PBS policy flaws putting patients at risk

Major policy flaws in the management of the Pharmaceutical Benefits Scheme could be putting patients at risk, Medicines Australia chairman Will Delaat told the Senate Community Affairs References Committee today.

Mr Delaat urged the Committee to recommend the abolition of the Government’s therapeutic group policy, which groups together medicines deemed to be “interchangeable” and links the price of those medicine to the lowest-priced in that therapeutic group. It is not at all clear whether these medicines are interchangeable.

The mandatory Cabinet approval for new medicines costing more than $10 million per annum before they can be PBS listed should also be reviewed so that patients can have earlier access to the medicines they need, Mr Delaat told the Committee.

“This measure was introduced in 2001 and implemented to reduce financial risk to the Government,” Mr Delaat said. “But given Cabinet does not reject new listings on the PBS, it is hard to see what financial risk is being reduced.”

“The real issue is that the need for Cabinet approval can delay the listing of these medicines by up to 12 months or more.

“While patients wait for the Cabinet to review a recommendation that has already been made by the clinical experts at the Pharmaceutical Benefits Advisory Committee, there is no subsidised consumer access to that new medicine.

“As a direct result of this policy, patients may experience deterioration of their condition before gaining access to their medicine – even premature death.

“New medicines undergo a comprehensive cost effectiveness assessment by the PBAC to determine value for money. So the Cabinet approval process doesn’t make sense.

“At the very least, the $10 million cost threshold at which Cabinet approval becomes mandatory should be doubled. That would have an enormous impact, halving the number of medicines that get caught up in the Cabinet process after the PBAC has already deemed them cost-effective, without leading to an increase in expenditure.”

Mr Delaat also raised patient safety concerns arising from the Government’s therapeutic group policy and confusion as to whether or not medicines within the same group were interchangeable.

“The risk for consumers is whether these medicines are truly interchangeable on an individual patient basis – whereby patients are able to switch from one medicine to another medicine in that group, without detriment to their health,” Mr Delaat said.

Medicines Australia’s submission is available from here


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