NPC Outlines Needed Improvements to ICER's Revised Value Assessment Framework

The National Pharmaceutical Council today submitted comments to the Institute for Clinical and Economic Review (ICER), offering constructive suggestions on ways to further improve its revised value assessment framework.

Although ICER has made a number of changes to its framework, NPC remains concerned about several key areas that could result in inaccurate assessments. NPC outlined the following recommendations, among others, in our comments:

• Provide full model transparency. ICER should make its economic models fully available and transparent to the point that the results can be reproduced and tested. If stakeholders can reproduce and understand the model, then they will be able to have more fully informed dialogues about the assessment.
• Review and update assessments on a regular basis. Medical innovation is continuing at a rapid pace, as is the development of evidence about how products work in the real world. ICER should review and update its assessments on a regular basis to account for new evidence and to ensure that it isn’t promoting outdated information. If ICER lacks the staff or resources to conduct needed updates, then it should remove the reviews in question and label them as outdated.
• Expand assessment topics. To meet its stated goal of “sustainable access to high-value care for all patients,” ICER should review more non-drug health care interventions. Drugs comprise one small segment of overall health care spending; by looking across the entire health system, ICER could seek to identify existing low-value care in all areas of health care.
• Use sound methodology. Although we support and appreciate ICER’s interest in quantitatively including patient and societal factors in its assessments, the method it proposes is, as yet, untested, subjective and not based on established and accepted health economic methodologies.
• Recognize serious limitations of QALY. Using a quality-adjusted life year (QALY) in assessments poses significant ethical, methodologic and disease-specific concerns. ICER should include alternative measures, such as “cost per consequence.” For example, when examining treatments intended to prevent strokes, ICER could include the “cost per stroke averted.”
• Reconsider QALY thresholds. In its framework revisions, ICER suggests using a lower QALY threshold of $50,000 to evaluate cost effectiveness under certain circumstances. There is no compelling evidence that this threshold is relevant in the U.S., and thresholds should undergo a multi-stakeholder evaluation process prior to use.
• Eliminate affordability assessment. Budget impact is a measure of resources; affordability is how society decides whether or where it wants to allocate those resources. ICER’s framework does not incorporate these societal considerations that are necessary for an affordability assessment.

Last year, NPC developed a set of guiding practices that can serve as a guidepost for framework developers. As NPC has noted, establishing and adhering to guiding practices can help ensure that value assessment frameworks are effective tools for advancing patient care and achieving better clinical, economic and humanistic outcomes, rather than well-intentioned but not yet mature tools that impede such progress. NPC also has emphasized that multiple frameworks are needed to provide information that can be used by a variety of decision-makers.

In addition to the guiding practices, NPC has produced several educational resources about value assessment frameworks:

• Video: Incorporating Stakeholder Views Into Value Assessment Frameworks
• Current Landscape: Value Assessment Frameworks
• Assessing Value: Promise and Pitfalls Conference and Video