NPC Evaluates ICER’s Revised Value Assessment Framework

The Institute for Clinical and Economic Review (ICER) today released its revised value assessment framework, which included a number of changes reflected in NPC's extensive public comments, but NPC remains concerned about several key provisions that ICER has not addressed.

The Institute for Clinical and Economic Review (ICER) today released its revised value assessment framework, which included a number of changes reflected in the National Pharmaceutical Council’s (NPC) extensive public comments. These comments were based in large part on NPC’s Guiding Practices for Patient-Centered Value Assessment that can serve as a guidepost for framework developers.

NPC appreciates that ICER’s revised framework incorporates many of the suggestions we put forth in our comments, including:

  • Consistent with our recommendations, ICER will not implement an untested methodology to quantitatively incorporate patient and societal benefits in the assessment equations. ICER will instead pilot test a simpler methodology that has the potential to quantitatively assess these benefits in the future.
  • ICER also has adopted our recommendation to identify low-value care in all areas of health care, and will add a new section to its reviews on potential cost-saving measures across the health system for the clinical area under review. Drugs comprise one small segment of overall health care spending; by looking across the entire health system with an eye toward low-value care, ICER could identify important opportunities to create headroom in health care budgets.
  • ICER also has adopted our recommendation to include “cost per consequence” (e.g., cost per stroke averted) as a core part of each review. While we continue to have significant concerns about the considerable limitations of the quality-adjusted life year (QALY), we appreciate that a non-QALY based measure, cost per consequence, will be included as an alternate data point.
  • As we suggested, ICER will post an annual list of anticipated topics. This change will give stakeholders much earlier notice of upcoming topics and will allow them time to set aside resources for an upcoming review that impacts them.

However, NPC remains concerned about several key provisions that ICER has not addressed, such as:

  • Providing full model transparency. As NPC stated in its comments, ICER should make its economic models fully, physically 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. ICER indicated, however, that it is working toward a process to release the model after an embargoed period, and that it is making this a priority issue to address within the year. We look forward to monitoring progress in this area.
  • Reconsidering QALY thresholds. In its proposed framework revisions, ICER suggested using a new lower bound QALY threshold of $50,000 in its calculations of cost effectiveness and a value-based price benchmark. While we are pleased to see that ICER has decided not to use this new lower bound in its calculations, we are disappointed that this figure could come into play during the voting process at ICER’s public meetings. This is somewhat mitigated by the use of a higher upper bound of $175,000 that could be voted on as well, although we believe the upper bound should be even higher and thresholds should undergo a multi-stakeholder evaluation process prior to use.
  • Eliminating 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 revised framework does not incorporate these societal considerations that are necessary for an affordability assessment.

As NPC has noted repeatedly, 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 flawed 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; a one-size-fits all approach will not meet the needs of different stakeholders.

NPC is looking forward to continuing our dialogue with ICER as it moves forward with revisions to its value assessment framework.

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