Value assessments are rapidly evolving in the United States today. Long used to assess the value of treatments in countries around the world, methodologies for comparative and cost effectiveness first gained traction in the United States when the Academy of Managed Care Pharmacy released its Format for Formulary Submissions in 2000.1 Since then, the combination of value-based care initiatives across the healthcare spectrum, the emergence of value frameworks, and the heightened activity of the Institute for Clinical and Economic Review (ICER) in the last 5 years has increasingly thrust value assessments of therapies into coverage and prescribing decisions.

The methodologies employed in value assessments, especially by ICER, primarily measure value through quality-adjusted life-years (QALYs). While also the common metric used in cost-effectiveness assessments by other countries, its application in the United States has generated significant controversy.2-4 While the focus on QALY pros and cons is valid, and additional measures will be considered, another tremendous challenge with today’s value assessments is that they rarely evolve, even as new, relevant evidence becomes available. Yet the amount of relevant evidence concerning the therapy, the condition it treats, and other treatments continues to grow over time. Often, this compilation of evidence over time provides the clearest view of a therapy’s value.

As one of the primary roadblocks to using structured methodologies that support comparative and cost-effective analyses, the reliance solely on RCTs is compounded as new evidence becomes available. This suggests that value assessments should be updated periodically to improve the accuracy and precision of the findings. Because these methodologies are typically not employed even in marketing approval, actual updates to value assessments as new evidence becomes available are even rarer.

In an environment where all payers are pushing toward a value-based system, we must elevate our diligence in assessing value, both by incorporating structured methodologies and updating when new evidence becomes available. ICER’s methods of assessing value have ranged from omitting key elements of value to ignoring patient choice and using QALY as the key measure. There are both supporters and detractors of these methods but clearly they and others who propose value frameworks have elevated the use of structured methodologies. Given government pressures and threats to redraw the rules, the private sector has an opportunity to leverage greater use of structured methodologies and ongoing assessment to be part of the solution to addressing concerns about price by focusing on value.


  1. Academy of Managed Care Pharmacy (AMCP). Format for Formulary Submissions. Published October 2000.
  2. Smith WS. Key questions for legislators about the Institute of Clinical and Economic Review (ICER) [white paper number 189]. Pioneer Institute. Published January 2019.
  3. Cohen JT, Ollendorf DA, Neumann PJ. Will ICER’s response to attacks on the QALY quiet the critics? Center for the Evaluation of Value and Risk in Health (CEVR). Tufts Medical Center. Published December 18, 2018. Accessed March 20, 2019.
  4. Partnership to Improve Patient Care (PIPC). Responding to stakeholder input: finding the patient voice in ICER’s value assessments. Published October 1, 2018. Accessed March 20, 2019.