The Australian government has said that no new medicines will be added to the national subsidised drugs scheme until 2013, by which time it aims to have the federal budget back in surplus.
The move, which critics say will delay the approval of as many as 100 new medicines each year, is expected to save the government up to A$200 million. However, it will require patients to pay up to A$100 a month for their treatments, instead of the monthly A$34.20 (A$5.40 for pensioners) which they pay for drugs supplied under the A$8.3 billion Pharmaceutical Benefits Scheme (PBS), which provides around 75% of all prescription drugs sold in Australia.
Health Minister Nicola Roxon has also said that any new PBS subsidies must now be approved by the federal cabinet. Previously, such approval was required only for new drugs which would cost the system more than A$10 million a year, and medical and industry leaders have claimed that the government is now politicising the drug approval and supply process.
The controversy began last month when the government, after being advised by the Pharmaceutical Benefits Advisory Committee (PBAC) that eight new products should be added to the PBS, announced that their listings would be deferred for two years.
For the first time ever, "the government has listened to the advice of its own experts and decided not to take that advice. I think patients and the companies who have developed these medicines are owed a proper explanation," said Brendan Shaw, chief executive of industry group Medicines Australia, responding to the government’s announcement.
The introduction of "an extra layer of bureaucracy," with the cabinet now intervening on the listing of new medicines that fall well below the A$10 million threshold, is "extremely alarming, because it may translate to delays in patients getting access to medicines they need," he added.
Andrew Pesce, president of the Australian Medical Association, asked who is advising ministers if they are rejecting the recommendations of the PBAC, and warned that medicines must not be rationed on cost grounds.
“People should have access to the latest medicines that the expert body, [the PBAC], has assessed as being safe and cost-effective,” Dr Pesce said last Friday (March 11).
The products whose PBS listings have been deferred by the cabinet are: Allergan's Botox (onabotulinumtoxinA) for severe sweating; GlaxoSmithKline's Duodart (dutasteride and tamsulosin) for enlarged prostate; Janssen's Invega Sustenna (paliperidine palmitate extended-release) for schizophrenia; Mundipharma's Targin (oral oxycodone/naloxone prolonged-release) for chronic disabling pain; AstraZeneca's Symbicort (budesonide and formoterol) for asthma and chronic obstructive pulmonary disease (COPD); Eisai's anticoagulant Fragmin (dalteparin sodium); Pfizer's in vitro fertilisation (IVF) treatment Synarel (nafarelin); and Pfizer's pneumococcal conjugate vaccine Prevenar 13.
Defending the decision, Ms Roxon said that alternative treatments are available for all these products and added that the government had approved 50 new medicines worth A$50 billion since taking office.