PBS restrictions on infliximab in Crohn’s disease have been eased for biosimilar brands to allow Streamlined or Telephone Authority for ongoing prescriptions.
The easing of the restrictions, intended by the government to drive uptake of biosimilars such as Renflexis and Inflectra, will mean clinicians no longer have apply in writing by post and wait for weeks to receive authorisation for continuing infliximab prescriptions.
The change, which comes into effect on 1 July, applies to adult patients with severe Crohn’s disease who are stabilised for nine months on any brand of infliximab. Following a recommendation by the Pharmaceutical Benefits Advisory Committee in November 2017, biosimilar brands of infliximab can be prescribed with a Streamlined Authority in public hospitals and Telephone Authority in private hospitals for subsequent ongoing treatment.
The change removes the need to post test results to the Department of Health to secure Written Authority for ongoing subsidised treatment.
The PBS written authority requirement remains for biosimilar initiation scripts (three months) and first continuing treatment prescriptions (six months) and also for all treatment phases for the infliximab originator brand Remicade.
According to MSD, which markets Renflexis, the Streamlined Authority approval process is likely to improve uptake of biosimilar infliximab, based on experience with the company’s other biosimilar brand of etanercept, Brenzys.
Usage of Brenzys more than tripled after a Streamlined Authority was introduced for etanercept in November 2017, the company announced. The proportion of etanercept 50mgused represented by the biosimilar brand increased from 1.8% in November 2017 to 7% in April 2018, according to MSD.
“Increased prescribing of MSD’s etanercept biosimilar in recent months indicates that prescriber and patient acceptance of biosimilars is on the rise and that Government policy is working,” said Speciality Care Director at MSD Australia, Margie Austin.
“The early success of biosimilar uptake drivers will provide other sponsors with the confidence to bring biosimilars to market, providing additional choice for prescribers, while generating sizeable PBS savings,” she added.
In 2015, the Federal Government estimated that the increased use of biosimilar medicines will deliver $880 million in PBS savings by 2020.