The Institute for Clinical and Economic Review (ICER) is a Boston-based independent nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures.
It was founded in about 2005 by physician-researcher Steven D. Pearson, MD, MSc, FRCP. Until 2014 it concentrated on assessing health care costs (rather than evaluating drugs). It evaluates the cost effectiveness of drugs in a similar way to the UK's NICE, and has come under some criticism from the drug industry. It has issued a number of drug evaluations since 2014. especially since July 2015. The institution is funded by the Laura and John Arnold Foundation, drug makers, insurers, and government grants.
Threshold cost criteria
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.
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).
After discussions in 2016 ICER broadened its quality-adjusted life year threshold to $50,000 - $150,000.
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.
Drugs evaluated - reports issued
As of May 2016 ICER published final reports on
- Multiple myeloma - Palliative care
This section needs expansion. You can help by adding to it. (April 2016)
Drug evaluations planned
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.
Advisory and Governance Boards
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
- Pizzi, LT (2016). "The Institute for Clinical and Economic Review and Its Growing Influence on the US Healthcare". Am Health Drug Benefits. 9 (1): 9–10. PMC 4822973. PMID 27066190.
- "This nonprofit is helping frame the drug prices discussion". Statnews.com. 12 April 2016. Retrieved 25 June 2019.
- "Institute for Clinical and Economic Review Seeks to Enhance Healthcare Value". Ajpb.com. Retrieved 25 June 2019.
- "Series of reports will analyze cost, benefit of pricey drugs". Modern Healthcare. 21 July 2015. Retrieved 25 June 2019.
- "Cancer-fighting PARP drugs from AstraZeneca, Clovis and Tesaro largely overpriced, watchdog says". FiercePharma.com. Retrieved 25 June 2019.
- "Materials". Icer-review.org. Retrieved 25 June 2019.
- "Are new bone drugs from Amgen and Radius cost-effective? Not even close, ICER says". FiercePharma.com. Retrieved 25 June 2019.
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