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NICE recommends Ajovy®▼ for episodic migraine patients

Posted in Industry News on 16th Dec 2021

  • AJOVY®, the first targeted preventive injectable to be recommended by NICE for chronic migraine patients, is soon to be offered to episodic patients [1]
  • It is estimated there are 8 million episodic migraine patients compared to 1 million chronic migraine sufferers in the UK [2]
  • Recent research by The Migraine Trust found a ‘postcode lottery’ of NHS Trusts offering anti-CGRPs (and of those offering, only an average of 71 patients in each Trust per year are treated) [3]

Teva UK Limited announced on 16th December 2021 that the National Institute for Health and Care Excellence (NICE) has recommended AJOVY® (fremanezumab) in its Final Appraisal Document (FAD) for the prophylaxis of migraine in adults with episodic migraine, in addition to the existing recommendation for chronic migraine.1 AJOVY® belongs to a class of medications called anti-Calcitonin gene-related peptide (CGRP). CGRP plays an important role in the pathophysiology of migraine, and anti-CRGPs target the underlying mechanism that contributes to migraine. It can be injected every month or every three months to prevent migraine attacks.

NICE now recommends AJOVY® for sufferers who have four or more migraine days a month and have not responded to at least three preventative drugs (these are medications typically designed to treat other health conditions, such as epilepsy medication or beta blockers). NICE’s decision follows the Scottish Medicines Consortium acceptance of AJOVY® within NHS Scotland for both chronic and episodic migraine in January 2020.[4]

“It is very good news that NICE have now approved the use of fremanezumab on the NHS in England and Wales for patients with episodic migraine, thus bringing it into line with other available CGRP monoclonal antibodies.” Said Dr Mark Weatherall, Consultant Neurologist. “Patients with high frequency episodic migraine can be highly disabled by their neurological disorder. Fremanezumab, and the other members of this class of migraine treatments, are already making a huge difference to lives of hundreds of people in the UK with chronic migraine, and this decision by NICE will allow clinicians to extend that opportunity to many other sufferers.”

Originally AJOVY® was only recommended for use by NICE in England for people with chronic migraine – defined as a debilitating 15 or more headache days per month (with at least eight having migraine features). However episodic migraine can also be severe and debilitating, affecting a person’s ability to study, achieve career goals and enjoy family life. Migraine typically presents as a moderate to severe headache, often accompanied by nausea and/or vomiting, with sensitivity to noise, light and/or smell.[5] Women are three times more likely to be affected than men.2

Tasha Eagle, 35, a Physiotherapist from Norfolk who suffers from episodic migraine explains: “People who don’t have migraine don’t understand how debilitating it is. My migraine attacks can last three days – I feel sick, exhausted, a pounding headache kicks in and I lose half my vision. During an attack, I find word finding difficult and my speech can be slurred. I have been hospitalised five times with a migraine attack – on one occasion, I was given morphine for the pain. I live in fear every day that I might get a migraine, ‘what if’ I get one while out? Or before an event? How will I work?”

Despite over 200,000 UK patients meeting the criteria to receive anti-CGRPs, only a small proportion are treated with them in the NHS.[6] The Migraine Trust, the leading advocacy organisation for people with migraine, has highlighted difficulties accessing anti-CGRPs (despite it being approved for use within the NHS) in their recent 2021 report ‘Dismissed For Too Long’. Only 13 NHS Trusts in England (out of 128 contacted) had a specialist headache clinic and only 15 stated that eligible patients could access anti-CGRP treatment – just 12%.3 Trusts in England were only treating around 71 patients per year (on average) with anti-CGRPs.3 The report outlined ‘a broken healthcare system that migraine patients struggle to navigate’ and also revealed that over half of people who experience migraine haven’t been officially diagnosed by a doctor. 3

Currently, there is just one Neurologist available for every 100,000 people and just 52 specialist headache/migraine centres in the whole of the UK.[7],[8] Rob Music, Chief Executive of The Migraine Trust, commented earlier this year: “Most migraine patients never see a headache specialist, even those with chronic migraine [may be] referred to Neurologists without any expertise in migraine. People who are eligible for the new CGRP antibody migraine medication – the first ever [class of] drugs developed to prevent migraine – have struggled to access them, despite their being recommended for use on the NHS. There is clearly a postcode lottery of care where only the lucky few can access a treatment which has proven transformational for many migraine patients. This should be such an exciting and positive time, but right now this lack of access is leading to continued poor health and deep frustration. The lack of adequate migraine treatment is bad for the NHS too: migraine causes 16,500 emergency admissions every year, at a cost of £11.5m.”[9]

Migraine diagnosis typically takes years not months. A recent report from Teva Pharmaceuticals Europe revealed that one in 10 UK patients report waiting over 10 years for a formal diagnosis.[10] The Migraine Trust’s recent report calls for the recruitment of additional headache specialists and consultant neurologists to bring the UK in line with other European countries. Visit www.migrainetrust.org for support.

 

References

[1] NICE FAD on Fremanezumab/Ajovy – https://www.nice.org.uk/guidance/gid-ta10915/documents/final-appraisal-determination-document-2

[2] Calculated using statistics on The Migraine Trust website: migraine experienced by 1 in 7 (14%) of population; chronic migraine experienced by 2 in 100 (2%) of population, therefore 12% of population estimated to be episodic migraine sufferers (Current UK population estimate 67.22million) https://migrainetrust.org/understand-migraine/what-do-we-currently-know-about-migraine/#page-section-2 [Last accessed December 2021]

[3] The Migraine Trust Dismissed For Too Long Report (2021) https://migrainetrust.org/news/new-report-highlights-broken-uk-migraine-healthcare-system/ [Last accessed December 2021]

[4] SMC Decision Explained: Fremanezumab/Ajovy (2020) https://www.scottishmedicines.org.uk/media/4987/decision-explained-fremanezumab-ajovy.pdf [Last accessed December 2021]

[5] NHS Migraine Symptoms (2019) https://www.nhs.uk/conditions/migraine/symptoms/ [Last accessed December 2021]

[6] NICE. Resource impact report: Galcanezumab for preventing migraine (TA659). Published: November 2020

[7] Neurology Workforce Survey conducted by the Association of British Neurologists 2018-2019

[8] The Migraine Trust – Headache Clinics https://migrainetrust.org/live-with-migraine/healthcare/migraine-clinics/#page-section-7  [Last accessed: December 2021]

[9] The Migraine Trust Change Is Urgently Needed blog (2021) https://migrainetrust.org/news/change-is-urgently-needed/ [Last accessed December 2021]

[10] Teva Europe Beyond Migraine: The Real You (Survey of 1,0001 UK migraine patients conducted by Teva Europe (2020)). Data on file.