ARA position statement welcomes biosimilars but urges careful prescribing

Medicines

By Tony James

25 Nov 2016

A formal position statement from the Australian Rheumatology Association welcomes the introduction of biosimilars to the market but reiterates the need for better pharmacovigilance.

The statement published yesterday urges the government to commit to an enhanced program of surveillance and pharmacovigilance for biosimilars as soon as possible.

“Prescribers must also have information on what is actually dispensed to the patient in real time,” it says.

Speaking to the limbic earlier in the year chair of the ARA biosimilars working group Dr Mona Marabani said the ARA was disappointed about the lack of commitment from the government to fund an enhanced surveillance and pharmacovigilance program.

“We believe that such monitoring is vital in order to fill the evidence gap,” she said at the time.

The Department of Human Services had given the ARA assurances that electronic submission of bDMARD applications would be possible by the end of the year, but there had been no news on progress, meaning the timeline was “unlikely to be met” Dr Marabani said.

The urgent need for progress on a program that can adequately track the prescriptions of patients is particularly pressing in Australia where originator biologics can be substituted for its biosimilar without notifying the prescriber.

“The decision to prescribe any medication should rest with the prescriber, in consultation with an informed patient,” according to the statement.

“It is possible to override unauthorised substitution by ‘ticking the box’ on prescriptions to prevent substitution.”

The ARA also wants the TGA to determine whether an originator and biosimilar are interchangeable, following uncertainty about whether that role has rested with the PBAC.

“Decisions regarding interchangeability and extrapolation of indications should be based on evidence, and where evidence is not available, this should be made clear,” it says.

The ARA is also concerned about repeated switching between products, as most clinical trials have considered only a single switch and a relatively short duration of treatment.

The government is yet to decide on a naming convention for biosimilars, which will determine whether the originator and biosimilars will be known by the same generic name, for example ‘infliximab’ or ‘etanercept’, or by clearly distinguishable names.

Related story: Biosimilar naming convention undecided for now 

The ARA claims a naming convention is essential to facilitate tracking.

“Until a decision is made, we recommend prescribing by brand name and ticking the ‘brand substitution not permitted’ box to provide certainty about what has actually been dispensed to the patient,” it says.

In summary, the ARA advises prescribers to:

  • consider ticking ‘brand substitution not permitted’ on prescriptions
  • prescribe by brand name to assist tracking if an adverse event occurs
  • encourage patients to keep packaging or photograph the actual medicine dispensed and its barcode, and to bring this to every consultation
  • enrol patients into the ARA database to facilitate pharmacovigilance of originator and biosimilar agents.

“We recognise the potential for competition to reduce prices and provide savings,” the statement also noted.

“The ARA would like to see these savings reinvested in health, including broadening access for patients who need these therapies and currently do not meet the stringent requirements for subsidised treatment.”

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