— ICER will select 2019 topics from a wide range of treatments, medical devices, and IT-based interventions —

Boston, Mass., August 2, 2018 – The Institute for Clinical and Economic Review (ICER) has released its preliminary list of potential assessment topics for 2019. The list 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 – are applied to produce this preliminary list of potential topics.

ICER has already announced that its February 2019 public meeting will review canakinumab (Novartis) for the treatment of atherosclerosis, and its March 2019 public meeting will review AVXS-101 (Novartis/AveXis) and nusinersen (Spinraza®, Biogen) for the treatment of spinal muscular atrophy.

The list below presents drugs and other health care interventions that are currently identified as potential additional topics for 2019 ICER reviews. 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 New England Comparative Effectiveness Public Advisory Council (New England CEPAC), and the Midwest CEPAC.

Prescription Drug Topics Under Consideration for 2019 Review

  • AR101 (Aimmune Therapeutics): peanut allergy
  • Diroximel fumarate (Biogen/Alkermes): relapsing multiple sclerosis
  • Brolucizumab (Novartis): wet age-related macular degeneration
  • Buprenorphine/Samidorphan (Alkermes): major depressive disorder
  • Esketamine (Johnson & Johnson): major depressive disorder
  • Lasmiditan (Eli Lilly): acute migraine
  • Lisocabtagene maraleucel (Celgene/Juno): CAR-T for diffuse large B-cell lymphoma
  • Lumateperone (Intra-Cellular Therapies): schizophrenia
  • NKTR-181 (Nektar Therapeutics): chronic lower back pain
  • OMS721 (Omeros): hemolytic uremic syndrome; IgA nephropathy
  • Ozanimod (Celgene): relapsing multiple sclerosis
  • Ravulizumab (Alexion Pharmaceuticals): paroxysmal nocturnal hemoglobinuria
  • Siponimod (Novartis): secondary progressive multiple sclerosis
  • Upadacitinib (AbbVie): rheumatoid arthritis
  • Viaskin® Peanut (DBV Technologies): peanut allergy

Non-Drug Topics Under Consideration for 2019 Review

  • dermaPACE® (Sanuwave): medical device to treat diabetic foot ulcers
  • Information technology interventions: behavioral health conditions
  • Optune® (Novocure): medical device to treat glioblastoma multiforme
  • Ultrasonic osteogenesis stimulators: bone fractures

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.

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.