Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for reimbursement in the prevention of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age.

No clinical added value of the new 300 mg pre-filled syringe presentation compared to the existing 150 mg pre-filled syringe presentation already available.


Clinical Benefit

Substantial

The clinical benefit of SPEVIGO 300 mg (spesolimab) is substantial in the MA indication.


Clinical Added Value

no clinical added value

This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the proprietary medicinal product already listed SPEVIGO 150 mg (spesolimab), solution for injection in pre-filled syringe.


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Évaluation des médicaments