Institute for Clinical and Economic Review (ICER)

Ethical Goals and Design Criteria for ‘Fair Access” to Drugs in the US Health Care System
31 March 2021
In the contentious debate around US drug prices, less well understood is: if the price of a drug is a fair, value-based, price, how we assess…

Cornerstones of “Fair” Drug Coverage: Appropriate Cost – Sharing and Utilization Management Policies for Pharmaceuticals
1 September 2020
In the focus on US drug prices, ICER has contributed thinking on determining when price aligns with patient benefits. Less debated is whether insurance coverage provides…

Value, Access, and Incentives for Innovation: Policy Perspectives on Alternative Models for Pharmaceutical Rebates
1 March 2019
OHE Research Paper 19/02: The combination of rising drug costs in the US and increasing financial stress for individual patients has triggered intense national concern. One…

Early Experience with Health Technology Assessment of Gene Therapies in the United States: Pricing and Paying for Cures
1 February 2019
Gene therapies, which can provide cures for diseases, are a new area of research for ICER. Some are within two to three years of becoming available…

New Publications: Real-World Evidence for Coverage and Formulary Decisions
7 December 2018
Two articles, published in the Journal of Comparative Effectiveness Research, explore the use of real-world evidence for coverage and formulary decisions.

Real World Evidence for Coverage Decisions: Opportunities and Challenges
3 January 2018
OHE Research Paper 18/01: This paper sets out the potential opportunities and important challenges and limitations that must be addressed in considering options for using RWE…

Understanding the Context, Selecting the Standards: A Framework to Guide the Optimal Development and Use of Real-World Evidence for Coverage and Formulary Decisions
1 March 2018
OHE Research Paper 18/02: Real World Evidence (RWE) – This paper provides a framework and specific steps to help both manufacturers and payers meet the challenge…

Gene Therapy: Understanding the Science, Assessing the Evidence, and Paying for Value
1 March 2017
This report presents an analysis of the significant clinical potential of gene therapy and the unique challenges in developing and evaluating evidence on their effectiveness and…