This paper aims to create a clearer understanding of both the opportunities and challenges inherent in the FDA’s accelerated approval pathway (AAP), and to present an analysis of the potential risks and benefits of a range of reform options that policymakers may consider in efforts to strengthen the AAP moving forward. Date of publication: […]
The price of many existing drugs, both brand and generic, can increase substantially over time, and questions are frequently raised regarding whether these price increases are justified. State policymakers have been particularly active in seeking measures to address this issue. For example, both California and Vermont now have laws tracking substantial drug price increases, requiring drug manufacturers […]
ICER’s white paper provides a brief overview of approaches to manage the pricing of novel vaccines and treatments in times of public health emergencies. After summarizing the experiences and lessons learned from previous epidemics and the annual flu vaccine, the paper analyzes the potential advantages and disadvantages of six alternative approaches to pricing that policymakers from […]
The purpose of the white paper is to analyze the ethical and practical dimensions of insurance coverage policy, while presenting a corresponding set of criteria that will support a more transparent discussion among all health care stakeholders about whether specific cost sharing and utilization management policies are delivering “fair” patient access to prescription drugs. Date […]
The 2015 ICER Policy Summit convened an influential group of evidence policy leaders from insurers, pharmacy benefit management firms, and life science companies to discuss indication-specific pricing (ISP) of biopharmaceuticals and to explore the opportunities and challenges of ISP in the US health care system. Date of review: December 2015 For more information, please contact […]
This white paper was developed following a December 2016 meeting of ICER’s membership program, during which leaders from 20 payer and manufacturer organizations convened to share their perspectives on the future of gene therapy. The paper explores the scientific frontier being opened up by emerging gene therapies, with the potential for curing or substantially improving the […]
These papers evaluates potential opportunities, challenges, and limitations that must be addressed in considering options for using RWE to inform insurer coverage decisions. Date of review: December 2017 For more information, please contact info@icer.org Final Documents Below you will find the final documents from the policy paper review process:
In January 2020, ICER issued an update to the framework that underpins our evidence reports on new drugs and other health care interventions. ICER’s value framework is the product of more than 10 years’ experience working with all participants in the health care system to develop methods to assess the comparative clinical effectiveness and the […]
ICER evaluated selected high-impact drugs with substantial price increases. ICER reviewed changes in the evidence base for each of these drugs and assess whether or not new clinical data exists that could suggest that the drugs could be significantly more beneficial for patients than what was previously understood. ICER published the final draft of its […]
On January 12, 2021, ICER published our latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. Among the top drugs with price increases in 2019 that had substantial effects on US spending, ICER determined that seven of 10 lacked adequate new evidence to demonstrate a substantial clinical benefit that was not […]