Payer and HTA Evaluation Criteria and Considerations for Coverage and Reimbursement of Patient Self-Monitoring Technology
Author(s)
Abbie Malyon, MS1, S. Pinar Bilir, MS2, Paco Cerletti, MSc, PhD3, Susan Chang, PharmD4, Sumudu Dehipawala, MPH2, James Karichu, BSc, MPH, PhD4, Conor Maher, MBiochem2, Matthew O'Hara, MBA2.
1Roche Diagnostics Limited, Burgess Hill, United Kingdom, 2Trinity Life Sciences, Waltham, MA, USA, 3Roche Diagnostics International AG, Basel, Switzerland, 4Roche Molecular Systems, Pleasanton, CA, USA.
1Roche Diagnostics Limited, Burgess Hill, United Kingdom, 2Trinity Life Sciences, Waltham, MA, USA, 3Roche Diagnostics International AG, Basel, Switzerland, 4Roche Molecular Systems, Pleasanton, CA, USA.
OBJECTIVES: Patient self-monitoring technologies (PSMTs) are increasingly utilized for the management of chronic diseases, offering the potential to improve clinical outcomes and reduce healthcare resource utilization. While PSMTs are a well-established modality in diabetes and cardiovascular diseases, significant gaps remain in the understanding of how payers and health technology assessment bodies (HTAs) evaluate their evidence, especially if expanded into additional indications. As a step towards developing a PSMT evidence development framework, this study derives payer/HTA considerations for coverage/reimbursement decisions via a mixed methodology.
METHODS: An AI-enabled targeted literature review (TLR) was conducted using Nested Knowledge (NK) to evaluate the current patient self-monitoring literature base. Primary studies (randomized controlled trials, real-world evidence, cost-effectiveness models, etc.), reviews (narrative reviews, systematic literature reviews, etc.), and grey literature (HTA documents, frameworks, etc.) were used to train the NK AI screening model.
Findings were validated through qualitative interviews with N=10 payers and healthcare professionals (HCPs) in US, UK, and Germany to elucidate evaluation processes and evidence requirements.
RESULTS: From 9,102 articles (9,073 from a PubMed search; 29 hand-searched), 184 were manually screened to train the NK model. 99 articles were included for data extraction. Key value drivers across four themes were identified from the literature: clinical (14), economic (8), humanistic (7), and societal (12). Payer/HTA interviews confirmed these value drivers as an accurate approach to assessing the value of PSMTs. Payers weighted the importance of evidence in decision-making as 60% clinical, 20% economic, 10% humanistic, and 10% societal, in addition to recommending impactful evidence generation activities for specific markets.
CONCLUSIONS: This study identified key value drivers and payer/HTA considerations for effective evaluation of evidence and resulting coverage/reimbursement determination of PSMTs. Qualitative interviews substantiated and prioritized concepts from the TLR, while noting accepted evidence generation activities; this basis will be refined into a holistic evidence development framework for evaluating PSMTs.
METHODS: An AI-enabled targeted literature review (TLR) was conducted using Nested Knowledge (NK) to evaluate the current patient self-monitoring literature base. Primary studies (randomized controlled trials, real-world evidence, cost-effectiveness models, etc.), reviews (narrative reviews, systematic literature reviews, etc.), and grey literature (HTA documents, frameworks, etc.) were used to train the NK AI screening model.
Findings were validated through qualitative interviews with N=10 payers and healthcare professionals (HCPs) in US, UK, and Germany to elucidate evaluation processes and evidence requirements.
RESULTS: From 9,102 articles (9,073 from a PubMed search; 29 hand-searched), 184 were manually screened to train the NK model. 99 articles were included for data extraction. Key value drivers across four themes were identified from the literature: clinical (14), economic (8), humanistic (7), and societal (12). Payer/HTA interviews confirmed these value drivers as an accurate approach to assessing the value of PSMTs. Payers weighted the importance of evidence in decision-making as 60% clinical, 20% economic, 10% humanistic, and 10% societal, in addition to recommending impactful evidence generation activities for specific markets.
CONCLUSIONS: This study identified key value drivers and payer/HTA considerations for effective evaluation of evidence and resulting coverage/reimbursement determination of PSMTs. Qualitative interviews substantiated and prioritized concepts from the TLR, while noting accepted evidence generation activities; this basis will be refined into a holistic evidence development framework for evaluating PSMTs.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR156
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas