Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement for:

  • BYFAVO (remimazolam) 20 mg powder for solution for injection in adults for procedural sedation,
  • BYFAVO (remimazolam) 50 mg powder for concentrate for solution for injection/infusion in adults for intravenous induction and maintenance of general anaesthesia.

Clinical Benefit

Substantial

The Committee deems that the clinical benefit of BYFAVO (remimazolam) 20 mg powder for solution for injection is substantial in the MA indication.

The Committee deems that the clinical benefit of BYFAVO 50 mg (remimazolam) powder for concentrate for solution for injection/infusion is substantial in the MA indication.


Clinical Added Value

no clinical added value

BYFAVO (remimazolam) 20 mg powder for solution for injection provides no clinical added value (CAV V) in the care pathway for procedural sedation in adults.

BYFAVO (remimazolam) 50 mg powder for concentrate for solution for injection/infusion provides no clinical added value (CAV V) in the care pathway for intravenous induction and maintenance of general anaesthesia in adults.


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