Research Type: Assessment

Menopause: Vasomotor Symptoms

Dec 2022 | Assessment

Intervontions of Interest: fezolinetant (Astellas Pharma Inc.) 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 […]

Hemophilia A and B

Nov 2022 | Assessment

Intervontions of Interest: etranacogene dezaparvovec (CSL Behring) valoctocogene roxaparvovec (Roctavian ™; BioMarin) For questions, please contact Monica Frederick, Program Associate, at mfrederick@icer.org. View the Key Stakeholder List.

Multiple Sclerosis: CIS, RRMS, and SPMS

Jan 2023 | Assessment

Intervontions 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 […]

Obesity Management

Sep 2022 | Assessment

Interventions of Interest: subcutaneous semaglutide (Wegovy®, Novo Nordisk) phentermine/topiramate (Qsymia, Vivus Pharmaceuticals) naltrexone/bupropion (Contrave, Currax Pharma) liraglutide (Saxenda®, Novo Nordisk) Obesity is an increasingly common chronic condition that is associated with increased risk of chronic diseases such as diabetes, cancer, and heart disease. Individuals who are overweight or those with obesity face considerable social stigma […]

Amyotrophic Lateral Sclerosis (ALS)

Aug 2022 | Assessment

Interventions of Interest: AMX0035 (Amylyx Pharmaceuticals, Inc.) oral edaravone (Mitsubishi Tanabe Pharma Development America, Inc.) Amyotrophic lateral sclerosis (ALS) is a rare, progressive, neurodegenerative disease characterized by loss of motor neurons in the brain and spinal cord. ALS often begins with localized weakness that will progress to involve most muscles. People with ALS typically die […]

Alzheimer’s Disease

Mar 2023 | Assessment

ICER decided to extend its timeline for assessing beta-amyloid antibodies for early Alzheimer’s disease pending the biologics license application submissions for donanemab (Eli Lilly & Co.) and lecanemab (Eisai Co., Ltd).  The timeline was updated on June 7, 2022.  Interventions of Interest: donanemab (Eli Lilly & Co.) lecanemab (Eisai Co., Ltd) aducanumab (Aduhelm™, Biogen) For […]

Beta Thalassemia

Jun 2022 | Assessment

Interventions of Interest: betibeglogene autotemcel (Zynteglo/LentiGlobin, bluebird bio) The evidence was judged to demonstrate that beti-cel provides net health benefit to patients with transfusion-dependent thalassemia. 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 million with an outcomes-based agreement. However, if the […]

COVID-19

Apr 2022 | Assessment

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 […]

Chemotherapy-Induced Neutropenia

Mar 2022 | Assessment

Interventions of Interest: plinabulin (BeyondSpring Pharmaceuticals) trilaciclib (Cosela™, G1 Therapeutics) Trilaciclib received FDA approval in 2021 to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Plinabulin was under development to prevent chemotherapy-induced neutropenia when it received a complete response letter from the […]

Diabetes: Type 2

Jan 2022 | Assessment

Interventions of Interest: tirzepatide (Mounjaro™, Eli Lilly) Tirzepatide has a novel dual GIP and GLP-1 receptor agonist mechanism of action and is seen as an add-on type 2 diabetes therapy; tirzepatide would achieve common thresholds for cost-effectiveness if priced between $5,500 – $5,700 per year.  At the January 20 virtual meeting, ICER’s independent appraisal committee […]