Latest on Availability of Anti-CGRP medications in Ireland
The following information on the Anti-CGRP medications is correct as of December 2021…
Regarding the CGRP (Calcitonin Gene Related Peptide) MABs (Monoclonal Antibodies) – Ajovy (Fremanezumab) by Teva and Aimovig (Erenumab) by Novartis
- HSE are strictly applying the High Tech Protocols for prescribing the treatments. This means that these medications MUST be prescribed by a Hospital Consultant only, and only one who has signed up for the program. GPs cannot prescribe them.
- There are some delays in transferring patient records to the High Tech scheme
- MAI has flagged the issues with the HSE and have been told that the High Tech Protocol has a strict process that needs to be followed.
- There is information about the scheme on the HSE website https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/cgrp-mabs/
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There are 2 main approaches for targeting CGRP in migraine: large molecule monoclonal antibodies given by injection to prevent attacks and small molecule absorbable tablets for acute and possibly preventative treatment.
Medications act by either blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R), or binding to the substance (CGRP) and not allowing it to reach the nerve.
CGRP – What is it and what does it do?
- It’s a substance that is released in the trigeminal nerve.
- It spikes during migraine.
- CGRP dilates blood vessels.
- Degrades mast cells (cells which control inflammation during allergic reactions)
- Creates an inflammatory fluid in the blood vessels.
For more information see Prof. Peter Goadsby’s Interview from the European Academy of Neurology Congress 2016 on our website
Several pharmaceutical companies are involved in the manufacture of CGRP and other drugs. The main ones are Amgen/Novartis Inc, Teva, Eli Lilly, Lundbeck, Allergan and Biohaven Pharmaceuticals.
Here are the names of some of the Anti-CGRP Medications which will hopefully enter the Irish market soon.
|Auto-injector once a month
|Subcutaneous injection once a month or quarterly
|Subcutaneous injection once a month
|Intravenous injection once every 3 months
What’s available and what’s coming?
The Marketing Authorisation was granted in Ireland in the Summer 2018 and Novartis is currently awaiting the results of the Health Technology Assessment for the Irish licensing application. The Migraine Association wrote the supporting patient organisation document as part of this process.
Erenumab was available on a managed access programme but this has been closed to new patients in June 2019.
The National Centre for Pharmacoeconomics (NCPE) has recommended Erenumab for chronic migraine only –
HSE: In October 2021 the HSE approved Erenumab for reimbursement. See the process of prescription and pharmacy distribution here https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/cgrp-mabs/hse-managed-access-protocol-cgrp-mabs.pdf
Teva’s version of anti-CGRP medication, Fremanezumab (Ajovy) became available on a ‘Free of Charge’ or ‘Compassionate Grounds’ programme, which is similar to the managed access programme, from July 2019. New patients can only access Fremanezumab through their Neurologists, and only after meeting certain criteria, one of which is having tried and failed three or four other preventative medications.
Teva is also awaiting the results of the Health Technology Assessment for the Irish licensing application. The Migraine Association wrote the supporting patient organisation document as part of this process.
Patients can only access fremanezumab through their Neurologist as explained above, after having failed three or more preventative medications. Other criteria may also apply.
The NCPE has recommended Fremanezumab for both Episodic and Chronic Migraine
HSE: In November 2021 the HSE approved Fremanezumab for reimbursement. See the process of prescription and pharmacy distribution here https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/cgrp-mabs/hse-managed-access-protocol-cgrp-mabs.pdf
Lilly’s Galcanezumab is next, but we have no news as to its availability yet. Galcanezumab has been granted FDA approval in the US to treat episodic Cluster Headache in adults. So far it is the only one of the new treatments to be approved for Cluster Headache.
They are currently awaiting submissions of HTAs which will be looking at the efficacy of the medication and cost effectiveness against current treatments.
Eptinezumab (Vyepti) by Lundbeck has yet to be submitted to the NCPE for evaluation and authorisation.
Gepants and Ditans
Gepants are ‘cousins’ of erenumab, fremanezumab, etc., they are small molecule drugs which block the CGRP receptor and are effective at relieving migraine. They are currently only available in the US and as acute treatments. Gepants rapidly penetrate the brain so work quickly. Studies on the preventative properties of gepants are ongoing.
The FDA in the US has authorised two Gepants, but they have not arrived in Ireland yet.
- Utopgepant (Ubrelvy)
- Rimegepant (Nurtec ODT)
Lasmiditan (Reyvow) by Eli Lilly, is not an anti-CGRP medication but the first of a new group of headache medicines that are called a “ditan”. It is an antagonist at the 5-HT 1F serotonin receptor, where as triptans work on the 5-HT 1B and 5-HT 1D receptors. Like a triptan, Lasmiditan can stop a migraine when taken at the appropriate time, but unlike a triptan, it is thought to decrease stimulation of the trigeminal system and treat migraine pain without causing vasoconstriction so may be helpful for people for whom triptans are contraindicated due to cardiovascular problems. Lasmiditan is not available in Ireland yet.
So far, the side-effects reported for both Erenumab and Fremanezumab seem to be few and mild with mostly pain at the injection site, possibly a skin rash near the site. Other people have reported having more frequent headaches for a short while but less severe in intensity. As they are relatively new medications, long-term effects are still unknown.
Much of the information that is currently available in relation to these new anti-CGRP medications applies to the UK or the US, e.g. The Scottish Medicines Consortium has passed both Erenumab and Fremanezumab for use in migraine in Scotland. They recommend Erenumab for people with chronic migraine and Fremanezumab for both chronic and episodic migraine, in patients who have failed to respond to 3 other preventatives.
For further information and updates on the latest information on the availability of the new Anti-CGRP medications in Ireland keep an eye on our website.
For general updates you can go to https://www.cgrpforum.org/ where you can sign up for a newsletter every few weeks.
See our earlier updates…
The information contained in this article is for information only and not intended to replace medical advice or diagnosis.