Health technology assessment

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 2472 of February 10, 2022, Tuscany Regional Healthcare has published assessments of five medical devices of various therapeutic areas, such as cardiovascular and peripheral vascular areas.

The Belgian Health Care Knowledge Center (KCE) initiated a study aimed at defining a clear and transparent procedure for the evaluation of digital health technologies in Belgium.

On February 07, 2022, the Dental and Pharmaceutical Benefits Agency has announced the withdrawal of the assessments of the PhysioMem PM 100 and CardioMem CM 100 XT and the finalization of the assessments of the Zenicor ECG, Coala Heart Monitor Pro, and KardiaMobile. For the conducted assessments, it was outlined that the portable devices provide more limited information than standard ECG measurements; therefore, it was mainly estimated for atrial fibrillation.

In February 2022, the Finnish Coordinating Center for Health Technology Assessment announced the release of the seven accomplished rapid hospital assessments performed by the Helsinki, Tampere, and Oulu University Hospital. The accomplished rapid HTAs concern the diagnostic imaging, e-Health, endocrine, endoscopy, men’s health, neuromodulation technology groups.

At the end of February 2022, the Dental and Pharmaceutical Benefits Agency (TLV) has launched a theme survey on products for monitoring and diagnostics of sepsis to identify products that may be relevant for health economic assessments at TLV. The suggestions for the products of interest, ongoing clinical studies, or innovation projects could be received until 23 March 2022.

On February 14, 2022, the Danish Treatment Council (Behandlingsråd), a new body for assessing treatments and health technologies that became fully operational in late May 2021, has announced its symposium, which will take place in Aalborg on May 11, 2022.

In January 2022, the Basque Office for Health Technology Assessment (OSTEBA) released an HTA report aiming to assess and compare the efficacy, effectiveness, and safety of the mechanical circulatory support devices most used in the healthcare setting for the treatment and prevention of cardiogenic shock, including Impella® devices, intra-aortic balloon pumps, and extracorporeal membrane oxygenation.

On January 26, 2022, the HAS published standards for medical telemonitoring of four chronic pathologies (chronic respiratory failure, chronic heart failure, chronic renal failure, and diabetes). These standards must be met by technologies in order to be reimbursed by the new reimbursement framework for telemonitoring, which is expected to enter into force in July 2022.

The "New Method" is currently developing criteria for which methods other than drugs shall be prioritized for assessment within the framework at the national or local levels. On January 17, 2022, the project status was presented at the Ordering Forum for "New Method." It was reported that the project would require more resources and time than initially thought.

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.