Diabetes

The French National Authority for Health (HAS) 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 (CNEDiMTS) in March 2023. Fifteen 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 (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, endoscopy, gastrointestinal, surgical, and diagnostic imaging devices, as well as medical aids.

In mid-December 2022, the Danish Health Data Agency (Sundhedsdatastyrelsen) published an update of the Health Care Classification System (Sundheds-væsenets Klassifikations System, SKS). The most significant changes include: 11 new diagnosis codes, 27 new procedure codes, and eight additional codes (Tillægskoder) were added. The newly added procedure codes mainly concern the obstetrics and gynecology, surgical procedures, endocrine, gastrointestinal, and radiology fields, and some other technology groups.

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.

On May 31, 2022, the French National Authority for Health (HAS) published the final positive opinion on the coverage of the endoscopic gastroplasty with the ENDOMINA triangulation platform under the Innovation package (Forfait innovation).

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 and April 2022, three more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, thirty-three health apps are now available at the DiGA Directory.

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, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (stereotactic radiosurgery for trigeminal neuralgia, and microwave ablation for primary or metastatic cancer in the lung), two new Diagnostic Guidance (EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules, PredictSURE IBD and IBDX to guide treatment of Crohn's disease), and four new Medtech Innovation Briefings (Insides System for managing intestinal failure, d-Nav insulin management app for type 2 diabetes, GaitSmart for personalized exercise rehabilitation, AposHealth for knee osteoarthritis)

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.

In January 2022, the Scottish Health Technology Group released a recommendation of the closed-loop systems and the artificial pancreas for type one diabetes mellitus. The limited use of closed-loop systems in routine clinical care makes it difficult to estimate device-related adverse event rates. No evidence was identified for artificial pancreas systems (multi-hormone closed-loop systems) available on the UK market.

On January 26, 2022, the HAS published standards for medical telemonitoring of four chronic pathologies (chronic respiratory failure, chronic heart failure, chronic renal failure, and diabetes). These standards must be met by technologies in order to be reimbursed by the new reimbursement framework for telemonitoring, which is expected to enter into force in July 2022.

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.