–ICER solicits input on Value Assessment Framework; will give webinar on current version July 29th–

July 14, 2016 – To inform a planned 2017 update to the methods that underpin its 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 its value assessment framework.  We invite all interested parties to provide comments on the current ICER value framework, highlighting elements that are perceived to work well and others that should be re-examined.  Where change is recommended, we are most hopeful of receiving specific proposals presenting alternative methods accompanied by arguments examining the potential advantages and disadvantages of multiple options.  ICER will welcome comments though Monday, September 12th.  We will use the suggestions received to guide internal review and further discussions with stakeholders, following which an updated version of the value framework will be finalized, announced, and used for ICER reports beginning in January 2017.

ICER’s value framework is the product of nearly 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.  Approximately one year ago, the framework was updated and made more explicit following a formal two-year process of comprehensive review involving the input of multiple stakeholders.  The goal of the value assessment framework is to provide a consistent approach that ICER uses to integrate the perspectives and information gathered from patients and clinical experts, to evaluate the existing scientific literature and other sources of evidence, and to present these findings in our reports in a way that reflects the multiple domains of value.  The ICER value framework also underpins public deliberation of our reports by independent panels. During that deliberation, and with input from patients, clinical experts, and others, judgments of the comparative clinical effectiveness and value of different care options are discussed.  The ultimate goal of the value framework is to support this public dialogue — among life science companies, insurers, patient groups, and others — on how best to use evidence as the cornerstone of improvements in clinical practice, coverage policies, and pricing.

The latest iteration of the framework has been in use for over a year, and with feedback and experience it has evolved during that time.  For example, a section in ICER reports now explicitly examines potential “additional benefits or disadvantages” to guide consideration by the independent panels that debate ICER reports at public hearings.  Another recent change eliminates a separate vote by the independent panels on “Provisional Health System Value,” the term in the ICER value framework representing integration of long-term value with considerations of shorter-term affordability.  Following on these iterative changes, ICER is planning a broader reflection on all aspects of the value framework and seeks comprehensive and directed comments from all health care stakeholders.

Comments and suggested improvements are welcome on any part of the framework.  We believe that among the highest priority areas for potential revision are the following:

  1. Methods to integrate patient and clinician perspectives on the value of interventions that might not be adequately reflected in the scientific literature, elements of value intended to fall in the current value framework within “additional benefits or disadvantages” and “contextual considerations”
  2. Incremental cost-effectiveness ratios: appropriate thresholds, best practice in capturing health outcomes through the QALY or other measures
  3. Methods to estimate the market uptake and “potential” short-term budget impact of new interventions as part of judging whether the introduction of a new intervention may raise affordability concerns without heightened medical management, lower prices, or other measures.
  4. Methods to set a threshold for potential short-term budget impact that can serve as a useful “alarm bell” for policymakers to signal consideration of whether affordability may need to be addressed through various measures in order to improve the impact of new interventions on overall health system value.

There is no page limit to the comments but we would appreciate comments submitted by Monday, September 12th at 5pm ET in the following format:

  • Times New Roman, 12-point font size
  • Word document (no PDFs)
  • Electronic copy only

Comments should be sent via email to publiccomments@icer-review.org

For those interested in a detailed explanation of ICER’s current value framework and how it is used within ICER reports and to guide the deliberation of public meetings, ICER’s President, Steven D. Pearson, MD, MSc, will explain the framework in detail during a webinar on Friday, July 29th at 1PM Eastern.  You can register for the webinar here.

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.