The Pharmaceutical Benefits Advisory Committee (PBAC) will become gatekeeper in the government’s new push to increase the uptake of biosimilars.
From July 1, two new policies outlined in the latest five-year agreement between the federal government and Medicines Australia will empower the PBAC to recommend differential prescribing rules for biosimilars and reference biologics.
There are currently three biosimilars available in Australia, however the government has been open about its desire to drive uptake of the drugs to generate PBS savings.
The first policy enables the PBAC to recommend, on a case-by-case basis, “a different type of prescribing process for biosimilars and reference biologics through allowing a lower level of authority to the biosimilar” at the point of commencement or continuation of therapy.
The second allows the committee to recommend a biosimilar as drug of choice over a reference biologic for treatment naïve patients, with the document stating that this “may be further reinforced in the prescribing software”.
The changes, to apply to new PBS listings, are not intended to remove or restrict physician choice or change the function of the PBAC, according to the strategic agreement.
But experts suggest this may be easier said than done.
Dr Mona Marabani, co-chair of the Australian Rheumatology Association’s biosimilars working group, said allowing a lower level of authority for a script for a biosimilar will mean the application does not receive the same level of scrutiny for accuracy compared to what’s required for an originator biologic.
“Driving the treatment pathway in this way may have unintended consequences,” she told the limbic.
“It would be surprising to see the government intervene in such a way, favouring a particular brand, when both are the same price. It could give the biosimilar a major advantage in the market.”
She says while there is “a comfortable level of evidence” to prescribe biosimilar infliximab or etanercept in naïve patients with inflammatory rheumatic diseases, the follow-up periods of the studies are generally short, and numbers relatively small.
“All in all, it is disappointing that deals are being made around the use of biosimilars with various lobby groups including Medicines Australia and the Generic and Biosimilar Medicines Association (GBMA), but there has been no consultation with the expert physicians who prescribe these highly specialised drugs, nor the patients who use and rely on them.”
Meanwhile, Melbourne lawyer Ric Morgan, who specialises in patents for the pharmaceutical sector, says it’s unclear what lowering the authority means.
It may mean simply streamlining the process to reduce the administrative burden, however it could refer to lowering the threshold required for a patient to be eligible for a biosimilar on the PBS.
“If the authority requirements are different between the biosimilar and the reference biologic, it might mean a particular patient does not meet the requirements for one of them and this would remove prescriber choice if they want their patient to have a treatment that is reimbursed under the PBS.”
But Mr Morgan says the government could face legal hurdles if it goes down this road.
“The only basis on which the PBAC would currently recommend differential patient eligibility for a biosimilar from a reference biologic is if there was evidence provided by the sponsor that it ought to be treated differently.
“If this is the intention, the PBAC will need to be given a different mandate under the National Health Act.”
“Yet (the agreement says) ‘nothing in clause 8 is intended to change the function of the PBAC’.
“So it seems to me there is a conflict between what’s being proposed and what’s possible”.