PBAC world-first biosimilar drug decision

The Australian Government remains committed to accepting the expert advice of Australia’s independent Pharmaceutical Benefits Advisory Committee (PBAC) without ‘fear or favour’.

Page last updated: 19 June 2015

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19 June 2015

The Abbott Government remains committed to accepting the expert advice of Australia’s independent Pharmaceutical Benefits Advisory Committee (PBAC) without ‘fear or favour’.

What we will not do is pick and choose PBAC advice to suit political purposes, like the previous Labor Government’s disastrous and dangerous attempt to halt listing new drug recommendations until it returned budget surplus.

The 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.

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.

This recommendation recognises the rapid growth in this type of treatment by Australians, with five of the Top 10 drugs subsidised on the Pharmaceutical Benefit Scheme (PBS) now biologic drugs that would cost patients between $400 and $1700 per treatment without taxpayer subsidisation.

This has in turn seen spending increase from about 4 per cent of the total cost of the Pharmaceutical Benefits Scheme (PBS) a decade ago to about a quarter (25%) of the PBS today.

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.

Consumers and their representatives should have confidence in the independent expert advice and processes of the PBAC in ensuring their continued access to affordable, safe medications.

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.

ENDS

Minister Ley’s Media Contact: Troy Bilsborough 0427 063 150

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