The Committee deems that the actual clinical benefit of AQUIPTA (atogepant) 10 mg and 60 mg, tablets, is substantial only for the preventive treatment of migraine in adult patients suffering from severe migraines with at least 8 migraine days per month, who have failed to respond to at least two prophylactic treatments and do not have cardiovascular impairment (patients with established cardiovascular or cerebrovascular disease, with recent history (< 6 months) of acute coronary syndrome or stroke/TIA, or AHT).
Insufficient
The Committee deems that the actual clinical benefit of AQUIPTA (atogepant) 10 mg and 60 mg, tablets, isinsufficient to justify public funding in the other marketing authorisation situations, in view of the alternatives available.
Clinical Added Value
no clinical added value
Considering:
the evidence of superiority of atogepant 60 mg and 10 mg versus placebo only in episodic and chronic migraine, and in particular in a study involving patients who had failed to respond to 2 to 4 prophylactic treatments, with a moderate effect size on the variation of the number of migraine days per month between inclusion and 12 weeks for atogepant 60 mg only (primary outcome measure): -2.4 days, in patients with 9 migraine days per month on average at inclusion,
the evidence of the superiority versus placebo in terms of quality of life (ranked secondary outcome measures) in patients who failed to respond to 2 to 4 prophylactic treatments with an effect size corresponding to a variation of 17.9 points out of 100 on the restrictive subscale of the MSQ questionnaire (version 2.1), in patients with a score of 42.3 points at inclusion, and variation of -6.4 points out of 78 on the HIT-6 migraine impact score in patients with a score of 64.5 points at inclusion,
the robust short-term safety data available and uncertainties about long-term safety, particularly in terms of cardiovascular risks in a context where patients with severe cardiovascular diseases were excluded from the studies,
the lack of robust data compared to an active comparator in a context where all of the patients in the ELEVATE study had failed to respond to 2 to 4 prior prophylactic oral treatments, with the majority failing to respond to 2 prophylactic treatments (56.0%),
and despite the medical need in this population with severe migraine whose quality of life is particularly impaired,
the Committee deems that AQUIPTA (atogepant) provides no clinical added value (CAV V) for the preventive treatment of migraine for adult patients suffering from severe migraines with at least 8 migraine days per month, who have failed to respond to at least two prophylactic treatments and do not have cardiovascular impairment (patients with established cardiovascular or cerebrovascular disease, with recent history (< 6 months) of acute coronary syndrome or stroke/TIA, or AHT).
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