Extended PBAC 'default' for biosimilars

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All future biosimilars will be automatically considered for one of the main new uptake drivers under a Department of Health proposal.

Stakeholder groups have been given until Friday to provide feedback on the proposed implementation of biosimilar uptake drivers negotiated with the sector earlier this year.

The new uptake drivers, including the introduction of prescribing by generic or biosimilar name - international non-proprietary name (INN) - preferential biosimilar prescribing for treatment naive patients and looser prescribing restrictions, will complement pharmacy-level substitution in place since 2015.

Under the implementation plan developed by the Department of Health, the current 'default' position of the Pharmaceutical Benefits Advisory Committee (PBAC), to consider pharmacy-level substitution for all biosimilars, will be extended to include looser prescribing restrictions. A note encouraging prescribing for treatment naive patients will be added in the PBS schedule for each biosimilar.

At present, companies with biosimilars request looser prescribing restrictions in submissions to PBAC, with MSD's BRENZYS (etanercept) the first.

The committee recommended a streamlined authority for BRENZYS at its special meeting in August. The streamlined authority will apply to 'subsequent continuing' prescriptions. All initiations and the first continuing prescription will remain a written authority.

The PBAC will consider loosening the prescribing criteria for MSD's other biosimilar bDMARD, RENFLEXIS (infliximab), at its November meeting.