Public Comments

09/13/2016

FasterCures Comments on ICER’s National Call for Proposed Improvements to its Value Assessment Framework

Steven D. Pearson, MD, MSc
President
Institute for Clinical and Economic Review
Two Liberty Square, Ninth Floor
Boston, MA 02109

Dear Mr. Pearson: 

INTRODUCTION

FasterCures, a center of the Milken Institute, is a non-profit, non-partisan action tank driven by a singular goal -- to save lives by speeding up and improving the medical research system. We appreciate the opportunity to share this input, prepared and authored by FasterCures, in response to ICER’s National Call for Proposed Improvements to its Value Assessment Framework.

At FasterCures, we believe it is critical for stakeholders to develop more systematic ways of capturing and integrating patient perspectives into all aspects of medical product development and delivery. Since its inception in 2003, FasterCures has been working to put patients forward as partners in the biomedical research enterprise. To that end, through our Patients Count program, we are focused on expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. This includes ensuring that patient perspectives, including patients’ real-world experience living with -- and undergoing treatment for -- their conditions are considered when assessing the value of a therapy and how specific patient populations will be able to access these treatments.

There has been growing concern, expressed by a variety of different stakeholders, about increased health care spending. These concerns have spurred several different initiatives and activities to explore appropriate ways to assess the value of treatment options. ICER’s ongoing work to assess the value of medical treatments using its value assessment framework has been a significant part of this discussion. We believe it is important to undertake these inquiries and take a critical look at how we pay for value in our healthcare system. However when assessing value, it must be informed by criteria that matter to patients.

ICER has identified four priority areas for potential revision. Our comments are focused on addressing ICER’s specific request for input regarding: “methods to integrate patient and clinician perspectives on the value of interventions that might not be adequately reflected in the scientific literature….”

  • We encourage ICER to create more meaningful opportunities through which patients and the organizations that represent them can submit data – both qualitative and quantitative – to be formally, and transparently, integrated into its Value Assessment Framework. Early and ongoing engagement with those directly impacted by the specific therapy or treatment under consideration will provide considerable benefit to the assessment process. To that end, stakeholders representing patients should be involved and integrated into the discussion as soon as a specific treatment area is under consideration. Patients can provide valuable input about available treatment options and outcomes that are meaningful to them. Patients and organizations who represent them can also help ensure that the appropriate populations are identified to ensure that different perspectives are taken into account. Many of these organizations also have access to unique sources of real-world evidence in the form of patient registries, biorepositories, social networks, and mobile health initiatives that can help define key subpopulations and quantify patient preferences. Moreover, these organizations are often the most trusted intermediaries for and stewards of patients’ data. Some have been involved in the development of validated patient-reported outcome measures and patient-relevant endpoints in their disease areas, as well as other efforts to capture the priorities of those most impacted by the clinical development process.
  • While we commend ICER for taking a more proactive approach to engaging patients and patient organizations in recent months, we encourage ICER to look for ways it can act on the input received through that outreach and improve the quality of its engagement with patients. Meaningful engagement requires more than passively receiving input. 

Last fall, we partnered with Avalere Health, to host a workshop at Partnering for Cures to discuss the existing value frameworks and identify gaps where additional work is needed. In March 2016 we published a report describing the workshop and laying out our plan to develop a value framework that incorporates patients’ perspective on value. In collaboration with Avalere Health we launched the Patient-Perspective Value Framework (PPVF) initiative this summer. The framework’s design will include a number of technically specified criteria, measures, and data sources that can be used to measure value from patients’ perspective. A draft version of the PPVF will be shared during our 2016 Partnering for Cures meeting. We look forward to continued engagement with ICER and other value framework developers to explore whether and how the PPVF can help existing frameworks better address value from the patients’ perspective.

At FasterCures, we believe patient-relevant outcomes drive value. To pay for value, payers and other stakeholders need to understand how care is impacting patients’ functioning in the real world. Evaluating value from the perspective of the patient in this way can have substantial benefit for all stakeholders.

We appreciate your consideration of these comments and look forward to continued engagement and ongoing dialogue with ICER as it revises and improves its value framework in the coming months. 

Sincerely, 

anderson signature

Margaret Anderson
Executive Director
FasterCures, a Center of the Milken Institute

 

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