What is the goal of the PPVF Initiative?

The goal of the PPVF Initiative is to develop a standalone value framework for assessing therapies, diagnostics, and other healthcare services, which is in line with patients’ conceptions of value. The framework’s design will include a number of technically specified criteria, measures, and data sources (e.g., observational data, patient reported data, clinical trial data) that can be used to measure value from the patient’s perspective.

A draft version of the PPVF will be shared at the 2016 Partnering for Cures Meeting and version 1.0 of the PPVF will be published in June 2017.

What is the purpose of the PPVF?

Our goal is to create a framework that ultimately can be used across a variety of applications, including the following:

1. The framework, or elements of the frameworks, could be incorporated into clinical decision support systems and used as a platform for shared decision-making between patients and clinicians.
2. Detailed elements of the framework could be integrated into existing value frameworks—such as ASCO’s value framework, ICER’s value assessment framework, NCCN’s Evidence Blocks, and Memorial Sloan Kettering’s DrugAbacus—to help them better address value from the patients’ perspective.
3. The framework could be used to support CMS programs, including the Center for Medicare and Medicaid Innovation’s (CMMI) demonstrations, categories within the Merit-Based Incentive Payment System (MIPS), and other payment programs
4. The standalone patient-perspective value framework could be applied to various conditions and therapeutic areas for de novo assessments of specific therapeutics, treatments, diagnostics and other healthcare services

This effort has the potential to produce a meaningful framework that can help patients evaluate treatments based on criteria that are meaningful to them. With respect to application #3 in the above list, “CMS is excited to be engaged in it,” said Sean Cavanaugh, who leads CMS’ Center for Medicare. “A successful Patient Perspective Value Framework will improve care throughout the health care continuum, generating additional treatment options for patients and their families by reinforcing the patient perspective.”

Because the intended use of the framework will impact how it is built—specifically, what criteria and measures are used to assess value to the patient, and what types of data sources are incorporated—we must prioritize the applications. Figure 1. outlines how we feel that each of the above proposed applications can serve to support and build off of one another, and thus how we ultimately plan to prioritize them.

Who are the Steering Committee Members?

To ensure that the PPVF is a robust, valuable and usable product, we have gathered a multi-stakeholder Steering Committee made up of a variety of stakeholders including patient groups, payers, life sciences companies, advocates and other key stakeholders. Below, we have outlined the PPVF’s Steering Committee members:

• Aetna
• American Heart Association (AHA)
• Amgen
• Astellas Pharma US
• Better Medicare Alliance (BMA)
• Biogen
• Cancer Support Community (CSC)
• CVS Health
• Edwards Lifesciences
• FasterCures
• Gilead Sciences
• GlaxoSmithKline (GSK)
• Johnson & Johnson (J&J)
• Leukemia & Lymphoma Society (LLS)
• Michael J Fox Foundation (MJFF)
• National Health Council (NHC)
• National Multiple Sclerosis Society (NMSS)
• Partnership to Improve Patient Care (PIPC)
• Patient-Centered Outcomes Research Institute (PCORI)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Sanofi

In addition to the above members of the Steering Committee, leadership and staff from across the Centers for Medicare and Medicaid Services (CMS) are participating in the meetings and contributing to the framework.

For further information on the PPVF Initiative, please contact Josh Seidman.