Responds to public comment and sets key parameters for evidence review methods and process for stakeholder engagement

Key points include commitment to incorporating patient-reported outcomes, broadening of cost-effectiveness range for committee votes on value, new voting mechanism on wider societal benefits, confirmation of new approach to potential budget impact analysis without estimation of uptake, and new report section seeking options to reduce waste to free up resources for innovation

Boston, Mass., June 22, 2017 – Following a second cycle of public comment, the Institute for Clinical and Economic Review (ICER) has posted the final statement of its current update to the ICER Value Assessment Framework. The Value Assessment Framework is the conceptual framework and set of associated methods that guides ICER’s development of reports on tests, treatments, and delivery system innovations. Linked to the framework, and discussed as part of this update, are the procedures for stakeholder engagement and public deliberation that are critical to the development of every ICER report and underpin its broader effort to help work towards a health system in which patients can have sustainable access to high-value care. This update will form the foundation of report development from 2017-2019. ICER plans a regular update cycle for its value framework every two years.

Over the course of a process that began in July 2016, ICER first received over 50 sets of comments from patient groups, life science companies, insurers, and policymakers, followed by a one-day meeting with over 40 health care stakeholders. The final update also builds upon iterative changes made over the past two years working with stakeholders to enhance the transparency of the framework, and to improve the ability of all parties to participate meaningfully in the report development process and public meetings. Following the posting of specific update proposals, ICER received comments from over 40 organizations and individuals. Reflections and responses to key public comments are woven into the final update document.

“To succeed in our mission, we constantly listen to patients and other stakeholders,” noted Steven D. Pearson, MD, MSc, ICER’s President. “The updates to our Value Assessment Framework are a direct result of the thoughtful input we have received in our two public comment phases. We believe the updates to our methods that have emerged with this input will add to the transparency of our value framework and make even clearer how ICER reports integrate different elements of value into a final whole. Yes, evidence on comparative clinical effectiveness and cost-effectiveness remain central components, but our updated methods and procedures for our public meetings will enhance the way that all stakeholders will be to contribute to the broader discussion of value that is required to guide decisions about coverage and pricing that affect patients every day.”

Key changes, updates, and restatements of current methods include:

  • ICER reaffirms its commitment to seek and include a wide range of sources of evidence, including patient-reported outcomes, in all its evidence reports.
  • The range of incremental cost-effectiveness ratios used to calculate the ICER value-based price benchmarks will remain $100,000 to $150,000 per additional quality adjusted life-year (QALY); however, a broader range of $50,000 to $175,000 per QALY will be used for voting by independent appraisal committees at ICER public meetings.
  • Prices used in primary cost-effectiveness analyses will be based on estimates of prices net of rebates in the US market, instead of wholesale acquisition costs (i.e. list prices).
  • Important conceptual domains of value labeled as “other benefits or disadvantages” and “contextual considerations” will receive a new, formalized treatment in reports and will be the subject of separate voting by independent appraisal committees. However, in view of concerns raised in public comments, these votes will serve as input for policymaking but will not be applied by ICER quantitatively to adjust cost-effectiveness thresholds or value-based price benchmarks.
  • Potential budget impact analyses will remain a core element of ICER reports, but ICER will continue its recent approach in which it does not attempt to estimate the unmanaged uptake of a new drug in clinical practice. Instead, an interactive graph will be developed to allow policymakers to input their own assumptions regarding uptake and price, and potential uptake and concerns about affordability and access will occur during the discussion of a Policy Roundtable at each ICER meeting.
  • A threshold for potential budget impact based on national estimates of economic growth will continue to serve as a tool to identify “access and affordability alerts,” should clinical expert and other stakeholder input at the public meeting suggest intended clinical use may lead to short-term strain on health budgets that merit additional policymaker efforts to ensure that patients can maintain access to high-value innovations.
  • ICER has updated its calculations for the potential budget impact threshold for new drugs. For 2017-2018, that figure is a net of $915 million annually, calculated over a five-year period.
  • ICER reaffirms the purpose of its potential budget impact analyses, and any “affordability and access alerts” are not to suggest a budget cap on spending for a particular drug, or for drugs as a category of spending in the US health care system.

Additional changes include updates to ICER’s process for making economic models as transparent as possible, and a new, longer timeline for report development that provides more opportunity for stakeholder engagement.

As part of this final update, and based on feedback received during the public comment period, an updated Patient Participation Guide has been posted to the ICER website. This guide offers key information on when and how patient groups can most effectively contribute to reports and ensure that reports fully capture the patient perspective. Our Manufacturer Engagement Guide is also available.

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.