— Accepting Open Input Through June 10, 2019 —
BOSTON, May 2, 2019 – To inform a planned update to the methods that underpin our evidence reports on new drugs and other health care interventions, the Institute for Clinical and Economic Review (ICER) is opening a national call for suggestions on how to improve our value assessment framework. ICER will welcome comments through Monday, June 10th. Based on the feedback we receive, we plan to publish draft revisions to our value assessment framework on August 21st*, welcome public comment on those proposed revisions through October 11th, and post our final updated framework on December 18th. This final framework will be applied to all assessments initiated in 2020 and beyond.
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 comparative value of health care tests, treatments, and delivery system innovations. The current iteration of the framework, which has guided ICER’s assessments from 2017 to 2019, reflects our legacy of listening to and learning from public feedback about how to enhance our methods in ways that further our mission. Past recommendations from the public were influential in guiding improvements to our methods and process, including efforts to:
- Modify our framework when we evaluate treatments for ultra-rare diseases;
- Share our economic models with manufacturers so they have the transparency necessary to evaluate certain assumptions;
- Prominently feature a calculation of an intervention’s Equal Value of Life Years Gained (evLYG) as a complement to the Quality-Adjusted Life Years (QALY) calculation, to ensure policymakers gain a broad perspective on cost-effectiveness findings;
- Highlight non-clinical benefits and contextual considerations that may be relevant in assessing the value of a medical intervention; and
- Invite each manufacturer to provide specific R&D cost information for inclusion in our report, if the company feels those investments justify a price that otherwise exceeds commonly cited thresholds for cost-effectiveness.
For this update, comments and suggested improvements are welcome on any element of the methods of value assessment or of our procedures for seeking maximum engagement and input from all stakeholders. Commenters are encouraged to review details of the current value assessment framework, including our cost-effectiveness Reference Case, and modifications for assessments of treatments for ultra-rare diseases. Where change is recommended, we encourage all commenters to propose new methods supported by arguments examining their potential advantages and disadvantages. In particular, we are eager to receive input on the following areas:
- The cost-effectiveness thresholds ICER uses to establish its value-based price benchmarks for treatments of both common and ultra-rare diseases;
- The approach ICER takes to evaluate the magnitude and certainty of net health benefit demonstrated by the clinical evidence, as well as how real-world evidence can be incorporated into these judgments;
- The use of both the QALY and the evLYG to evaluate the degree of improvement in health outcomes; and
- Methods by which to integrate those potential benefits, contextual considerations, and other factors relevant to judgments of an intervention’s value that cannot be easily captured through review of the clinical evidence or through cost-effectiveness modeling.
All comments should be submitted via email to publiccomments@icer.org by Monday, June 10th at 5pm ET in the following format:
- 10 pages maximum (excluding references and an appendix that may only contain data tables and figures from published evidence or grey literature, but not additional commentary)
- Times New Roman, 12-point font size
- Word document (no PDFs)
*NOTE: The original press release stated that ICER planned to post its draft revisions on August 16th. That date has now been changed to August 21st.
About ICER
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.