Flash glucose monitoring

In March 2024, several method assessments were initiated as a part of a framework for the managed introduction of innovations "New Methods" for cardiovascular, endocrine, gastrointestinal, men’s health, neurology and neurosurgery, neuromodulation, obstetrics and gynecology, robotic surgery, and some other fields.

Continuous glucose monitoring (rtCGM) and flash glucose monitoring (FGM) for adults with type 1 diabetes have been evaluated within the "New Methods" framework since June 2023. In November 2023, a simplified method assessment report was published. On December 11, 2023, the Decision Forum for "New Methods" recommended introducing rtCGM and FGM.

On July 1, 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) updated the conditions of reimbursement for continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM, commonly called flash glucose monitoring, FGM). Full coverage by health insurance became available to more patient categories.

In May 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries), two new Diagnostic Guidance (MRI fusion biopsy systems for diagnosing prostate cancer, automated ankle-brachial pressure index measurement devices to detect peripheral arterial disease), and three new Health Technology Evaluations (Digitally enabled therapies for adults with anxiety disorders / with depression, and point-of-care tests for urinary tract infections). Also, four clinical guidelines were updated.

In March 2023, the Danish Health Technology Council (Behandlingsrådet) completed a major analysis (større analyser) on patient-centered diabetes technology. The Council recommended that sensor-based glucose monitoring devices with alarms be offered to all adult patients with type 1 diabetes.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in November 2022. Twenty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular and neuromodulation, endocrine, ENT, endoscopic and dermatological devices, as well as devices for men’s health and medical aids.

On October 28, 2022, several Resolutions of the General Directorate of the Common Package of Benefits of the National Health and Pharmacy System were published concerning the use of the system for percutaneous repair of the mitral valve with clip, prioritization of patients with type 2 diabetes mellitus for the provision of glucose monitoring systems, and the use of glucose monitoring system with sensors (flash type) for type 1 diabetes mellitus in childhood and adolescence.

In mid-June, the Swiss Federal Office for Public Health announced the update of the Annexes of the Services Ordinance (KLV/OPre). Annexes 1, 2, and 3 were updated. The updates related to the endocrine, IVD, and interventional radiology technology groups.

In February 2022, Swedish Medical Technologies Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in type 2 diabetes (T2D). The initial recommendations were published by NT Council in 2018 and updated by MTP Council in 2020 to include FreeStyle Libre 2. In the 2022 update, MTP Council decreased the Hba1c limit from 70 to 60 mmol/mol and added a statement on lifestyle changes and treatment optimization with non-insulin antidiabetic drugs.

Dutch Healthcare Institute (ZIN) has issued a Pilot Horizon Scan of 39 new diabetes-related MedTech products that are expected on the Dutch market in 2022 or 2023. Patients with diabetes could benefit significantly from the use of these devices. However, available data on their effectiveness and efficiency is limited.

The Dutch Healthcare Institute (ZIN) is currently evaluating the implementation of the position on Flash Glucose Monitoring (FGM) published in 2019. The publication of the results of the first interim assessment is scheduled for the fourth quarter of 2021.

In December 2020, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Zio XT for detecting cardiac arrhythmias), three Medtech innovation briefings (ReStore Soft Exo-Suit for gait rehabilitation, Cytosponge for detecting abnormal cells in the esophagus, and Evoke Spinal Cord Stimulator for managing chronic neuropathic or ischemic pain). Also, nine clinical guidance documents were updated.