PBS moves to ease access to biosimilars for IBD


By Tessa Hoffman

25 Jan 2018

A leading gastroenterologist has welcomed moves to relax PBS authority requirements for infliximab biosimilars for IBD patients.

Following an application from MSD for the biosimilar Renflexis, the Pharmaceutical Benefits Advisory Committee has recommended streamlined authority access when patients have been stable on infliximab for two treatment cycles.

Renflexis is a biosimilar to the infliximab originator product Remicade, and there is another infliximab biosimilar under the Inflectra brand.

MSD requested that the current Authority Required (in writing) listing for Renflexis be changed to Authority Required (Streamlined) for patients continuing on treatment or switching from the reference biologic or from another bDMARD.

In a decision made at its November 2017 meeting, the PBAC advised that “there are no clinical or other concerns about appropriate use of medicines if the policy to lower the authority requirement for only the biosimilar brands of infliximab is adopted,”

The recommendation was made subject to retaining existing authority requirements and restrictions for all initial treatments with infliximab, and also for the first subsequent treatment with criteria retained for response to treatment.

A spokesman for Pfizer told the limbic that company believed the relaxed authority criteria would apply to all biosimilar infliximab brands including Inflectra.

The recommendation is part of the government’s ‘biosimilar uptake driver’ strategy and would make life easier for busy gastroenterologists without compromising patient outcomes, according to Professor Rupert Leong, senior staff specialist gastroenterologist at Concord Hospital, Sydney.

“This is one way of reducing a very significant hurdle where we have to make very complex mathematical calculations in order to renew a drug that’s obviously working on a patient,” he said.

“Because we are time poor as physicians and we have a lot of complex patients, this removal of a hurdle is going to be welcomed by the majority of gastroenterologists.”

Infliximab is indicated for treatment of refractory Crohn’s Disease, fistulising Crohn’s Disease and ulcerative colitis in adults and children, with the PBS subsidising almost 50,000 treatments for luminal and fistulising CD and acute severe UC between 2007-14, with a fourfold increase in use over that time.

In its decision, the PBAC confirmed its previous recommendation regarding ‘a’ flagging which is intended to support all brands of infliximab. The committee also responded positively to a  request for a change to prescribing software to give preference to Renflexis for infliximab naïve patients. The  PBAC said it “did not have any concerns about encouraging prescribing of a biosimilar brand for treatment naïve patients.”

The PBS  ‘biosimilar uptake driver’ program encourages prescribing of a biosimilar brand rather than the reference biological brand for treatment naïve patients.

According to Professor Leong, the biosimilar uptake driver scheme would help reduce health costs while retaining physicians’ autonomy.

“If they still want to use the originator infliximab they can do so,” he said.

Numerous studies have shown the originator and biosimilar medications lead to similar response rates in gastroenterological disease “so we have got reasonably good confidence that these drugs are going to behave in the same way,” he noted.

“There are also data that switching from originator to biosimilar on a one-off switch do not appear to disadvantage in any way. The same proportion demonstrate efficacy at least on short term follow-up, there is no long term follow up data because it’s a relatively new development over the last couple of years.

A ‘biosimilar uptake driver’ has already been applied by the PBS to the etanercept biosimilar Brenzys. This elicited criticism from the Australian Rheumatology Association which argued that any changes to authority requirements should apply to all bDMARDS.

Professor Leong sits on the advisory boards for Janssen, Abbvie, Pfizer, MSD and Takeda.

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