Interventions of Interest: Sickle cell disease (SCD) is an inherited blood disorder caused by a genetic mutation of the HBB gene responsible for the β-globin component of hemoglobin; hemoglobin is the protein in red blood cells that carries oxygen. ICER will be examining the comparative clinical and value of two gene therapies: exagamglogene autotemcel (“exa-cel”, […]
Interventions of Interest: For questions, please contact Liis Shea, Program Director, at lshea@icer.org. View the Key Stakeholder List.
Interventions of Interest: Eighty percent of women undergoing menopause experience vasomotor symptoms (VMS). VMS, characterized by hot flashes and night sweats, are thought to be brought on by decreased estrogen levels and increased neurokinin B (NKB) activity acting on the hypothalamus, which regulates body temperature. The change in hypothalamic thermoregulation increases blood flow to the […]
Interventions of Interest: ICER reviewed valoctocogene roxaparvovec for hemophilia A in 2020 (Valoctocogene Roxaparvovec and Emicizumab for Hemophilia A without Inhibitors: Effectiveness and Value). In this review, the two interventions will be considered separately as if we were performing two independent reviews in two different populations. For questions or to request a Spanish translated Report-at-a-Glance […]
Interventions of Interest: Monoclonal Antibodies natalizumab (Tysabri®, Biogen) ofatumumab (Kesimpta®, Novartis) ocrelizumab (Ocrevus®, Genentech) rituximab (Rituxan®, Genentech, and biosimilars) ublituximab (TG Therapeutics) Oral Therapies 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 […]
Interventions of Interest: subcutaneous semaglutide (Wegovy, Novo Nordisk) liraglutide (Saxenda, Novo Nordisk) phentermine/topiramate (Qsymia, Vivus Pharmaceuticals) naltrexone/bupropion (Contrave, Currax Pharma) The independent appraisal committee voted that evidence is adequate to demonstrate that semaglutide provides a net health benefit compared to lifestyle modification alone; however, at current pricing, semaglutide represents “low” long-term value for money. Semaglutide […]
Interventions of Interest: AMX0035 (RELYVRIO™, Amylyx Pharmaceuticals, Inc.) oral edaravone (Mitsubishi Tanabe Pharma Development America, Inc.) The majority of independent appraisal committee voted that the evidence is adequate to demonstrate that both AMX0035 and oral edaravone (in population narrower than its label) provide a net health benefit compared to standard of care. They also determined […]
Key Updates: As a result of additional information recently becoming available, ICER has decided to extend the timeline for its upcoming report on Alzheimer’s disease, “Beta-Amyloid Antibodies for Early Alzheimer’s Disease” and add lecanemab back into the report. For more information, click here. ICER decided to extend its timeline for assessing beta-amyloid antibodies for early […]
Interventions of Interest: betibeglogene autotemcel (Zynteglo, bluebird bio) The independent appraisal committee unanimously determined that the evidence is adequate to demonstrate that beti-cel provides a net health benefit compared to standard clinical management. Given the high costs of standard care, cost-effectiveness modeling finds beti-cel meets commonly accepted value thresholds at an anticipated price of $2.1 […]
Interventions of Interest: molnupiravir (Merck) PF-07321332/ritonavir (Paxlovid™, Pfizer) fluvoxamine (Investigator initiated) We have deemed this a “special assessment” since this is an early snapshot of emerging agents in the COVID-19 pipeline. Each company has evolving timelines around data availability and potential approvals. Independent appraisal committee voted 11-2 that the evidence is not adequate to demonstrate […]
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