Progress on PBS listing of Lilly’s CGRP inhibitor for chronic migraine

Pharma News: Eli Lilly Australia welcomes changes to the PBAC recommendation for the reimbursement of Emgality (galcanezumab) for the prevention of chronic migraine (15 or more headache days a month, eight of which are migraines) in patients with an unsatisfactory response or intolerance to at least three prophylactic therapies.

Lilly ANZ General Manager, Benjamin Basil said that progress had been made since the PBAC provided its initial advice in 2019.

“We remain hopeful of a solution that will allow for long-term, affordable access to Emgality for all eligible patients, and thank the Committee and all stakeholders for feedback relating to our revised funding proposal,” he said.

“We are now focused on working with the Department to ensure we have a complete understanding of the recommendation and whether the conditions of listing are viable for our company and, of course, the Commonwealth.”

The total economic costs, incorporating health system cost, productivity cost, carer cost, welfare payouts and deadweight costs (including lost taxation and informal care costs) of migraine in Australia in 2018 were estimated to be $35.7 billion.

The new and amended PBAC recommendation is based on an updated Risk Sharing Agreement developed by Lilly in consultation with neurologists and experts in the migraine field.

Mr Basil reaffirmed the commitment of Lilly to work with all stakeholders to address the significant unmet medical needs of Australians living with chronic and episodic migraine.

Migraine Australia is pleased to hear that Emgality has been recommended for a second time to be listed on the PBS for chronic patients. “To get on the PBS, we need the Health Minister on our side. Write to Greg Hunt or your local MP.”

According to Lilly, a separate PBAC submission for the reimbursement of Emgality for the prevention of episodic migraine (up to 14 headache days a month, four of which are migraines) in patients with an unsatisfactory response or intolerance to at least three preventative therapies was not recommended.

Amgen’s Aimovig (Erenumab) was recently withdrawn from the Pharmaceutical Benefits Advisory Committee (PBAC) approval process in Australia. However, new findings, published in Headache: The Journal of Head and Face Pain, demonstrate that Erenumab is an effective, well-tolerated migraine therapy, in real-world, complex patients, but will remain out of reach for most people due to cost.

Teva’s Ajovy (Fremanezumab) has received PBAC recommendation but are not yet listed on the PBS as the company has not reached an agreement with Government from a pricing perspective.