Reason for request

Extension of indication

New indication(s).


Key points

Favourable opinion for reimbursement in the MA indication.


Role in the care pathway?

Verapamil is a first-line treatment in the prevention of cluster headaches.

Clinical Benefit


The clinical benefit of the proprietary medicinal products ISOPTINE and ISOPTINE LP (verapamil) is substantial in the indication extension to the prophylactic treatment of cluster headaches, and at the MA dosages.

Clinical Added Value

no clinical added value


  • efficacy data from the literature having reported a superiority of verapamil 360 mg compared to placebo on reduction of the frequency of episodic cluster headache attacks with, nonetheless, a low level of evidence (study conducted on 30 patients, without calculation of the number of subjects required, duration limited to two weeks, questions with respect to transposability),
  • the known safety profile of verapamil and the specific cardiovascular warnings associated with this indication extension,
  • and despite the inadequately met medical need in this severe condition,

the Committee considers that the proprietary medicinal products ISOPTINE and ISOPTINE LP (verapamil) provide no clinical added value (CAV V) in the current care pathway.

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Évaluation des médicaments