New biosimilar policy benefits industry, not patients: AMA

Strategies to drive up prescribing of biosimilar medicines in a bid to save PBS dollars are proving unpopular with clinicians, with the AMA opposing two new proposals.

The government is consulting the medical world on a range of ‘uptake drivers’, which according to an AMA submission include plans to insert a ‘restriction’ note in the Pharmaceutical Benefits Schedule, integrated into doctors’ prescribing software, advising doctors that biosimilar medicines are the ‘preferred’ option to reference biologics for treatment naïve patients.

But the proposed note is ‘misleading’ because it implies a clinical justification for the preferential prescribing, rather than a fiscal one, the AMA argues in its October submission to the department of health.

The doctors’ group also condemns a second proposal to relax administrative burden to prescribe biosimilars by making them eligible for a streamlined authority, which has raised concerns for the ARA.

Related news: Concerns over unprecedented intervention into biologics market

Policies to drive biosimilar uptake may have unintended consequences experts warn

The use of the authority regulatory system to push prescribing of one brand over another is “inappropriate” and has “nothing to do with safety and quality and appears mostly to benefit certain pharmaceutical companies”, the AMA said.

The submission points out how the PBAC in July last year rejected a bid to use the authority system to drive prescribing of the etanercept biosimilar Brenzys, a move which the sponsor suggested would drive uptake generating savings of $150 million over five years based on statutory 16% price reduction while retaining prescriber autonomy.

At the time, the PBAC concluded that streamlined listings would not be appropriate “because of the large potential for leakage into less severe disease”, and also noted the financial estimates did not account for either the impact of price disclosure or the 5% statutory price reduction for etanercept in 2016, the submission said.

The AMA also questions the financial justification for the policy, arguing that while it supports moves to drive down costs to the PBS the government pays the same price for reference biologic Enbrel and Brenzys.

“If biosimilar brands had their restriction relaxed to ‘Authority streamlined’ without an obvious price difference, then the reference biological brand should also have its restriction relaxed to the same level,” the submission said.

In August this year, the PBAC considered the matter again and recommended that Brenzys be eligible for prescribing via the “streamlined authority”.

The move, if approved by Health Minister Greg Hunt, would represent an unprecedented intervention by the federal government into the biologics market, according to chair of the ARA biosimilars working group, Dr Mona Marabani.

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