Payment mechanism
As devices for continuous glucose monitoring belong to the devices used by patients at home (medical aid segment) in most European countries, to obtain reimbursement, they should be included in the list of medical aids guaranteed to the population.
Reimbursable lists of medical aids are often maintained at the national level; they might include a generic description of the device and guaranteed services (like the Medical Aids List in Germany) or a detailed description of the reimbursement category, the criteria for eligible populations, and maximum reimbursement tariffs (like in the List of Reimbursable Products and Services, LPPR, in France).
In some European countries, coverage of medical aids is determined at the regional level (e.g., Nordic countries, Spain).
The registration of continuous glucose monitoring devices for reimbursement can be either generic or specific to a brand. The reimbursement categories for continuous glucose monitoring can have defined eligibility criteria. For example, in France, the primary indications for continuous glucose monitoring include patients with either Type 1 or Type 2 diabetes who are on insulin therapy, particularly those with suboptimal glycemic control (HbA1c ≥ 8%) or a history of severe hypoglycemia. Many systems are approved for patients aged two years and older.
In some countries, continuous glucose monitoring is reimbursed via the DRG mechanism. For example, continuous glucose monitoring devices and consumables in the Netherlands are reimbursed via specific DRGs, including placement of continuous glucose monitoring sensor (DRG 040201021 "Placing a sensor (RT-CGM) in diabetes" with 2023 average cost of €1,700) and follow-up management of a patient (for example, DRG 040201009 "Examination(s) and/or treatment(s) in diabetes and presence of an insulin pump and/or sensor (RT-CGM)" with 2024 average cost of €1,135).
Policy considerations
Conditions for access to continuous glucose monitoring are usually determined as part of the reimbursement registration (where national lists exist, e.g., in France and Germany) or by relevant payers or decision-makers (e.g., via regional guidelines in the Nordic region).
For example, in 2022, the NHS England announced that Dexcom ONE real-time continuous glucose monitoring (rt-CGM) will be available to all people with type 1 diabetes on prescription, receiving their starter pack, including information on the product and usage, a sensor, and transmitter, from the hospital or GP once prescribed, after which they can go to the pharmacy for their repeat prescription. Dexcom ONE rt-CGM sensor was added to the NHS Drug Tariff Part IX in August 2022. Pharmacists are reimbursed with the Drug Tariff listed price by the NHS Prescription Services.
In Belgium, conditions of provision of continuous glucose monitoring are outlined in specific agreements between specialized centers and INAMI-RIZIV called "Conventions". Since July 2023, complete health insurance coverage for continuous glucose monitoring has been expanded to the following clinical indications: type 2 diabetes treated with three or more insulin injections per day; insulin-treated gestational diabetes; insulin-treated diabetes after organ transplantation; insulin-treated diabetes in patients receiving kidney dialysis; diabetic women who wish to become pregnant and who are treated with insulin and/or other injectable antidiabetic drugs.
Health technology assessment
As continuous glucose monitoring is an established category of medical devices, new HTAs are unlikely to be relevant.
However, there is a growing interest in closed-loop systems, which often require a health technology assessment. For example, in 2023, the National Institute for Health and Care Excellence (NICE) developed multiple technology appraisal guidance on hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes, which recommended hybrid closed-loop systems as an option for managing blood glucose levels in type 1 diabetes in adults who have an HbA1c of 58 mmol/mol (7.5%) or more or have disabling hypoglycemia, despite best possible management with at least one of the following: continuous subcutaneous insulin infusion (CSII), real-time CGM, intermittently scanned CGM ('Flash'); in children and young people; in people who are pregnant or planning a pregnancy.
Future challenges
Continuous glucose monitoring has achieved established reimbursement and funding in most European countries. However, several critical challenges remain. These include securing reimbursement for emerging technologies, such as closed-loop systems that integrate both monitoring and insulin delivery functions, as well as expanding indications for continuous glucose monitoring to non-diabetic populations (e.g., individuals with obesity). In many countries, such extensions require a high level of clinical evidence demonstrating consistent, long-term benefits beyond glucose control to justify coverage.
Another potential challenge is the development of reimbursement frameworks for telemedicine services utilizing continuous glucose monitoring data, particularly when used by non-endocrinologists and primary care providers. Aligning reimbursement policies with these evolving models of care will be essential for the broader integration of continuous glucose monitoring into routine clinical practice.
How can MTRC help?
Development of reimbursement analysis (procedure coding, payment mechanism, reimbursement tariffs, and policy considerations)
Development of market access strategy
Development of the value dossier
Performing evidence gap analysis for novel technologies
Development of reimbursement and HTA submission dossiers
Adaptation of the global health economic model to EU settings
MTRC has experience with more than 8 projects related to continuous glucose monitoring in Europe
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