Biosimilar options under consideration?

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Government could consider a range of options to improve the uptake of biosimilars in 2017. Many of these options could already have been considered during the planning process for last year's PBS Access and Sustainability Package.

It is understood the Generic Medicines Working Group has undertaken significant work on uptake drivers for biosimilars, consistent with the policy priorities agreed between government and the Generic and Biosimilar Medicines Association (GBMA).

The biosimilar policy debate has been dominated by 'a-flagging' - pharmacy-level substitution - coming out of the 2015 reforms and subsequent PBAC recommendations.

Biosimilar infliximab was listed on the PBS in December last year, having been 'a-flagged' by PBAC at its July 2015 meeting. PBAC also 'a-flagged' biosimilar insulin glargine in 2015 but Lilly declined the listing due to "unresolved conflicts" with the TGA's advice on interchangeability. The committee recommended the first biosimilar etanercept - MSD's BRENZYS - with an 'a-flag' in July this year and a listing consistent with the PBAC recommendation is anticipated in February next year.

BiotechDispatch understands 'a-flagging' for biosimilars was actually the PBAC's preferred option rather than that of policy-makers. It may have even rejected other options put forward by policy-makers to promote the uptake of biosimilars in favour of 'a-flagging'.

Some of those options, which could have included differential co-payments and changed prescribing arrangements, could now re-emerge as new uptake drivers.

Any further reforms will likely focus on promoting uptake, with related savings generated through price disclosure, rather than mandatory price reductions. Under its strategic agreement with government GBMA must be consulted on any price-related changes to medicines listed in the F2 formulary until 2020.

Increasing uptake is seen as key to promoting the development of an attractive market for biosimilar manufacturers. More manufacturers means more competition and ultimately lower prices.

Differential co-payments have long been discussed as a mechanism to encourage utilisation of off-patent medicines. Under this option, consumers would pay less for the biosimilar than the originator biologic, which would encourage pharmacy-level substitution.

Another option could be to follow the lead of Italy, where health authorities have promoted uptake through the requirement for clinicians to prescribe biosimilars to all treatment-naïve patients.

Giving biosimilars first-line status for new patients, and pushing originator biologics to second-line, might take some prescribing authority away from clinicians but would probably be done based on PBAC advice. In effect, PBAC would simply adjust prescribing criteria in the same way it does for any therapy.

Other options, including a biosimilars-only approach to hospital-based formularies, would be more difficult given the disparate nature of hospital administration across Australia. Many state and territory hospitals already operate tenders for biologics and their biosimilars that generate significant price reductions.