Health technology assessment

On December 9, 2021, the Danish Treatment Council (Behandlingsråd), during its meeting, approved three topics selected for developing the so-called major analyses (større analyser) in 2022. The approved topics include handheld focused ultrasound in emergency medicine, artificial intelligence (AI) as decision support for colonoscopy, and intelligent/high-tech beds for use in intensive care units.

In December 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) finished the theme survey in the obstructive pulmonary diseases field, which was conducted as a part of the Orderly Introduction for Medical Technologies framework. Identified technologies could potentially be included in the Orderly Introduction of Medical Technologies framework, which aims to facilitate the introduction of novel technologies on the national level.

In November 2021, the National Institute for Health Research (NIHR) in England released three MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned delivery for preterm birth, thoracolumbar fracture, and knee replacement. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 20520 of November 22, 2021, Tuscany Regional Healthcare has published assessments of seventeen medical devices of various therapeutic areas, including devices belonging to neurology, as well as gastrointestinal, urology, cardiovascular, orthopedics, peripheral vascular, and other fields of care.

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) systematically evaluates healthcare technologies and practices from medical, economic, ethical, and social standpoints. The following assessments were initiated in the third quarter of 2021: ultrasound-guided arterial catheters insertion in adults, the basis for national guidelines for heart disease. The final reports will be published on the SBU website upon completion

In 2015, the Federal Office for Public Health launched an HTA program intending to reassess the benefits already reimbursed by compulsory health insurance. The following ongoing re-evaluations are in progress: multigene expression tests in breast cancer, cardiac catheterization for coronary artery disease, invasive procedures for coronary artery disease, removal of osteosynthesis materials, etc.

The Dutch Organization for Health Research and Development (ZonMw), in collaboration with the National Health Care Institute (ZIN), initiated the new HTA Methodology Program for 2021-2024. On November 4, 2021, the ZonMw published the gap analysis of the needs of important stakeholders regarding HTA and formulated recommendations that can provide guidance for the 2021-2024 HTA Methodology Program.

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

On November 9, 2021, the Belgian Health Care Knowledge Center (KCE) published the health technology assessment report "Remote monitoring of patients with cardiovascular implantable electronic devices (CIED)". Analysis of efficacy and safety of remote monitoring showed an advantage in various aspects. Cost-effectiveness analysis indicates that remote cardiac monitoring of ICDs and PMs is cost-effective compared to monitoring based on in-clinic visits.

On November 17, 2021, the National Authority for Health (HAS) in France announced its reorganization and the creation of a new Department of Evaluation and Access to Innovation (Direction de l’évaluation et de l'accès à l'innovation, DEAI).

In late October 2021, the Treatment Council (Behandlingsråd) published three topics chosen for developing the so-called major analyses (større analyser) in 2022. The selected topics include patient-centered diabetes technology, hand-held focused ultrasound in emergency medicine, and artificial intelligence as decision support for colonoscopy.

In October 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (genicular artery embolization for pain from knee osteoarthritis, laparoscopic renal denervation for loin pain hematuria syndrome, percutaneous endovascular forearm arteriovenous fistula creation for hemodialysis access), and one new Medical Technologies Guidance (DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography). Also, two new clinical guidelines were published.