Cladribine and Natalizumab for Highly Active 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

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.