New listings on the Pharmaceutical Benefits Scheme 1 April 2006
31 March 2006
The Australian Government has decided to add four new drugs to the Pharmaceutical Benefits Scheme (PBS) for severe psoriasis, opiate dependence, a fatal form of brain tumour and established osteoporosis. Over the next four years, these drugs are expected to benefit approximately 35,000 patients at a cost to government of $180 million.
The Commonwealth Government has decided to add four new drugs to the Pharmaceutical Benefits Scheme (PBS) for severe psoriasis, opiate dependence, a fatal form of brain tumour and established osteoporosis.
Over the next four years, these drugs are expected to benefit approximately 35,000 patients at a cost to government of $180 million.
The following drugs will be available on the PBS from tomorrow:
Efalizumab (RAPTIVA®) is used to treat severe psoriasis. It is estimated that 6,000 patients will be treated in the first four years of listing at a cost of $171 million.
Buprenorphine Hydrochloride with Naloxone Hydrochloride (SUBOXONE®) is used in the treatment of opiate dependence. It is estimated that there will be 29,402 patients treated in the first four years of listing at an additional cost of $7.2 million.
Carmustine (GLIADEL®) is used in the treatment of malignant glioma, a fatal form of brain tumour. It substitutes for another drug already listed for treating this condition and is not expected to have any financial impact on the PBS. It is estimated that up to 307 patients will obtain treatment in the first four years of listing.
Risedronate Sodium and Calcium Carbonate (ACTONEL COMBI®) is used in the treatment of established osteoporosis. This is a new formulation that some patients will find more convenient.
An additional 46 new generic branded products of drugs already listed on the PBS will be added to the PBS and 12 drugs will have changes to their availability (see attached sheet for information on these drugs). These extensions will add an extra $79 million to the PBS over four years.
In March 2005 the pharmaceutical industry agreed that new generic medicines entering the PBS after 1 August would list at 12.5 per cent below the current benchmark price. In 2005 the policy triggered a 12.5 per cent price reduction for 20 drugs which flowed on to a further 26 drugs in the same reference pricing groups. From tomorrow a further eight drugs will have a 12.5 per cent reduction and this will flow on to an additional eight drugs. This brings to 12 the total number of reference pricing groups that have reduced by the 12.5 per cent policy.
Information on drugs with changes to their availability
Spironolactone now has an unrestricted listing on the PBS. It was previously listed for hypoaldosteronism and female hirsutism. There is not likely to be any change in patients treated or expenditure.
The restriction for Alendronate 70 mg tabs, risedronate 5 mg and 35 mg tabs, Raloxiphene 60 mg and Disodium etidronate and calcium tabs was amended to sole therapy for established osteoporosis.
The restriction on Capecitabine has been extended to include patients who have had surgery for Stage III Colon cancer. The extension to the listing will provide treatment for about 2,000 patients in the first four years of listing. It is expected to add $9 million to the PBS expenditure. Capecitabine is currently listed on the PBS for the treatment of metastatic colorectal cancer and advanced breast cancer.
Cyclosporin is used in the treatment of organ transplantation and nephrotic syndrome, severe psoriasis and severe atopic dermatitis, and severe rheumatoid arthritis. Many patients will now have more convenient access to this drug through their community pharmacy. Previously patients would generally have had to gain access this drug through a hospital. There is no increase in numbers of patients treated and PBS expenditure expected.
The PBAC recommended the addition of two indications to the current listing for ezetimibe, namely peripheral vascular disease and heterozygous familial hypercholesterolaemia. This addition is expected to benefit approximately 19,000 people by the fourth year of listing. The additional expenditure on the PBS will be $20 million. The PBAC also considered that this amended restriction should apply to Vytorin (ezetimibe plus simvastatin) when that drug is listed on the PBS.
Balsalazide and Mesalazine are used to treat colitis and other inflammatory conditions. The PBAC amended the restriction wording of balsalazide, mesalazine, olsalazine and sulfasalazine to ensure consistency in the restriction wording between these drugs across these drugs. There is not likely to be any change in patients treated or expenditure for the PBS.
The restriction wording forModafinil has been amended to allow an additional group of specialist prescribers, neurologists, to prescribe modafinil. This drug is used in the treatment of narcolepsy. No financial impact on the expected expenditure is expected following this change in restriction.
Risperidone is used in treatment of bipolar disorder. Previously this drug was only subsidised for schizophrenia and behavioural disturbances in patients with dementia. It is estimated that this drug will substitute for other therapies that are currently available and therefore there will be no additional cost to the PBS.
In addition, two ‘section 100’ drugs (those delivered through hospitals and other arrangements, not community pharmacies) have extensions to their availability.
Adefovir (10mg tablet) is used in the treatment of Hepatitis B. The restriction wording has been amended to provide clarification in relation to the place of adefovir and lamivudine in treating hepatitis B. There is no expected impact on expenditure or patients treated.
The restriction for Peginterferon alfa-2a, peginterferon alfa-2b, ribavirin plus peginterferon alfa-2a, ribavirin plus peginterferon alfa-2b has been amended to allow patients with hepatitis C to be treated without needing a liver biopsy. This is expected to enable an additional 928 patients per year to receive treatment (3,712 patients over four years). The additional expenditure is expected to be $50 million over four years.