Value Viewpoint: December 20, 2024

Yesterday, ICER released their fourth annual Fair Access report. Our team shared an evidence-based response and spoke with STAT and Managed Healthcare Executive.

The report evaluates the alignment of select prescription drug coverage policies with a small subset of “Fair Access” criteria that ICER developed in 2020. Though the report has limitations, it highlights a persistent challenge in the U.S. healthcare system: patients continue to face unnecessary and harmful barriers to care due to poorly designed health benefits.

On Monday this week, ICER released their Final Evidence Report assessing the comparative clinical effectiveness of tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

The report was the subject of the November 2024 public meeting of the New England CEPAC in which the appraisal committee agreed that there was adequate evidence to demonstrate a net health benefit for tabelecleucel when compared to usual care.

Committee members also highlighted the following as particularly important issues:

• “There is substantial unmet need despite currently available treatments."
• "The treatment is likely to produce substantial improvement in caregivers’ quality of life."
• "The treatment offers a substantial opportunity to improve access to effective treatment by means of its mechanism of action or method of delivery.”

The November/December 2024 issue of Value & Outcomes Spotlight was released this week and has several interesting articles on the QALY and the value assessment ecosystem:

• Measuring Value—The QALY Turns 50: What Has It Achieved and What Is Its Future? explores the history of the QALY, which health systems around the world currently use the QALY and in what capacity, the benefits and limitations of QALY use, and criticisms of and alternatives to the QALY.
• Value Assessments: Are We There Yet? likewise evaluates the historical use of the QALY in healthcare decision-making, provides an account of current criticisms of the QALY, introduces possible alternatives, and discusses what the future possibly has in store for the QALY.
• What Is This Thing Called Value? takes a look at the evolving field of value assessment and the need to broadly consider value across the healthcare ecosystem, taking into account the full range of costs and benefits over a sufficiently long time horizon.
• Seeing the Bigger Picture: How Capacity Constraints Impact Value discusses the important and often overlooked impact that capacity constraints play in the healthcare system and argues that value assessment should explicitly consider alleviating capacity constraints when evaluating new treatments.?

Finally this week, the Center for Innovation & Value Research has issued a call for speakers for its 6th Annual Methods Summit taking place on March 19, 2025, in Washington, D.C. Panel sessions for this year’s summit include:

• Session 1: Defining Patient-Centered Value Research

This session will outline and clarify what constitutes patient-centered value in healthcare research, establishing foundational principles and exploring varied perspectives on measuring patient value.

• Session 2: Engaging Patients Early - Innovative Approaches to Co-Designing Research

This session will showcase innovative methods for involving patients as co-creators in research design, emphasizing the benefits of early engagement in generating relevant, actionable findings.

• Session 3: Execution and Monitoring - Real-Time Adaptation and Integration of Patient Data

This session will discuss strategies for implementing and continuously refining research in real-time, leveraging patient data to ensure research stays aligned with evolving patient needs.

• Session 4: Dissemination and Assessment - Communicating Findings and Evaluating Impact on Patient-Centered Value Research

This session will explore effective ways to communicate research findings to diverse audiences and assess the real-world impact of patient-centered research on healthcare value.

The application deadline is December 30, 2024. More information can be found here.?

??? Eye on ICER

A calendar of ICER’s upcoming reports & meetings:

Policy White Papers/Special Assessments:

- 3/4/25: Special Assessment to Inform CMS Drug Price Negotiation: Breo Ellipta and Trelegy Ellipta — Final Report

Value Assessment Reports:

- 2/5/25: Acute Pain — Revised Evidence Report

- 2/6/25: Retinitis Pigmentosa — Draft Evidence Report

- 3/26/25: Retinitis Pigmentosa — Revised Evidence Report

- 3/27/25: Acute Pain — Final Evidence Report

- 4/10/25: Multiple Sclerosis: SPMS — Draft Evidence Report

- 5/12/25: Retinitis Pigmentosa — Final Evidence Report

- 5/29/25: Multiple Sclerosis: SPMS — Revised Evidence Report

- 7/15/25: Multiple Sclerosis: SPMS — Final Evidence Report

Meetings:

- 2/28/25: Acute Pain — Public Meeting (Midwest CEPAC)

- 4/11/25: Retinitis Pigmentosa — Public Meeting (New England CEPAC)

- 6/14/25: Multiple Sclerosis: SPMS (California Technology Assessment Forum CTAF)?

Contributing author: Brian Sils