The ICER value framework describes the conceptual framework and set of associated methods that guide the development of ICER evidence reports. The purpose of the value framework is to form the backbone of rigorous, transparent evidence reports that, as a basis for broader stakeholder and public engagement, will help the United States evolve toward a health care system that provides sustainable access to high-value care for all patients. For treatments for ultra-rare, serious disease, please see ICER’s framework adaptations.
The initial framework was developed with input from a multi-stakeholder workgroup that included the perspective of patient advocates, clinical societies, life sciences companies, pharmaceutical benefit managers, and insurers. All participants provided input into the development of the value assessment framework but none should be assumed to approve of its approach.
Dr. Steven Pearson presents ICER’s updated Value Assessment Framework. *NOTE: Potential Budget Impact threshold discussed in this webinar has been updated for 2018-2019. Click here to download the updated slide deck.
Potential Budget Impact Threshold Updated for 2018-2019
ICER is committed to ensuring its methods and processes are aligned with current information on the health care environment in the US. In May 2018, ICER increased its annual budget impact threshold for prescription drug therapies from $915 million to $991 million. This update reflects new estimates for US medical spending, pharmaceutical spending, and gross domestic product (GDP).
When annual US spending on a specific drug is likely to exceed this threshold, ICER’s report will highlight potential short-term affordability and access challenges. The report will also include the maximum percentage of eligible patients who would be able to receive the therapy, at multiple possible price points, without exceeding the threshold.
The budget impact threshold will continue to be calculated as double the average net budget impact that would contribute to overall health care cost growth exceeding the anticipated growth in the US economy. Updated calculations with sources for data are shown below.
Value Framework Update
In 2016, ICER’s existing value framework was opened to public comment as part of a planned update to ICER’s methods. ICER received over 50 sets of comments from patients, clinicians, life science companies, and other stakeholders. In addition, ICER convened a one-day meeting with over 40 health care stakeholders to review the current Value Assessment Framework.
Based on feedback received during the public comment period and at the stakeholder meeting, ICER published a set of proposed changes to the Value Assessment Framework in February of 2017. This document was again opened to public comment until April 3, 2017. During this time, an additional 43 sets of comments were received, which are woven into the final document.
A regular update cycle is planned for every two years.
Adaptation of the ICER value framework for the assessment of treatments for ultra-rare conditions
ICER’s modified framework for ultra-rare conditions is the culmination of a nine-month public process of engagement with the rare disease patient community, the life sciences industry, and US health care payers. As part of this process, ICER published a white paper discussing the evidentiary and ethical challenges associated with evaluating treatments for rare conditions, hosted a multi-stakeholder policy summit, and accepted public comment from more than 50 organizations and individuals regarding an initial proposal of framework modifications. ICER looks forward to ongoing input from the entire stakeholder community, and it plans to launch a formal update to these methods in 2019.