The Institute for Clinical and Economic Review (ICER) today released its revised value assessment framework (VAF). Although the revised VAF included changes reflecting the public comments from the National Pharmaceutical Council (NPC) and other stakeholders, it is a disservice to patients and those who practice the scientific application of value methods that several key provisions were either postponed or not addressed in the updated VAF.
NPC’s continued engagement with ICER signifies our commitment to the critical dialogue necessary to ensure the development of high-quality, meaningful value assessment tools that help patients, physicians, payers, and others make informed decisions about all aspects of their healthcare. NPC’s comments sought to constructively improve the transparency, credibility, and methodological rigor of the proposed VAF by suggesting that:
- ICER’s assessments should rely on scientifically supported methods and align with best practices for value assessment.
- ICER proposes multiple changes intended to tackle pervasive problems in the healthcare system, including accounting for health equity, productivity, and patient engagement. Significant improvements are needed to address these problems in reliable, appropriate, and patient-focused value assessments.
- ICER is progressively eroding the transparency and rigor of its assessments, procedures, and interactions with stakeholders.
Areas where ICER’s revised framework incorporates many of the suggestions we put forth in our comments include:
- Consistent with NPC’s comments, ICER did not lower its threshold range when stating its opinion on the value of treatments. However, ICER continues to threaten to put its thumb on the pricing scale of innovative treatments. Doing so signals a narrowly focused interpretation of a treatment’s value and can do more harm than good to patient access.
- ICER documented enhanced approaches to patient engagement. However, it remains to be seen whether these efforts will lead to more patient-focused inputs being incorporated into ICER’s analyses and results vs. being another box-checking exercise.
- We appreciate ICER’s further description and efforts to include patient and caregiver productivity within all future assessments but note that these efforts do not automatically translate into ICER’s recommended prices.
NPC remains concerned about several key provisions that ICER has not addressed, such as:
- ICER’s framework is more accurately referred to as a Partial Value Assessment and Price Opinion Framework, because it does not comprehensively assess all elements of value and requires opinion when assigning health benefit price benchmarks.
- Despite best practices and calls from diverse stakeholders, ICER did not include the societal perspective in its base case for all assessments leading to a missed opportunity to broadly measure and value a treatment.
- ICER received many requests to incorporate dynamic pricing within this update, but failed to do so. NPC and others will continue to advance research on the dynamics of a treatment’s value.
- Despite other assessment groups moving toward further quantification and weighting of novel value elements such as severity, ICER has at best, postponed the inclusion of such elements within its price opinion algorithms, and at worst, declined to recognize their importance and value.
- ICER continues to pursue its “shared savings” concept despite the lack of any intellectual support for the notion and, further, outlines subjective and difficult-to-predict criteria for the use of the concept.
- ICER’s clinical trial diversity ratings may have unintended consequences beyond its goal of conversations around equity.
Research suggests the use of value assessment frameworks is growing. Relying on incomplete frameworks or those that rely heavily on opinion can undervalue treatments important to patients and society. NPC will continue to conduct research and engage in dialogue with all stakeholders - including ICER - about the role of value assessment frameworks in healthcare decision-making and the implications for patients and the field of getting value assessment wrong.