Understanding the Disconnect: Characterizing Trends in Inclusion of Family and Informal Caregiver Spillover in US Value Assessments

OBJECTIVES: While data on caregiver burden is increasingly disseminated by advocacy groups, patients, and caregivers, there remains criticism about the insufficient focus on such spillover effects in US value assessments. This review sought to characterize the inclusion of family and informal caregiver spillover effects in value assessments conducted by the Institute for Clinical and Economic Review (ICER).

METHODS: Key concepts on the burden of family spillover effects were identified via a targeted thematic analysis of ICER value assessments published between February 2019 and April 2023, including: financial burden (unpaid caregiver-time or direct costs), quality of life, productivity, health, and opportunity costs. These concepts were characterized based on themes included across standard sections of the reports: long-term cost-effectiveness, other relevant information (i.e., Patient and Caregiver Perspectives, Potential Other Benefits, and Contextual Considerations), and public comments submitted by patient advocacy groups.

RESULTS: Of the 38 reports reviewed, 31 (82%) included information on family spillover effects. Although these effects were highlighted in the majority of public comments by advocacy groups (72%) and discussed qualitatively in the relevant sections of ICER reports (74%), caregiver burden was only integrated in the economic models in 47% of assessments. The public comments underscored financial burden, quality of life and productivity, but most information lacked proper characterization, measurement, and suitability for the economic model.

CONCLUSIONS: Recent ICER assessments routinely include information on informal caregiving spillover effects and themes largely align with information submitted by patient advocacy organizations. However, these effects were less frequently included in the economic models, which may lead to challenges in understanding the relative burden of diseases across assessments. Our findings suggest the need for alignment between ICER and advocacy organizations on the specifications of the data needed to ensure key family spillover themes can be included in economic evaluation.