Health technology assessment

On August 26, 2022, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning within the Orderly introduction framework for products that promote the transition to so-called “Close care” (Nära vård). Products of interest should enable diagnosis, treatment, and follow-up outside a healthcare facility, for example, remote monitoring. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until September 28, 2022.

On July 27, 2022, the EUnetHTA 21 released the assessment framework for high-risk medical devices (MDs) and in-vitro-diagnostics (IVDs). The objective of this deliverable is to define the framework for Joint Clinical Assessments of high-risk MDs and IVDs with a view to fostering national uptake of the Joint Clinical Assessments reports early in the life cycle of a single technology.

On August 09, 2022, NICE updated the Evidence standards framework for digital health technologies, initially published in 2018. Artificial intelligence and data-driven technologies with adaptive algorithms are now included in the framework and user guide. NICE also aligned digital health technology classifications with regulatory requirements and outlined a subset of early deployment standards that can be used within evidence generation programs.

In July 2022, the French National Authority for Health (HAS) published seven new opinions which were based on health technology assessment reports. These are related to endoscopy, IVD tests, neuromodulation, and primary care settings. The main goal of these HTA reports was to spoort decision-making for the creation of new procedure codes in the Common Classification of Medical Procedures (CCAM) and the Nomenclature of Medical Biology Procedures (NABM).

In the second quarter of 2022, Health Technology Wales (HTW) published four MedTech-related guidance (extreme hypofractionated radiotherapy for localized prostate cancer, video laryngoscopes for use in pre-hospital care, electronic blood management systems, and stereotactic ablative radiotherapy for the treatment of renal cell carcinoma). A total of 12 MedTech-related Topic Exploration Reports (TERs) were released in Q2. Based on the TERs conclusions, HTW decided to proceed with a full appraisal on three topics – photobiomodulation, topical oxygen therapy (NATROX) in chronic wounds, and video feedback interventions.

On July 15, 2022, the Austrian Institute for HTA (AIHTA) published five decision support documents, which provide recommendations regarding the inclusion of new medical interventions in the catalog of individual medical services of the performance-oriented hospital financing (Leistungsorientierten Krankenanstaltenfinanzierung, LKF) model, as well as four updates to previous decision support documents. The decisions relate mainly to cardiovascular and gastrointestinal technology groups.

On July 20, 2022, Health Institute Carlos III released two HTA reports regarding endoanchoring systems in endovascular aortic aneurysm repair and transanal irrigation in bowel dysfunction.

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency providing advice to NHSScotland on using new and existing health technologies, likely to significantly impact healthcare. In July 2022, SHTG published three reports (KardiaMobile for detecting atrial fibrillation, complex endovascular aneurysm repair, and Togetherall platform). Currently, the SHTG is working on assessments of technologies in the field of cancer, radiotherapy, musculoskeletal diseases, transplantation, and other topics.

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.

In July 2022, the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) published on its website five Digi-HTAs in the fields of eHealth and in-vitro diagnostics.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 13241 of July 4, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the cardiovascular area.

In June 2022, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (vertebral body tethering for idiopathic scoliosis, nerve graft for corneal denervation, and synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis). Also, four new clinical guidelines were published.