Health technology assessment

On December 17, 2021, the Belgian Health Care Knowledge Center (KCE) published a health services research report “Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions”. In this report, KCE examined the lack of comparative evidence health technology assessment (HTA) agencies and payers face in evaluating new medicinal products and high-risk medical devices at market entry.

In December 2021, the National Institute for Health Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned improving continence in children and young people with neurodisability, and augmented trabeculectomy in glaucoma. 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.

In December 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (endobronchial nerve ablation for chronic obstructive pulmonary disease and transanal total mesorectal excision for rectal cancer), two new Medical Technologies Guidance (ClearGuard HD antimicrobial barrier caps, and Endo-SPONGE for treating low rectal anastomotic leak), and one new Medtech Innovation Briefings (FreeO2 automatic oxygen titration). Also, one new clinical guideline was published, and five were updated.

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.