Key Takeaways
- ICER will evaluate the clinical effectiveness and value of tolebrutinib for Secondary Progressive MS (SPMS).
- The assessment will be presented at the CTAF meeting in June 2025.
- Stakeholders can comment on the Draft Scoping Document until December 10, 2024.
The Institute for Clinical and Economic Review (ICER) has announced plans to assess the clinical effectiveness and value of tolebrutinib (developed by Sanofi) for the treatment of Secondary Progressive Multiple Sclerosis (SPMS). The findings of this assessment will be presented during the California Technology Assessment Forum (CTAF) meeting in June 2025.
The evaluation will include a deliberation and voting session by an independent evidence review panel on the data presented in ICER’s report. ICER has also published a Draft Scoping Document outlining its methodology for the assessment, which is now open for public feedback.
Public Comments Invited
Stakeholders, including patient advocacy groups, clinical experts, and the treatment manufacturer, are invited to provide input on the Draft Scoping Document. Public comments can be submitted until December 10, 2024, and must adhere to ICER’s submission guidelines, including a three-page limit and a specific formatting requirement.
In addition to refining the assessment scope, ICER is soliciting examples of low-value care practices within the SPMS treatment space. These insights will contribute to a report section addressing resource optimization and strategies for reducing waste while prioritizing high-value treatments.
Key Dates and Next Steps
After the public comment period, ICER will release a revised scoping document on or about December 18, 2024.
This revised version will guide the comprehensive evaluation process leading up to the CTAF meeting in June 2025. For additional details, stakeholders can review the Draft Scoping Document and related guidance on ICER’s official website.
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