The protracted saga of listing migraine preventive drugs on the PBS has taken a new turn with the Pharmaceutical Benefits Advisory Committee now redefining the criteria it will use for migraine attacks.
The PBAC has said it wants to abandon terms such as ‘chronic’ and ‘episodic’ migraine in PBS listing criteria and replace them with ‘manageable’ and ‘difficult to manage’ migraine.
In its decision to reject an application for listing galcanezumab (Emgality) on the PBS for treatment-resistant episodic migraine, the PBAC said there was no clear distinction between treatment-resistant chronic and episodic migraine, and therefore it would be difficult to approve separate PBS listing for these diagnoses.
Instead, it suggested manufacturer Eli Lilly resubmit an application for a single PBS listing covering both chronic and episodic treatment-resistant migraine.
“The PBAC considered episodic and chronic migraine are on a continuum, and patients may cycle between the two, rather than discrete clinical entities for the purpose of PBS listing,” it said in its Public Summary Document for the PBAC’s November 2020 meeting
“The PBAC considered a single listing for treatment-resistant migraine would be a more reasonable approach. The PBAC noted Migraine Australia was supportive of changing the terminology from episodic and chronic to ‘manageable’ and ‘difficult to manage’.”
Galcanezumab was previously recommended for PBS listing for the treatment of treatment resistant chronic migraine in July 2019. At that time the PBAC accepted it would be cost effective for people who had ≥15 headache days per month of which ≥8 were migraine headache days, and after an inadequate response, to three or more prophylactic migraine medications.
However the PBS listing did not proceed, with Migraine Australia blaming stalled pricing negotiations and government insistence on funding caps for CGRP migraine prophylaxis similar to the existing migraine treatment, Botox.
In response to the additional minor submission for episodic migraine, the PBAC said it would not recommend the listing of galcanezumab because of uncertainty over cost effectiveness.
“The PBAC considered a listing for treatment-resistant migraine would be appropriate and that any resubmission would need to address offsets for patients that might otherwise be attributed for in the chronic migraine population,” it said.
Lobby group Migraine Australia has been urging government to overcome the deadlock on PBS listings for CGRP migraine prophylaxis drugs including erenumab (Aimovig) and fremanezumab (Ajovy).
A spokesperson for Eli Lilly Australia said; “in line with the PBAC recommendation made in November 2020, [it] was working closely with the Department of Health to help secure long-term affordable access to Emgality (galcanezumab) at the earliest possible opportunity 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 preventative therapies.”
“Lilly will also continue its efforts to secure a PBS listing 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,” the company said.’
“Should an episodic listing follow a chronic listing Lilly has noted comments from the PBAC about the terminology used to categorise all potential patient populations who may benefit from reimbursed access to Emgality.”