The CGRP anti-migraine prophylaxis drug erenumab (Aimovig) has had its application for listing on the PBS withdrawn by manufacturer Novartis.
The company said it had decided not to proceed with a third erenumab submission to the Pharmaceutical Benefits Advisory Committee (PBAC) after being rejected twice for a listing for prevention of migraine
It said erenumab would continue to be available via private prescription, at an estimated cost of $750-850/month and all Australian patients currently enrolled on Aimovig access program would continue to access the drug until 30 April 2020.
“Patients are advised to speak to their treating physician to understand the options available to them,” the company said in a statement.
“This decision has not been taken lightly and follows thorough consideration of recent developments in the reimbursement of innovative migraine treatments in Australia,” said Richard Tew, General Manager Novartis Pharmaceuticals Australia and New Zealand.
“We acknowledge this will be disappointing news to those living with migraine, as well as healthcare professionals, awaiting a PBS listing to new preventive targeted therapies.”
Lobby group Migraine Australia said it was disappointed but not surprised by the manufacturer’s decision to remove the drug from consideration at the November meeting of the Pharmaceutical Benefits Advisory Committee (PBAC).
The group said it understood the move was related to the PBAC’s insistence on a capped restriction on reimbursement for migraine prophylaxis drugs, based on its estimates that subsidies would cost $100 million over the first six years for 200,000 patients.
In 2018 the PBAC rejected a PBS listing submission for erenumab, saying there was potential for blowout in costs.
“The PBAC considered that the cost to Government was underestimated by the submission, both because the number of patients with chronic migraine was underestimated by the submission and because of the significant risk of leakage outside the proposed limited PBS listing (for example, patients with episodic migraine),” the Committee stated in its decision.
Chair of Migraine Australia’s organising committee, Raphaella Crosby, likened the decision of the PBAC to “bullying the drug companies into giving away their drug for free.”
“It is not clear if the problem is the PBAC dismiss migraine as ‘just a headache’, or something else, but we are really unhappy about the way we are being treated,” she said.
“To deny us a chance at a normal life, confined to welfare or constantly at risk of losing our jobs, unable to have a productive life, simply because there’s too many of us, is cruel and inexplicable,”.
Erenumab is one of three CGRP targeted migraine prophylaxis drugs that are being considered for PBS listing, along with galcanezumab (Emgality) and fremanezumab (Ajovy).
Galcanezumab was recommended for PBS listing by the PBAC at its July meeting, while fremanezumab will have its submission considered at the next PBAC meeting in November.