Institute for Clinical and Economic Review

Institute for Clinical and Economic Review
Name	Institute for Clinical and Economic Review
Abbreviation	ICER
Formation	2006
Headquarters	Boston, Massachusetts
Leader title	President

Institute for Clinical and Economic Review is an independent nonprofit health technology assessment organization based in Boston, Massachusetts. The organization conducts comparative clinical effectiveness research and cost-effectiveness analyses to inform decisions by Centers for Medicare and Medicaid Services, Food and Drug Administration, private insurers such as UnitedHealth Group, pharmacy benefit managers like Express Scripts, and health technology manufacturers including Pfizer. Its reports have been cited in debates involving Affordable Care Act, Medicare Part D, Medicaid expansion, and pharmaceutical pricing controversies linked to companies such as Gilead Sciences and Novartis.

History and founding

The organization was established in 2006 amid high-profile policy debates following the passage of the Medicare Prescription Drug, Improvement, and Modernization Act and efforts by stakeholders including Commonwealth Fund, Blue Cross Blue Shield Association, and academic centers such as Harvard Medical School to improve evidence synthesis. Early collaborators and advisors included figures from Yale School of Medicine, University of Pennsylvania, Johns Hopkins University, Brigham and Women's Hospital, and policy experts from Kaiser Family Foundation. The founding coincided with initiatives by payers like CVS Health and federal actors such as the Centers for Disease Control and Prevention to standardize assessments of clinical value.

Mission and governance

The stated mission emphasizes evidence-based assessment to promote value-driven access to therapies for stakeholders including State Medicaid Directors', pharmacy benefit managers like CVS Caremark, and government entities such as the Department of Health and Human Services. Governance structures have involved board members from institutions such as Massachusetts General Hospital, legal scholars with ties to Harvard Law School, health economists affiliated with London School of Economics, and patient advocates from organizations like Patient-Centered Outcomes Research Institute. Executive leadership has engaged with advisory committees that include representatives from AcademyHealth, Society for Medical Decision Making, and pharmaceutical companies including Roche and AstraZeneca.

Methodology and value assessment framework

The organization applies a multi-step framework integrating systematic review methods used by Cochrane Collaboration, health economic modeling comparable to work at Institute for Health Metrics and Evaluation, and grading approaches similar to GRADE Working Group. Core elements include comparative effectiveness synthesis referencing trials published in journals like The New England Journal of Medicine, cost-effectiveness thresholds informed by analyses from National Institute for Health and Care Excellence and modeling techniques used by researchers at Johns Hopkins Bloomberg School of Public Health. Inputs include clinical endpoints validated by organizations such as American Medical Association, quality-of-life measures like those endorsed by National Institutes of Health, and pricing information from entities such as IQVIA.

Major reports and key reviews

Notable assessments have covered high-profile therapies for conditions discussed in New England Journal of Medicine and The Lancet, such as hepatitis C antivirals from Gilead Sciences, oncologic agents from Bristol Myers Squibb and Merck & Co., and gene therapies developed by Spark Therapeutics and Novartis. Reports often analyze cost-effectiveness scenarios referenced in hearings before the United States Congress and policy briefings at Brookings Institution and Peterson Center on Healthcare. Reviews have influenced coverage debates for products spotlighted at conferences hosted by American Society of Clinical Oncology and European Society for Medical Oncology.

Influence on policy and payer decision-making

Findings have been used by private insurers including Aetna and public programs such as Veterans Health Administration to inform formulary and coverage determinations, and cited in testimony before committees like the Senate Finance Committee and panels at National Academy of Medicine. Collaborations and stakeholder meetings have connected the organization with advocacy groups such as Families USA and industry coalitions including Pharmaceutical Research and Manufacturers of America. Its analyses have figured in pricing negotiations involving multinational corporations like Johnson & Johnson and influenced procurement strategies in state programs like Massachusetts Health Connector.

Criticisms and controversies

Critics from patient advocacy groups including Mothers Against Medical Error and some clinicians at institutions such as Cleveland Clinic and Mayo Clinic have argued that reliance on cost-effectiveness metrics can limit access to novel therapies, echoing critiques leveled in editorials in The Washington Post and The New York Times. Industry trade groups such as BIO (trade association) and some legislators in U.S. House of Representatives have expressed concerns about the potential for analyses to be used in ways analogous to decisions by National Institute for Health and Care Excellence, leading to contentious exchanges during hearings featuring representatives from PhRMA. Methodological debates have involved health economists from University of California, San Francisco and Columbia University challenging assumptions about quality-adjusted life years and discounting.

Funding and partnerships

Funding sources have included foundations such as Robert Wood Johnson Foundation and Commonwealth Fund, in-kind support from academic partners like Harvard Pilgrim Health Care Institute, and contracts with state agencies including Massachusetts Department of Public Health. Partnerships and engagements have involved private sector entities such as Eli Lilly and Company, research organizations like RAND Corporation, and international bodies including World Health Organization for methodological exchange. Financial transparency and potential conflicts of interest have been topics of scrutiny in analyses by investigative outlets including ProPublica and reports to committees in the United States Congress.

Category:Health care quality