England’s National Institute of Care and Health Excellence (NICE) has granted approval for Pfizer’s Vydura (rimegepant) as a treatment for migraine headaches, following its earlier recommendation for preventing migraines. Vydura is set to become the first medication approved in the United Kingdom for the treatment of episodic (acute) migraine attacks. In the United States, it is commercially known as Nurtec and gained FDA approval for acute migraine attacks in February 2020, followed by approval as a preventative therapy 15 months later. Both uses of rimegepant were approved by the European Union in 2022.
NICE previously endorsed the use of Vydura to prevent migraines in May, also suggesting its approval for treating acute attacks, albeit as a fourth-line option with certain restrictions. The latest endorsement will provide approximately 13,000 patients in the UK access to the drug.
However, NICE has not recommended Vydura for primary use at this time. According to the draft guidance, rimegepant is recommended for adults who have not experienced success with at least two triptan medicines. It is also suggested for individuals who cannot take triptans and have not achieved positive results with nonsteroidal anti-inflammatory drugs (NSAIDs) or the beta blocker paracetamol.
NICE mentioned that while rimegepant could potentially be used in primary care in the future, its initial administration should begin in secondary care, allowing for flexibility in local or regional implementation.
Rimegepant is administered as a dissolvable wafer under the tongue and has demonstrated the ability to reduce pain within two hours of ingestion. It functions by inhibiting the release of calcitonin gene-related peptide (CGRP), a protein believed to contribute to the pain associated with migraine attacks. The cost of a 75 mg tablet in the UK is £12.90 ($16.12), according to NICE.
Biohaven initially developed rimegepant and Pfizer acquired it as part of an $11.6 billion acquisition of the company. In July, Pfizer reported that Nurtec generated $247 million in sales during the second quarter of the year.
AbbVie’s Qulipta, another CGRP antagonist migraine treatment, is also awaiting a decision from NICE this year. It received FDA approval in 2021 as a preventative therapy and in April 2022 as a treatment for chronic migraines, which occur more frequently and are more debilitating than episodic attacks (at least 15 times per month). Qulipta reported sales of $96 million in the second quarter of this year. Migraines are more prevalent in women and typically begin between the ages of 35 and 45, often triggered by hormonal changes. Migraine-related absenteeism costs the UK up to 43 million workdays annually, and the total healthcare and productivity costs to the UK economy are estimated to be between £6 billion ($7.5 billion) and £10 billion ($12.5 billion) per year, according to Pfizer.
