US healthcare stakeholders are increasingly expected to define the value of technology and services provided. This is especially applicable to health technology manufacturers who are responsible for demonstrating the value of their treatments to payers, providers, patients, policymakers, and other stakeholders.

A product’s value may be considered from multiple angles, including clinical effectiveness, economic impact, patient-centered outcomes (PCOs), and broader societal value. A drug may improve clinical symptoms, leading to reduced healthcare utilization, which may increase a patient’s ability to work, resulting in economic benefit to the patient through increased wages and to the employer through increased productivity. Coverage policies may rely on the conclusions of a value assessment process, making consideration of patient-centered outcomes essential if those decisions are to be centered on patients and people with disabilities.

This research was conducted to better understand the current role of PCOs in the value assessment process, utilizing select assessments from the Institute for Clinical Economic Review (ICER) as a case study. Findings from this analysis highlighted that the use of PCOs in these values assessments were limited and often did not impact the quantitative assessments of value.

Unlike other countries, the US does not have a designated governmental organization or process mandated to assess the value of health technologies. ICER has emerged as a value assessor in the US market. ICER typically reviews new treatments around the time of launch to assess their long-term value and short-term affordability, producing a “health benefit price benchmark.” While these results are not binding on coverage determinations or price negotiations, results are increasingly considered in payer decision-making. In the process of updating its value framework in 2019, ICER noted its intention to better integrate patient input and preferences in its evidence reviews. However, it is unclear the extent to which the PCOs used in ICER’s evidence reviews impact ICER’s health benefit price benchmark calculations on which payers may rely to make decisions related to coverage and utilization management.

To assess the extent to which ICER has integrated PCOs in its assessments, The Partnership to Improve Patient Care engaged Avalere to review four reports released since ICER introduced its 2020–2023 value assessment framework. The review covered materials across ICER’s review process, from the scoping document to the final evidence report and recommendations. The review reveals that:

• ICER’s use of PCOs in assessments varies widely
• ICER’s current approach often does not effectively account for disease- and population-level variation in patient preferences and outcomes
• Across most of the reviewed assessments, the inclusion of PCOs was purely qualitative and did not impact the health benefit price benchmarks

This conclusion underscores some limitations of prevailing value assessment methodologies that influence benefit design and coverage decisions, which, in turn, may affect patient access to care. Additionally, it also highlights opportunities to make value assessment more patient centered. Introducing a patient lens in health technology and service valuation can enable healthcare decisionmakers to better understand the risks and benefits from the patient’s view. Capturing patient-centric dimensions of value is crucial to properly demonstrate the value of medical innovations. Further, as methods for value assessment mature, flexible modeling approaches that can incorporate PCOs into the quantitative analysis will need to be researched, developed, and established to properly align assessment methods with the needs of patients and people with disabilities.

The white paper “Use of Patient-Centered Outcomes in ICER Assessments” is available for download.

Funding for this white paper was provided by The Partnership to Improve Patient Care.  Avalere retained full editorial control.

To learn more about incorporating patient preferences into value assessment, connect with us.