Institute for Clinical and Economic Review

ICER estimates the amount of money available to be spent annually on new drugs and then divides that amount by the number of expected US Food and Drug Administration approvals to set an affordability benchmark.[1]

Since drugs that combat rarer diseases are typically spread over smaller patient pools, companies will often charge a higher price for the drug in order to recoup their investment. As a result, some critics argue ICER tends to report that these rare disease drugs are not worth the high cost listed for them, without taking into account the input of physicians, patients, or other societal factors when determining a drug’s value. According to the Pioneer Institute, “A recent ICER review of two breakthrough treatments for Spinal Muscular Atrophy (SMA) concluded that neither therapy met ‘traditional cost-effectiveness thresholds.’”

ICER's affordability calculations adjust for drugs targeting prevalent diseases and/or those presenting a significant clinical benefit by setting the threshold at double the available funds divided by the expected number of new drugs (approved by FDA).[1][2]

After discussions in 2016 ICER broadened its quality-adjusted life year threshold to $50,000 - $150,000.[5]

ICER is also seen as a watchdog for drug price hikes that are not backed by clinical evidence. ICER released a study in 2019 that reported, “In 2017 and 2018, out of nine identified drugs that had substantial price increases on top of already high current spending, seven drugs had no new important evidence to support their price increases. The net price increases on these seven drugs alone cost American insurers and patients an additional $4.8 billion over two years.”

QALY stands for Quality-Adjusted Life Year and it is one measurement system used by ICER to determine the value of a drug. One QALY is equal to one perfect year of health. Critics of the QALY argue that the measurement is too subjective to be used broadly. Proponents of the system agree that it may be imperfect, but consider it to be the best available measurement system for quality and quantity of life.

It issued a draft report that said Sovaldi wasn’t worth the list price of about $84,000 a year.[2]

As of May 2016 ICER published final reports on

- Multiple myeloma - Palliative care[6]

It has criticized the high price of drugs for osteoporosis, multiple sclerosis, PCSK9 cholesterol meds, and immuno-oncology therapies.[5][7]

In 2017 it issued a controversial draft report on PARP inhibitors for ovarian cancer.[5]

A preliminary list of drugs to be evaluated includes rociletinib, AZD-9291, necitumumab, nivolumab, and pembrolizumab for small-cell lung cancer; fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab, and daclizumab for multiple sclerosis; and ixekizumab and brodalumab for psoriasis or psoriatic arthritis.[1]

ICER's governing boards include various health experts, including several insurance executives.

Governance Board: Ellen Andrews, PhD, Executive Director, Connecticut Health Policy Project Carmella Bocchino, RN, MBA, President and CEO, CRB Strategies, LLC Wendy Everett, ScD, Special Advisor, NEHI Ron Pollack, JD, Chair Emeritus, Families USA Murray Ross, PhD (Chair), Vice President and Director, Kaiser Institute for Health Policy Kaiser Permanente Lewis Sandy, MD, Executive Vice President, Clinical Advancement, UnitedHealth Group Mark Skinner, JD, President and CEO, Institute for Policy Advancement Anya Rader Wallack, PhD, Associate Director, Center for Evidence Synthesis in Health at Brown University

Advisory Board: Robert W. Dubois, MD, PhD, Chief Science Officer, National Pharmaceutical Council Jon Gavras, MD, Senior Vice President, Chief Medical Officer, Prime Therapeutics Colleen Haines, RPh, Chief Clinical Officer, IngenioRx, a subsidiary of Anthem Vivian Herrera, Executive Director, Head Immunology & Dermatology and Medical Access, US Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation Kjel A. Johnson, PharmD, Vice President, Specialty Strategy and Client Solutions, CVS Health Ron Preblick, PharmD, MPH, Sr. Director, Global Business Partner, Rare Blood Disorders, Sanofi Andreas Kuznik, Senior Director, Health Economics and Outcomes Research, Regeneron Pharmaceuticals Chris Leibman, PharmD, Senior Vice President, Value and Access, Biogen Dave Macarios, MBA, MSc, Vice President, Global Evidence and Value Development, Allergan Martin Marciniak, PhD, Vice President, US Medical Affairs, Customer Engagement, Value, Evidence, and Outcomes, GlaxoSmithKline Kendra Martello, JD, Senior Director, Public Policy, Government Affairs & Public Policy, Mallinckrodt Pharmaceuticals Michael Sherman, MD, MBA, MS, Senior Vice President and Chief Medical Officer, Harvard Pilgrim Health Care David R. Strutton, PhD, MPH, Vice President, Global Pharmaceuticals and Policy Evidence Research, Center for Observational and Real-World Evidence (CORE), Merck & Co., Inc. Sean D. Sullivan, PhD, MSc, Professor and Dean, University of Washington School of Pharmacy Marcus Thygeson, MD, Chief Health Officer, Bind Benefits John Watkins, PharmD, MPH, BCPS, Pharmacy Manager, Formulary Development, Premera Blue Cross David Weinstock, MD, Professor of Medicine and Pediatrics, Harvard Medical School and Dana-Farber Cancer Institute

• Academy of Managed Care Pharmacy, an older US organisation that evaluates drug cost effectiveness

• ICER website