New Listings and Changes 1 November 2011

ADDITIONS

Alterations – Restriction

3410L Colchicine, Tablet 500 micrograms (Colgout, Lengout)
2272N Methotrexate, Tablet 10 mg (Methoblastin)
2395C Methotrexate, Injection 50 mg in 2 mL (Hospira Pty Limited, Pfizer Australiaa Pty Ltd)

The PBAC (July 2011) recommended an amendment to the number of repeats available on the PBS to 5 for colchicine and for methotrexate 50 mg vials.  The PBAC also recommended an amendment to the number of repeats for methotrexate 10 mg tablets (maximum quantity of 15) from 1 to 3.

 

9317J Clopidogrel, Tablet 75 mg (as hydrogen sulfate) (Iscover, Plavix, Clopidogrel Winthrop)
9296G Clopidogrel with Aspirin, Tablet 75 mg (as hydrogen sulfate)‐100 mg (DuoCover, CoPlavix, Clopidogrel Winthrop plus aspirin)

The PBAC (July 2011) recommended a minor amendment to the listings for clopidogrel to replace ‘acute coronary syndromes’ with ‘acute coronary syndrome’ which was considered to better describe the PBS-eligible population.

 

8495D Donepezil Hydrochloride, Tablet 5 mg (Aricept)
8496E Donepezil Hydrochloride, Tablet 10 mg (Aricept)
8770N Galantamine Hydrobromide, Capsule 8 mg (base) (prolonged release) (Reminyl, Galantyl)
8771P Galantamine Hydrobromide, Capsule 16 mg (base) (prolonged release) (Reminyl, Galantyl)
8772Q Galantamine Hydrobromide, Capsule 24 mg (base) (prolonged release) (Reminyl, Galantyl)
1956Y Memantine Hydrochloride, Tablet 10 mg (Ebixa, Memanxa, APO-Memantine)
9306T Memantine Hydrochloride, Tablet 20 mg (Ebixa)
9161E Rivastigmine, Transdermal patch 9 mg (releasing approximately 4.6 mg per 24 hours) (Exelon Patch 5)
9162F Rivastigmine, Transdermal patch 18 mg (releasing approximately 9.5 mg per 24 hours) (Exelon Patch 10)
8497F Rivastigmine Hydrogen Tartrate, Capsule 1.5 mg (base) (Exelon)
8498G Rivastigmine Hydrogen Tartrate, Capsule 3 mg (base) (Exelon)
8499H Rivastigmine Hydrogen Tartrate, Capsule 4.5 mg (base) (Exelon)
8500J Rivastigmine Hydrogen Tartrate, Capsule 6 mg (base) (Exelon)
8563Q Rivastigmine Hydrogen Tartrate, Oral solution 2 mg (base) per mL, 120 mL (Exelon)

The PBAC (July 2011) recommended a minor change to the listings for the above anti-dementia drugs to allow diagnosis to be made in consultation with a specialist/consultant physician (including a psychiatrist) in view of delays experienced in some remote areas for appointments to be made with one of these specialists. The current restriction specifies that the consultation must be with a specialist/consultant.

 

3401B Esomeprazole Magnesium Trihydrate, Tablet (enteric coated), equivalent to 40 mg esomeprazole (Nexium)

Esomeprazole magnesium trihydrate 40 mg is a restricted benefit for the healing of gastro-oesophageal reflux disease and pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion. For consistency with the PBS listings of other proton pump inhibitors, the PBAC (July 2011) recommended extending the listing of esomeprazole 40 mg to include scleroderma oesophagus.

 

5465P Nicotine, Transdermal patch releasing approximately 21 mg per 24 hours (Nicabate P)
3414Q Nicotine, Transdermal patch releasing approximately 21 mg per 24 hours (Nicotinell Step 1)

The PBAC (July 2011) recommended that the listings of the existing nicotine patches releasing approximately 21 mg per 24 hours be extended to include use in the Aboriginal and Torres Strait Islander patient population for greater consistency in the PBS Schedule.

 

8626B Tiotropium Bromide Monohydrate, Capsule containing powder for oral inhalation 18 micrograms (base) (for use in HandiHaler) (Spiriva)

The PBAC (July 2011) recommended simplifying the wording of the restriction to ‘Chronic obstructive pulmonary disease’ from ‘For the long-term maintenance treatment of bronchospasm and dyspnoea with chronic obstructive pulmonary disease’.

 

SECTION 100 – HIGHLY SPECIALISED DRUGS PROGRAM

Addition – Item

5825N Eltrombopag, Tablet 25 mg (as olamine) (Revolade) (Public)
5827Q Eltrombopag, Tablet 25 mg (as olamine) (Revolade) (Private)
5826P Eltrombopag, Tablet 50 mg (as olamine) (Revolade) (Public)
5828R Eltrombopag, Tablet 50 mg (as olamine) (Revolade) (Private)

The PBAC (March 2011) recommended the listing of eltrombopag for patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP), restricted to the same population as romiplostim.

Chronic ITP is a long-term autoimmune disorder characterised by persistently low platelet counts (thrombocytopenia) and bleeding. Bleeding can range from mild (bruising and purpura) to severe (intracranial or gastrointestinal haemorrhage) and can sometimes result in death. Eltrombopag assists in treating ITP by increasing the platelet count to a safe level.

Eltrombopag is an alternative to romiplostim for patients where splenectomy has failed or is contraindicated and where patients are unresponsive or intolerant to corticosteroids and intravenous immunoglobulin (IVIg) therapy.

 

Alterations – Restriction

9696H Romiplostim, Powder for injection 375 micrograms (250 micrograms in 0.5 mL when reconstituted) (Nplate) (Public)
9697J Romiplostim, Powder for injection 375 micrograms (250 micrograms in 0.5 mL when reconstituted) (Nplate) (Private)
9698K Romiplostim, Powder for injection 625 micrograms (500 micrograms in 1 mL when reconstituted) (Nplate) (Public)
9699L Romiplostim, Powder for injection 625 micrograms (500 micrograms in 1 mL when reconstituted) (Nplate) (Private)

Romiplostim is listed on the PBS for the treatment of severe thrombocytopenia in an adult patient with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP). The PBAC (July 2011) recommended the addition of the following note to the restriction for romiplostim to allow patients up to 24 weeks to trial either romiplostim or an alternative drug, eltrombopag, which will be available on the PBS from 1 November 2011 (see above).

Note: Patients will be able to trial either eltrombopag and/or romiplostim within the initial 24 weeks treatment period. Patients who fail to demonstrate a response to treatment with either eltrombopag and/or romiplostim under the initial restriction will not be eligible to receive further PBS‐subsidised treatment with either of these drugs.

 

6450L Adefovir Dipivoxil, Tablet 10 mg (Hepsera) (Private)
5606C Adefovir Dipivoxil, Tablet 10 mg (Hepsera) (Public)
5711N Entecavir Monohydrate, Tablet 0.5 mg (Baraclude) (Public)
9602J Entecavir Monohydrate, Tablet 0.5 mg (Baraclude) (Private)
5712P Entecavir Monohydrate, Tablet 1 mg (Baraclude) (Public)
9603K Entecavir Monohydrate, Tablet 1 mg (Baraclude) (Private)
5759D Interferon Alfa-2a, Injection 3,000,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Public)
6210W Interferon Alfa-2a, Injection 3,000,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Private)
5760E Interferon Alfa-2a, Injection 4,500,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Public)
6211X Interferon Alfa-2a, Injection 4,500,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Private)
5761F Interferon Alfa-2a, Injection 6,000,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Public)
6212Y Interferon Alfa-2a, Injection 6,000,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Private)
5762G Interferon Alfa-2a, Injection 9,000,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Public)
6213B Interferon Alfa-2a, Injection 9,000,000 i.u. in 0.5 mL single dose pre-filled syringe (Roferon-A) (Private)
5768N Interferon Alfa-2b, Solution for injection 10,000,000 i.u. in 1 mL single dose vial (Intron A) (Public)
6246R Interferon Alfa-2b, Solution for injection 10,000,000 i.u. in 1 mL single dose vial (Intron A) (Private)
5763H Interferon Alfa-2b, Solution for injection 18,000,000 i.u. in 1.2 mL multi-dose injection pen (Intron A Redipen) (Public)
6253D Interferon Alfa-2b, Solution for injection 18,000,000 i.u. in 1.2 mL multi-dose injection pen (Intron A Redipen) (Private)
5766L Interferon Alfa-2b, Solution for injection 18,000,000 i.u. in 3 mL single dose vial (Intron A) (Public)
6218G Interferon Alfa-2b, Solution for injection 18,000,000 i.u. in 3 mL single dose vial (Intron A) (Private)
5767M Interferon Alfa-2b, Solution for injection 25,000,000 i.u. in 2.5 mL single dose vial (Intron A) (Public)
6219H Interferon Alfa-2b, Solution for injection 25,000,000 i.u. in 2.5 mL single dose vial (Intron A) (Private)
5764J Interferon Alfa-2b, Solution for injection 30,000,000 i.u. in 1.2 mL multi-dose injection pen (Intron A Redipen) (Public)
6254E Interferon Alfa-2b, Solution for injection 30,000,000 i.u. in 1.2 mL multi-dose injection pen (Intron A Redipen) (Private)
5765K Interferon Alfa-2b, Solution for injection 60,000,000 i.u. in 1.2 mL multi-dose injection pen (Intron A Redipen) (Public)
6255F Interferon Alfa-2b, Solution for injection 60,000,000 i.u. in 1.2 mL multi-dose injection pen (Intron A Redipen) (Private)
5771R Lamivudine, Oral solution 5 mg per mL, 240 mL (Zeffix) (Public)
6271C Lamivudine, Oral solution 5 mg per mL, 240 mL (Zeffix) (Private)
5770Q Lamivudine, Tablet 100 mg (Zeffix) (Public)
6257H Lamivudine, Tablet 100 mg (Zeffix) (Private)
9515T Peginterferon Alfa-2a, Injection 135 micrograms in 0.5 mL single use pre-filled syringe (Pegasys) (Public)
6439X Peginterferon Alfa-2a, Injection 135 micrograms in 0.5 mL single use pre-filled syringe (Pegasys) (Private)
9516W Peginterferon Alfa-2a, Injection 180 micrograms in 0.5 mL single use pre-filled syringe (Pegasys) (Public)
6449K Peginterferon Alfa-2a, Injection 180 micrograms in 0.5 mL single use pre-filled syringe (Pegasys) (Private)
9562G Telbivudine, Tablet 600 mg (Sebivo) (Public)
9630W Telbivudine, Tablet 600 mg (Sebivo) (Private)
9563H Tenofovir, Tablet containing tenofovir disoproxil fumarate 300 mg (Viread) (Public)
6358P Tenofovir, Tablet containing tenofovir disoproxil fumarate 300 mg (Viread) (Private)

The PBAC (July 2011) recommended that for treatment naïve patients with hepatitis B, the evidence of chronic liver injury be determined by confirmed elevated serum alanine aminotransferase (ALT) or by liver biopsy, and that the specific thresholds for Hepatitis B virus DNA (HBV DNA) be applied to the restrictions.

 

9653C Zoledronic Acid, Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL (Zometa) (Public)
6371H Zoledronic Acid, Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL (Zometa) (Private)