BOSTON, July 9, 2019 – The Institute for Clinical and Economic Review (ICER) has released its preliminary list of potential assessment topics for 2020. The list is drawn from ICER horizon scans of new and emerging therapies, conversations with stakeholders, and suggestions submitted by the public. ICER’s topic selection criteria – including the projected timing and likelihood of FDA approval, and whether a review of the evidence would suggest specific actions for payers, physicians, patients, and policymakers to improve clinical practice – are applied to produce this preliminary list of potential topics.

ICER has already announced that its January 2020 public meeting will review rimegepant (Biohaven), ubrogepant (Allergan), and lasmiditan (Eli Lilly) for the treatment of acute migraine. The list below presents drugs and other health care interventions that are currently identified as potential additional topics for ICER reviews that will conclude after January 2020.

This list is intended to provide stakeholders with an early summary of topics currently being considered by ICER. It is possible that not every topic listed here will be subject to an ICER review, just as it is possible that ICER may review other topics not included on this preliminary list. The final decision on the topic for each ICER review will be formally announced at the outset of the review process which begins approximately eight months prior to a corresponding public meeting held under the auspices of one of ICER’s three public 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).

Prescription Drug Topics Under Consideration for 2020 Review:

  • Beta thalassemia: luspatercept (Acceleron Pharma) and lentiviral beta-globin gene transfer (Zynteglo®, bluebird bio)
  • Breast cancer: sacituzumab govitecan (Immunomedics) and trastuzumab deruxtecan (Daiichi Sankyo and AstraZeneca)
  • Cystic fibrosis: VX-445/tezacaftor/ivacaftor (Vertex Pharmaceuticals)
  • Hemophilia A: valoctocogene roxaparvovec (BioMarin Pharmaceutical)
  • High LDL-cholesterol: bempedoic acid (Esperion Therapeutics) and bempedoic acid/ezetimibe (Esperion Therapeutics)
  • HIV and pre-exposure prophylaxis (PrEP): cabotegravir/rilpivirine (ViiV Healthcare) and emtricitabine/tenofovir alafenamide (Descovy®, Gilead Sciences)
  • Lymphoma: lisocabtagene maraleucel (Celgene)
  • Multiple sclerosis: ozanimod (Celgene)
  • Non-alcoholic steatohepatitis (NASH): obeticholic acid (Ocaliva®, Intercept Pharmaceuticals), seladelpar (CymaBay Therapeutics), and cenicriviroc (Allergan)
  • Osteoarthritis-associated pain: tanezumab (Pfizer and Eli Lilly)
  • Postpartum depression: zuranolone (Sage Therapeutics) and brexanolone (Zulresso™, Sage Therapeutics)
  • Rheumatoid arthritis: filgotinib (Gilead Sciences)
  • Sickle cell disease: crizanlizumab (Novartis) and voxelotor (Global Blood Therapeutics)
  • Ulcerative colitis: class review
  • Wet age-related macular degeneration: brolucizumab (Novartis)

ICER desires to time reports so that they are released as close to FDA approval as possible. Due to the eight-month timespan required to conduct each assessment, some of the drugs under consideration have not yet been submitted to the FDA for approval.

In addition to these prescription drug topics, ICER plans to allocate resources to assessing the clinical and economic value of other types of interventions that have the opportunity to change the paradigm of care for many patients across the health care system. Specific non-drug topics in 2020 may include oncology care pathways, digital apps to reduce health disparities for people with disabilities, and telehealth approaches to treat behavioral health conditions.

Topic suggestions are always welcome. Submissions can be made via this online form.

About ICER

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.