Health technology assessment

On February 4, 2021, the guide on dossier submission to the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) for the inclusion of the device in the List of Reimbursable Products and Services (LPPR) was published in English. Furthermore, the guide was recently updated with the information dedicated to the technologies falling within the scope of artificial intelligence.

In early February 2021, the final method and process frameworks of the Treatment Council (Behandlingsråd) were approved in Denmark. The Treatment Council is a new model for assessing treatments and health technologies, expected to become fully operational in early 2021.

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.

In Finland, the Health Care Services Selection Council (Terveydenhuollon palveluvalikoimaneuvosto, PALKO) is responsible for making recommendations regarding the research, treatment, and rehabilitation methods. Currently, the Council is working on assessments of chronic low back pain treatment and screening for severe combined immune deficiency in a neonatal heel sample.

In January 2021, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (self-expanding implant insertion into the intersphincteric space for faecal incontinence and minimally invasive radical hysterectomy for early stage cervical cancer), two new medical technologies guidance (the PLASMA system for transurethral resection and haemostasis of the prostate, and the VAC Veraflo Therapy system for acute infected or chronic wounds), and six Medtech innovation briefings (Optilume for anterior urethral strictures, AI in mammography, AI for analyzing chest CT images, AcQMap for mapping the heart atria to target ablation treatment, and others). Also, two clinical guidelines were updated.

On January 19, 2021, Belgian Health Care Knowledge Center (KCE) published a health services research report "Barriers and facilitators for eHealth adoption by general practitioners”. Findings from the research show that there is a wide range of factors contributing to the uptake of eHealth technology by healthcare professionals. These factors range from the quality of the eHealth technology, use, and user satisfaction, net benefits, individual, organizational, and implementation characteristics to country-specific factors (such as governance, standards, funding, or trends).

On December 30, 2020, the French National Authority for Health (HAS) published a report "Economic evaluation of telemonitoring to inform public decision-making", based on the systematic literature review. According to the results of the review, telemonitoring can be considered as a way to improve the organization of care and reduce care costs.

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 December 31, 2020, the French National Authority for Health (HAS) published a methodological guide clarifying aspects related to the organizational impact of health technologies under the evaluation. As the organizational impact can be documented when submitting an evaluation file for a drug, medical device, or a procedure, the guide aims to define the types of organizational impact and to propose criteria to measure these effects.

In 2013, Norway established a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In the second half of 2020, eight new mini-HTA projects of medical technologies were launched in Norway: tissue allotransplantation, pain treatment via neuromodulation, among others.

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 November 2020, Stockholm Region issued a preliminary version of the prospective report for the management of health care up to 2040. The report raised the need for new ways of organizing health care in the Stockholm Region and outlined the increase of standardization and alignment trend, emerge of collaborative governance models, the increase of care structure complexity, etc.