The calcitonin gene-related peptide (CGRP) inhibitor galcanezumab (Emgality) will be PBS listed for the treatment of chronic migraine from June 1.

The long-awaited PBS listing was part of the Federal Government’s Budget 2021-22 announcement which included $43 billion allocated over four years to the PBS.

Neurologist Associate Professor Richard Stark, from the Alfred Hospital, welcomed the PBS listing of the CGRP inhibitor.

“This is a tremendous milestone which will prompt the reassessment of a large number of patients at the severe end of the migraine spectrum,” he said in a statement from Eli Lilly.

“Chronic migraine can be severely disabling, with recurrent attacks giving patients little respite or capacity to engage in, or enjoy, the activities of daily life. The importance of new forms of effective and well-tolerated migraine prevention cannot be overstated,” he said.

Evidence for galcanezumab includes the 2018 REGAIN study which found patients receiving the CGRP inhibitor had fewer migraine headache days per month than patients on placebo (4.8 v 2.7 days).

More recently, a post-hoc analysis of results from three phase 3 RCTs, confirmed galcanezumab was efficacious in reducing the severity and symptoms of migraine in patients with episodic and chronic migraine.

“Among patients treated with galcanezumab, there was a greater reduction in the percent of migraine headache days with nausea and/or vomiting for both episodic and chronic migraine trials, and a reduction in the percent of migraine headache days with photophobia and phonophobia in the episodic migraine trials compared with patients treated with placebo.”

Galcanezumab will be available on the PBS for chronic migraine patients – 15 or more headache days a month, eight of which are migraines – who have had an unsatisfactory response or are intolerant to at least three prevention therapies.

Eli Lilly said the Emgality access program currently offered by the company will remain in place for patients not eligible for PBS reimbursement.