Australia's government has announced that 13 new drugs, including Merck & Co's Erbitux (cetuximab) for late-stage bowel cancer, are to be subsidised under the Pharmaceutical Benefits Scheme (PBS).
The PBS listing for Erbitux - which can cost up to A$30,000 a year without subsidy and will help around 2,700 patients in Australia - is "complex," said the Minister for Health and Ageing, Nicola Roxon, announcing the decision this week.
This is because it will be the first time any Australian government has listed a medicine on the PBS while also attempting to list a co-dependent genetic test on the national health insurance programme Medicare, she said.
"While the assessment of Medicare funding for the genetic test is still ongoing, the drug manufacturer has offered to pay for the genetic test in the meantime. This offer has allowed the government to bring forward its consideration of Erbitux," said Ms Roxon.
The Minister added that "in particular, I am pleased to announce" the listing of Novartis' Gilenya (fingolimod) for patients with relapsing-remitting multiple sclerosis (MS) - the first oral treatment for the disease.
Combined, the treatments which will newly be made available on the PBS from September 1 are expected to cost the Scheme around A$200 million a year. The others are: - Pfizer's Diflucan (fluconazole) for certain fungal infections in immunocompromised children and the elderly; - Novartis' Glivec (imatinib) for patients with a high risk of recurrence of tumour following the surgical removal of a gastrointestinal tumour; - Amgen's Neulasta (pegfilgrastim), used to stimulate the production of white cells in immunocompromised patients with Hodgkin's disease; - Novartis' Topi (tobramycin) for lung infection cause by a specific bacterium in patients with cystic fibrosis; - Pfizer's Fragmin (dalteparin sodium) for blood clots; - GlaxoSmithKline (GSK)'s Revolade (eltrombopag) for patients with a potentially life-threatening bone marrow disorder; - AFT Pharmaceuticals' Ferro Tab (ferrous fumarate) for anemia; - Lundbeck's Fluanxol (flupenthixol) and Clopixol (zuclopenthixol) for psychosis; - Janssen's Risperdal Consta (risperidone) long-acting injection for patients with bipolar disorder; and - GSK's Duodart (dutasteride with tamsulosin hydrochloride) for the treatment of enlarged prostate.
The government has also agreed to list the new 60mg vial size of Roche's breast cancer drug Herceptin (trastuzumab) through the Medicare-administered late-stage Herceptin programme, and will list GSK's seasonal flu vaccine Fluarix on the National Immunisation Program later this year.
However, a further seven drugs which the government had been advised by the independent Pharmaceutical Benefits Advisory Committee (PBAC) should be covered by the PBS have again been deferred. "The Cabinet will continue to consider all new PBS drug listings and how these listings compare with other health spending priorities such as training new doctors and nurses, opening new hospital beds and investing in new preventative health programmes," said Ms Roxon.
Industry and consumer groups have attacked the government for ignoring the recommendations of its own expert advisory committee and empowering the Cabinet to make reimbursement decisions - previously, Cabinet approval was required only for drugs costing more than A$10 million a year - and say that political leaders have turned the issue of medicines subsidies into a "political football." On June 21, 60 consumer health organisations and patient groups again urged the government to reconsider its decision to defer the remaining seven drugs' listings until the financial situation improves, pointing out that shelving new treatments will likely increase health costs because many people will be unable to access the most appropriate medications for their conditions.
However, Ms Roxon said yesterday that the government's position would not change, and she called on the protesters to "also think about all the other patients in Australia who would welcome new health investments aside from new drug listings.”