New Listings and Changes 1 April 2010

ADDITIONS

Additions - Items

 

9330C Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid, Oral liquid 125 mL, 36 (TYR Anamix junior LQ)

On the advice of the Nutritional Products Working Party the PBAC recommended that TYR Anamix Junior LQ^® be made available for the treatment of tyrosinaemia, and that the product be listed on the same cost basis per gram of protein as the currently listed products for tyrosinaemia.

Tyrosinemia is a genetic disorder characterised by elevated blood levels of the amino acid tyrosine, a building block of most proteins.

 

9326W Cephazolin, Powder for injection 2 g (Cefazolin Sandoz)

This is a new strength in addition to the 500mg and 1g strengths currently PBS listed as a restricted benefit for patients with:

-          Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent;

-          Septicaemia, suspected;

-          Septicaemia, proven; and

-          Cellulitis.

 

9322P Dabigatran etexilate, Capsule 75 mg (as mesilate) (Pradaxa)

9318K Dabigatran etexilate, Capsule 75 mg (as mesilate) (Pradaxa) (Diff. Max. Rpts)

9320M Dabigatran etexilate, Capsule 75 mg (as mesilate), 60 (Pradaxa)

9323Q Dabigatran etexilate, Capsule 110 mg (as mesilate) (Pradaxa)

9319L Dabigatran etexilate, Capsule 110 mg (as mesilate) (Pradaxa) (Diff. Max. Rpts)

9321N Dabigatran etexilate, Capsule 110 mg (as mesilate), 60 (Pradaxa)

The PBAC recommended the Authority Required PBS listing of dabigatran for prevention of venous thromboembolic events in a patient undergoing total hip replacement and total knee replacement on a cost minimisation basis compared with enoxaparin. Dabigatran is the second PBS listed oral anti-thrombotic agent (rivaroxaban being the first which was listed on 1 Aug 09) for prevention of venous thrombosis following hip or knee replacement surgery.

Venous thromboembolism remains a significant cause of complications and mortality post joint replacement surgery despite previously available anticoagulants. Oral dabigatran offers consumers an alternate prophylactic medicine that is easy to take following discharge from hospital. See also Clinical Practice Guidelines for the prevention of venous thromboembolism in patients admitted to Australian hospitals. http://www.nhmrc.gov.au/_files_nhmrc/file/nics/programs/vtp/guideline_prevention_venous_thromboembolism.pdf

                                   

9329B Essential amino acids formula, Powder 200 g, 2 (Essential Amino Acid Mix)

On the advice of the Nutritional Products Working Party the PBAC recommended Essential Amino Acid Mix^® should be made available for the treatment of urea cycle disorders and gyrate atrophy of the choroid and retina.

Gyrate atrophy of the choroid and retina is an inherited disorder characterised by progressive vision loss.

Urea cycle disorder is a genetic disorder caused by a deficiency of one of the enzymes in the urea cycle which is responsible for removing ammonia from the blood stream. The urea cycle involves a series of biochemical steps in which nitrogen, a waste product of protein metabolism, is removed from the blood and converted to urea.

 

9324R Glucose indicator—blood, Test strips, 50 (WaveSense Jazz)

9325T Glucose indicator—blood, Test strips, 50 (WaveSense Jazz) (Diff. Max. Rpts)

The PBAC recommended an additional agent for use by people with diabetes to test the amount of glucose in their blood.

This product is also listed under the 08/09 Budget Policy Proposal Outcome 3 part 2, expense measure, Medicare Benefits Schedule – reduction of repeat prescription requirements for patients with chronic conditions. Where patients are receiving treatment under a GP management plan or team care arrangement prescribers can use item 9325T to provide up to 11 repeats of glucose indicators.

 

9331D Lansoprazole, Tablet 15 mg (orally disintegrating) (Zoton FasTabs)

This is a dispersible tablet formulation of lansoprazole listed for the treatment of gastro-oesophageal reflux disease and scleroderma. This formulation is bioequivalent to lansoprazole capsules.

 

2240X Lansoprazole, Capsule 30 mg (Zopral)

This is a capsule formulation listed for the treatment of peptic ulcer. This formulation is bioequivalent to the dispersible 30 mg tablet formulation of lansoprazole currently PBS listed.

 

2241Y Lansoprazole, Capsule 30 mg (Zopral) (Diff. Max. Rpts)

This is a capsule formulation listed for the treatment of gastro-oesophageal reflux disease and scleroderma. This formulation is bioequivalent to the 30 mg dispersible tablet formulation of lansoprazole currently PBS listed.

 

9327X Triglycerides, medium chain, Emulsion 250 mL (Liquigen)

The PBAC noted the advice of the Nutritional Products Working Party that Liquigen^® should be made available as an Authority required listing for use in chylous ascites; chylothorax; fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis and gastrointestinal disorders; hyperlipoproteinaemia type 1; intractable childhood epilepsy requiring a ketogenic diet; long chain fatty acid oxidation disorders.

Liquigen^® is an emulsion which mixes easily into food and drink and is therefore more acceptable. This listing is unlikely to result in more patients starting treatment but rather patients will switch from other medium chain triglyceride formulations to Liquigen^®.

 

9328Y Vitamins, minerals and trace elements with carbohydrate, Powder 200 g (Paediatric Seravit)

The PBAC noted the advice of the Nutritional Products Working Party that Paediatric Seravit^® should be made available for use in infants and children where vitamin and mineral intake is insufficient due to highly restrictive therapeutic diets, and recommended the product be listed as an Authority Required benefit.

The PBAC agreed with the advice of the Nutritional Products Working Party that Paediatric Seravit^® should be reserved for patients with a specific diagnosis on a significantly restricted therapeutic diet, including but not limited to, patients with some rare metabolic disorders; and the advice of a dietician and a paediatrician should be sought before use.

 

ALTERATIONS

Alterations - Item Descriptions

 

From: 9468H Rivaroxaban, Tablet 10 mg (Xarelto)

To: 9468H Rivaroxaban, Tablet 10 mg, 10 (Xarelto)

As a result of this change, the Maximum Quantity for item 9468H is changing from 10 to 1.

From: 9469J Rivaroxaban, Tablet 10 mg, 15 (Xarelto)

To: 9469J Rivaroxaban, Tablet 10 mg (Xarelto)

As a result of this change, the Maximum Quantity for item 9469J is changing from 1 to 15.

Due to reported confusion with providing an adequate supply for a course of rivaroxaban the description of form and maximum quantity has been altered to allow the 15 tablet pack size to be broken and the 10 tablet pack size to not be broken.

 

Alterations - Restrictions

 

8071T Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL (Taxotere)

8074Y Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL and 1 single use vial solvent 6 mL (Taxotere)

The PBAC recommended listing of docetaxel on the PBS for the adjuvant treatment of operable breast cancer in combination with cyclophosphamide compared with the chemotherapy regimen doxorubicin with cyclophosphamide. Docetaxel plus cyclophosphamide regimen will provide an alternative non-anthracycline adjuvant treatment for operable breast cancer.

 

1471K Fluconazole, Capsule 50 mg (DBL Fluconazole, Diflucan, Dizole 50, Fluconazole Sandoz, Fluzole 50,Ozole)

1472L Fluconazole, Capsule 100 mg (Ozole, DBL Fluconazole, Diflucan, Dizole 100, Fluconazole Sandoz, Fluconazole Winthrop)

1475P Fluconazole, Capsule 200 mg (APO-Fluconazole, DBL Fluconazole, Diflucan, Dizole 200, Fluconazole Sandoz, Fluconazole Winthrop, Fluzole 200, Ozole)

1473M Fluconazole, Solution for I.V. infusion 100 mg in 50 mL (Diflucan, Fluconazole Hexal)

1474N Fluconazole, Solution for I.V. infusion 200 mg in 100 mL (Baxter Healthcare Pty Ltd, Diflucan, Fluconazole Hexal)

1757L Fluconazole, Solution for I.V. infusion 400 mg in 200 mL (Baxter Healthcare Pty Ltd)

9363T Voriconazole, Tablet 50 mg (Vfend)

9364W Voriconazole, Tablet 200 mg (Vfend)

9452L Voriconazole, Powder for oral suspension 40 mg per mL, 70 mL (Vfend)

The PBAC recommended that the requirement for patients to be not able to tolerate amphotericin be removed from the fluconazole restrictions for the treatment of cryptococcal meningitis and the treatment of serious and life-threatening Candida infections.  The PBAC also recommended the removal of the requirement to fail or not be able to tolerate amphotericin from the voriconazole restrictions for the treatment and maintenance of serious Candida infections and serious invasive mycosis.  These restriction wording changes were recommended due to the deletion of amphotericin powder for injection from the PBS and there being currently no alternate injectable amphotericin product.

 

8298R Naratriptan, Tablet 2.5 mg (as hydrochloride) (Naramig) (Special Pharmaceutical Benefit)

9734H Naratriptan, Tablet 2.5 mg (as hydrochloride) (Naramig) (Special Pharmaceutical Benefit) (Diff.Restriction)

8144P Sumatriptan, Tablet 50 mg (as succinate) (Imigran, Sumatab, Sumagran 50)

8885P Sumatriptan, Tablet (fast disintegrating) 50 mg (as succinate) (Imigran FDT)

8341B Sumatriptan, Nasal spray 20 mg in 0.1 mL single dose unit (Imigran)

8266C Zolmitriptan, Tablet 2.5 mg (Zomig) (Special Pharmaceutical Benefit)

9736K Zolmitriptan, Tablet 2.5 mg (Zomig) (Special Pharmaceutical Benefit) (Diff. Restriction)

The following restriction changes were proposed at the November 2009 PBAC meeting in line with current migraine treatment guidelines:

- remove the requirement to trial ergotamine prior to use of a 5HT₁ agonist (triptan) to treat an acute migraine attack in line with current migraine treatment guidelines; and

- remove the requirement to fail a reasonable trial of prophylactic medication before use of a triptan, but retain triptans as second line treatment after failure of or contraindication to simple analgesics for the treatment of acute migraine.

 

9202H Quetiapine, Tablet (modified release) 50 mg (as fumarate) (Seroquel XR)

9203J Quetiapine, Tablet (modified release) 200 mg (as fumarate) (Seroquel XR)

9204K Quetiapine, Tablet (modified release) 300 mg (as fumarate) (Seroquel XR)

9205L Quetiapine, Tablet (modified release) 400 mg (as fumarate) (Seroquel XR)

The PBAC recommended that quetiapine modified release tablets be listed with the same restrictions as the immediate release preparations for the treatment of bipolar I disorder on the basis of demonstrated efficacy in the treatment of acute mania and bipolar depression.

 

9288W Zoledronic acid, Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL (Aclasta)

The PBAC recommended extending the listing of zoledronic acid to include treatment for corticoid-induced osteoporosis in a patient on long-term, high-dose corticosteroid therapy with a Bone Mineral Density (BMD) T-score of -1.5 or less on a cost-minimisation basis with risedronate.  

The PBAC also recommended amending the listing of zoledronic acid 5 mg infusion to include men with established osteoporosis with fractures other than hip fracture due to minimal trauma, and men aged 70 years or older with a Bone Mineral Density (BMD) T-score of -3 or less on the basis of non-inferiority to alendronate sodium in these patient groups.

The PBAC noted the TGA approved indications for zoledronic acid had recently been extended to include these two patient groups.

 

The following are now "Authority required (STREAMLINED)" items:

1417N Flutamide, Tablet 250 mg (Eulexin, Flutamin)

8131Y Nilutamide, Tablet 150 mg (Anandron)

8875D Leuprorelin acetate, I.M. injection (modified release), powder for injection 7.5 mg with diluent in pre-filled dual-chamber syringe (Lucrin Depot 7.5mg PDS)

8876E Leuprorelin acetate, I.M. injection (modified release), powder for injection 22.5 mg with diluent in pre-filled dual-chamber syringe (Lucrin Depot 3 Month PDS)

8877F Leuprorelin acetate, I.M. injection (modified release), powder for injection 30 mg with diluent in pre-filled dual-chamber syringe (Lucrin Depot 4 Month PDS)

8707G Leuprorelin acetate, Suspension for subcutaneous injection (modified release), 7.5 mg injection set (Eligard 1 month)

8708H Leuprorelin acetate, Suspension for subcutaneous injection (modified release), 22.5 mg injection set (Eligard 3 month)

8709J Leuprorelin acetate, Suspension for subcutaneous injection (modified release), 30 mg injection set (Eligard 4 month)

8859G Leuprorelin acetate, Suspension for subcutaneous injection (modified release), 45 mg injection set (Eligard 6 month)

9378N Triptorelin, Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles (Diphereline)

9379P Triptorelin, Powder for I.M. injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles (Diphereline)

The PBAC considered that the PBS listings for oral anti-androgens, leuprorelin acetate and triptorelin acetate for the treatment of prostate cancer should be amended to a Streamlined Authority Required listing.  Prescribers will no longer need to phone Medicare Australia for an approval to prescribe.

The PBAC noted that Streamlined Authorities are limited to those Authority Required medicines that treat chronic and stable long-term conditions, with stable dosage regimens and those that are less susceptible to misuse.

 

8654L Levetiracetam, Tablet 250 mg (Keppra)

8655M Levetiracetam, Tablet 500 mg (Keppra)

8656N Levetiracetam, Tablet 1 g (Keppra)

9169N Levetiracetam, Oral solution 100 mg per mL, 300 mL (Keppra)

The listings for levetiracetam were amended to a Streamlined Authority Required listing in order to be consistent with other PBS listed anti-epileptic products.

 

SECTION 100 - HIGHLY SPECIALISED DRUGS PROGRAM

ADDITIONS

Additions - Items

 

9572T Maraviroc, Tablet 150 mg (Celsentri)

9573W Maraviroc, Tablet 300 mg (Celsentri)

The PBAC recommended the PBS listing of maraviroc tablets in the Section 100 Highly Specialised Drugs Program for the treatment of HIV. Maraviroc is used in combination with other HIV medications in patients who have previously been on HIV medications and who meet certain criteria.

 

9574X Methoxy polyethylene glycol-epoetin beta, Injection 30 micrograms in 0.3 mL pre-filled syringe (Mircera)

9575Y Methoxy polyethylene glycol-epoetin beta, Injection 50 micrograms in 0.3 mL pre-filled syringe (Mircera)

9576B Methoxy polyethylene glycol-epoetin beta, Injection 75 micrograms in 0.3 mL pre-filled syringe (Mircera)

9577C Methoxy polyethylene glycol-epoetin beta, Injection 100 micrograms in 0.3 mL pre-filled syringe (Mircera)

9578D Methoxy polyethylene glycol-epoetin beta, Injection 120 micrograms in 0.3 mL pre-filled syringe (Mircera)

9579E Methoxy polyethylene glycol-epoetin beta, Injection 200 micrograms in 0.3 mL pre-filled syringe (Mircera)

9580F Methoxy polyethylene glycol-epoetin beta, Injection 360 micrograms in 0.3 mL pre-filled syringe (Mircera)

The PBAC recommended the PBS listing of methoxy-polyethylene glycol-epoetin beta in the Section 100 Highly Specialised Drugs Program for treatment of anaemia requiring transfusion, where intrinsic renal disease is the primary cause of anaemia.

 

9571R Nevirapine, Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL (Viramune)

The PBAC recommended the listing of nevirapine oral suspension 10 mg per mL on the basis of comparable effectiveness with the solid dose preparation mg for mg. The PBAC considered there is a clinical need for a liquid formulation of nevirapine for use in children on the PBS, and that the drug has an important place in the treatment of HIV in a clearly defined population. 

The PBAC noted the application for listing had followed from a request from the Paediatric Medicines Advisory Group that the sponsor consider listing the suspension on the PBS. 

 

ALTERATIONS

Alteration - Restriction

 

9616D Darunavir, Tablet 300 mg (as ethanolate) (Prezista)

The PBAC recommended that darunavir co-administered with ritonavir be listed for the treatment of HIV in combination with other antiretroviral agents for patients who have failed previous treatment with, or have resistance to, one antiretroviral treatment regimen, on a cost minimisation basis compared with lopinavir with ritonavir (Kaletra^®).  This will enable darunavir to be available earlier in the treatment pathway.