New Listings and Changes 1 September 2011

Additions – Items

5276Q Calcipotriol with Betamethasone Dipropionate, Gel 50 micrograms-500 micrograms (base) per g (0.005%-0.05%), 30 g (Daivobet 50/500 gel)

Treats chronic stable plaque type psoriasis of the scalp not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy. The PBAC (November 2010) recommended out of session the listing of a new formulation of calcipotriol with betamethasone, on a cost-minimisation basis with the currently PBS-listed ointment formulation.

 

5447Q Cetuximab, Solution for I.V. infusion 100 mg in 20 mL (Erbitux)
5448R Cetuximab, Solution for I.V. infusion 500 mg in 100 mL (Erbitux)

Treats various cancers. The PBAC (July 2010) recommended listing cetuximab on the PBS as an Authority Required listing for the treatment of metastatic colorectal cancer in patients who meet certain criteria on the basis of high but acceptable cost-effectiveness compared with best supportive care.

 

5564W Ciprofloxacin, Eye drops 3 mg per mL (0.3%), 5 mL (Ciloxan, CiloQuin) (Optometrical)

Treats bacterial keratitis. The PBAC (April 2011) recommended the addition of thisitem to the list of preparations which may be prescribed by authorised optometrists. This item is already PBS listed in the General Schedule.

 

5436D Clopidogrel, Tablet 75 mg (Clopidogrel DRLA)

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events. Prevention of recurrence of myocardial infarction or unstable angina in patients. The PBAC recommended out of session the listing of clopidogrel (free base) tablets on a cost-minimisation basis with the currently listed clopidogrel products.

 

5445N Dalteparin Sodium (low Molecular Weight Heparin Sodium—porcine mucous) , Injection 12,500 units (anti-Xa) in 0.5 mL single dose pre-filled syringe (Fragmin)

The PBAC (November 2010) recommended to extend the listing of dalteparin on the PBS as a Restricted Benefit for the management of symptomatic venous thromboembolism in a patient with a solid tumour(s) on a cost-minimisation basis compared with enoxaparin.

 

5565X Dexamethasone, Eye drops 1 mg per mL (0.1%), 5 mL (Maxidex) (Optometrical)

Treats inflammation of the eyes. The PBAC (April 2011) recommended the addition of this itemto the list of preparations which may be prescribed by authorised optometrists. This item is  already PBS listed in the General Schedule.

 

5434B Enoxaparin Sodium, Injection 80 mg (8,000 i.u. anti-Xa) in 0.8 mL pre‐filled syringe (Clexane)
5435C Enoxaparin Sodium, Injection 100 mg (10,000 i.u. anti-Xa) in 1 mL pre‐filled syringe (Clexane)

It is an anti-coagulant. The PBAC (March 2011) recommended that these higher strengths of enoxaparin sodium be also made available as pharmaceutical benefits for use in haemodialysis in addition to the lower strengths which are already available for this use.

 

5265D Fentanyl, Transdermal patch 1.28 mg (releasing approximately 12 micrograms per hour) (Denpax)
5437E Fentanyl, Transdermal patch 2.063 mg (releasing approximately 12 micrograms per hour) (Fenpatch 12)
5438F Fentanyl, Transdermal patch 4.125 mg (releasing approximately 25 micrograms per hour) (Fenpatch 25)
5439G Fentanyl, Transdermal patch 8.25 mg (releasing approximately 50 micrograms per hour) (Fenpatch 50)
5440H Fentanyl, Transdermal patch 12.375 mg (releasing approximately 75 micrograms per hour) (Fenpatch 75)
5441J Fentanyl, Transdermal patch 16.5 mg (releasing approximately 100 micrograms per hour) (Fenpatch 100)

Treats chronic severe disabling pain not responding to non-narcotic analgesia. The PBAC recommended Denpax® on a cost-minimisation basis to Durogesic® fentanyl patches (March 2011) and Fenpatch® in November 2009. Denpax® , Fenptach ® and Durogesic® are considered equivalent for the purposes of substitution.

 

8985X Ferrous Fumarate, Tablet 200 mg (equivalent to 65.7 mg iron) (Ferro-tab)

The PBAC (March 2011) recommended listing of ferrous fumarate 200 mg tablet on the PBS as an unrestricted benefit as an additional option for the treatment of anaemia . The PBAC agreed that the availability on the PBS of a funded iron preparation would improve access especially for disadvantaged groups including Aboriginal and Torres Strait Islanders and those on a low income.

The PBAC noted that the only available iron tablet  on the PBS contains folic acid (ferrous fumarate with folic acid) which may not be needed by some patients. Preparations containing only iron are available over-the-counter, but may not be affordable for concessional patients. The PBAC noted that the listing of the ferrous fumarate tablet would result in its likely replacement of current prescriptions for Ferro-F-Tab and Ferro-Liquid and therefore there would be minimal impact on the PBS expenditure.

 

5262Y Fingolimod, Capsule 500 micrograms (as hydrochloride) (Gilenya)

Subsequent to the PBAC March 2011 meeting after further negotiation with the sponsor, the PBAC recommended the listing fingolimod on the PBS as an Authority Required benefit for the initial and continuing treatment of clinically relapsing-remitting multiple sclerosis (RRMS) in a patient who meets certain criteria on the basis of an acceptable cost-effectiveness ratio compared with interferon beta-1a.

 

5446P Fluconazole, Powder for oral suspension 50 mg in 5 mL, 35 mL (Diflucan)

The PBAC recommended listing of fluconazole powder for oral suspension on the PBS as an Authority Required listing for the same indications as the currently listed fluconazole capsules for patients unable to take a solid dose form of fluconazole.

 

5566Y Gentamicin Sulfate, Eye drops 3 mg (base) per mL (0.3%), 5 mL (Genoptic) (Optometrical)

It is an anti-infective for eyes. The PBAC (April 2011) recommended the addition of this item to the list of preparations which may be prescribed by authorised optometrists. This itemis already PBS listed in the General Schedule.

 

5266E Glucose Indicator—blood, Test strips, 50 (TRUEresult)
5267F Glucose Indicator—blood, Test strips, 50 (TRUEbalance)
5268G Glucose Indicator—blood, Test strips, 50 (TRUEresult)
5269H Glucose Indicator—blood, Test strips, 50 (TRUEbalance)

Assists with the management of diabetes. The PBAC recommended out of session the listing of additional brands of test strips under the same conditions and at the same price as the currently listed test strips. Use will substitute for currently listed products.

 

5443L Imatinib, Tablet 100 mg (as mesylate) (Glivec)
5444M Imatinib, Tablet 400 mg (as mesylate) (Glivec)

The PBAC (March 2011) recommended to extend the current listing of imatinib on the PBS as an Authority Required benefit for the adjuvant treatment of GIST following complete resection of the primary tumour on the basis of an acceptable cost-effectiveness ratio compared with placebo.

 

5567B Ofloxacin, Eye drops 3 mg per mL (0.3%), 5 mL (Ocuflox) (Optometrical)

Treats bacterial keratitis. The PBAC (April 2011) recommended the addition of these items to the list of preparations which may be prescribed by authorised optometrists. These items are already PBS listed in the General Schedule.

 

5568C Prednisolone Acetate with Phenylephrine Hydrochloride, Eye drops 10 mg‐1.2 mg per mL (1%-0.12%), 10 mL (Prednefrin Forte) (Optometrical)

Treats uveitis (eye condition). The PBAC (April 2011) recommended the addition of these items to the list of preparations which may be prescribed by authorised optometrists. These items are already PBS listed in the General Schedule.

 

5569D Tobramycin, Eye drops 3 mg per mL (0.3%), 5 mL (Tobrex) (Optometrical)
5570E Tobramycin, Eye ointment 3 mg per g (0.3%), 3.5 g (Tobrex) (Optometrical)

It is an anti-infective for eyes. The PBAC (April 2011) recommended the addition of these items to the list of preparations which may be prescribed by authorised optometrists. These items are already PBS listed in the General Schedule.

 

Alterations – Restriction

8780D Risperidone, Powder for I.M. injection 25 mg (modified release) with 2 mL diluent in pre-filled syringe (Risperdal Consta)
8781E Risperidone, Powder for I.M. injection 37.5 mg (modified release) with 2 mL diluent in pre-filled syringe (Risperdal Consta)
8782F Risperidone, Powder for I.M. injection 50 mg (modified release) with 2 mL diluent in pre-filled syringe (Risperdal Consta)

The PBAC recommended extending the listing of risperidone (modified release) long acting injection (LAI) on the PBS as an Authority Required (STREAMLINED) benefit for maintenance treatment, in combination with lithium or sodium valproate, of treatment refractory bipolar I disorder on a cost-minimisation basis with oral olanzapine.

 

Section 100 – Highly Specialised Drugs Program

Alterations – Restriction

5654N Deferasirox, Tablet 125 mg (dispersible) (Exjade) (Public)
6499C Deferasirox, Tablet 125 mg (dispersible) (Exjade) (Private)
5655P Deferasirox, Tablet 250 mg (dispersible) (Exjade) (Public)
6500D Deferasirox, Tablet 250 mg (dispersible) (Exjade) (Private)
5656Q Deferasirox, Tablet 500 mg (dispersible) (Exjade) (Public)
9600G Deferasirox, Tablet 500 mg (dispersible) (Exjade) (Private)

Treats chronic iron overload in patients with disorders of erythropoiesis. Deferasirox is currently available for this patient group, but only if they are intolerant to desferrioxamine (DFO) or in whom DFO has proven ineffective (i.e. only second-line use after DFO is allowed). The PBAC (April 2011) recommended a change in the current PBS restriction for deferasirox to allow access to this therapy for the treatment of chronic iron overload as a first line agent for paediatric patients. Service volume is very low (around 2,300 services over the last 12 months). As only a fraction of these would be for 2-5 yr olds, no expected material impact to the PBS is expected from first line access.

 

5830W Filgrastim, Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim) (Private)
5829T Filgrastim, Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim) (Public)
6291D Filgrastim, Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) (Private)
5742F Filgrastim, Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) (Public)
9693E Filgrastim, Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) (Private)
9692D Filgrastim, Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) (Public)
6126K Filgrastim, Injection 300 micrograms in 1 mL (Neupogen) (Private)
5741E Filgrastim, Injection 300 micrograms in 1 mL (Neupogen) (Public)
6292E Filgrastim, Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) (Private)
5744H Filgrastim, Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) (Public)
9695G Filgrastim, Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) (Private)
9694F Filgrastim, Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) (Public)
6127L Filgrastim, Injection 480 micrograms in 1.6 mL (Neupogen) (Private)
5743G Filgrastim, Injection 480 micrograms in 1.6 mL (Neupogen) (Public)

It is an immunostimulant. Flow-on changes from the restriction changes recommended by the PBAC (March 2011) for pegfilgrastim (see below).

 

9514R Pegfilgrastim, Injection 6 mg in 0.6 mL single use pre-filled syringe (Neulasta) (Public)
6363X Pegfilgrastim, Injection 6 mg in 0.6 mL single use pre-filled syringe (Neulasta) (Private)

The PBAC (March 2011) recommended listing pegfilgrastim on the PBS under section 100 for the treatment of Hodgkin disease (HD) with first-line chemotherapy, escalated BEACOPP (BE), on the basis of clinical need.

 

Section 100 – Opiate Dependence Treatment Program

Additions – Items

9749D Buprenorphine with Naloxone, Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) (Suboxone Film 2/0.5)
9750E Buprenorphine with Naloxone, Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) (Suboxone Film 8/2)

Treatment of opiate dependence within a framework of medical, social and psychological treatment. The PBAC (March 2011) recommended listing buprenorphine with naloxone sublingual soluble film 2mg - 0.5 mg and 8mg - 2mg on the PBS as a Section 100 listing (Opiate Dependence Treatment Program) on a cost-minimisation basis compared with the currently listed sublingual tablets at the same price per milligram.