Treatment of secondary progressive multiple sclerosis (SPMS) patients with the investigational oral therapy Mayzent (siponimod) significantly reduced the risk of disability progression and decreased inflammation, compared to best supportive care, according to a preliminary draft evidence report from the Institute for Clinical and Economic Review (ICER).
The report and the draft voting questions on clinical evidence, other benefits or disadvantages, and Mayzent’s long-term cost value are open to public comment until 5 p.m. EDT April 10. All interested parties are invited to submit formal comments by email. Details about how to do so are available here.
Based on feedback it receives, ICER may revise its findings in a final evidence report, to be published on May 2. This report will be subject to deliberation in a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), to be held in Rosemont, Illinois, on May 23. Click here to register for the public meeting and the live webcast.
For the preliminary report, ICER, a non-profit watchdog organization, spoke with patients, clinical experts, insurers, and manufacturers.
The assessment compared the effectiveness and safety of Novartis’ Mayzent to that of Tysabri (natalizumab, by Biogen), Ocrevus (ocrelizumab, by Genentech), the interferon beta-1a medications Rebif (by EMD Serono), and Avonex (by Biogen), as well as the interferon beta-1b therapies Betaseron/Betaferon, by Bayer, and Novartis’ Extavia.
Mayzent, currently seeking approval in the U.S. and Europe to treat SPMS, also was compared to best supportive care, which is defined as any intervention not using a disease-modifying therapy and directed toward managing disease symptoms rather than treating its underlying process.
Specifically, the analysis focused on disability progression (as assessed with the Expanded Disability Status Scale), mobility, quality of life, cognitive function, adverse events (side effects), mortality, and other key outcomes.
Mayzent was designed to inhibit the activity of two sphingosine-1-phosphate receptors on the surface of immune cells. The therapy prevents immune cells from migrating to the brain and spinal cord, which reduces the inflammatory reaction that drives SPMS progression.
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