Novartis has decided to withdraw their application for Aimovig to be listed on the PBS. This decision will distressing for many people in our community. If you need support, reach out to the community in the Migraine Australia Chat Group, or call Lifeline on 13 11 14.
Aimovig has been rejected by the Pharmaceutical Benefits Advisory Committee (PBAC) twice. The main concern in both rejection summaries was around the cost to the economy, and they wanted more data. Specifically, the PBAC was concerned about the number of potential patients, and said the cost was “high and uncertain”.
Aimovig, like the other new anti-CGRP monoclonal antibodies which are all similar in price and efficacy, is likely to change the lives of hundreds of thousands migraine patients in Australia. Even at the heavily discounted ‘special buy’ price that the Government pays for PBS medicines, that would be millions of dollars. The PBAC estimated $100m over the first 6 years for 200,000 patients.
When the PBAC made a positive recommendation from Emgality to be listed on the PBS, it had this line in the notification:
Additionally, the PBAC considered it would be appropriate for galcanezumab and Botox to be combined in the same subsidisation caps under a Risk Sharing Arrangement.
While there has been a lot of confusion about what exactly this means and how it would work, the force and effect is that the PBAC is making the companies to give away their drug for free. The PBAC is saying is that there’s only so much they’re prepared to spend on migraine – for every patient prescribed Emgality, there’s one less on Botox the Government will subsidise. Or to put it another way, the PBAC thinks that migraine isn’t important enough to treat, but we can have our new drugs so long as it doesn’t cost the budget any more than is already being spent on Botox.
Novartis is not prepared to give their products away to hundreds of thousands of patients forever, and so have withdrawn from the PBS process.
And we understand that. Novartis has been incredibly generous with thousands already receiving the drug for free on the patient familiarisation program (PFP) and three month free trials. They have also invested in our community and done much to raise awareness of migraine, including funding the Deloitte Access Economics white paper on migraine in Australia.
Additionally, by withdrawing the application now, Novartis has demonstrated they care about us. If Novartis had continued with the doomed application, they would not have been able to say anything about it until December 20, because the PBAC rules don’t allow them to. Withdrawing the application now enables people living with migraine more time to make decisions, get in to see their neurologists, and it means people won’t miss the news during the busy Christmas/New Year period.
I’m on Aimovig. What does this mean for me?
If you are on the PFP you will continue to receive your Aimovig for free until April 30, 2020.
If you are currently on a three month free trial you will continue to get your 3 doses of Aimovig for free. The three month free trial program will also end on April 30, 2020.
If you are on a compassionate access program, you will also be unaffected, and continue to get Aimovig for free for however long you have been offered access. Speak to your neurologist if you are unsure if your compassionate access has an end date.
Once your trial or PFP has ended, you can continue to be prescribed Aimovig but will have to pay the retail price of $750-850, varying on your pharmacist’s mark up. (Best to shop around!)
What other options do I have?
Ajovy (Teva) is offering a PFP called MigraineHQ. Like the one Novartis offered, this is limited to 10 patients per doctor. Those on the PFP will receive Ajovy for free until the PBS or further notice. Ajovy remains on the PBAC agenda for November. **UPDATE** The PFP has been fully subscribed and is no longer available.
Emgality (Eli Lilly) does have a positive recommendation from the PBAC, but they have to negotiate the details with the Department of Health, before the Minister can sign off, and then – and only then – will it be added to the PBS. There is no guarantee of when Emgality will be added to the PBS. They have an access offer of two months free and then a discounted price with a voucher that either your neuro or GP can get for you.
The next anti-CGRP preventatives, Eptinezumab being developed by Alder (Lundbeck), and a number of gepants, are still in the final stages of clinical trials, and will not be available until approximately late 2020.
Who can I contact?
To discuss your personal decision about whether to stay on Aimovig and switch, talk to your neurologist or pain specialist.
If you are on the PFP, you can also call the MyAim program on 1800 979 607, or email PFP@myaimprogram.com.au. If you are not on the PFP, call Novartis Medical Information on 1800 671 203 or email email@example.com.
If you need support, please join us in the Migraine Australia Chat Room. You can also email firstname.lastname@example.org and we will do our best to help you.
What is Migraine Australia doing about this?
Have no doubt that we will be making ourselves heard. Your submissions to the PBAC, as well as our organisation submission including your comments, were read and considered by PBAC prior to this decision.
We have already been in touch with politicians, the PBAC, and will be making our case in the media as the story unfolds.
This is a hard one to fix, as the PBAC seems to have made a grave error – but the way the system is designed, no one can tell the PBAC they have done something wrong, or not to do something. We will continue to work on it until we find a solution.
What can I do about this?
- Contact the politicians that represent you and tell them you’re not happy: just enter your postcode on this page https://www.aph.gov.au/Senators_and_Members then click through for contact details about each politician. Don’t use offensive language or be abusive; remember the politicians didn’t make this decision, but we will need their help to fix it.
- Contact the Health Minister Greg Hunt Greg.Hunt.MP@aph.gov.au
- Donate to help fund the set up costs for Migraine Australia.
- Join the Migraine Australia Chat Group as we work to support each other and get through this latest hurdle together.