LAMZEDE (velmanase alfa) - Alpha-mannosidosis

Opinions on drugs - Posted on Jan 10 2025

Reason for request

Modification of the listing conditions

Summary of opinion

Favourable opinion:

for reimbursement in the non-hospital setting,
for maintenance of reimbursement in the hospital setting with the new CIP code,

in the enzyme replacement therapy of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.

Clinical Benefit

Substantial

The clinical benefit of LAMZEDE 10 mg (velmanase alfa) powder for solution for infusion is substantial to justify public funding in the MA indication.

Clinical Added Value

minor

Inclusion in the list for non-hospital use does not modify the Committee’s previous conclusions. The Transparency Committee considers that LAMZEDE 10 mg (velmanase alfa) powder for solution for infusion provides a minor clinical added value (CAV IV) in the management of non-neurological manifestations in patients with mild to moderate alpha-
mannosidosis.

Avis rectifié en date du 16/01/2025