New Listings and Changes 1 December 2009

 

ADDITIONS

 

9499Y Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid, Oral liquid 125 mL,36 (MSUD Anamix Junior LQ^®) 

Listed for treatment of maple syrup urinary disease, noting the advice of the Nutritional Products Working Party that it be made available for this purpose. 

Minimal additional expense to the PBS is expected as it will be used in the place of one of the currently listed products.

 

9498X Artemether with lumefantrine, Tablet 20 mg-120 mg (Riamet®) 

Listed for the treatment of suspected or confirmed malaria due to plasmodium falciparum. The PBAC noted that the submission was in response to a Government initiative to address the health care needs of refugees and humanitarian entrants to Australia.

  

9494Q Calcipotriol with betamethasone dipropionate, Ointment 50 micrograms-500 micrograms (base) per g (0.005%-0.05%), 30 g (Daivobet®) 

Listed for the treatment of chronic stable plaque type psoriasis vulgaris in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy. 

 

3117C Calcium, Tablet 600 mg (as carbonate) (Calci-Tab 600®)

Listing of a new strength of calcium carbonate for hyperphosphataemia associated with chronic renal failure.

 

9296G Clopidogrel with aspirin, Tablet 75 mg (as hydrogen sulfate)-100 mg (CoPlavix, DuoCover®) 

Three new Authority required (Streamlined) restrictions. The first is the treatment of acute coronary syndromes (myocardial infarction or unstable angina) to prevent early and long-term atherothrombotic events. The second is treatment following cardiac stent insertion. The third is the prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin.

 

9485F Glucose indicator—blood, Reagent strips, 50 (Lifeline Attest®)

9486G Glucose indicator—blood, Reagent strips, 50 (Lifeline Attest®) (Diff. Max. Rpts) 

Listed for use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the arrangements.

  

9487H Hydroxyethyl starch 130/0.4, I.V. infusion 30 g per 500 mL, 500 mL (Voluven 6%)

This is an unrestricted listing of hydroxyethyl starch.

 

9294E Olanzapine, Powder for injection 210 mg (as pamoate monohydrate) with diluent (Zyprexa Relprevv®)

9295F Olanzapine, Powder for injection 300 mg (as pamoate monohydrate) with diluent (Zyprexa Relprevv®)

Olanzapine pamoate monohydrate modified release injection listed as an Authority required (Streamlined) benefit for the treatment of schizophrenia.

A Caution has been added to the listing to monitor for post-injection syndrome for at least three hours after each injection.

 

9491M Polyethylene glycol 400, Eye drops 2.5 mg per mL (0.25%), 15 mL (Blink Intensive Tears®)

9492N Polyethylene glycol 400, Eye drops 2.5 mg per mL (0.25%), 15 mL (Blink Intensive Tears®) (Diff. Max. Rpts)

9493P Polyethylene glycol 400, Eye drops 2.5 mg per mL (0.25%), single dose units 0.4 mL, 20 (Blink Intensive Tears®)

5559N Polyethylene glycol 400, Eye drops 2.5 mg per mL (0.25%), 15 mL (Blink Intensive Tears®) (Optometrical)

5560P Polyethylene glycol 400, Eye drops 2.5 mg per mL (0.25%), single dose units 0.4 mL, 20 (Blink Intensive Tears®) (Optometrical)

Polyethylene glycol 400 is listed on the General and Optometric Schedules for patients with severe dry eye syndrome including Sjogren Syndrome. This is available as multi-dose and single dose unit drops. Single dose units are for those who are sensitive to the preservatives in multi-dose drops. Single dose unit drops are authority required items. Authorisation is streamlined when prescribed by medical practitioners.

Item 9492N multi dose drops are for use in these patients receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the plan or coordination of the arrangements.

 

9495R Prasugrel, Tablet 5 mg (as hydrochloride) (Effient®)

9496T Prasugrel, Tablet 10 mg (as hydrochloride) (Effient®)

Prasugrel is Authority required (Streamlined) listed for treatment of acute coronary syndrome (myocardial infarction or unstable angina) managed by percutaneous coronary intervention in combination with aspirin.

 

9488J Sunitinib, Capsule 12.5 mg (as malate) (Sutent®) (Diff. Restriction)

9489K Sunitinib, Capsule 25 mg (as malate) (Sutent®) (Diff. Restriction)

9490L Sunitinib, Capsule 50 mg (as malate) (Sutent®) (Diff. Restriction)

Sunitinib listed for the treatment of gastrointestinal stromal tumour. It will initially be prescribed as monotherapy of a patient with WHO performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance. Patients with WHO performance status of 2 or less would range from fully active to “able to walk and manage self-care, but unable to work. Out of bed more than 50% of waking hours”.

Continuation of treatment with sunitinib requires patients to have a WHO performance status of 2 or less and no evidence of  progressive disease. Patients who have progressive disease on sunitinib are no longer eligible for PBS-subsidised sunitinib.

Authority is required to initiate and continue this sunitinib treatment. Grandfathering of patients who are enrolled on the Sunitinib Compassionate Program is possible providing the initiation criteria are met.

 

ALTERATIONS — RESTRICTIONS

 

8628D Montelukast sodium, Chewable tablet 5 mg (base) (Singulair®)

The PBAC recommended new Authority required (Streamlined) restrictions for 5mg chewable montelukast sodium in July 2009:

- First-line preventer medication, as the single preventer agent for children aged 6 to 14 years with frequent intermittent or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium.

- Prevention of exercise-induced asthma, as an alternative to adding salmeterol xinafoate or eformoterol fumarate, in a child aged 6 to 14 years whose asthma is otherwise well controlled while receiving optimal dose inhaled corticosteroid, but who requires short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms.

 

9151P Pramipexole hydrochloride, Tablet 125 micrograms (Sifrol®)

9152Q Pramipexole hydrochloride, Tablet 250 micrograms (Sifrol®)

9153R Pramipexole hydrochloride, Tablet 1 mg (Sifrol®)

Listed for treatment of Parkinson disease. This is an extension of the current listing which will now allow patients with early Parkinson disease to use pramipexole as initial monotherapy.

 

SECTION 100 - HIGHLY SPECIALISED DRUGS PROGRAM

ADDITIONS

 

9648T Ambrisentan, Tablet 5 mg (Volibris®)

9649W Ambrisentan, Tablet 10 mg (Volibris®)

Ambrisentan listed as a Section 100 Highly Specialised Drugs Program public and private hospital authority required benefit for the treatment of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease in patients with disease of WHO functional class III or IV severity. 

Pulmonary hypertension is an increase in blood pressure in the pulmonary artery, pulmonary vein, or pulmonary capillaries, together known as the lung vasculature, leading to shortness of breath, dizziness, fainting, and other symptoms, all of which are exacerbated by exertion. Pulmonary hypertension can be a severe disease with a markedly decreased exercise tolerance and heart failure. Pulmonary venous hypertension typically presents with shortness of breath while lying flat or sleeping (orthopnea or paroxysmal nocturnal dyspnea), while pulmonary arterial hypertension (PAH) typically does not.

WHO functional class III indicates marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnoea or fatigue, chest pain or near syncope. WHO functional class IV indicates inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.

Authorisation requirements, notes and cautions are similar to those for other PBS-listed PAH agents such as bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sidenafil citrate and sitaxentan sodium.

Patients are eligible for PBS-subsidised treatment with only 1 of the above PAH agents at any one time. Eligible patients may only swap between PAH agents if they have not failed prior PBS-subsidised treatment with that agent.

 

ALTERATIONS — RESTRICTIONS

 

9642L Lenalidomide, Capsule 5 mg (Revlimid®)

9643M Lenalidomide, Capsule 10 mg (Revlimid®)

9644N Lenalidomide, Capsule 15 mg (Revlimid®)

9645P Lenalidomide, Capsule 25 mg (Revlimid®)

A number of changes have been made to the wording of the restriction for lenalidomide to make it consistent with the recent changes to the bortezomib restriction. The changes further clarify eligibility for the treatment.

 

6358P Tenofovir disoproxil fumarate, Tablet 300 mg (Viread®)

The PBAC recommended the extension of the restriction in July 2009 to include treatment of chronic hepatitis B: in patients who are nucleoside analogue naïve; and in patients who have failed antihepadnaviral therapy. These patients must satisfy specific criteria that are further described in the extended restriction.

Notes on use of the drug state that: patients should have undergone a liver biopsy at some point since initial diagnosis to obtain histological evidence of chronic hepatitis; and that patients may receive tenofovir treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.