyclosporin (Neoral®) 10 mg capsule and 100 mg/mL oral solution was recommended to be priced independently of other strengths and formulations of cyclosporin, on the basis that the presentations are marketed as service items for a small group of patients for whom there is a clinical need for fine dose titration of cyclosporin.  Also refer to Section 100 items.

8.    Etanercept was recommended on a cost-effective basis compared to placebo for treatment of severe active rheumatoid arthritis and severe active psoriatic arthritis.  Special pricing arrangements apply.  Also refer to Section 100 items.

9.     Etanercept was recommended on a cost-minimisation basis compared to infliximab for active ankylosing spondylitis.  For the purposes of pricing the TGA-recommended dosage regimen, namely etanercept 25 mg given twice weekly is considered as being equivalent to infliximab 5 mg/kg initially, then at two and six weeks, and six weekly thereafter. Also refer to Section 100 items.

10.    Adalimumab was recommended for extension to listing to include severe chronic plaque psoriasis on a cost minimisation basis with entanercept at TGA recommended steady state continuous doses (ie adalimumab 40 mg fortnightly and etanercept 50 mg weekly are equi-effective).  Special pricing arrangements apply.

11.    Etanercept was recommended to allow for continuous treatment in the management of chronic plaque psoriasis on the basis of cost-minimisation with efalizumab continuous treatment. The equi-effective doses are etanercept 50 mg/week and efalizumab 1 mg/kg/week during both initial and maintenance treatment periods.

12.    Ustekinumab was recommended for the treatment of severe chronic plaque psoriasis on the basis of acceptable cost-effectiveness compared with etanercept. Special pricing arrangements apply.

13.    Certolizumab (Cimzia®) was recommended for listing on a cost minimisation basis with adalimumab on drug costs alone. The equi-effective doses are certolizumab 400 mg at weeks 0, 2, 4 followed by 200 mg every 2 weeks or 400 mg every 4 weeks and adalimumab 40 mg administered every 2 weeks. Special pricing arrangements apply.

14.    Golimumab (Simponi®) was recommended for the treatment of adult patients with active ankylosing spondylitis on a cost minimisation basis with etanercept. The equi-effective doses are golimumab 50 mg every 4 weeks and etanercept 50 mg weekly.

15.    Golimumab (Simponi®) was recommended for the treatment of adult patients with severe active psoriatic arthritis on a cost minimisation basis with adalimumab and etanercept. The equi-effective doses are golimumab 50 mg every 4 weeks, adalimumab 40 mg every 2 weeks and 50 mg etanercept weekly.

16.    Golimumab (Simponi®) was recommended for listing in combination with methotrexate for the treatment of adult patients with severe active rheumatoid arthritis on a cost minimisation basis with adalimumab and etanercept. The equi-effective doses are golimumab 50 mg every 4 weeks, adalimumab 40 mg every 2 weeks and 50 mg etanercept weekly. Special pricing arrangements apply.

17.    Adalimumab (Humira®) was recommended for listing for severe active polyarticular course juvenile idiopathic arthritis on a cost-minimisation basis compared to etanercept. The equi-effective doses are adalimumab: 15 kg to <30 kg 20 mg and ≥ 30 kg 40 mg SC every other week  compared with etanercept: 0.4 mg/kg up to 25 mg SC twice weekly. Also refer to Section 100.

18.    Tacrolimus (Prograf XL ®) prolonged release capsules was recommended for listing for patients with organ or tissue transplants on a cost-minimisation basis with immediate release tacrolimus (Prograf ®) on a mg:mg basis at the same price per mg.  Also refer to Section 100.

19.    Adalimumab was recommended for use in complex, refractory fistulising Crohn disease on a cost-minimisation basis with infliximab, at the same price as the current listing for adalimumab for severe refractory Crohn disease.  Special pricing arrangements apply.  

20.    Fingolimod was recommended for listing on the basis of cost-effectiveness compared with interferon beta-la. Special pricing arrangements apply.

21.    A subcutaneous presentation of abatacept was recommended for listing for the treatment of severe, active rheumatoid arthritis in adults on a cost-minimisation basis to etanercept 50 mg weekly, with the price taking into account the intravenous (IV) loading dose of abatacept. The equi-effective doses are abatacept 125 mg in 1 mL subcutaneously weekly plus, for patients not previously treated with IV abatacept, a weight based IV loading dose given on day one, and etanercept 50 mg subcutaneously weekly. Special pricing arrangements apply.

22.  Mycophenolate was recommended for extension to listing to include the treatment of  biopsy-proven WHO Class III, IV or V lupus nephritis on a cost–minimisation basis to IV cyclophosphamide in the induction phase and on a cost-minimisation basis to azathioprine in the maintenance phase.

23.    Teriflunomide was recommended for the initial and continuing treatment of relapsing-remittting multiple sclerosis in ambulatory patients on a cost-minimisation basis to interferon β-1a and interferon β-1b.  The equi-effective doses are teriflunomide 14 mg once daily to Rebif® 42.09 mcg three times weekly to Avonex® 30 mcg once weekly to Betaferon® 8 million IU every second day.  Special pricing arrangements apply.

ATC M01 – Antiinflammatory and Antirheumatic Products    Effective Date:  09/07  

1.    Ibupropen and indomethacin are the older non-steroidal anti-inflammatory drugs and have traditionally been compared on an average daily treatment cost basis.

    Diclofenac, naproxen, ketoprofen, diflunisal, sulindac, piroxicam and tenoxicam had been considered comparable on an average daily treatment cost basis but with a premium over 1.

    However, in 1989, the PBAC advised that all of these (plus tiaprofenic acid) drugs can generally be considered to be of equal safety and efficacy notwithstanding individual preferences by some patients.  All of the drugs in this group are thus compared on the weighted average daily treatment costs.

The PBAC's advice was confirmed in 1991.

2.    Dispersible piroxicam tablets were listed on the basis of no advantage compared to piroxicam capsules.

3.    Diclofenac potassium was accepted as equivalent to diclofenac sodium.

4.    Naproxen sodium 550mg was listed on the basis that it had no advantage over naproxen 500mg plain tablet.

5.    Leflunomide was recommended for listing on the basis that it would mainly replace IM gold injections and cyclosporin. This turned out not to be the case and continued listing (and assumed cost-effectiveness) was achieved through a series of price reductions to realise a total price reduction of approximately 34% compared to the initial listing prices.

6.    Celecoxib and meloxicam (and rofecoxib which was withdrawn from the market in late 2004) were initially listed on the basis that the drugs were of similar safety and efficacy but that they caused less gastrointestinal adverse effects compared to the older conventional NSAIDs.  Following a review (completed in 2004) of the most recent clinical data, the PBAC decided that the advantages compared to the conventional NSAIDS were less than first determined and that the health benefits from the two drugs were different, with celecoxib having advantages over meloxicam.  Consequently, since 2004, the drugs have been priced on an individual basis.

ATC M03 – Muscle Relaxants    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC M04 – Antigout Preparations    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC M05 – Drugs for Treatment of Bone Diseases    Effective Date:  04/14

1.    For use in the management of osteoporosis, Didrocal® (one pack provides three months therapy) was accepted as being equivalent to calcitriol capsule 0.25 micrograms twice daily.

2.    For use in the management of osteoporosis, alendronic acid was accepted for listing on the basis of acceptable cost-effectiveness compared to calcitriol (at doses of 10mg alendronic acid daily and calcitriol 0.25 micrograms twice daily).

3.    For use in the management of osteoporosis, raloxifene was recommended by the PBAC on the basis of cost minimisation compared to alendronic acid. The Pricing Authority accepted that a small premium over alendronic acid was warranted based on the reduced incidence of breast cancer.

4.    For use in osteoporosis, risedronic acid was recommended for listing on the basis that 5mg daily is similar to alendronic acid 10mg daily. Special pricing arrangements apply.

5.    In use associated with multiple myeloma and bone metastases from breast cancer, sodium clodronate tetrahydrate 1.6g orally daily was accepted as being no worse in terms of effectiveness and safety than 90mg disodium pamidronate by IV infusion monthly. See also relativity 20 of sheet Section 100 (relativity between the drugs in hypercalcaemia of malignancy).

6.    Risedronic acid tablet 35mg taken once weekly was recommended on the basis of cost minimisation compared to risedronic acid 5mg tablet once daily.

7.    In relation to the bisphosphonates used for Paget disease, from the relativities initially advised by PBAC, the Pricing Authority initially accepted that a 60 mg infusion of pamidronate = six months’ of alendronic acid = three months’ of tiludronate = two months’ of risedronic acid. Following further advice, partly based on usage data, the Authority has now accepted that a 60 mg infusion of pamidronate = three months’ of alendronic acid = 1.5 months of tiludronate = 1.5 months’ of risedronic acid. For pricing purposes, the Authority has decided to compare the three oral drugs in accordance with this ratio and to review the pricing of pamidronate separately.

8.    The combination pack of Actonel Combi® containing 4 tablets of risedronic acid 35 mg and 24 tablets of calcium carbonate 1.25 gm was recommended for listing on a cost minimisation basis compared to the risedronic acid 35 mg once weekly preparation, on a mg per mg basis.

9.    Alendronic acid with colecalciferol tablet equivalent to 70 mg alendronic acid with 70 micrograms colecalciferol (Fosamax Plus®) was recommended on a cost minimisation basis on a mg per mg basis of the alendronic acid component.
 
10.    Risedronic acid and risedronic acid acetate was recommended on a cost minimisation basis compared to alendronic acid for the primary treatment of osteoporosis.  The equi-effective doses are risedronic acid 35 mg weekly = alendronic acid 70 mg weekly.

11.    Strontium was recommended for listing as the sole PBS-subsidised antiresorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density (BMD) T-score of -3.0 or less on a cost minimisation basis compared to alendronic acid.  Strontium ranelate 2 g daily is equivalent to alendronic acid 70 mg weekly. 

12.    Risedronic acid, calcium carbonate and cholecalciferol (vitamin D3), which treats established osteoporosis in patients who have an inadequate intake of calcium and who have low vitamin D levels, was recommended on a cost minimisation basis compared with risedronic acid and the combination product containing risedronic acid and calcium carbonate.

13.    Alendronic acid with colecalciferol tablet equivalent to 70 mg alendronic acid with 140 micrograms colecalciferol (Fosamax Plus® 70 mg/140 mcg) was recommended on a cost minimisation basis on a mg per mg basis of the alendronic acid component. 

14.    Ibandronic acid tablets was recommended for listing on a cost minimisation basis compared with oral clodronate, the equi-effective doses are ibandronic acid 50 mg daily and clodronate 1600 mg daily, both for long term administration.

15.    Zoledronic acid was recommended for extension to listing to include the treatment of osteoporosis in women 70 years of age or older with a bone mineral density (BMD) T- score of -3.0 or less, on a cost –minimisation basis compared with alendronic acid, and recommended the equi-effective doses are alendronic acid 70 mg weekly for 52 weeks versus zoledronic acid 5 mg once per year, less the cost of infusing zoledronic acid.

16.    Zoledronic acid solution for I.V. infusion 5mg (Aclasta®) was recommended on a cost-minimisation basis compared to disodium pamidronate.  The equi-effective doses are one 5 mg zoledronic acid infusion to two 60 mg pamidronate infusions.

17.    Fosamax Plus D-Cal®, containing 4 tablets equivalent to 70 mg alendronic acid with 140 mcg colecalciferol and 48 tablets calcium 1.25g (equivalent to 500mg calcium) was recommended for listing at the same price as alendronic acid 70mg plus colecalciferol 140 mcg, 4 tablets.

18.    Denosumab injection was recommended for listing on a cost effectiveness basis compared with zoledronic acid for the treatment of bone metastases from breast cancer and hormone resistant prostate cancer.

19.    Denosumab injection was recommended for listing for use in osteoporosis in women 70 years and over with a BMD T-score of -3 or less and in women with a fracture due to minimal trauma, on a cost minimisation basis compared with zoledronic acid. The equi-effective doses are denosumab 60 mg administered every six months and zoledronic acid 5 mg administered once per year, with an adjustment to the price to account for the different requirements for administration.

20.    An extension to the listing of denosumab to include use in women 70 years and over with a BMD T-score of -2.5 or less was recommended on a cost-minimisation basis with alendronate. The equi-effective doeses are denosumab 60 mg every 6 months and alendronate 70 mg once weekly.

21.    An extension to the listing of strontium to include treatment for osteoporosis in men aged 70 years of age or older with a BMD T-score of -3 or less, and to include treatment for established osteoporosis in men with fracture due to minimal trauma was recommended on a cost-minimisation basis compared with risedronate.  The equi-effective doses are strontium ranelate 2 g daily and risedronate sodium 35 mg weekly.

22.    An extension to the listing of risedronate and its combinations to include treatment of patients aged 70 years of age or older with a BMD T-score less than or equal to -2.5 was recommended on a cost-minimisation basis with alendronate monotherapy.

23.    An extension to the listing of denosumab to include both male and female patients was recommended on a cost-minimisation basis with zoledronic acid.  The equi-effective doses are denosumab 60 mg once every 6 months and zoledronic acid 5 mg once every 12 months.

24.    An extension to the listing of denosumab to include treatment of giant cell tumour of bone in adults and skeletally mature adolescent patients was recommended on a cost-effectiveness basis over placebo.

ATC N02 - Analgesics    Effective Date:  05/13

1.    Kapanol sustained release morphine sulphate capsules were accepted for listing with the advice that they are of similar safety and efficacy to MS Contin controlled release tablets.

2.    Pizotifen has historically had a considerable price premium over the other antihistamine, cyproheptadine.

3.    Zolmitriptan 2.5mg was accepted on the basis of cost minimisation compared to sumatriptan 50mg.

4.    Naritriptan tablet 2.5 mg was accepted on a cost minimisation basis compared to 50 mg sumatriptan.

5.    The nasal spray formulation of sumatriptan was recommended for listing on the basis of producing similar overall results to sumatriptan tablet.

6.    Fentanyl transdermal patches were initially listed on the basis of cost minimisation compared to subcutaneous morphine and the pricing arrangements included a price-volume agreement.  Subsequently, the patches were transferred to the same listing as for oral sustained release morphine on the basis that they deserved a small premium over oral sustained release morphine, at the dose relativity of 1.5 mg fentanyl = 200 mg morphine.  The Pricing Authority agreed to listing with a premium of 15%. 

    In March 2006, the PBAC recommended extending the listing to include use in non-cancer pain on a cost minimisation basis compared to oral sustained-release morphine.  The equi-effective doses are now 1 mg fentanyl and 98.8 mg morphine across the two indications of cancer and non-cancer pain. 

7.    Oxycontin® controlled release tablets were listed on the basis that 1mg of these formulations was of similar safety and efficacy compared to 1.5mg of oral sustained release morphine sulfate formulations.

8.    Hydromorphone hydrochloride injections and oral liquid were recommended on the basis of cost minimisation compared to morphine, with 1 mg hydromorphone being similar to 5 mg morphine. The immediate release tablets were recommended on the basis that 1 mg hydromorphone is of similar safety and efficacy to 4 mg oxycodone hydrochloride (from immediate release tablets and capsules).

9.    Tramadol hydrochloride immediate release capsule 50mg was recommended on the basis of acceptable cost-effectiveness compared with the combination of paracetamol 500mg and codeine phosphate 30mg and with codeine phosphate 30mg alone.  Tramadol oral drops 100 mg per mL, 10 mL was listed on the basis of same price as for 20 x 50 mg immediate release tablets.

10.    MS Mono® formulations were listed on the basis of equivalent safety and efficacy to the same mg daily dose of ‘MS Contin® (half the daily dose taken twice daily).
 
11.    Tramadol hydrochloride twice a day sustained release tablets were recommended for listing on the basis of acceptable cost-effectiveness compared with the immediate release capsule formulation.

12.    Tramadol hydrochloride injection 100mg was recommended on the basis of similar overall safety and efficacy compared to pethidine hydrochloride (now available only on the private market) injection 100mg (may be slightly less effective, but less respiratory depression and reduced potential for abuse as well as being schedule 4 rather than schedule 8).

13.    Paracetamol modified release tablet 665 mg was recommended on the basis that 6 x 665 modified release tablets = 8 x 500 mg immediate release tablets of paracetamol.

14.    Buprenorphine transdermal patches were recommended for pain management on a cost minimisation basis compared with oxycodone controlled release tablets.  The equi-effective doses are transdermal buprenorphine 5 mg, 10 mg and 20 mg every seven days equivalent to oxycodone controlled release tablets 10 mg, 20 mg and 30 mg twice daily, respectively.

15.    Topiramate was recommended on a cost-effectiveness basis compared to placebo for migraine prophylaxis.  Special pricing arrangements apply.

16.    Fentanyl lozenges (Actiq®) was recommended on a cost-effectiveness basis compared to placebo for breakthrough pain in palliative care patients.

17.    Tramadol once a day extended release tablets (Durotram XR®)  was recommended for listing on a cost-minimisation basis with tramadol twice a day sustained release preparations at the same price per mg.

18.    Hydromorphone hydrochloride prolonged release (PR) tablets was recommended for the treatment of chronic severe disabling pain not responding to non-narcotic analgesics on a cost minimisation basis to oxycodone controlled release (CR) tablets. The equi-effective doses are 26.4 mg hydromorphone hydrochloride prolonged release to 74 mg oxycodone hydrochloride controlled release, giving a ratio of 1:2.8.

19.    Rizatriptan wafers were recommended on a cost minimisation basis with sumatriptan tablets. The equi-effective doses are rizatriptan 10 mg to sumatriptan 50 mg.

20.    Eletriptan (Relpax®) was recommended for listing on a cost-minimisation basis with sumatriptan. The equi-effective doses are eletriptan 40 mg and sumatriptan 50 mg.

21.    Oxycodone with naloxone was recommended on the basis of an acceptable cost-effectiveness compared with oxycodone controlled release, without prophylactic laxatives.

22. Pregabalin was recommended for listing for the treatment of refractory neuropathic pain not controlled by other drugs on the basis of acceptable cost-effectiveness compared with placebo in patients dissatisfied with their current pain relief.  Special pricing arrangements apply.

ATC N03 - Antiepileptics    Effective Date:  10/12

1.    Carbamazepine sustained release tablets were accepted for listing as having no advantage over the immediate release formulations.

2.    Lamotrigine was recommended for listing on the basis of similar safety and efficacy to vigabatrin, with 250mg being compared to 2g vigabatrin; gabapentin was accepted on the basis of 1.2g gabapentin compared to 2-2.5g vigabatrin; 300mg of topiramate was accepted as similar to 300mg lamotrigine; and 30mg tiagabine is similar to 250mg lamotrigine.

3.    Topamax Sprinkle® was initially accepted for listing on the basis of bioavailability data indicating the ‘sprinkle’ is equivalent with the plain tablet presentation.  At its March 2006 meeting, the PBAC advised that a small price advantage over the other anti-epileptic drugs in the reference pricing group was acceptable for the sprinkle formulation of this drug on the grounds that it provides a formulation for patients unable to take a solid dose form, in particular for paediatric patients with Lennox-Gastaut syndrome, a unique indication for topiramate, and for disabled patients with other forms of epilepsy for which topiramate is PBS-listed.

4.    Oxcarbazepine was recommended for listing on a cost minimisation basis with 1.2g of oxcarbazepine being equivalent to 300mg lamotrigine.

5.    Levetiracetam was recommended for listing on a cost minimisation basis compared to lamotrigine with 2 gram of levetiracetam being considered equivalent to 300 mg lamotrigine.

6.    Lacosamide was recommended for listing on a cost-effectiveness basis compared with placebo plus standard background therapy. Special Pricing Arrangements apply.

7.    Pregabalin was recommended for listing on a cost-minimisation basis compared with gabapentin. The equi-effective doses are pregabalin 349 mg daily and gabapentin 1188 mg daily.

8.    Zonisamide was recommended for listing on the PBS on a cost minimisation basis compared with lamotrigine. 

ATC N04 – Anti-Parkinson Drugs    Effective Date:  05/13 

1.    The approximate relativities between benztropine, benzhexol, biperiden are:

milligram
Benzhexol 2 5
Benztropine 2
Biperiden  2

   
    Historically, there has been a relativity between benzhexol hydrochloride, benztropine mesylate and biperiden hydrochloride, as indicated in the table: 5 mg of benzhexol is approximately equivalent to 2 mg of benztropine, while 2 mg of benzhexol is approximately equivalent to 2 mg of biperiden.  

2.    At its meeting in September 1992, the Pricing Authority accepted a proposal that it was appropriate for the levodopa with carbidopa items, and the levodopa with benserazide items, to be compared on an average daily treatment cost basis.  (Prior to this it had been accepted that 100mg-25mg levodopa-benserazide was equivalent to the same strength of levodopa-carbidopa.) 

3.    Pergolide was accepted for listing as being cost effective compared to bromocriptine.

4.    Madopar Rapid® dispersible tablets were accepted on the basis of equivalence to the same strength plain tablets.

5.    Entacapone was accepted for listing on the basis of cost minimisation compared to pergolide.  The clinical trial data indicated average daily doses of 1.2g for entacapone and 2.8mg for pergolide, although Australian usage data has indicated that the average Australian dose will be closer to 920mg.

6.    In the treatment of Parkinson’s disease, cabergoline was recommended for listing on the basis of cost minimisation compared to bromocriptine with 4mg cabergoline being of similar safety and efficacy to 25-30mg bromocriptine **.  Listing was effected on the understanding that pricing would be reviewed on a weighted average monthly treatment cost basis.

7.    The combination products containing levodopa with carbidopa combined with entacapone, Stalevo®, were listed on the basis of cost minimisation compared to the sum of the components.

8.    Pramipexole was recommended to list on a cost minimisation basis compared to bromocriptine with 2.8 mg pramipexole being equivalent to 20.8 mg bromocriptine. Special pricing arrangements apply.

9.    Rasagiline was recommended for listing on a cost minimisation basis compared to selegiline as a primary comparator and compared to entacapone as a secondary comparator.  The equi-effective doses are rasagiline 1 mg daily versus selegiline 10 mg daily and rasagaline 1 mg daily versus entacapone 953 mg daily.   

10.    Rotigotine transdermal patch (Neupro®) was recommended for listing for the treatment of advanced stage Parkinson disease in combination with levodopa-decarboxylase inhibitor
combinations on a cost-minimisation basis to cabergoline.  The equi-effective doses are 12.95 mg per day rotigotine to 5.19 mg per day cabergoline.
   
**    Bromocriptine also in group G02 - OTHER GYNECOLOGICALS

ATC N05 - Psycholeptics    Effective Date:  08/13

1.    The antipsychotic drugs chlorpromazine, trifluoperazine, haloperidol and pericyazine while all having different individual properties are considered to be equally effective.  The relative approximate potencies for the oral products are:

INCREASING STRENGTHS -------->

milligram
Chlorpromazine 10 25 100
Trifluoperazine 1 2 5
Haloperidol 0.5 1.5 5
Pericyazine 2.5 10

               
          The PBAC confirmed this view, specifically in relation to pericyazine, by stating that this drug is considered to be similar to the other phenothiazines.

2.    Listing of haloperidol decanoate injection was on the basis that 50mg is approximately equivalent to 25mg fluphenazine decanoate.

3.    Zuclopenthixol decanoate was listed on the basis that 200mg is approximately equivalent to 40mg flupenthixol decanoate.

4.    Flupenthixol decanoate was recommended for listing with the advice that 40mg flupenthixol decanoate is approximately equivalent to 25mg fluphenazine decanoate.

5.    The PBAC has advised that nitrazepam 5mg and temazepam 10mg should be considered as clinically equivalent.

6.    Before the maximum quantity of oxazepam was reduced from 50 to 25mg oxazepam 15mg and diazepam 2mg were considered to have similar clinical use and were approximately the same price, as were the 30mg and 5mg products.  Since the reduction in oxazepam maximum quantities, the approximate pricing relativity has been maintained.

7.    Risperidone oral solution was listed with the same price per mg as the 2mg tablet.

8.    Olanzapine was recommended for listing on the basis of acceptable cost-effectiveness compared to risperidone in the treatment of schizophrenia.  Special pricing arrangements apply for olanzapine powder for injection (Zyprexa Relprevv®).

9.    Olanzapine wafers were accepted as equivalent with olanzapine tablets.

10.    Quetiapine was recommended for listing for schizophrenia on a cost minimisation basis compared with risperidone.  The equi-effective doses are 317mg quetiapine fumarate and 4.5mg risperidone.
 
11.    Amisulpride was recommended on a cost minimisation basis compared to risperidone with the equivalent doses being 800mg amisulpride = 8mg risperidone with pricing to be reviewed on a weighted average monthly treatment cost basis.

12.    Aripiprazole was recommended for listing on a cost minimisation basis versus olanzapine with 23.1 mg aripiprazole = 16.3 mg olanzapine.

13.    In acute mania associated with bipolar 1 disorder, risperidone was recommended for listing on a cost minimisation basis compared with olanzapine.  The equi-effective doses are risperidone 3.75 mg per day for 2 to 4 months and olanzapine 10.4 mg per day for 2 to 4 months.

14.    Ziprasidone was recommended for listing on a cost minimisation basis compared to olanzapine.  The equi-effective doses are ziprasidone 120.30 mg/day and olanzapine 14.38 mg/day.

15.    Quetiapine for the treatment, as monotherapy, of an acute episode of mania associated with bipolar 1 disorder on a cost minimisation basis compared with olanzapine. For pricing purposes, the price of quetiapine for the treatment of bipolar 1 disorder should be on the basis of the therapeutic relativity of quetiapine to risperidone. The equi-effective doses are quetiapine 300 mg (base) per day, risperidone 3.75 mg per day and olanzapine 10.4 mg per day.

16.    Paliperidone was recommended for listing for schizophrenia on a cost minimisation basis compared with olanzapine. The equi-effective doses were paliperidone 9.83mg per day and olanzapine 12.91mg per day.

17.    Quetiapine tablet, modified release (Seroquel XR®) for the treatment of schizophrenia was recommended on a cost-minimisation basis against immediate release quetiapine on a mg per mg of drug basis.

18.    Ziprasidone was recommended for extension to listing to include the treatment of acute mixed mania or mixed episodes associated with bipolar disorder 1 on a cost-minimisation basis with olanzapine and recommended that the equi-effective doses are ziprasidone 119.85 mg and olanzapine 15.19 mg daily (risperidone 5.4 mg daily).

19.    Quetiapine was recommended for extension to listing to include maintenance treatment of bipolar 1 disorder in combination of lithium or valproic acid on the basis of cost-minimisation with olanzapine and where the equi-effective doses are quetiapine 506.8 mg per day, olanzapine 8.6 mg per day ie a dose relativity of 58.9:1.

20.    Risperidone injection (Risperdal Consta ®) was recommended for listing as being of acceptable cost-effectiveness over oral risperidone. Special pricing arrangements apply.

21.    Asenapine for the treatment of bipolar I disorder was recommended for listing on a cost minimisation basis with quetiapine.  The equi-effective doses are asenapine 16.3 mg and quetiapine 556.9 mg in the monotherapy setting and asenapine 13.4 mg and quetiapine 506.7 mg in the adjunctive setting.

22.    Asenapine for the treatment of schizophrenia was recommended for listing on a cost minimisation basis with risperidone.  The equi-effective doses are asenapine 8.3 mg daily and risperidone 5.3 mg daily.

23.    Paliperidone long acting injection was recommended on a cost minimisation basis compared with risperidone modified release injection  The dose relativity accepted by the are 1:1.32 for injected risperidone and injected paliperidone.  With an additional cost offset for the reduction in injections.

24.   The oral disintegrating tablet formulation of olanzapine was recommended for listing at the same price as olanzapine wafers.

25.    Diazepam oral solution was recommended for listing with a price premium over the diazepam tablets.

ATC N06 - Pyschoanaleptics    Effective Date:  04/06   

1.    The tricyclic antidepressants, amitriptyline, nortriptyline, imipramine and desipramine were for many years regarded as being equivalent on a mg to mg basis. However, in 2002 nortriptyline was transferred to a restricted benefit listing for use where other antidepressant therapy is inappropriate at a price which represented a premium over the other TCAs.

2.    Doxepin and dothiepin are regarded as being equivalent but were listed as being a minor advance over group 1.

3.    Initially moclobemide was recognised by the PBAC as having advantages over the other MAO inhibitors and was recommended for listing with the advice that it appeared to be of similar safety and efficacy compared to mianserin.  Subsequently (November 1994) the PBAC agreed to the transfer of moclobemide from authority required to restricted benefit on the basis of acceptable cost-effectiveness compared to the tricyclics.

4.    Transfer from Authority required to restricted benefit of fluoxetine was on the basis of 28.4mg fluoxetine daily compared to 419.4mg moclobemide daily.

5.    Paroxetine, sertraline, fluvoxamine, nefazodone and citalopram were initially accepted for listing as being equivalent to fluoxetine with the following dosage comparisons:  20mg fluoxetine = 20mg paroxetine, 50mg sertraline, 100mg fluvoxamine and 20mg citalopram; and 25mg fluoxetine = 430mg nefazodone.  However, review of pricing of these drugs is undertaken on a weighted average monthly treatment cost basis.

6.    Mirtazapine tablet 30mg was accepted for listing on the basis of cost minimisation compared to fluoxetine hydrochloride 20mg.

7.    Donepezil and rivastigmine were recommended for listing on the basis of acceptable cost-effectiveness in the patient group covered for the PBS listing.  The two drugs were considered to be of similar effectiveness and toxicity, based on the data available at that time.

8.    Galantamine hydrobromide immediate release formulations were listed on cost minimisation compared to donepezil, with 16 mg galantamine being considered equivalent to 10mg donepezil.  The prolonged release capsule formulations of galantamine hydrobromide (once daily) were recommended on a cost minimisation basis compared to the immediate release tablet forms (twice daily, at the same total daily dose).

9.    Reboxetine mesilate was recommended for subsidy on a cost minimisation basis with 8.73mg of reboxetine being considered equivalent to 25.67mg of fluoxetine.

10.    Escitalopram oxalate was recommended for listing on a cost minimisation basis with escitalopram 10mg being equivalent to citalopram 20mg and escitalopram 20mg being equivalent to citalopram 40mg.
 
11.    Methylphenidate hydrochloride was recommended on a cost minimisation basis compared to dexamphetamine sulfate with the equi-effective doses being 10 mg methylphenidate = 5 mg dexamphetamine.

12.    Methylphenidate hydrochloride extended release tablets Concerta® was accepted for listing as being of acceptable cost-effectiveness over immediate release methylphenidate at the new price proposed.   

13.    Atomoxetine was recommended on a cost-effectiveness basis compared to placebo in the treatment of ADHD.  Special pricing arrangements apply.

14.    Methylphenidate hydrochloride extended release capsule (Ritalin LA®) was recommended for listing on a cost minimisation basis compared with methylphenidate hydrochloride extended release tablets (Concerta®). 

15.    Venlafaxine was accepted initially on the basis of cost minimisation compared to fluoxetine. It was subsequently accepted that it was more effective than the SSRIs for some patients. Following the presentation of further data to the PBAC at its June 2003 meeting, venlafaxine was then accepted as being of acceptable cost effectiveness compared to the SSRIs (at the prices then applying).

16.    Venlafaxine modified release capsules were accepted for listing on the basis that the 75 mg and 150 mg once daily is similar to the 37.5 mg and 75 mg plain tablets twice daily, respectively.

17.    Duloxetine was recommended for listing on the PBS for major depressive disorders on a cost minimisation basis compared with venlafaxine and that the equi-effective doses are duloxetine 60 mg and venlafaxine 150 mg.

18.    Rivastigmine transdermal patches were recommended on the basis of cost minimisation with rivastigmine capsules. The equi-effective doses for the purposes of cost minimisation are one 18 mg rivastigmine patch (releasing approximately 9.5 mg per 24 hours, Exelon® Patch 10) is equivalent to rivastigmine capsules at a dose of between 9 mg and 12 mg.

19.    Memantine was recommended on a cost-effectiveness basis (less costly and less effective) compared to donepezil, galantamine and rivastigmine as monotherapy for the treatment of moderately severe Alzheimer’s disease.

20.    Desvenlafaxine was recommended for listing for major depressive disorders on a cost minimisation basis with the parent drug venlafaxine. The equi-effective doses are desvenlafaxine 50 mg and venlafaxine 75 mg.  Special pricing arrangements apply.

ATC N07 – Other Nervous System Drugs    Effective Date:  12/13

1.    For use in alcohol dependence, naltrexone was recommended on the basis of cost minimisation compared with acamprosate calcium i.e. similar monthly treatment costs.

2.   Nicotine transdermal patch, releasing 15 mg per 16 hours were recommended for listing at the price requested in the submission on the basis of (a) non-inferior efficacy, superior safety and lower cost compared to bupropion, and (b) uncertain and possibly inferior efficacy, superior safety and lower cost compared to varenicline.

3.    Nicotine transdermal patch, releasing 21 mg per 24 hours was recommended for listing on a cost minimisation basis with the 15 mg per 16 hour patches.

4.    Nicotine transdermal patches, releasing approximately 14 mg per 24 hours and approximately 7 mg per 24 hours were recommended at a price equal to the 21 mg per 24 hour patches.

5.    Dimethyl fumarate was recommended for the treatment of relapsing remitting multiple sclerosis on a cost-minimisation basis with the ABCR therapies (intramuscular interferon beta-1a, subcutaneous interferon beta-1a, interferon beta-1b and glatiramer acetate).  Special pricing arrangements apply.

ATC P01 - Antiprotozoals    Effective Date:  04/99  

1.    Metronidazole tablet 400mg x 5 and tinidazole tablet 500mg x 4 are used for similar indications however tinidazole has been reported as having higher cure rates and has had a premium.

2.    Quinine bisulfate and quinine sulfate 300mg tablets are considered interchangeable.

3.    Atovaquone oral suspension at a dose of 750mg twice daily was accepted as being similar to 750mg three times daily using the 250mg tablet formulation.

ATC P02 – Anthelmintics    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC P03 – Ectoparasiticides, including Scabicides, Insecticides and Repellants    Effective Date:  08/95  

1.    Permethrin cream was accepted for listing as being of acceptable cost-effectiveness compared to the price of benzyl benzoate.

ATC R01 – Nasal Preparations    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC R03 – Drugs for Obstructive Airways Diseases    Effective Date:  04/14

1.    Data submitted to the PBAC indicated that budesonide seemed to have a marginal advantage over beclomethasone at equivalent dosages. 

2.    Data in support of listing of sodium cromoglycate 5mg dose aerosol indicated only marginal improvement compared to the 1mg strength aerosol.

3.    The recommended dosages of salbutamol and terbutaline respirator solutions indicate they are approximately comparable on a mg to mg basis. 

4.    The relativity in 3 does not apply to the oral inhalation preparations where 100mg of salbutamol by  inhalation is approximately equivalent to 250mg of terbutaline by similar administration. 

5.    Nedocromil sodium 2mg by aerosol is accepted as being equivalent to sodium cromoglycate 5mg by aerosol. 

6.    Salmeterol was recommended for listing on the basis of acceptable cost-effectiveness relative to theophylline. 

7.    Eformoterol fumarate dihydrate 12 micrograms was accepted as being equivalent to 50 micrograms salmeterol. 

8.    Eformoterol when administered from the Oxis Turbuhaler® was accepted on a cost minimisation basis compared to the drug delivered from the Foradile Aerolizer®. 

9.    Fluticasone was accepted as being of acceptable cost-effectiveness for very severe asthmatics (those covered by the previous authority listing) and equivalent to beclomethasone/budesonide in other asthmatics patients.  The price is based on the weighted use between the two groups.

10.    Airomir Autohaler® (restricted to use by poor co-ordinators) was priced on the basis of costing no more per dose than the salbutamol sulfate powders for oral inhalation eg. Ventolin Disks®.

11.    QVAR® brand of CFC-free beclomethasone dipropionate oral pressurised inhalation was listed on the basis that 50 micrograms from this presentation provided similar efficacy to 100 micrograms from the already listed CFC-containing formulations and 100 micrograms was similar to 250 micrograms of the CFC-containing products.

12.    The salmeterol with fluticasone combined inhalation (Seretide®) was accepted on a cost minimisation basis compared with the individual components.
 
13.    Montelukast was recommended for listing on the basis of similar safety and efficacy to sodium cromoglycate with each 4mg or 5mg tablet being considered equivalent to 27.8mg cromoglycate by oral inhalation.

14.    Symbicort®, the combination of budesonide plus eformoterol, was recommended for listing on the basis of the sum of the individual components.

15.    Tiotropium bromide capsule for oral inhalation was recommended on the basis of acceptable cost-effectiveness compared with ipratropium bromide.

16.    Ciclesonide oral pressurised inhalation was recommended on a cost minimisation basis compared to fluticasone with the drugs considered as equi-potent eg 100 mcg ex valve = 100 mcg ex valve.

17.    Fluticasone propionate with salmeterol xinafoate was recommended for listing for the treatment of COPD on a cost minimisation basis compared to tiotropium bromide monohydrate.  The equi-effective doses are fluticasone 500mcg/salmeterol 50mcg inhaled twice daily = tiotropium bromide monohydrate 18 mcg inhaled once daily.

18.    Adrenaline (EpiPen®) was recommended on a cost-effectiveness basis compared to no intervention in the treatment of acute allergic reactions and anaphylaxis.

19.    Adrenalin (Anapen®) single dose syringe auto-injector was recommended for listing on a cost-minimisation basis with adrenaline I.M. injection single dose syringe auto-injector (EpiPen).  The equi-effective doses are one Anapen® and one EpiPen®.

20.    Indacaterol was recommended on the basis of cost minimisation compared with fluticasone with salmeterol and tiotropium.  The equi-effective doses were considered are indacaterol 150 micrograms daily, fluticasone with salmeterol 250/25 micrograms, 2 puffs twice daily and tiotropium 18 micrograms daily.

21. Budesonide with eformotel fumarate dehydrate powder for inhalation fixed dose combination 400/12 was recommended for the treatment of chronic obstructive pulmonary disease on a cost minimisation basis with fluticasone with salmeterol fixed dose combination, with the equi-effective doses being with budesonide 400 micrograms eformoterol 12 micrograms and salmeterol 50 micrograms with fluticasone 500 micrograms, both twice daily.

22.    Fluticasone with eformoterol pressurised metered dose inhalers (MDI) was recommended for listing for maintenance treatment of asthma on a cost-minimisation basis with fluticasone with salmeterol pressurised MDI, with the following equi-effective doses:

  • fluticasone propionate 50 mcg with eformoterol fumarate 5 mcg MDI, 2 actuations twice daily is equivalent to fluticasone propionate 50 mcg with salmeterol 25 mcg MDI, 2 actuations twice daily;
  • fluticasone propionate 125 mcg with eformoterol fumarate 5 mcg MDI, 2 actuations twice daily is equivalent to fluticasone propionate 125 mcg with salmeterol 5 mcg MDI, 2 actuations twice daily; and
  • fluticasone propionate 250 mcg with eformoterol fumarate 10 mcg MDI, 2 actuations twice daily is equivalent to fluticasone propionate 250 mcg with salmeterol 25 mcg, 2 actuations twice daily.

23.    Glycopyrronium was recommended for use in chronic obstructive pulmonary disease on a cost-minimisation basis compared with tiotropium.  The equi-effective doses are glycopyrronium 50 micrograms once daily and tiotropium 18 micrograms once daily.

ATC R05 – Cough and Cold Preparations    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC R06 – Antihistamines for Systemic Use    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC S01 - Ophthalmologicals    Effective Date:  09/13

1.    The combination antibiotic products are priced with a small premium over the single antibiotic product.

2.    Gentamicin and tobramycin were recommended for listing as being equivalent.  They are restricted items enabling a premium over other anti-bacterial (unrestricted) eye drops.

3.    Ciprofloxacin and ofloxacin eye drops were accepted for listing as being equivalent to gentamicin/tobramycin eye drops.

4.    Dexamethasone, fluorometholone and fluorometholone acetate eye drops are all in 5mL packs, are intended for allergic or inflammatory conditions of the eye and are considered as alternatives.

5.    The PBAC initially advised that betaxolol has a superior safety profile compared to timolol which justifies a price premium. However, following the consideration of clinical data (in 1995) which showed that timolol causes a greater reduction in IOP and causes less local stinging, the PBAC reviewed its advice, and is now of the view that, overall, betaxolol and timolol should be seen as equivalent.

6.    Betoptic S 0.25% was accepted as being of similar safety and efficacy to Betoptic 0.5% aqueous solution.

7.    Timoptol XE applied once daily was accepted as being of similar safety and efficacy to Timoptol aqueous applied twice daily.

8.    Hypromellose with dextran single unit eye drop was recommended on a cost minimisation basis compared to carmellose sodium 0.5% single unit eye drop.

9.    Brimonidine tartrate eye drop 0.2% was initially recommended on a comparison versus timolol 0.5% eye drop, however, following the presentation of further data, pricing is now based on it being no worse than dorzolamide 2% or brinzolamide 1% eye drops in terms of effectiveness and toxicity.

10.    Brinzolomide and dorzolomide were recommended by the PBAC on the basis that they deserved a small premium over beta-blocker and other ‘add-on’ eye drops, such as dipivefrine and pilocarpine.  The Pricing Authority viewed the two drugs as being of similar safety and efficacy.

11.    Carbomer 974 lubricating eye gel 0.3% (Poly Gel®) single dose units were listed on a cost minimisation basis compared with carmellose sodium 0.5% eye drop single dose units (Cellufresh®).

12.    The combination eye drop of dorzolamide plus timolol was recommended for listing on the basis of cost minimisation compared to the individual components.

13.    Carbomer 980 ocular gel in single dose units (Viscotears®) was listed on the basis of cost minimisation compared to other listed single dose unit lubricating eye drops.

14.    Travoprost 0.004% and bimatoprost 0.03% eye drops were recommended for listing on a cost minimisation basis compared to latanoprost eye drops 0.005%.

15.    Following a review by the PBAC in 2004, the Committee advised that all multi-dose lubricant eye drops should be considered equivalent for pricing purposes, and any claims for a premium would need to be supported by data demonstrating any claimed therapeutic advantages.

16.    Nyogel®, eye gel containing 0.1% timolol, was listed on the basis of cost minimisation compared to timolol aqueous eye drops 0.25%.

17.    The combination eye drop of brimonidine tartrate plus timolol maleate, 0.2%-0.5%, 5 mL, was recommended on a cost minimisation basis compared to concomitant use of the components.

18.    The combination eye drops of latanoprost with timolol 50 micrograms - 5 mg (base) per mL, (Xalacom®) was recommended on a cost minimisation basis compared with the individual components.  The PBAC advised that latanoprost with timolol maleate should be priced on a mg per mg basis compared to the individual components.

19.    Travoprost with timolol maleate eye drop 0.004%-0.5%, 2.5mL, DuoTrav®, was recommended on a cost minimisation basis with Xalacom® (latanoprost 0.005% with timolol 0.5%).  The equi-effective doses are the fixed dose combination of travoprost 40µg/mL (0.004%) with timolol 5mg/mL (0.5%), one drop instilled once daily and the fixed dose combination of latanoprost 50µg/mL (0.005%) and timolol 5mg/mL (0.5%), one drop instilled once daily.

20.    Tamarindus indica seed polysaccharide (TSP) was recommended on a cost minimisation basis compared with carmellose, available as sodium eye drops (Cellufresh®) 5 mg per ml, single dose units.  The equi-effective doses were 2 units of TSP eye drops daily (24 hours) and 3 units of Cellufresh® daily (24 hours).

21.    Ranibizumab was recommended on a cost-effectiveness basis compared to verteporfin in the treatment of age related macular degeneration.  Special pricing arrangements apply to ranibizumab.

22.    Polyethylene glycol 400 with propylene glycol, eye drops single dose untils (Systane®) is listed on the basis that 2 x single dose units Systane are equivalent to 2 x single dose units tamarindus indica seed polysaccharide (TSP, Visine Professional®) over 24 hours.
 
23.    Bimatoprost with timolol maleate was recommended for listing on the PBS and Optometrical Schedule in accordance with the combination guidelines on a cost minimisation basis compared with it constituent components, bimatoprost 0.03% and timolol maleate 0.5% eye drops given concomitantly.

24.    Soy lecithin liposomal eye spray (Tears Again®) was recommended for listing on a cost-minimisation basis compared to single dose unit lubricant eye drops with 2 sprays of soy lecithin considered to be equi-effective to one single dose unit of carmellose sodium (Cellufresh®).

25.    Carmellose sodium with glycerin single dose units (Optive®) was recommended on a cost-minimisation basis at the same cost per unit as other carmellose sodium single dose unit products.

26.    Brinzolamide with timolol eye drops 1%-0.5% (Azarga®) was recommended for listing on a cost-minimisation basis with the equi-effective doses being one drop of the combination brinzolamide with timolol eye drops is equi-effective to one drop of brinzolamide 1 % eye drops plus one drop of timolol 0.5 % eye drops; and that one drop of the combination brinzolamide with timolol eye drops (Azarga®) is equi-effective to one drop of the combination dorzolamide with timolol eye drops (Cosopt®).

27.   Brimonidine tartrate eye drops 0.15% (Alphagan P 1.5®) was recommended for listing on a cost- minimisation basis against brimonidine 0.2 % eye drops.

28.   Carbomer with triglyceride lipids multi-dose and single-dose units (Artelac®) were recommended for listing on a cost-minimisation basis with the other PBS listed multi-dose and single dose lubricant eye drops.

29.   Aflibercept was recommended for listing for treatment of subfoveal choroidal neovascularisation due to age-related macular degeneration on a cost-mimisation basis with ranibizumab, with one aflibercept 2 mg injection being equivalent to one ranibizumab 0.5 mg injection.  Special pricing arrangements apply.

30.    Paraffin with retinyl palmitate eye ointment (VitA-POS®) was recommended for listing on a cost minimisation basis against paraffin eye ointment on a gram for gram basis with no price advantage for the Vitamin A content.

31.    Sodium hyaluronate was recommended for listing for treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi dose eye drops on the basis of cost minimisation compared to other PBS listed eye products.

32.     Tafluprost was recommended for listing at a lower price than latanoprost due to the failure to demonstrate statistical non-inferiority in IOP reduction when compared to latanoprost.  The reference doses for pricing purposes are one drop daily of tafluprost 15 micrograms per mL (0.0015%) and one drop daily of latanoprost 50 micrograms per mL (0.005%).

ATC S02 - Otologicals    Effective Date:  08/95  

1.    The ear-drop preparations containing a corticosteroid in combination with one or more antibiotics, as used in general practice, may be considered as alternatives.

2.    The four gram and five gram ear ointments have been considered as alternatives.

ATC S03 – Ophthalmological and Otological Preparations    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC V01 – Allergens    Effective Date: 06/11

There are currently no therapeutic relativities for this group.

ATC V03 – All Other Therapeutic Products    Effective Date:  05/13

1.    For use in alcohol dependence, naltrexone was recommended on the basis of cost minimisation compared with acamprosate calcium i.e. similar monthly treatment costs.

2.    Sevelamer was recommended on a cost-effectiveness basis compared to calcium carbonate in the treatment of hyperphosphataemia.  Special pricing arrangements apply. Also refer to Section 100

3.    Lanthanum carbonate was recommended for listing on a cost minimisation basis compared to sevelamer. The equi-effective average daily doses were estimated as 1936 mg for lanthanum and 5231 mg for sevelamer based on the dose relativity of 2.7. Special pricing arrangements apply.

4.    Naloxone hydrochloride injection 0.4 mg in 1 mL was recommended for listing to replace naloxone injection 2 mg in 5 mL.

ATC V04 – Diagnostic Agents    Effective Date:  07/03  

1.    While patients may have preferences for features of the individual products, all of the glucose inductors - blood reagent strips are considered to be 'clinically' equivalent (in that they all help the treatment of diabetes in that they monitor blood glucose concentrations), and any claims for a premium would need to be supported by data demonstrating that the claimed advantages actually improve the outcome of the disease.

2.    Clinistix® is a qualitative test for detecting the presence of glucose in urine.  Diastix® is a qualitative and semi-quantitative test for the estimation of glucose in urine and has a premium over Clinistix®.

ATC V06 – General Nutrients    Effective Date:  04/14

1.    Pepti-Junior® was accepted for listing as being essentially equivalent to Alfare®.

2.    S -26 LF® was accepted as equivalent to De-Lact Infant®.

3.    Phenex-2®, providing 30 g of protein equivalent per 100 g of powder, was recommended for listing on a cost minimisation basis compared with ‘XP Maxamum®/XP Maxamaid®,which provide 39 g/25 g of protein equivalent per 100 g of powder.

4.    PKU® gel sachet of Vitaflo was recommended at the same cost per day as for XP Maxamaid® on a per gram of protein basis. PKU gel provides 42 g per 100 g of gel and XP Maxamaid 25 g per 100 g of powder.

5.    Phlexy-10® capsule 500 mg was recommended as deserving a small premium over XP Maxamum®, on a per gram of protein basis. Phlexy-10 provides 83.3 g per 100 g and XP Maxamum 39 g per 100 g of powder. The 1 g tablet formulation was listed on the basis of same price per g of protein as for the 500 mg capsule

6.    Elecare® brand of synthetic amino acid formula was listed on a cost minimisation basis compared to Neocate Advance®, per kilojoule of energy basis. Both products provide 1,990 kilojoules per 100 g.

7.    PKU Express® amino acid formula, supplied in sachets and providing 60 g of protein per 100g, was recommended on the basis of cost minimisation compared to XP Maxamum®, which provides 39 g of protein per 100 g of powder. The name PKU Express® was later changed to PKU Express 15®.

8.    MSUD-gel®, supplied in sachets and which provides 42 g of protein per 100 g of gel, was recommended on the basis of cost minimisation compared to MSUD Maxamaid®, which provides 25 g of protein per 100 g of powder.

9.    PKU Anamix Junior® brand of amino acid formula with vitamins and minerals without phenylalanine, providing 29 g of protein per 100 g of powder, was recommended for listing on a cost minimisation analysis compared with XP Maxamaid®, which provides 25 g of protein per 100 g of powder.

10.    TYR gel® brand of Amino Acid Formula with Vitamins and Minerals without Phenylalanine and Tyrosine, sachets 20 g, providing 42 g per 100 g of gel, was listed on the basis of cost minimisation versus Xphen, Tyr Maxamaid® , which provides 25 g of protein per 100 g of powder.

11.    MSUD Express® brand of Amino Acid formula with Vitamins and Minerals without Valine, Leucine and Isoleucine, sachets 25g, providing 60 g per 100 g, was listed on the basis of cost minimisation versus MSUD Maxamaid® , which provides 25 g of protein per 100 g of powder. The name MSUD Express® was later changed to MSUD Express 15®.

12.        Carbohydrate Free®  brand of Milk Protein and Fat formula with Vitamins and Minerals-Carbohydrate Free, powder, was recommended for listing on a cost minimisation basis versus RCF® brand of Soy Protein and Fat Formula with Vitamins and Minerals-Carbohydrate Free liquid on a kilojoule per kilojoule comparison.  Carbohydrate free mixture provides 668 kcal per 100 g and RCF provides 81 kcal per 100 mL.

13.    Caprilon®  brand of Triglycerides-Medium Chain, Formula compound powder was recommended for listing on the basis of acceptable cost-effectiveness compared with Monogen®  brand compound powder.

14.    HCU gel®, supplied in sachets, was recommended on a basis of cost minimisation (per gram of protein equivalent) compared to XMET Maxamaid® powder.

15.    TYR Express® brand of Amino Acid Formula with Vitamins and Minerals without Phenylalanine and Tyrosine, sachets 25g, was listed on the basis of cost minimisation versus Xphen, Tyr Maxamum® powder on a gram for gram of protein basis.

16.    HCU express®, in sachets of 25 g, was recommended on an equivalent cost per gram of protein basis compared to XMET Maxamum®. HCU express®provides 60 g of protein per 100 g of product.

17.    Easiphen® oral liquid formulation was recommended on an equivalent cost per gram of protein basis compared to XP Maxamum® and Phenex-2®. Easiphen® provides 6.7 g of protein per 100 mL of product.

18.    MSUD Anamix Junior®, in sachets of 29 g, was recommended on an equivalent cost per gram of protein basis compared to MSUD Maxamaid® and Ketonex-2®. Mapleflex® provides 29 g of protein per 100 g of product.

19.    Lophlex®, in sachets of 27.8 g, was recommended on an equivalent cost per gram of protein basis compared to PKU Express®, XP Maxamum® and Easiphen® . Lophlex provides 20.02 g of protein per 27.8 g sachet of powder.

20.    PKU-Express Liquid® (amino acid formula) providing 10 g of protein per 100 mL, was recommended on the basis of cost minimisation compared to Easiphen® which provides 6.7 g of protein per 100 mL, XP Maxamum® which provides 39 g of protein per 100 g of powder, and Phenex-2® which provides 30 g of protein per 100 g of powder.  The name PKU- Express Liquid® was changed to PKU Cooler®.
 
21.    Add Ins® (amino acid formula) was recommended on a cost minimisation basis compared to XP Maxamum® at an equivalent cost per gram of protein.

22.    The PBAC accepted that maple syrup urine disease, tyrosinaemia and homocystinuria are all rare metabolic diseases with similar prevalence and products used to treat these diseases should be priced at the same cost per gram of protein.

23.    The PBAC recommended that as the prevalence of Glutaric Aciduria Type 1 (GA1), Methylmalonic acidaemia (MA) and Propionic acidaemia (PA) is similar to maple syrup urine disease, tyrosinaemia and homocystinuria, products used to treat these conditions should be priced at the same cost per gram of protein.

24.    The PBAC recommended that Essential Amino Acid Mix® (Essential Amino Acid Formula) should be listed at the same price per gram of protein as Dialamine (Essential Amino Acid Formula with Minerals and Vitamin C).

25.    Liquigen® brand of Triglycerides medium chain was recommended by the PBAC at an equivalent price per gram of fat to MCT ProCal®. 

26.    Elecare LCP® brand of Amino Acid Synthetic Formula supplemented with Long Chain Polyunsaturated Fatty Acids was recommended by the PBAC on a cost-minimisation basis with Neocate LCP®. 

27.    The PBAC recommended that the ProZero® brand of Triglycerides Long Chain with Glucose Polymer be listed at the same price per gram of protein as Duocal®

28.    MMA/PA Gel® brand of Amino Acid with Vitamins and Minerals without Methionine, Threonine and Valine and low in Isoleucine was recommended by the PBAC at the same cost per gram of protein to XMTVI Maxamaid®.

29.    MMA/PA Express® brand of Amino Acid with Vitamins and Minerals without Methionine, Threonine and Valine and low in Isoleucine was recommended by the PBAC at the same cost per gram of protein to XMTVI Maxamum®. The name MMA/PA Express was later changed to MMA/PA Express 15®.

30.    Neocate LCP+MCT® brand of Amino Acid Synthetic Formula supplemented with Long Chain Polyunsaturated Fatty Acids and Medium Chain Triglycerides was recommended at the same price as Neocate LCP®. The name Neocate LCP+MCT was later changed to Neocate Gold.

31.    GA Express® brand of Amino Acid with Vitamins and Minerals without Lysine and Low in Tryptophan was recommended at the same price per gram of protein as XLYS LOW TRY Maxamaid®.

32.    PKU Squeezie® brand of Amino Acid Formula with Vitamins and Minerals without Phenylalanine was recommended at the same price per gram of protein as PKU Gel.

33.    Neocate Advance Vanilla® was recommended for listing under the same price and listing conditions as the currently listed Neocate® products.

34.    HCU Lophlex LQ 20® brand of Amino Acid Formula with Vitamins and Minerals without Methionine was recommended by the PBAC at the same cost per gram of protein to comparator products, HCU Cooler®, XMET Maxamaid® and XMET Maxamum®.

35.    TYR Lophlex LQ 20® brand of Amino Acid Formula with Vitamins and Minerals without Phenylalanine and Tyrosine was recommended by the PBAC at the same cost per gram of protein to comparator products, TYR Cooler®, XPhen Tyr Maxamaid® and XPhen Tyr Maxamum®.

36.    MSUD Lophlex LQ 20® brand of Amino Acid Formula with Vitamins and Minerals without Valine, Leucine and Isoleucine was recommended at the same cost per gram of protein to MSUD Cooler®, MSUD Maxamaid® and MSUD Maxamum®.

37.    MMA/PA Cooler® brand of Amino Acid Formula with Vitamins and Minerals without Methionine, Threonine and Valine and low in Isoleucine was recommended at the same cost per gram of protein to comparator product MMA/PA Express®. 

38.    Lipistart® brand of Triglycerides – Medium chain formula was recommended on the basis of cost minimisation compared to Monogen® at an equivalent cost per 100 kilojoule of formula at 69.5c per 100 kJ.

39.    Camino Pro® products were recommended at an equivalent price of gram of protein as the comparators, XP Maxamum® and XP Maxamaid®.

40.    PKU Lophlex Sensation 20®  was recommended for the management of phenylketonuria on a cost-minimisation basis compared to PKU Lophlex LQ 20® and PKU Cooler 20®, at an equivalent price per gram of protein.

41.    Alfamino® brand of Amino Acid Formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides was recommended for listing on a cost-minimisation basis compared to Neocate Gold® and at an equivalent price per gram of protein.

42.    Betaquik® brand of Triglycerides Medium Chain oral liquid was recommended for listing at the same price per kilojoule as Liquigen®.

43.    CarbZero® brand of Triglycerides Long Chain oral liquid was recommended for listing at a lower price than the comparator Ketocal®, and other alternatives Liquigen® and BetaQuik®. 

44.    BaseCal 100® and BaseCal 200® brands of carbohydrates, fat, vitamins, minerals, trace elements and supplemented with arachidonic acid and docosahexaenoic acid providing 100 or 200 kilocalories oral liquid (powder) were priced based on the same price per kilojoule as Energivit®.

45.    DocOmega® brand of docosahexanoic acid with carbohydrate containing 200 mg docosahexanoic acid oral liquid (powder) and KeyOmega® brand of arachidonic acid and docosahexaenoic acid with carbohydrate containing 200 mg arachidonic acid and 100 mg docosahexaenoic acid oral liquid (powder), were both listed at the same price for peroxisomal biogenesis disorders.