Australia’s PBAC makes world-first biosimilar drug substitution decision

Australia’s independent Pharmaceutical Benefits Advisory Committee (PBAC) has made a world-first recommendation to allow clinicians and pharmacists to give patients the option of substituting expensive biologic medicines at the chemist if there is a cheaper replacement or ‘biosimilar’ available that has been determined by experts to be a safe, equally-effective treatment.

Biosimilar versions of biologic medicines can offer comparable health benefits safely at a lower price, just like generics did for common chemical-based synthetic medicines a decade ago. There are already biosimilar versions of medicines listed on the Pharmaceutical Benefits Scheme (PBS) that are being safely prescribed to patients as equally-effective treatments to biologics, according to a Department of Health and Ageing statement.

Allows consumers to choose to substitute biosimilar version of biologic medicine

What this PBAC recommendation simply relates to is the ability for consumers to be able to choose to substitute their biologic medicine for a cheaper biosimilar at the chemist if it is approved as a safe and equally effective treatment by the Therapeutic Goods Administration, the PBAC and their doctor.

Doctors and specialists would continue to have a say over whether or not substitution should occur for a patient when writing their script if they do not consider it appropriate in their individual case, just like they currently do with generic medicines. It is important consumers are also aware they would still have the ultimate choice regarding whether they receive the biologic medicine or the biosimilar at the chemist when they fill their script, the ministry said.

This recommendation recognizes the rapid growth in this type of treatment by Australians, with five of the top 10 drugs subsidized on the PBS now biologic drugs that would cost patients between A$400 ($310) and A$1,700 per treatment without taxpayer subsidisation. This has in turn seen spending increase from about 4% of the total cost of the PBS a decade ago to about a quarter (25%) of the PBS today.

Essential to ensure taxpayer investment in this rapidly growing sector

And with more and more expensive biologic medicines due to come onto the market – and a large number of existing biologics set to come off-patent – in the near future, it is essential government and drug regulators have a plan to deal with this policy challenge and ensure taxpayer investment in this rapidly growing sector is as efficient as possible, the ministry said.

To reiterate, the PBAC has made it clear that any biosimilar version of a biologic medicine would have to be approved as a safe and equally effective treatment by both the Therapeutic Goods Administration (TGA) and the PBAC before it could be considered for substitution.

The PBAC has also made it clear each case for listing a biosimilar for optional substitution at the chemist would be individually assessed on its merit – it would not mean blanket approvals for biosimilar substitution.