— Independent appraisal committee voted that evidence is not adequate to demonstrate a superior net health benefit for ublituximab when compared to other monoclonal antibodies —
— Analyses suggest ublituximab and all currently available monoclonal antibodies labeled for MS would achieve common thresholds for cost-effectiveness if priced between $16,500- $34,900 per year, a range far lower than current market prices net of all rebates —
— Payers should ensure that savings from lower-cost biosimilars and generic formulations are shared with patients through the alignment of copay and coinsurance charges —
BOSTON, February 21, 2023 – The Institute for Clinical and Economic Review (ICER) today released a Final 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 (Briumvi™, 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)
ICER’s report on these therapies was the subject of the January 2023 public meeting of the of the New England CEPAC (New England CEPAC), one of ICER’s three independent evidence appraisal committees.
“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. “In this report, ICER focused primarily on evaluating the comparative effectiveness of currently available monoclonal antibody treatments, including the recently-approved agent ublituximab, and 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 to meet traditional standards for cost-effectiveness.”
ICER’s Virtual Public Meeting: Voting Results on Clinical Effectiveness and Contextual Considerations
For adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary-progressive multiple sclerosis:
- All panelists (10-0) found that current evidence is not adequate to distinguish a net health benefit of ublituximab when compared to other monoclonal antibodies (natalizumab, ofatumumab, ocrelizumab, and rituximab).
- A majority of panelists (9-1) found that current evidence is adequate to demonstrate a net health benefit of ublitixumab when compared to fumarates (dimethyl fumarate, diroximel fumarate, and monomethyl fumarate).
- A majority of panelists (9-1) found that current evidence is adequate to demonstrate a net health benefit of ublitixumab when compared to fingolimod.
During their deliberations, panel members also weighed ublituximab’s potential benefits and disadvantages beyond its direct health effects, and broader contextual considerations. Voting highlighted the following as particularly important for payers and other policymakers to note:
- The magnitude of the lifetime impact of MS on individual patients is substantial;
- Effective treatments for MS have broad effects on people’s ability to achieve major life goals related to education, work, or family life;
- Similarly, effective treatments for MS can have important effects on caregivers’ quality of life and/or ability to achieve major life goals related to education, work, or family life.
ICER’s Virtual Public Meeting: Voting Results on Long-Term Value for Money
Because the clinical evidence was insufficient to differentiate the overall net health benefits among monoclonal antibodies, ICER presented one health-benefit price benchmark (HBPB) range across all modeled monoclonal antibodies (rather than a separate range for each intervention). We estimate that ublituximab, natalizumab, ofatumumab, and ocrelizumab will achieve common thresholds of cost-effectiveness if priced between $16,500- $34,900 per year.
After reviewing the clinical evidence and considering the treatments’ other potential benefits, disadvantages, and contextual considerations noted above, the New England CEPAC evaluated the long-term value of ublitixumab at its current pricing:
- A majority (9-1) of panelists found that ublitixumab versus dimethyl fumarate represents “low” long-term value for money.
Key Policy Recommendations:
ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including manufacturers, clinical experts, patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include:
- Payers should ensure that savings from lower-cost biosimilars and generic formulations should be shared with patients through the alignment of copay and coinsurance charges. Specifically, all fairly priced drugs should be placed on the lowest relevant tier and cost sharing for generic drugs with a lower net price must not trigger a higher out-of-pocket cost to the patient compared with branded drugs.
- Manufacturers should seek to set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments. In the setting of new interventions for MS that are similar in efficacy and safety to other treatments, manufacturer pricing should reflect these considerations in moderating launch pricing.
- Payers should remove barriers to access to rituximab for RMS patients who are appropriate candidates for this therapy. This includes coverage of biosimilar rituximab with little or no prior authorization given the lack of concern regarding use in appropriate patients and how inexpensive it is compared with other monoclonal antibodies of equal effectiveness.
ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.