BEYOND VALIDATION: A CONCEPTUAL FRAMEWORK FOR DIGITAL ENDPOINT REIMBURSEMENT & ASSESSMENT
Author(s)
Artem T. Boltyenkov, MBA, PhD1, Anita D. Burrell, BA, MA, MBA2, Annette Champion, BSc, MBA3, Arturo Cabra, BS, MSc4, Brian Seal, MBA, RPh, PhD5, Michael Joseph Cangelosi, MA, MPH6.
1Head, Global HEOR, Siemens Healthcare Diagnostics Inc., Lexington, SC, USA, 2Anita Burrell Consulting LLC, Flemington, NJ, USA, 3Healthcare Research Insights, Inc, Lake Forest, IL, USA, 4GE HealthCare, Miami, FL, USA, 5Organon, Germantown, MD, USA, 6Boston Scientific, Natick, MA, USA.
1Head, Global HEOR, Siemens Healthcare Diagnostics Inc., Lexington, SC, USA, 2Anita Burrell Consulting LLC, Flemington, NJ, USA, 3Healthcare Research Insights, Inc, Lake Forest, IL, USA, 4GE HealthCare, Miami, FL, USA, 5Organon, Germantown, MD, USA, 6Boston Scientific, Natick, MA, USA.
OBJECTIVES: To develop a conceptual framework for digital endpoint reimbursement and assessment, examining how reimbursement context influences HTA evaluation across endpoints, technologies, and care delivery models. Digital endpoints are evaluated inconsistently across health technology assessment (HTA) entities. Their acceptance depends on validation, but also on what is being reimbursed: the endpoint, the technology, or the care it supports.
METHODS: A targeted review of HTA guidance, reimbursement frameworks, and assessments across major agencies (e.g., G-BA, NICE, CADTH, ICER, CMS) was conducted. A comparative analysis identified patterns and informed framework development.
RESULTS: Three reimbursement logics were identified: (1) Validated surrogate endpoints, assessed under conventional HTA standards, (2) Novel endpoints, evaluated under uncertainty-tolerant or provisional pathways, and (3) Service-embedded endpoints, supporting reimbursed care delivery. This framework appears consistent across devices (e.g., wearables), software (e.g., apps), and monitoring services. Where digital endpoints function as validated surrogates, HTA agencies apply conventional evidentiary standards. Continuous glucose monitoring is an example, with acceptance following demonstration of comparative and cost-effectiveness, and budget impact. Although evidentiary focus differs across countries, with Germany’s GBA emphasizing added benefit and Ireland and Australia prioritizing budget impact, the principle of validation remains consistent. For novel endpoints, approaches diverge. Germany's DiGA pathway and France's PECAN and LATM frameworks allow provisional uncertainty, granting early access while evidence is generated. In contrast, NICE, CADTH, and ICER evaluate such endpoints as unvalidated surrogates, often resulting in unfavorable assessments. A third logic operates outside HTA processes. CMS reimburses remote monitoring as an adjunct to professional services, in which digital data supports clinician review, rather than facility fees reimbursing directly. Belgium and France follow similar models. Service-embedded endpoints require demonstration of clinical actionability and workflow integration.
CONCLUSIONS: Evidence requirements for digital endpoints vary with context. Aligning evidence generation with the intended pathway may improve market access.
METHODS: A targeted review of HTA guidance, reimbursement frameworks, and assessments across major agencies (e.g., G-BA, NICE, CADTH, ICER, CMS) was conducted. A comparative analysis identified patterns and informed framework development.
RESULTS: Three reimbursement logics were identified: (1) Validated surrogate endpoints, assessed under conventional HTA standards, (2) Novel endpoints, evaluated under uncertainty-tolerant or provisional pathways, and (3) Service-embedded endpoints, supporting reimbursed care delivery. This framework appears consistent across devices (e.g., wearables), software (e.g., apps), and monitoring services. Where digital endpoints function as validated surrogates, HTA agencies apply conventional evidentiary standards. Continuous glucose monitoring is an example, with acceptance following demonstration of comparative and cost-effectiveness, and budget impact. Although evidentiary focus differs across countries, with Germany’s GBA emphasizing added benefit and Ireland and Australia prioritizing budget impact, the principle of validation remains consistent. For novel endpoints, approaches diverge. Germany's DiGA pathway and France's PECAN and LATM frameworks allow provisional uncertainty, granting early access while evidence is generated. In contrast, NICE, CADTH, and ICER evaluate such endpoints as unvalidated surrogates, often resulting in unfavorable assessments. A third logic operates outside HTA processes. CMS reimburses remote monitoring as an adjunct to professional services, in which digital data supports clinician review, rather than facility fees reimbursing directly. Belgium and France follow similar models. Service-embedded endpoints require demonstration of clinical actionability and workflow integration.
CONCLUSIONS: Evidence requirements for digital endpoints vary with context. Aligning evidence generation with the intended pathway may improve market access.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA126
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas