BOSTON, December 21, 2022 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for multiple sclerosis (MS):
- natalizumab (Tysabri®, Biogen)
- ofatumumab (Kesimpta®, Novartis)
- ocrelizumab (Ocrevus®, Genentech)
- rituximab (Rituxan®, Genentech, and biosimilars)
- ublituximab (TG Therapeutics)
- dimethyl fumarate (Tecfidera®, Biogen, and generics)
- diroximel fumarate (Vumerity®, Biogen)
- monomethyl fumarate (Bafiertam®, Banner Life Sciences)
- fingolimod (Gilenya®, Novartis)
- ozanimod (Zeposia®, Bristol Myers Squibb)
- ponesimod (Ponvory®, Janssen)
- siponimod (Mayzent®, Novartis)
- teriflunomide (Aubagio®, Sanofi)
“Multiple sclerosis is a burdensome condition, and individuals with MS manage declining function and neurologic symptoms such as weakness, fatigue, vision changes, pain, and balance problems for the rest of their lives,” said Jon Campbell, PhD, MS, ICER’s Senior Vice President of Health Economics. “ICER focused on evaluating the comparative benefits of currently available monoclonal antibody treatments and the emerging agent ublituximab, which has an expected FDA approval date later this month, against other first line disease modifying therapies (DMTs). All assessed DMTs demonstrate clinical benefits versus placebo, but there was insufficient evidence to differentiate between the benefit of ublituximab and other monoclonal antibodies. Our analysis also found that monoclonal antibodies would need to be priced considerably lower than they are now in order to meet traditional standards for cost-effectiveness.”
This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC (New England CEPAC) on January 20, 2023. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
Register here to watch the live webcast of the virtual meeting.
A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.
Key Clinical Findings
ICER found insufficient evidence to differentiate the net health benefit of ublituximab compared with other monoclonal antibodies. Ublituximab was judged to be comparable or better to oral DMTs in reducing annualized relapse rate (ARR) and confirmed disability progression (CDP). Based on head-to-head trial data, we had higher certainty that ublituximab provides a small net health benefit over teriflunomide. ICER did not have sufficient evidence to rate ublituximab versus siponimod due to differences in trial populations.