UPDATED: PBS restrictions on infliximab have been eased for biosimilar brands to allow Streamlined or Telephone Authority for ongoing prescriptions, but only for Crohns disease at the present time.
The easing of the restrictions, intended by the government to drive uptake of infliximab 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 only to patients with severe Crohns diease who are stabilised for nine months on any brand of infliximab.
Infliximab is PBS listed for severe active rheumatoid arthritis, active ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis as well as inflammatory bowel disease.In its advice to prescribers, the Department of Health says it expects the uptake drivers will be extended for arthritic indications in the future.
“These listing changes will be rolled out for further indications for infliximab over time. [The Biosimilars Uptake Driver] factsheet will be updated for listing changes as they occur for each indication,” its factsheet states.
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.
[This story was updated on 15 July to reflect PBS factsheet advice on the infliximab indications for which uptake drivers currently apply].