Last week, The Institute for Clinical and Economic Review (ICER) published a highly anticipated update to its Value Assessment Framework. Overall, the changes aim to value a more holistic perspective (e.g., health equity, what is meaningful to a patient, societal value).

We anticipate most stakeholders – manufacturers included – will get behind the spirit of the new framework. However, the controversy will ultimately lie in the methodology and key provisions used to achieve this. The timing of the new framework amid the ongoing implementation of the Inflation Reduction Act’s Medicare Drug Negotiation Program is highly noteworthy as well.

Will ICER’s new framework influence (directly or indirectly) how CMS assesses “fair prices” under the Medicare Drug Negotiation Program? This scenario is not out of the realm of possibility.

With this, let’s look at the main updates to the ICER Value Framework:

Notable Updates:

  • Clinical trial diversity: Pivotal trials of interventions under review will be rated on the relative diversity of participants’ race/ethnicity, sex, and age (older adults).
  • Patient perspective in clinical trial design: Manufacturers will be encouraged to submit a description of the methods used to collect patient experience data and outline how they identified the outcomes most meaningful to patients. 
  • Productivity effects: Patient utility scores and US-based patient time-use data will be assessed to determine productivity effects (return to full work and family activities).
  • New public meeting voting questions: Beyond clinical trials and cost-effectiveness modeling, new voting questions will be added to help capture other value considerations (e.g., unmet need, disease severity, caregiver impact). 
  • Cost-effectiveness scenarios (generic competition or Medicare drug price negotiation): Due to the policy implications of the Inflation Reduction Act, ICER will engage several stakeholders on how best to approach price dynamics within a scenario analysis (i.e., generic competition, Medicare price negotiation provisions). 
  • Potential use of the Generalized Risk-Adjusted Cost-Effectiveness (GRACE) framework: In a GRACE model, treatments for more severe illness have greater value than in standard cost-effectiveness methods. This may appeal to those who believe “QALY,” a metric currently used, is discriminatory.

What manufacturers can do:

  • Think about value assessment early (well before commercialization). As an example, the time to influence clinical trial diversity is when setting up clinical trial enrollment plans.
  • Engage with external stakeholders (patient advocacy groups, policymakers, employer groups) who can substantiate the value your therapy delivers from a more holistic perspective via:
    • Collaborative evidence generation.
    • Communications that increase awareness of the social disparities, access barriers, disease severity, and caregiver needs that you can address by working together.

Stakeholders began to weigh-in during a public webinar late last week, and manufacturers continue to seek to pick up any additional signals of how the new value assessment framework may impact approved or future therapies. 

About the Author:

Patrick Rigby joined Syneos from the private sector where he specialized in corporate communication, government relations, and public affairs across the healthcare industry. Patrick served as Director of Communications and later as Chief of Staff for the New Jersey Office of Homeland Security and Preparedness under two administrations. He also served as an Advisor to the Chairman of the U.S. Senate Foreign Relations Committee. Prior to government service, Patrick held positions with Bloomberg L.P., the Council on Foreign Relations, U.S. House of Representatives, and in the financial services industry. Patrick brings with him over 15 years of managing large teams and directing complex communications and reputation management programs for businesses and government.