Introduction to Global Market Access and Reimbursement Models for Continuous Glucose Monitors
The global market for Continuous Glucose Monitors (CGMs) has undergone significant transformations, driven by regulatory changes and evolving standards of care for diabetes management. This section provides an overview of the current landscape of global market access and reimbursement models for CGMs.
Regulatory Framework and Reimbursement Drivers
The regulatory framework for CGMs varies by region, with key drivers influencing reimbursement decisions:
- United States: The Centers for Medicare and Medicaid Services (CMS) have expanded coverage for CGMs, including basal-only insulin users and individuals with problematic hypoglycemia [1]. This shift from categorizing CGMs as Durable Medical Equipment (DME) to considering them under Pharmacy Benefit channels has enhanced patient access.
- Europe: Health Technology Assessment (HTA) bodies, such as the National Institute for Health and Care Excellence (NICE) in the UK and the Federal Joint Committee (G-BA) in Germany, have established coverage for Type 1 Diabetes based on cost-utility analyses [2].
- Asia-Pacific: The National Diabetes Services Scheme (NDSS) in Australia exemplifies a successful single-payer model, offering universal coverage for Type 1 Diabetes while implementing price controls [3].
Strategic Implications for Manufacturers
The competitive landscape among CGM manufacturers (Abbott, Dexcom, Medtronic) has shifted towards emphasizing economic evidence (cost-effectiveness) in addition to hardware features [4]. Conducting clinical trials to demonstrate \