Last Updated : March 28, 2025
Details
FilesProject Status:
Active
Project Line:
Reimbursement Review
Project Sub Line:
Streamlined Drug Class Review
Project Number:
TS0004-000
Final Recommendation/Report:
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.
| Call for patient/clinician/industry input open | 29-Aug-24 |
| Call for patient/clinician/industry input closed | 13-Sep-24 |
| Review initiated | 29-Aug-24 |
| Expert committee meeting (initial) | 30-Jan-25 |
| Draft recommendation posted for stakeholder feedback | 20-Feb-25 |
| Draft report posted for stakeholder feedback | 20-Feb-25 |
| End of feedback period | 06-Mar-25 |
| Final recommendation posted | 28-Mar-25 |
| Review report(s) posted | 23-Apr-25 |
Files
Last Updated : March 28, 2025