Continuous glucose monitoring (CGM)

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.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in September 2022. Thirty-eight 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 and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and medical aids.

On May 09, 2022, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in April 2022, as well as other modifications made during this period. New devices that were introduced in the LPPR list belong to the endocrine and gastrointestinal technology groups.

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated.

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.

On December 2, 2021, the Digital Health Strategy of the National Health System (SNS) was approved by the Interterritorial Council of the National Health System (CISNS) with an endowment of more than €675 million within the Transformation, Recovery, and Resilience Mechanism of the Government of Spain. The Digital Health Strategy is expected to promote the SNS values such as equity, sustainability, and transparency and boost the transformation of the SNS care model in the upcoming years.

At the end of August, the complete method assessment for continuous glucose measurement for patients with type I diabetes with the main focus on patients over 18 years old was initiated as a part of a “New Method” framework. The assessment will be carried out at the National Institute of Public Health; besides the use of continuous glucose monitoring, flash glucose monitoring is considered as well.

On June 30, 2021, the Interterritorial Council of the National Health System has approved the inclusion of real-time continuous glucose monitoring (rt-CGM) systems in the Common Package of Benefits for adult patients meeting certain criteria. The inclusion of rt-CGM devices in the Common Package of Benefits means that these devices are now guaranteed to the defined population nationwide.

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.

In November 2020, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for swallowable gastric balloon capsule for weight loss), five Medtech innovation briefings (for QuickChange Incontinence Wrap for urinary incontinence in men, Magseed for locating breast cancer lesions, Dexcom G6 for continuous glucose monitoring, and others). Also, one clinical guidance (for acute coronary syndromes) was updated.

In March 2020, the Dutch Healthcare Institute advised the Ministry of Health, Welfare, and Sport to simplify the reimbursement to diabetes care aids. In accordance with this advice, the Real-Time Continuous Glucose Monitoring (RT-CGM) and ketone test strips will no longer fall under specialist medical care (MSZ) but will be covered by medical aid care (HMZ). The new scheme is intended to take effect on 1 January 2021.