Growing Questions About Frameworks Highlight Need for Guiding Practices for Value Assessment

Guiding Practices for Patient-Centered Value Assessment

For several years, the National Pharmaceutical Council (NPC) has been keeping a close eye on value assessment frameworks and engaging with developers on ways to improve their methodologies, involve patient organizations and use a broad range of evidence-based considerations. NPC’s recommendations were further outlined in our Guiding Practices for Patient-Centered Value Assessment.

To their credit, many framework developers are making changes in line with the Guiding Practices. But there are still flaws in their methodologies and processes, and NPC is not alone in expressing our concerns about them, especially when it comes to the Institute for Clinical and Economic Review (ICER). ICON plc surveyed payers and biopharmaceutical manufacturers about ICER and found these stakeholders are also concerned about ICER’s use of quality-adjusted life years (QALYs) and lack of consensus on methods and transparency among other issues. (Note: NPC was not involved in any aspect of this survey.)

Patient organizations may also see some of their concerns about the use of ICER’s reports being realized. Payers surveyed said they use ICER reports to inform decisions on whether to require prior authorization and step edits, both of which can be barriers for patients seeking access to a specific treatment option.

It’s clear that payers and manufacturers are paying attention to ICER, given the ICON survey and recent media attention to the organization and its funders. As NPC has pointed out in Health Affairs articles, payers like CVS and other decision-makers need to rely on more than one data point, not just ICER assessments, when determining whether to include an innovative treatment on a formulary.

The ICON survey is also a reminder that value assessment in the United States is still an evolving process, and that good practices need to be established to guide meaningful value assessments. NPC’s Guiding Practices, which outline how to address key aspects of value assessment, are a good place to start.