Unlocking the Value of Patient Self-Monitoring Technologies: A Multi-Country Framework to Calibrate Payer and HTA Coverage and Reimbursement Considerations with Innovation

Background Patient self-monitoring (PSM) is emerging as an innovative modality for chronic disease management. While PSM technologies are established in therapeutic areas including diabetes and cardiovascular diseases, current payer and health technology assessments (HTA) do not adequately evaluate the unique facets of their value. Objectives This study developed a multi-country, stakeholder-informed framework that considers the value drivers of PSM technologies, mapping these to payer and HTA evaluation criteria to guide evidence generation and reimbursement decision making. Methods A sequential mixed methodology study of an artificial intelligence-enabled targeted literature review using Nested Knowledge® and qualitative primary research with 10 payer and healthcare practitioner respondents in the United States, United Kingdom, and Germany was used to inform development of the framework. Results The framework comprises three interconnected core components: value drivers, evaluation criteria, and evidence generation considerations. The value drivers component consists of four themes: clinical, economic, humanistic, and societal. Primary research respondents weighted the respective emphasis of decision making as 60% clinical, 20% economic, 10% humanistic, and 10% societal value. Key value drivers included treatment efficacy/clinical utility, diagnostic efficacy, and healthcare resource utilization. Evaluation criteria indicate the coverage/reimbursement requirements of key payer and HTA organizations. Evidence generation considerations comprise potential study types and evidence generation activities. Conclusions This framework provides a conceptual foundation for stakeholders including payers, HTA bodies, physicians, and developers to align upon evidence requirements for PSM technologies. It can support streamlined strategic evidence generation and consistent evaluation to improve patient access to innovative chronic disease self-monitoring technologies.