Australia has listed 48 new medicines for supply under the Pharmaceutical Benefits Scheme (PBS), including six which have been deferred by the Cabinet since February.

Listing of the six deferred products has become possible because of price reductions "arising from more competitively-priced medicines, as well as a number of recent Pharmaceutical Benefits Advisory Committee (PBAC) recommendations," said Prime Minister Julia Gillard and Health Minister Nicola Roxon, in a joint statement. They added that more than 160,000 Australians every year will benefit from the decision to list the 48 new drugs, most of which will be available on the PBS starting December 1.

The products deferred by the Cabinet in February and which have now been listed are: - Allergan's Botox (botulinum toxin type A) for severe sweating; - Janssen's Invega Sustenna (paliperidone palmitate) for schizophrenia; - Mundipharma's Targin (oral oxycodone/naloxone) for the treatment of severe cancer pain; - AstraZeneca's Symbicort (budesonide and formoterol) for lung disease; - Eisai's anticoagulant Fragmin (dalteparin sodium) for the treatment of blood clots in patients with cancer; and - Pfizer's in vitro fertilisation (IVF) treatment Synarel (nafarelin).

Other major products which are now PBS-listed include Merck & Co's Fosamax (alendronate) for the treatment of osteoporosis; - Merck & Co's Saphris (asenapine) for bipolar 1 disorder and schizophrenia; and - Janssen's Velcade (bortezomib) for the treatment of multiple myeloma in patients with severe acute renal failure.

In addition, the government has agreed to increase the prices of 23 drugs which are already covered by the PBS, but it also reports that the proposed listing of Boehringer Ingelheim's blood-thinner Pradaxa (dabigatran) is to be referred to former PBAC chairman Professor Lloyd Sansom for further consideration.

It is estimated that Pradaxa would cost the budget up to A$1 billion over the forward estimates, and while the PBAC has recommended it as a safe, efficacious and cost-effective therapy for some at-risk stroke patients, the panel also raised some important questions, says the government. In particular, the PBAC had advised it that the drug's benefit observed in a clinical trial "may or may not be reflected wholly in the Australian population, which may lead to this medicine being overprescribed without an adequate education campaign for doctors, pharmacists and patients."

Announcing the new listings, the government also said that it has now agreed new commitments with industry groups Medicines Australia and the Generic Medicines Industry Association of Australia (GMIA) and with the Consumers Health Forum of Australia to "improve the certainty around the PBS listing process." In particular, the government has pledged not to defer any drugs that cost less than A$10 million annually for the coming year "while it works with all parties to achieve longer-term PBS sustainability."

The agreement also includes undertakings by the government, industry and consumer representatives to work together on further savings for the 2012-13 Budget and other savings following the expiry of the memorandum of understanding (MoU) between the industry and government, and the drugmakers have agreed to legislative amendments to complete price disclosure reforms, which will "help to end anomalies in the current pricing system," it says. 

The government's agreed commitments include accepting price increases recommended by the independent Pharmaceutical Benefits Pricing Authority, and to involve all parties in future MoU discussions and agreements between the pharmaceutical industry and the government.

Medicines Australia says it welcomes the new PBS listings and the joint agreement on finding a solution, but emphasises that deferral of new medicines that have been recommended by the PBAC is bad policy.

"Questions still remain, and there is still no commitment from the government to consign to the dustbin its poor policy of deferring medicines," said Medicines Australia chief executive Brendan Shaw.

"Deferrals mean patients are denied access to the medicines they need. The policy also creates uncertainty for industry and makes it harder for companies to bring new medicines to Australia," he added.