KESIMPTA (ofatumumab) - Multiple sclerosis (RMS)

Opinions on drugs - Posted on Jun 12 2025

Reason for request

Reassessment at the request of the TC.

Summary of opinion

Favourable opinion for maintenance of reimbursement in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Clinical Benefit

Substantial

The clinical benefit of KESIMPTA (ofatumumab) remains substantial in the MA indication.

Clinical Added Value

Comments without ASMR value

The Committee deems that the data provided in the context of this reassessment are not likely to modify the assessment of the clinical added value expressed in the previous opinion of 2 June 2021.