Differential HTA Recommendations for Continuous Glucose Monitors (CGMs): A Global Comparative Review of HTA Focus, Challenges, and Solutions
Author(s)
elena demian, BSc, MSc1, Mo Amin, PhD, MD2, Rosanne Campbell, BA, MSc3.
1Syneos Health, Paris, France, 2Syneos Health Consulting, Milton, ON, Canada, 3Syneos Health Consulting, London, United Kingdom.
1Syneos Health, Paris, France, 2Syneos Health Consulting, Milton, ON, Canada, 3Syneos Health Consulting, London, United Kingdom.
OBJECTIVES: Continuous glucose monitors (CGMs) have been evaluated by various HTA agencies worldwide, yet recommendations differ. This study compares HTA methodologies and outcomes to identify key drivers of CGM adoption and offers solutions for greater acceptability.
METHODS: HTA reports from NICE-UK, CDA-Canada, Medicare-US, IQWiG-Germany, and HAS- France/ TLV-Sweden were reviewed and categorized by clinical effectiveness criteria, economic modeling approaches, and reimbursement decisions. Analyses focused on HbA1C reduction, glucose variability, adverse events, quality-adjusted life years (QALYs), real-world evidence (RWE), budget impact analysis (BIA), and distributional cost-effectiveness analysis (DCEA).
RESULTS: HTA recommendations varied significantly:
Proposed solutions: (1) validating surrogate endpoints with Bayesian methods, (2) incorporating real-world registry and claims data, (3) adopting discrete-event simulation (DES) and microsimulation models for dynamic interventions, (4) including BIA to assess total costs, (5) applying DCEA to evaluate equity impacts.
CONCLUSIONS: HTA agencies recognize CGMs' clinical benefits in controlling blood glucose parameters, but CE and medical integration remain key barriers due to user adherence and disparity in access. NICE and CDA require stronger economic justification, while HAS and TLV emphasize preventive benefits. Future evaluations should prioritize validated surrogate endpoints, RWE, and adaptive economic modeling to enhance HTA acceptability.
METHODS: HTA reports from NICE-UK, CDA-Canada, Medicare-US, IQWiG-Germany, and HAS- France/ TLV-Sweden were reviewed and categorized by clinical effectiveness criteria, economic modeling approaches, and reimbursement decisions. Analyses focused on HbA1C reduction, glucose variability, adverse events, quality-adjusted life years (QALYs), real-world evidence (RWE), budget impact analysis (BIA), and distributional cost-effectiveness analysis (DCEA).
RESULTS: HTA recommendations varied significantly:
- NICE: Supports CGMs for Type 1 diabetes (T1D) but highlights cost concerns for NHS funding.
- CDA: Endorses CGMs for T1D but requires strong CE justification for Type 2 diabetes.
- Medicare: Covers CGMs for frequent insulin users, with private insurers imposing HbA1c thresholds.
- IQWiG: Supports CGMs for T1D but mandates longitudinal CE validation.
- HAS & TLV: Fully reimburse CGMs, emphasizing preventive benefits and reduced hospitalizations.
Proposed solutions: (1) validating surrogate endpoints with Bayesian methods, (2) incorporating real-world registry and claims data, (3) adopting discrete-event simulation (DES) and microsimulation models for dynamic interventions, (4) including BIA to assess total costs, (5) applying DCEA to evaluate equity impacts.
CONCLUSIONS: HTA agencies recognize CGMs' clinical benefits in controlling blood glucose parameters, but CE and medical integration remain key barriers due to user adherence and disparity in access. NICE and CDA require stronger economic justification, while HAS and TLV emphasize preventive benefits. Future evaluations should prioritize validated surrogate endpoints, RWE, and adaptive economic modeling to enhance HTA acceptability.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA111
Topic
Health Technology Assessment, Medical Technologies
Topic Subcategory
Decision & Deliberative Processes
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)