CGRP inhibitor progressing to PBS listing within months


By Michael Woodhead

30 Mar 2021

The Department of Health says it is moving quickly to list the anti-CGRP monoclonal antibody galcanezumab (Emgality) on the PBS for prevention of migraine.

In response to questions in parliament from Senators on delays in progression of listing approvals listing for anti-migraine drugs, officials told a Senate Estimates hearing that it was moving forward as quickly as possible following a breakthrough in pricing negotiations with the manufacturer of galcanezumab.

“The one made by Eli Lilly submitted a pricing proposal on 4 March that is consistent with the PBAC’s recommendation, and that drug is now progressing through government approval processes,” said Adriana Platona, from the Federal Department of Health.

Officials said the usual timeframe was six months for listings following such agreements, and would depend on factors such as Cabinet approval for high cost drugs and supply arrangements by industry.

“The medicine will be listed at the first available opportunity,” said Penny Shakespeare, Deputy Secretary of the Department at the Senate Community Affairs Legislation Committee hearing on 24 March

“We’ll move as quickly as we possibly can … I don’t know whether it will be next month or the month after that.”

“We still have work to do with the company, to see what date they can supply from to get the necessary approvals from government to change the legislation, to put it on the list and to get that information out to all the pharmacies that we’ll need to supply,”

The Senate Estimates hearing was told that PBS listing had also been approved for fremanezumab (Ajovy) but its manufacturer Teva had yet to submit the documentation necessary to fulfil the PBAC recommendation.

“We would welcome a listing application from the company at any time,” said Ms Shakespeare.

“There is no impediment for progressing the drug by the name of Ajovy, other than the company’s willingness to move forward,” added Ms Platona.

An application to list a third CGRP inhibitor erenumab (Aimovig) has been abandoned by manufacturer Novartis, according to the PBS Medicine Status website.

“The pharmaceutical company has withdrawn their submission for this medicine prior to the medicine being considered at the PBAC meeting [in November 2019]. The process for listing this medicine has ceased.”

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