New Listings and Changes 1 August 2010
New Listings and Changes 1 August 2010
ADDITIONS
3417W Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid, Oral liquid 125 mL, 36 (HCU Anamix junior LQ)
Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid, (HCU Anamix Junior LQ®) is listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of pyridoxine non-responsive homocystinuria. This product is listed at the same cost basis per gram of protein (ex-manufacturer) as the currently listed products for pyridoxine non-responsive homocystinuria.
3438Y Brinzolamide with timolol maleate, Eye drops 10 mg-5 mg (base) per mL (1%-0.5%), 5 mL (Azarga)
5562R Brinzolamide with timolol maleate, Eye drops 10 mg-5 mg (base) per mL (1%-0.5%), 5 mL (Azarga) (Optometrical)
Brinzolomide with timolol maleate (Azarga®) is a new combination eye drop being listed on the PBS for the reduction of elevated intraocular pressure in certain patients with open-angle glaucoma or ocular hypertension that are not controlled on monotherapy (the single components). This product is being listed under the same restriction as other similar combination eye drops Combigan® and Cosopt®, also used in treating glaucoma. Brinzolomide with timolol maleate will offer patients an alternative to these preparations.
3425G Certolizumab pegol, Injection 200 mg in 1 mL single use pre-filled syringe (Cimzia)
Certolizumab pegol (Cimzia®) is a new biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for treatment of severe active rheumatoid arthritis. This alternative bDMARD is listed under the same restriction as adalimumab. The recent changes to eligibility criteria for all bDMARDS for severe active Rheumatoid Arthritis will also apply to Certolizumab pegol.
3410L Colchicine, Tablets 500 micrograms, 30 (Lengout, Colgout)
This new item relates to the listing of a new pack size of 30 tablets in a child resistant bottle to replace the current pack size of 100 tablets. Colchicine is used in the treatment of gout and the maximum recommended dose is three tablets a day over 4 days (a maximum of 12 tablets in total). The 100 tablet pack size means that there was wastage of this medicine and potentially large quantities of unused tablets being kept in people’s homes, posing an increased risk of accidental poisoning.
3423E Exenatide, Injection solution 5 micrograms per dose in pre-filled pen, 60 doses (Byetta 5 microgram)
3424F Exenatide, Injection solution 10 micrograms per dose in pre-filled pen, 60 doses (Byetta 10 microgram)
Exenatide (Byetta®) is a new injectable treatment for people with type 2 diabetes. It is prescribed as an adjunctive treatment to improve blood glucose control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of both. Exenatide, like insulin, is an injectable treatment but unlike insulin the dose is not titrated to blood glucose levels. Exenatide comes in a prefilled syringe for subcutaneous injection in two strengths; 5mg and 10mg. The injection is intended to be self administered night and morning. This new product offers an alternative treatment to the use of other third line oral hypoglycaemic agents such as thiozolidinediones (rosiglitasone, pioglitazone), gliptins (sitagliptin) or insulin.
3411M Glucose indicator—blood, Test strips, 100 (Accu-Chek Advantage/Sensor Comfort)
3412N Glucose indicator—blood, Test strips, 100 (Accu-Chek Advantage/Sensor Comfort) (Diff. Max. Rpts)
A new brand and quantity of blood glucose test strips is listed at the same price as other currently listed glucose indicator strips.
3437X Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen (Simponi) (Diff. Max. Rpts)
3435T Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen (Simponi) (Diff. Max. Rpts)
3434R Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe (Simponi) (Diff. Max. Rpts)
3436W Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe (Simponi) (Diff. Max. Rpts)
Golimumab (Simponi®) is a human monoclonal antibody that acts as an anti-inflammatory and immune regulatory agent in conditions such as ankylosing spondylitis, psoriatic arthritis, rheumatoind arthritis and other chronic inflammatory diseases.
The listing of Golimumab for active ankylosing spondylitis will provide an alternative bDMARD to other currently listed medicines such as adalimumab, etanercept and infliximab. Golimumab may offer some additional convenience to patients as it is only administered once monthly as a subcutaneous injection, Other bDMARDs have more frequent dosing schedules and some require infusions that are administered over 2 hours.
3431N Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen (Simponi) (Diff. Max. Rpts)
3433Q Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen (Simponi) (Diff. Max. Rpts)
3430M Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe (Simponi) (Diff. Max. Rpts)
3432P Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe (Simponi) (Diff. Max. Rpts)
Listed on the PBS as an authority required item for the treatment of adult patients with severe active psoriatic arthritis.
3427J Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen (Simponi)
3426H Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe (Simponi)
3429L Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen (Simponi) (Diff. Max. Rpts)
3428K Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe (Simponi) (Diff. Max. Rpts)
Golimumab (Simponi®) is a new bDMARD for treatment of severe active rheumatoid arthritis. This alternative bDMARD is listed under the same restriction as adalimumab.
3416T Macrogol 3350, Powder for oral solution 510 g (OsmoLax)
5427P Macrogol 3350, Powder for oral solution 510 g (OsmoLax) (Palliative Care)
5426N Macrogol 3350, Powder for oral solution 510 g (OsmoLax) (Palliative Care) (Diff. Max. Rpts)
This is a new form of macrogol 3350 laxative (Osmolax®) listed in the General and Palliative Care Schedules. The submission claims that macrogol without electrolytes will replace some of the current macrogol with electrolytes on the PBS.
3413P Mesalazine, Tablet 1 g (prolonged release) (Pentasa)
This listing is for a new strength of prolonged release mesalazine (Pentasa®) formulation restricted for the treatment of ulcerative colitis and Crohn disease in patients who are intolerant or hypersensitive to sulphonamides (sulphasalazine).
3439B Metformin hydrochloride, Tablet 1 g (extended release) (Diabex XR 1000)
This listing is a new higher strength of the extended release oral hypoglycaemic, to be used in the treatment of type 2 diabetes.
3440C Methylphenidate hydrochloride, Capsule 10 mg (modified release) (Ritalin LA)
This is a new lower strength of the modified release formulation that will allow for more flexibility in accommodating paediatric doses.
3418X Pramipexole hydrochloride, Tablet 0.375 mg (extended release) (Sifrol ER)
3419Y Pramipexole hydrochloride, Tablet 0.75 mg (extended release) (Sifrol ER)
3420B Pramipexole hydrochloride, Tablet 1.5 mg (extended release) (Sifrol ER)
3421C Pramipexole hydrochloride, Tablet 3 mg (extended release) (Sifrol ER)
3422D Pramipexole hydrochloride, Tablet 4.5 mg (extended release) (Sifrol ER)
The listing of the above extended release (ER) formulations of pramipexole (Sifrol®) will allow patients with Parkinson disease to be treated with a single daily dose, instead of three doses per day. The ER formulation is likely to increase patient convenience and possibly compliance. There will be no change in the number of patients eligible for treatment.
3415R Vildagliptin, Tablet 50 mg (Galvus)
In March 2010 the PBAC recommended the listing of vildagliptin (Galvus®) as an Authority required (Streamlined) benefit for the treatment of Type 2 diabetes mellitus, in combination with metformin or a sulfonylurea, in a patient whose HbA1c is greater than 7 % despite treatment with either metformin or a sulfonylurea and where a combination of metformin and a sulfonylurea is contraindicated or not tolerated. Listing was recommended on a cost-minimisation basis with sitagliptin.
Type 2 diabetes is a metabolic disorder characterised by hyperglycaemia resulting from resistance to the action of insulin, insufficient insulin secretion or both. Diet and lifestyle modifications are the first steps in managing the disease, followed by the addition of drug therapy with metformin. When diet, lifestyle modifications and metformin monotherapy is inadequate in controlling blood sugar levels, current treatment guidelines recommend adding a sulfonylurea. If dual therapy with metformin and a sulfonylurea is not tolerated or contraindicated, then the option is to add another oral hypoglycaemic agent such as a thiazolidinediones (glitasones), sitagliptin or vildaglitpin.
ALTERATIONS
Alterations — Restrictions
9099X Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira)
9100Y Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira) (Diff. Max. Rpts)
9101B Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira) (Diff. Max. Rpts)
9102C Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira) (Diff. Max. Rpts)
9103D Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira) (Diff. Max. Rpts)
9104E Adalimumab, Injection 40 mg in 0.8 mL pre-filled pen (Humira) (Diff. Max. Rpts)
8737W Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira)
8741C Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira)(Diff. Max. Rpts)
9033K Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira) (Diff. Max. Rpts)
9034L Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira) (Diff. Max. Rpts)
9077R Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira) (Diff. Max. Rpts)
9078T Adalimumab, Injection 40 mg in 0.8 mL pre-filled syringe (Humira) (Diff. Max. Rpts)
There are a number of restriction changes for adalimumab (Humira®) relating to quantities and repeats of section 100 items, the addition of three new drugs for severe active Rheumatoid Arthritis (RA), and new initiation and continuation criteria in RA.
8773R Anakinra, Injection 100 mg in 0.67 mL single use pre-filled syringe (Kineret)
8774T Anakinra, Injection 100 mg in 0.67 mL single use pre-filled syringe (Kineret) (Diff. Max. Rpts)
There are a number of restriction changes for anakinra (Kineret®) relating to maximum quantities and repeats of section 100 items, the addition of three new drugs for RA and new initiation and continuation criteria in RA.
8808N Aprepitant, Pack containing 1 capsule 125 mg and 2 capsules 80 mg (Emend)
The restriction for aprepitant (Emend®) has been extended to include the treatment of nausea and vomiting in patients receiving the following moderately emetogenic chemotherapies which does not respond to other anti emetics .
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide at a dose of less than 1500 mg per square metre per day;
(e) cytarabine at a dose of greater than 1 g per square metre per day;
(f) dactinomycin;
(g) daunorubicin;
(h) doxorubicin;
(i) epirubicin;
(j) fotemustine;
(k) idarubicin;
(l) ifosfamide;
(m) irinotecan;
(n) melphalan;
(o) methotrexate at a dose of 250 mg to 1 g per square metre;
(p) oxaliplatin;
(q) raltitrexed.
8361C Capecitabine, Tablet 150 mg (Xeloda)
8362D Capecitabine, Tablet 500 mg (Xeloda)
The current restriction for Capecitabine (Xeloda®) has been altered to include treatment of previously untreated advanced (Stage III or IV) oesopho-gastric cancer, in combination with a cisplatin-based regimen, in a patient with a WHO performance status of 2 or less.
8778B Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Enbrel)
8779C Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Enbrel) (Diff. Max. Rpts)
9035M Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Enbrel) (Diff. Max. Rpts)
9036N Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Enbrel) (Diff. Max. Rpts)
8637N Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Enbrel) (Diff. Max. Rpts)
8638P Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Enbrel) (Diff. Max. Rpts)
9455P Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel)
9456Q Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)
9457R Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)
9458T Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)
9459W Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)
9460X Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4 (Enbrel) (Diff. Max. Rpts)
9085E Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel)
9086F Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
9087G Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
9088H Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
9089J Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
9090K Etanercept, Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Enbrel) (Diff. Max. Rpts)
There are a number of restriction changes for etanercept (Enbrel®) relating to quantities and repeats of section 100 items, addition of three new drugs for RA and new indication and continuation criteria.
9111M Imatinib, Tablet 100 mg (as mesylate) (Glivec)
9112N Imatinib, Tablet 400 mg (as mesylate) (Glivec)
There has been an alteration to the initiation criteria for existing use in the treatment of gastro intestinal tumour (GIST).
8540L Oxaliplatin, Powder for I.V. infusion 100 mg (Hospira Pty Limited, Oxalatin, Oxaliplatin Alphapharm, Oxaliplatin Actavis, Oxaliplatin Ebewe, Oxaliplatin Link, Winthrop
Oxaliplatin)
8539K Oxaliplatin, Powder for I.V. infusion 50 mg (Hospira Pty Limited, Oxalatin, Oxaliplatin Alphapharm, Oxaliplatin Actavis, Oxaliplatin Ebewe, Oxaliplatin Link)
8847P Oxaliplatin, Solution concentrate for I.V. infusion 50 mg in 10 mL (DBL Oxaliplatin Concentrate, Eloxatin)
8848Q Oxaliplatin, Solution concentrate for I.V. infusion 100 mg in 20 mL (DBL Oxaliplatin Concentrate, Eloxatin)
2310N Oxaliplatin, Solution concentrate for I.V. infusion 200 mg in 40 mL (Eloxatin)
There has been an alteration to the restriction to include treatment of advanced or metastatic colorectal cancer in combination with capecitabine.
SECTION 100 — HIGHLY SPECIALISED DRUGS PROGRAM
Additions — Items
9674E Infliximab, Powder for I.V. infusion 100 mg (Remicade)
This listing is for a new restriction (and item) for treatment of complex refractory fistulising Crohn disease. There are currently no other effective therapies available on the PBS for patients with this debilitating condition. Crohn disease is a chronic inflammatory disorder of the gastrointestinal tract that can be complicated by the development of fistulae, which are abnormal passageways from the bowel to other parts of the body, both internal and external. These fistulae can cause significant morbidity, through pain, infection and abnormal loss of body fluids.
Currently available forms of medical management of this condition including steroids and antibiotics have a low success rate in healing active fistulae.
9677H Ritonavir, Tablet 100 mg (Norvir)
New listing of a tablet form to replace the currently listed capsules.
9676G Tipranavir, Oral liquid 100 mg per mL, 95 mL (Aptivus)
Liquid formulation for those that are unable to swallow other oral forms currently listed.
9671B Tocilizumab, Concentrate for injection 80 mg in 4 mL (Actemra)
9672C Tocilizumab, Concentrate for injection 200 mg in 10 mL (Actemra)
9673D Tocilizumab, Concentrate for injection 400 mg in 20 mL (Actemra)
New listing for severe active rheumatoid arthritis. This medicine will share the market with other currently listed bDMARDs for rheumatoid arthritis.
9675F Valganciclovir hydrochloride, Powder for oral solution 50 mg (base) per mL, 100 mL (Valcyte)
The PBAC recommended the listing of valganciclovir powder (Valcyte®) for oral solution on the PBS under the same circumstances as the currently subsidised tablets for treatment of Cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome; and Prophylaxis of cytomegalovirus infection and disease in solid organ transplant patients at risk of cytomegalovirus disease
ALTERATIONS
Alterations — Restrictions
9621J Abatacept, Powder for I.V. infusion 250 mg (Orencia)
There are a number of restriction changes for abatacept relating to the addition of three new drugs for RA and and new initiation and continuation criteria in RA.
6448J Infliximab, Powder for I.V. infusion 100 mg (Remicade)
6397Q Infliximab, Powder for I.V. infusion 100 mg (Remicade) (Diff. Restriction)
6496X Infliximab, Powder for I.V. infusion 100 mg (Remicade) (Diff. Restriction)
There are a number of restriction changes for infliximab (Remicade®) relating to maximum quantities and repeats of section 100 items, the addition of three new drugs for RA and golimumab for ankylosing spondilitis, and new initiation and continuation criteria in RA.
9629T Raltegravir potassium, Tablet 400 mg (base) (Isentress)
Raltegravir (Isentress®) is currently PBS listed for use in combination with other antiretroviral agents in an antiretroviral experienced patient, for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. In March 2010 the PBAC recommended an alteration to the current restriction to include the treatment of naïve patients (patients that have not received any prior antiretroviral medicines) on a cost minimisation basis compared with efavirenz (also currently PBS listed for the treatment of naïve patients). Raltegravir will provide an alternate treatment option for patients initiating antiretroviral medicines for HIV infection.
9611W Rituximab, Solution for I.V. infusion 500 mg in 50 mL (Mabthera)
This alteration to the restriction for rituximab (Mabthera®) incorporates changes to the initiation and continuation criteria for all bDMARDs in rheumatoid arthritis.
HUMAN GROWTH HORMONE PROGRAM
ADDITIONS
9585L Somatropin (recombinant human growth hormone), Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative) (Genotropin GoQuick)
9586M Somatropin (recombinant human growth hormone), Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative) (Genotropin GoQuick)
These new pens deliver different dose increments to the currently PBS listed somatropin 5 mg and 12 mg re-usable pens.
IVF/GIFT PROGRAM
ADDITIONS
Additions — Items
9583J Ganirelix, Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe (Orgalutran)
9584K Ganirelix, Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe (Orgalutran) (Diff. Max. Qty)
Ganirelix (Orgalutran®) is a new listing in the Section 100 (IVF GIFT Program) for prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. Ganirelix (0.25 mg) is injected subcutaneously once daily, starting preferably on day 6 of FSH administration. Daily treatment with ganirelix should be continued up to the day that sufficient follicles of adequate size are present.
Infertility is affecting an increasing number of people, with prevalence estimates of 7-15% in developed countries and becomes more common with increasing age in women and in women who are over-weight or under-weight. The average prevalence of infertility has been estimated at 5.5% at age 25-29 years, 9.4% at age 30-34 years and 19.7% at age 35-39 years (National Collaborating Centre for Women's and Children's Health 2004).
In Australia the current infertility and lifetime infertility rates[1] are documented as 3.5% and 19.1% respectively (Boivin et al. 2007). However, this Australian data, based on a 1988 survey (Webb and Holman 1992) is unlikely to reflect social and cultural change resulting in women waiting to have children until later, increasing obesity etc, and so the figures are likely to be conservative estimates of infertility.
[1] Current infertility/sub-fecundity was surveyed by the question -‘Are you presently experiencing a delay in conception/difficulty in carrying a child?’ and lifetime infertility by – ‘Have you ever experienced a delay in conception/carrying a child?’) or a period of childlessness after marriage (After being married for [specified number] years do you have a child?.