Aimovig traitement de fond ne sera pas remboursé

Aimovig background treatment will not be reimbursed

Feb 13, 2021

Aimovig is a treatment of moderate clinical interest. Only in patients with severe migraine, with at least 8 migraine days per month. As well as in failure to at least two prophylactic treatments and without cardiovascular damage. In fact, no clinical advantage has been demonstrated in the therapeutic strategy.

Given the lack of relevant data, its reimbursement is not justified in other migraine patients.

Indeed, AIMOVIG has Marketing Authorization in the prophylaxis of migraine in adults, having at least 4 days of migraine per month. The superiority of AIMOVIG 70 and 140 mg has been demonstrated compared to placebo in episodic migraine. As well as in chronic migraine, with modest effect amounts on the change in the number of migraine days per month. In addition, the superiority of AIMOVIG 140 mg is also demonstrated compared to placebo. In episodic migraine in patients failing 2 to 4 prophylactic treatments. As well as in a subgroup of patients with 8 to 14 migraine days per month. On the other hand, safety data are available in the short term. With in particular uncertainty about cardiac tolerance, observed in patients initially free of severe cardiovascular disease.

Actual benefit (SMR)

Moderate
The SMR by AIMOVIG is moderate only in patients with severe migraine with at least 8 migraine days per month. Also in patients failing at least two prophylactic treatments and without cardiovascular disease. (patients who have had a myocardial infarction, stroke, TIA, unstable angina or coronary bypass).
Insufficient
The SMR by AIMOVIG is insufficient for reimbursement by national solidarity in the other patients within the scope of the Marketing Authorization indication.

Improvement in actual benefit (ASMR)

V (absent)
Considering:
  • superiority of erenumab 70 and 140 mg demonstrated over placebo in episodic migraine with a modest amount of effect on the change in the number of migraine days per month. (-1.04 to -1.85 days depending on the dose in patients with 8 migraine days per month on inclusion),
  • superiority of erenumab 70 and 140 mg demonstrated over placebo in chronic migraine with a modest amount of effect on the change in the number of migraine days per month. (-2.45 to -2.46 days depending on the dose in patients with 18 migraine days per month on inclusion),
  • safety data available in the short term. With in particular uncertainty about the cardiac tolerance observed in the open-label phases of the studies (up to 1 year of follow-up for 52% of exposed patients) in patients initially free of severe cardiovascular disease,
  • superiority of erenumab 140 mg demonstrated over placebo in episodic migraine. In patients failing 2 to 4 prophylactic treatments (30.3% of responders versus 13.7% (OR = 2.73, 95% CI). With a superiority also observed in the stratified subgroup of patients having 8 to 14 migraine days per month: 31% versus 15.1% (OR = 2.52, 95% CI).
The Committee considers that AIMOVIG does not improve the SMR (ASMR V) in adult patients suffering from severe migraine. With at least 8 migraine days per month, failing at least two prophylactic treatments and without cardiovascular damage. (patients who have had a myocardial infarction, stroke, TIA, unstable angina or coronary bypass).

As a result, Aimovig was the subject of an efficiency opinion issued by the Economic Evaluation and Public Health Commission on 02/12/2019.

Source: https://www.has-sante.fr/jcms/c_2908652/fr/aimovig

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