Appraisal consultation document

1 Recommendations

1.1 Rimegepant is not recommended, within its marketing authorisation, for acute treatment of migraine with or without aura in adults.

1.2 Rimegepant is not recommended, within its marketing authorisation, for preventing episodic migraine in adults who have at least 4 migraine attacks per month.

1.3 These recommendations are not intended to affect treatment with rimegepant that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Acute treatment

The company proposed rimegepant for acute treatment to be used after 2 or more triptans have not worked, or if people cannot have triptans, which is narrower than the marketing authorisation.

Clinical trial evidence for acute migraine shows that rimegepant is likely to reduce pain at 2 hours more than placebo. The company's evidence for people who have had 2 or more triptans that have not worked, or who cannot have triptans, is uncertain. So more analysis of the evidence is needed. Rimegepant might also reduce monthly migraine days. But there is a lack of comparative long-term evidence to support this.

Because of the clinical uncertainty, the cost-effectiveness estimates are uncertain. Also, the most likely estimates are above what NICE normally considers to be an acceptable use of NHS resources. So rimegepant is not recommended for acute treatment.

Preventing migraine

Standard treatment for preventing migraine after 3 or more treatments includes erenumab, fremanezumab or galcanezumab.

Clinical trial evidence for preventing migraine shows that rimegepant reduces monthly migraine days more than placebo. It has not been directly compared in a trial with erenumab, fremanezumab or galcanezumab, but indirect comparisons suggest that it is less effective than these.

The cost-effectiveness estimates suggest that rimegepant costs more and less effective than erenumab, fremanezumab and galcanezumab. The estimates are above what NICE normally considers to be an acceptable use of NHS resources. So rimegepant is not recommended for preventing migraine.