Cladribine and Natalizumab for Relapsing-Remitting Multiple Sclerosis

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Project Status:
Active
Project Line:
Reimbursement Review
Project Sub Line:
Streamlined Drug Class Review
Project Number:
TS0004-000
Final Recommendation:

Multiple sclerosis (MS) is a chronic autoimmune disease with the following clinical manifestations: demyelination, inflammation, neuronal loss, and gliosis (scarring). Relapsing-remitting multiple sclerosis (RRMS) is the most common type of the disease, with a subgroup of patients who have a more aggressive disease course — manifesting with a rapid accumulation of physical or cognitive deficits — which is referred to as highly active RR  MS.

Public drug programs have requested a review to assess the comparative efficacy and harms of cladribine and natalizumab for first-line treatment of highly active RRMS to inform reimbursement of these 2 drugs. 

Note that considering the input we received on the project scope, and in consultation with the clinical experts, the review protocol was amended after posting the project scope to incorporate the broader RRMS population.

Key Milestones
Call for patient/clinician/industry input open29-Aug-24
Call for patient/clinician/industry input closed13-Sep-24
Review initiated29-Aug-24
Expert committee meeting (initial)30-Jan-25
Draft recommendation posted for stakeholder feedback20-Feb-25
Draft report posted for stakeholder feedback20-Feb-25
End of feedback period06-Mar-25
Final recommendation posted28-Mar-25