12 March 2020 – Teva UK Limited today announced that the National Institute for Health and Care Excellence (NICE) has recommended AJOVY® (fremanezumab) in its Final Appraisal Document (FAD) for the prevention of migraine in adults with chronic migraine who have not responded to at least three prior preventive treatments. AJOVY® belongs to a class of treatments called anti-CGRP (calcitonin gene-related peptide) monoclonal antibodies, which have been specifically designed to target the underlying causes of migraine (CGRP levels have been shown to increase significantly during migraine attacks).

AJOVY® is the first anti-CGRP preventive therapy recommended by NICE. It offers monthly or quarterly dosing options and can be self-injected once patients are trained.1 Migraine prevention therapies in England and Wales are currently limited and none of the commonly used treatments (anti-epileptics, anti-depressants, beta blockers and botulinum toxin injections) were developed specifically to target the molecular pathways of migraine.2

"NICE's decision to approve the use of AJOVY® on the NHS in England and Wales for patients with chronic migraine is fantastic news,” comments Dr Mark Weatherall, President of the British Association for the Study of Headache. “Anyone who looks after people with chronic migraine understands just how debilitating this neurological disorder can be. We have waited a long time for this new class of drug to be made available in the NHS, but now that we can prescribe fremanezumab, I am excited to see what a difference it will make to the lives of many of my worst affected patients.”

Migraine remains under-diagnosed and under-treated in at least half of all patients. Less than half of people with migraine consult a doctor.3 Less than 30% of migraine patients have management of their condition.3

Migraine typically presents as a moderate to severe headache, often accompanied by nausea and/or vomiting, with sensitivity to noise, light and/or smell.4

1 in 7 UK adults are affected by migraine (over 7.2 million people) and women are three times more likely to be affected than men.5 Chronic migraine, defined as 15 or more headache days and at least 8 migraine days per month for at least 3 months affects an estimated 900,000 adults and can have a tremendous impact on quality of life.6,7

NICE recommends AJOVY® as an option for chronic migraine patients who have not responded to at least three prior preventive treatments. This decision is based on a dossier submitted to NICE for a Single Technology Appraisal (STA). Following publication of the FAD, NICE will provide its formal guidance to the NHS in England. The full NICE recommendations and conditions can be viewed on their website – www.nice.org.uk.

“Teva is very pleased to receive this decision by NICE as we seek to expand the availability of AJOVY® in the UK in an effort to ensure that patients living with migraine have access to this treatment option,” said Kim Innes, General Manager of Teva UK and Ireland. “To have the first anti-CGRP medicine approved by NICE is a great achievement for Teva. We’re committed to improving the lives of migraine patients, and believe that the introduction of AJOVY®, having been designed specifically for migraine prevention and with its flexible dosing options, will bring new opportunities and improve the lives of patients struggling to control this disabling condition.”

AJOVY® is the first and only anti-CGRP drug approved for use on the NHS in England and Wales (also approved in Scotland by the Scottish Medicines Consortium) that is designed for the prevention of migraine that offers both quarterly and monthly dosing options, with the flexibility to be self-injected at home by the patient (or carer).

-ENDS-

 

References

  1. AJOVY® Patient Information Leaflet. http://products.tevauk.com/mediafile/id/48238.pdf [Last accessed: March 2020]
  2. Khan S. et al. ‘CGRP, a target for preventive therapy in migraine and cluster headache: Systematic review of clinical data’. Cephalalgia (2019); 39(3): 374-389
  3. Pavone E. et al. ‘Patterns of triptans use: a study based on the records of a community pharmaceutical department’. Cephalalgia (2007); 27: 1000-1004.
  4. NHS – Migraine (www.nhs.uk/conditions/migraine/symptoms/) [Last accessed: March 2020]
  5. Migraine Trust – Facts and Figures https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/ (figure based on current UK adult population from the Office of National Statistics - www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/february2016) [Last accessed: March 2020]
  6. Buse DC. et al. ‘Chronic Migraine Prevalence, Disability, and Sociodemographic Factors: Results From the American Migraine Prevalence and Prevention Study’. J Head Face Pain52: 1456-1470. doi:10.1111/j.1526-4610.2012.02223.x
  7. Chronic migraine population calculated by using 12% of migraine population (1 in 7 total population) as cited by Buse (above) amongst context of current UK population statistics from Office of National Statistics. Population estimates for the UK, England and Wales, Scotland and Northern Ireland: mid-2018. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/bulletins/annualmidyearpopulationestimates/mid2018 [Last accessed: March 2020]

 

UK/CPE/18/0019(1)o
Date of Preperation: March 2020