Institute for Clinical and Economic Review Announces Potential Topics for Review in 2018

— Tentative list includes drugs for migraines, hemophilia, and cystic fibrosis —
Boston, Mass., July 26, 2017 – The Institute for Clinical and Economic Review(ICER) has released its preliminary list of prescription drug review topics for 2018. The list of topics for review is drawn from ICER horizon scans of new and emerging therapies, conversations with stakeholders, and suggestions submitted from 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 and/or policy – are applied to produce a preliminary list of drugs for review. ICER desires to time reports so that they are released as close to FDA approval as possible. Due to the time required for each report (typically 8 months), some of the drugs under consideration have not yet been submitted to the FDA for approval, but are expected to be filed in the near future. If submission plans or timing changes, alternate topics will be selected. Other than the two topics that have already been announced for the January and March 2018 public meetings, the following list is preliminary and subject to change:

  • Voretigene Neparvovec (Spark Therapeutics): vision loss associated with biallelic RPE65-mediated retinal disease, January 2018 public meeting
  • CAR-T Therapies, axicabtagene ciloleucel (Kite Pharmaceuticals) and tisagenlecleucel-t (Novartis): B-cell leukemia and lymphoma, March 2018 public meeting 
  • Apalutamide (Johnson & Johnson): prostate cancer
  • CTP-modified human growth hormone (Opko/Pfizer): short stature/ growth hormone deficiency
  • Damoctocog alfa pegol (Bayer), Emicizumab (Roche): hemophilia type A
  • Erenumab (Amgen), fremanezumab (Teva), galcanezumab (Eli Lilly):migraine and other headaches
  • Lanadelumab (Shire): hereditary angioedema
  • Larotrectinib (LOXO Oncology/Array BioPharma): solid tumors expressing a specific biomarker
  • Tezacaftor combination with ivacaftor (Vertex): cystic fibrosis

Final decisions for each drug will be made as we assign topics to one of ICER’s three public programs – California Technology Assessment Forum (CTAF), New England Comparative Effectiveness Public Advisory Council (New England CEPAC), or the Midwest CEPAC. The next topic announcement is scheduled for mid-August. 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.