Diabetes

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.

In August 2021, NHS announced rolling out genetic testing for monogenic diabetes and placental growth factor (PLGF) testing to rule out pre-eclampsia. These decisions are made in line with the NHS Long Term Plan committed to increasing access to genomic testing, improving diabetes care across the country, and investing in cutting-edge technologies.

In July 2021, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (inducing and maintaining normothermia using temperature modulation devices to improve outcomes after stroke or subarachnoid hemorrhage) and four new Medtech Innovation Briefings (HealthVCF for detecting vertebral compression fractures on CT scans, trublood-prostate for triaging and diagnosing people with prostate cancer symptoms, AI technologies for detecting diabetic retinopathy, and Acumen IQ sensor for predicting hypotension risk).

In early July 2021, two 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, nineteen health apps are now available at the DiGA Directory.

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.

The Health Sciences Institute in Aragon (IACS) systematically evaluates healthcare technologies and facilitates the promotion of research, effective innovation, and decision-making in health services through knowledge management. Currently, the IACS is working on assessments of efficacy, effectiveness, and safety of intraoperative radiation therapy in breast cancer, determination of preeclampsia biomarkers SFlt-1 and PlGF, treatment of congenital ventricular septal defect by cardiac catheterization, and others.

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

Health Information and Quality Authority (HIQA) develops national HTA guidelines to support decision-making in Ireland. In the first quarter of 2021, Health Information and Quality Authority published only one assessment on the topic of Extended Interval Screening by the Diabetic RetinaScreen Programme.

Healthcare Improvement Scotland develops HTAs and clinical guidelines to support decision-making. In the first quarter of 2021, Healthcare Improvement Scotland published assessments of targeted screening for early lung cancer in adults at high risk, gammaCore for cluster headache, and other topics, which mostly concern eHealth technologies.

Healthcare Improvement Scotland develops HTAs and clinical guidelines to support decision-making. In the fourth quarter of 2020, Healthcare Improvement Scotland published assessments of continuous glucose monitoring in pregnant women with type 1 diabetes, endobronchial valves for lung volume reduction in patients with severe emphysema, and other topics.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 554 of January 18, 2021, Tuscany Regional Healthcare has published assessments of eight medical devices of various therapeutic areas, including devices for the treatment of cardiovascular conditions, personal diabetes management system, endoscopic devices, and pedicle screw system.

The French Ministry of Solidarity and Health constantly announces the new experiments initiated under Article 51 of the Social Security Financing Act. These experiments are focused on various topics concerning medical technologies and organization of care. Eleven new experiments were initiated in the fourth quarter of 2020. The experiments concern areas of diabetes, nutrition, home monitoring of patients on oral cancer drugs, bariatric surgery, and others. More details about each of the experiments initiated in the fourth quarter of 2020 is provided in this article.