HTA

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.

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.

In January 2022, the Scottish Health Technology Group released a recommendation of the closed-loop systems and the artificial pancreas for type one diabetes mellitus. The limited use of closed-loop systems in routine clinical care makes it difficult to estimate device-related adverse event rates. No evidence was identified for artificial pancreas systems (multi-hormone closed-loop systems) available on the UK market.

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.

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.

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.

In early December 2021, NHS Accelerated Access Collaborative announced seven technologies that will be covered by the MedTech Funding Mandate (MTFM) in 2022/23: four for benign prostatic hyperplasia treatment (UroLift, GreenLight XPS, Rezum, and PLASMA system), and three for improving the patient experience during procedures (XprESS multi-sinus dilation system, Thopaz+, and Spectra Optia). Four technologies included in 2021/22 (placental growth factor-based testing, SecurAcath, HeartFlow, and gammaCore) will continue to be supported.

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.