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.”