Concern over “unprecedented” intervention into biologics market

Doctors could sidestep “onerous” prescribing obligations for the etanercept biosimilar Brenzys under new recommendations by the PBAC, which has flexed its differential prescribing powers for the first time.

In May, the government outlined two new policies to drive the uptake of biosimilars to curb spending on biologic drugs like etanercept (Enbrel), which at $167 million for 97,000 scripts was the drug with the seventh highest PBS spend for 2015-16.

One policy empowered the PBAC to recommend differential prescribing for biosimilar drugs and biologics, which it did in August selecting the etanercept biosimilar Brenzys to be eligible for streamlined authority for ‘subsequent continuing’ prescriptions.

The recommendation needs sign off by Health Minister Greg Hunt.

But if approved, this would mean once a patient was stabilised on Brenzys for six months, prescribers could avoid the protracted process of submitting blood tests and joint counts to the government to justify ongoing treatment and instead simply write a code on the prescription, said Dr Mona Marabani, chair of the ARA biosimilars working group.

The promise of faster, easier access could entice some rheumatologists to choose the biosimilar, she said.

But the ARA is concerned about the potential ramifications of giving Brenzys a significant advantage in the marketplace, and argues all reference biologics and biosimilars should be eligible for the simplified approval process.

“It is a direct intervention to try and drive prescribers down the path of prescribing Brenzys. What the consequences of that will be we don’t know. We do know that the cheapest biologic for inflammatory arthropathies is etanercept, regardless of brand. What we don’t know is what will happen if the market is heavily skewed towards one agent”, Dr Marabani said.

“Now we have this unprecedented potential new move with the government intervening directly in the market to favour one brand over another, when they are both marketed by large pharmaceutical companies and they are both as far as we are told in fact the same price.

While the ARA supports the government’s aim to make biologic and biosimilar medicines cheaper, it is not confident in the method being employed which appears to rely on price disclosure to drive down prices.

It also cautions that it should not be assumed that because the system drove down the cost of generic medicines, it will do the same for biosimilars.

The Brenzys recommendation may also be premature, given the uptake data for the biosimilar, only listed on the PBS this year, is not in.

Dr Marabani said the PBS called for the uptake drivers to address low (about 6%) uptake of PBS subsidised infliximab, for which the majority of dispensing occurred in hospital pharmacies outside of the PBS.

But uptake for PBS subsidised Brenzys may well be higher, given the subcutaneous injection is most often dispensed in retail pharmacies.

The ARA also questions how the new policy will interact with existing policy of a-flagging and notes that “the department itself says it recognises lowering the level of authority may impact the risk of use outside the PBS restriction”.

The department of health said it expects to continue to receive comments on biosimilar uptake drivers contained in consultation documents over the next few weeks.

In the meantime, the ARA awaits answers on how the streamlined authorities would work in the real world.

“Those onerous requirements will potentially not be there for the streamlined patients on Brenzys, but we have yet to see the real nuts and bolts of how this is going to work, whether there will be audits how this is going to be monitored, we don’t know.”

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