Diabetes

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.

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.

On November 27, 2020, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) released a recommendation about the registration of flash self-monitoring glucose system FREESTYLE LIBRE 2 in the LPPR list.

On August 18, 2020, Swedish Medical Technology Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in diabetes, which now includes FreeStyle Libre 2. The previous recommendation was published by New Therapy (NT) Council in 2018.

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.

In June 2020, two new apps entered the level 1 of the mHealthBelgium validation pyramid. Guardian Connect smartphone application is a component of the Guardian Connect Continuous Glucose Monitoring (CGM) system for diabetes management. The icompanion software is a decision-making tool that helps physicians to choose medication for patients with multiple sclerosis.

On June 9, 2020, NHS England announced new online services for diabetes patients. This remote support will supplement the appointments of patients, many of whom have been going on during the pandemic, via video or telephone consultations, and more recently in protected areas under COVID.