Updated: Australian patients part of a “world first” experiment

Australian rheumatology patients will be the subjects of a worrying “world first” experiment if pharmacists are permitted to substitute biologics for biosimilars, the ARA warns.

President Mona Marabani appeared at a Senate Economics Committee hearing on Thursday to voice concerns about the government’s move to save $800 million by allowing pharmacists to substitute biosimilars for brand name original biologics (termed ‘a’ flagging).

According to Marabani the big problem with the PBAC recommendation is that every time a patient goes for a prescription they could potentially get a different drug.

However there is no evidence that repeated switching is safe and there are good theoretical grounds for concerns that patients who switch multiple times could be at risk of immunogenicity and increased toxicity.

The ARA’s position is one that is based in evidence and best practice, says Marabani.

“This is a significant departure from that and one that cannot be allowed to happen without us making very clear our concerns.”

It flies in the face of every world-leading regulator, it’s not permitted in any other jurisdiction except Venezuela, she tells the limbic.

“It’s a big experiment and Australian patients are going to be the subjects of this experiment, the result of which we don’t know.”

The clock is ticking because the issue is tied up in a Bill that includes the 6th Community Pharmacy Agreement that expires on the 30th June.

“This idea about biosimilars has been bundled in with that and so there is an imperative to push it all through,” says Marabani.

“It may well happen because the issues are so complex that it just slips through because no one really understands what’s at stake,” she warns.

Reassurances from the government that patients and their doctors will ultimately have the final choice as to which version of the drug they receive has done little to allay the ARA’s concerns.

The reality, says Marabani, is that the pharmacist may override a tick made by the prescribing doctor in the ‘brand substitution not permitted’ box.

There is also a risk that the patient being told ‘there is a cheaper brand available’ might not understand what it means in the context of a biosimilar.

“It also puts the onus and potentially the risk back on the doctor and we don’t think it’s the right answer,” she says.

The Senate Economics Committee recommended that the government undertake immediately a broad and transparent public consultation across all stakeholders, with the aim of producing informed guidance on how and under what circumstances ‘a’ flagging of biosimilar medicines can occur.

It also recommended that the goverment give “close and careful” consideration to the role of the TGA with a view to ensuring that its role offers reassurance that the safety of patients would not be compromised by the process for determining whether a biosimilar is suitable for substitution at pharmacy level.

Following these recommendations the ARA has been invited to a PBAC led stakeholder forum on biosimilars in Sydney on 7 July.

“The ARA looks forward to participating  in the PBAC stakeholder forum on biosimilars and we intend to work positively, constructively and proactively in this process,” the Association told the limbic. 

It will also continue to engage with the TGA on its consultation of the draft revised guidelines, it said.

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