Second biosimilar heads down streamlined authority road

Hot on the heels of the Brenzys decision, the PBAC has been asked to relax prescribing requirements for a second biosimilar.

Sponsor MSD Australia has asked the PBAC to use its new powers to recommend streamlined authority access to its inflixmab biosimilar Renflexis for patients who are continuing on the agent, or switching from any other bDMARD.

The proposal was on the agenda for the PBAC’s November meeting.

MSD has already clocked a win with its etanercept biosimilar Brenzys, which clinicians will be able to be prescribe using a streamlined authority from 1 December for “subsequent continuing” scripts.

This will mean patients stable on the agent for six months or more will not have to submit blood tests and joint counts to the department of health to justify ongoing treatment.

The change has won the backing of rheumatologist Professor Stephen Hall, who said it has the potential to save time for doctors and reduce stress for patients.

“The existing process can be cumbersome and time-consuming for the prescriber and can result in significant delays for patients,” Professor Hall said in a company sponsored press release.

“Under the new arrangements, patients should receive their subsequent continuing prescriptions immediately rather than waiting up to a month for their medication.”

But the Australian Rheumatology Association does not support the differential application of streamlined authorities, arguing it goes against the integrity of the authority system and gives certain brands a leg-up in the market.

The AMA agrees, arguing the strategy has “nothing to do with safety and quality and appears mostly to benefit certain pharmaceutical companies”.

“We think the only reason to prescribe a biosimilar is because it’s cheaper and at this stage that doesn’t seem to be the case,” said ARA biosimilars working group co-chair Dr Mona Marabani.

“The authority system is about ensuring people meet the criteria for high cost drugs and we think all biologic drugs, after the first demonstration of response, should be allowed to be streamlined.”

MSD’s Renflexis request goes even further, seeking streamlined access for anyone switching over to the agent.

Dr Marabani said there would be “no medical reason” for such a switch and it was unlikely many prescribers would take up this opportunity when in most cases it would mean moving patients from a subcutaneous injection to an IV infusion.

“It may encourage movement to Renflexis from other infliximab brands, but this drug is not commonly accessed via community pharmacy anyway,” she said.

“I don’t know that would be a big drawcard for most rheumatologists, because what you save on administration by not having to fill out the forms you will lose in organising patients to have infusions, and it may not be suitable, they may not want that.”

Dr Marabani said Renflexis is the third infliximab biosimilar to come to market and it appeared that MSD is “looking for a way to get some market share”.

“The fact is the biosimilars are listed at the same price as the originators. There remain unresolved issues around nomenclature, interchangeability and traceability so we just have to be very cautious about the potential for things to go wrong if we don’t pay very close attention on how to use these drugs wisely.”

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