Boston, Mass., February 1, 2017 – The Institute for Clinical and Economic Review (ICER) has posted for public comment proposed updates to its Value Assessment Framework, the conceptual framework and set of associated methods that guides the development of ICER reports on tests, treatments, and delivery system innovations. The proposals are based on a previous public comment period during which ICER 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 proposed updates also build upon iterative changes made over the past two years as ICER worked 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. The update proposals will be open to further public comment for 60 days, following which ICER anticipates posting a final description of updates to the value framework by April 15th. This update will guide the development of ICER reports from 2017-2019.
“To succeed in our mission, we constantly listen to patients and other stakeholders. This draft contains proposed updates to our Value Assessment Framework that are a direct result of the thoughtful input we have received, and of our ongoing conversations with all stakeholders. The proposals seek to improve the ability of the ICER value framework to achieve one goal: to help inform collaborative dialogue and policies that will ensure sustainable access to high-value care for all patients ,” noted Steven D. Pearson, MD, MSc, ICER’s President.
Key proposed 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 assess the long-term value for money of different treatments will be expanded from $50,000 to $150,000 per additional quality-adjusted life year.
- Prices used in all analyses will be estimates of prices net of rebates in the US market instead of wholesale acquisition costs (i.e. list prices).
- Conceptual domains of value labeled as “other benefits or disadvantages” and “contextual considerations” will receive a new, formalized treatment in ICER reports and will be the subject of quantitative voting by independent appraisal committees. These votes will be used to “weight” the cost-effectiveness threshold within the range of $50,000-$100,000 per quality adjusted life-year, producing a single cost-effectiveness threshold that will anchor the ICER value-based price benchmark.
- Short-term affordability will remain a part of the ICER value framework but it will no longer be directly integrated in a vote on provisional health system value.
- ICER will no longer attempt to estimate “unmanaged” uptake of new drugs or other services as part of potential budget impact analysis. Instead ICER will provide analyses allowing stakeholders to ascertain the potential budget impact of a new service according to a wide range of assumptions on price and uptake.
- ICER has updated its calculations for a potential budget impact threshold for new drugs linked to a growth target in line with estimates of national growth in GDP, and the figure for 2017-2018 is a net $915 million per year increase over a five year period.
- ICER will include as part of its final report following the meeting of the independent appraisal committee an “affordability and access alert” if discussion among stakeholders at the meeting suggests that utilization driven by clinical need, at estimated net pricing, would exceed the budget impact threshold.
- ICER reaffirms that 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. The purpose is to signal to stakeholders and policymakers that the amount of added health care costs associated with a new drug may be difficult for the health system to absorb over the short-term without displacing other needed services or contributing to rapid growth in health care insurance costs. As a result, patient access to high-value care may be adversely affected unless policy makers take action.
There is no page limit to public comments on this set of update proposals; comments are due by April 3, 2017. Comments should be emailed to publiccomments@icer-review and should follow the format specifications below:
- Times New Roman, 12-point font size
- Word document (no PDFs)
- Electronic copy only
As part of ICER’s commitment to engaging with patients and patient groups, and based on feedback received during the public comment period, a new 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 ICER reports and ensure that reports fully capture the patient perspective. Our Manufacturer Engagement Guide has also been updated and is now available on our website. Comments will also be accepted on both guides during the 60-day comment period.
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.