Research Type: Policy Paper

Gene Therapy: Understanding the Science, Assessing the Evidence, and Paying for Value 

Dec 2016 | Policy Paper

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 […]

Methods Update: Value Assessment Framework

Jan 2020 | Policy Paper

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 […]

Unsupported Price Increases Occurring in 2017-2018

Oct 2019 | Policy Paper

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 […]

Unsupported Price Increases Occurring in 2019

Jan 2021 | Policy Paper

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 […]

Methods Update: Treatments for Ultra-Rare Diseases

May 2017 | Policy Paper

ICER hosted a multi-stakeholder policy summit to discuss methods for assessing the value of new drugs for rare conditions. The summit included discussion of how these methods can be applied to recommend fair prices that reflect the value of orphan drugs to patients and the health system to allow for broader insurance coverage for innovative […]

Alzheimer’s Disease: Evaluating Diagnostics

Dec 2012 | Policy Paper

ICER produced a comprehensive white paper on diagnostic testing for Alzheimer’s disease that was presented to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Date of review: January 2013 For questions, contact info@icer.org. Intervention of interest: Diagnostics for Alzheimer’s disease Final Documents Below you will find the final documents from the policy paper review […]

Methods Update: Valuing a Cure

Sep 2019 | Policy Paper

In January 2019, ICER launched a year-long project to engage with experts, US stakeholders, and influential international agencies to develop, test, and build consensus around methodological options for determining value-based prices for potential cures. ICER will ultimately create a roadmap for value assessment of potential cures that will have a direct and significant impact on […]

Alternative Models for Pharmaceutical Rebates

Dec 2018 | Policy Paper

The combination of rising drug costs at the health system level and increasing financial stress for individual patients has triggered intense national concern. One target has come under particular scrutiny: rebates. Drug makers in the US face no federal process whereby prices are evaluated in comparison to evidence of clinical benefit, but they must negotiate […]