Gepants finally approved in Australia
Australia's federal government's Therapeutic Goods Administration (TGA), the nation's drug and food regulator, has the past month finally approved drug sponsor Pfizer Australia's submission for Rimegepant ("Nurtec"😉 and has been officially registered.
It will be the first in this drug class available here, with related CGRP inhibitor injections Aimovig, Emgality and Ajovy having already recently been available (the latter two subsidised/affordable on Australia's Pharmaceutical Benefits Scheme (PBS), while Vyepti has recently also been approved, registered and approved for PBS listing.
Nurtec is still awaiting subsidy approval by the Pharmaceutical Benefits Access Committee (PBAC) to be listed on the PBS, if not and it remains as private, it could be prohibitively expensive for patients to access.
It will be Schedule 4 (Prescription Only Medicine) and also carry an Authority (Streamlined) which means only certain patients who meet the specific criteria can get access to the subsidised priced medicine if on the PBS where the prescriber (such as medical practitioner/doctor) must contact the PBS in Canberra (where federal government departments are based) for that authority number/approval, but as 'streamlined' can do it more easily/quicker via software.
Criteria will be 'migraine and patient must have failed at least two Triptan medications'. It will be officially indicated for this, as well as for acute treatment and every other day for prevention.
So it will be interesring to see what happens over coming weeks/months and how Pfizer act, but should certainly come as good news for headache sufferers, especially if various medications aren't well tolerated and/or not working properly, including injections, as well as it's multi-action and has become popular with strong results/feedback in the USA in recent years.
Any thoughts from Migraine .com family welcome...
- Grateful to you for letting us know about this development in Australia. Fascinating regarding the restriction of patients having to fail two triptans to qualify. Are you hoping to try one or more of these treatments? Warmly- Holly -migraine.com team.
UPDATE: Sadly, the government here has rejected Pfizer's submission for subsidy price listing, meaning it's highly unlikely it will go to market, at least for now. The committee cited 'economics' as the main factor, so it sounds like Pfizer's financial modelling did not stack up, rather than it being an issue with the class of or drug and its benefits itsself, which is looks like they agreed another migraine solution is needed and have at least recommended it for re-submission. Pfizer could go to market as a 'private' prescription, but the price per box per patient might be example: $300 or $1000... vs just $6.30 at its subsided cheapest! Hence.
READ HERE:https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/recommendations-made-by-the-pbac-july-2023.htmlThank you for keeping us updated as to this process in Australia. How upsetting (and yet unsurprising?) to hear how money and greed have hindered progress and kept these treatments out of the hands of those who need it. I'm afraid the link you provided doesn't open for me. Can you help us understand next steps? What is meant by them needing another migraine solution? What would that look like? Warmly- Holly -migraine.com team.
