HTA

In Q1 of 2022, Health Technology Wales (HTW) published one MedTech-related guidance on transcranial magnetic stimulation in depression treatment. A total of eleven Topic Exploration Reports (TERs) were released in Q1. Based on the TERs conclusions, HTW's Assessment Group decided to proceed with developing an Evidence Appraisal Report (EAR) and Guidance on one topic only - radiofrequency renal denervation for the treatment of resistant hypertension.

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated.

In February 2022, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned biomarkers for assessing acute kidney injury, non-invasive testing for neovascular macular degeneration, decision support tool to prevent falls in older people, endometrial scratch, distal radius fracture, and test for group B Streptococcus. 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.

On March 18, 2022, the Norwegian National Institute of Public Health released an HTA report on the evaluation of surgical procedures for obesity treatment. The authors concluded that it is uncertain whether there is any difference in the risk of early mortality and the effect on weight status between different types of surgical procedures for the treatment of obesity.

In February 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (stereotactic radiosurgery for trigeminal neuralgia, and microwave ablation for primary or metastatic cancer in the lung), two new Diagnostic Guidance (EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules, PredictSURE IBD and IBDX to guide treatment of Crohn's disease), and four new Medtech Innovation Briefings (Insides System for managing intestinal failure, d-Nav insulin management app for type 2 diabetes, GaitSmart for personalized exercise rehabilitation, AposHealth for knee osteoarthritis)

On March 17, 2022, the French National Authority for Health (HAS) published a standard for telemonitoring of patients with implantable cardiac devices (implantable defibrillators and pacemakers). In January 2022, the HAS also published standards for medical telemonitoring of four chronic pathologies (chronic respiratory failure, chronic heart failure, chronic renal failure, and diabetes). All 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.

In March 2022, NHS England and NHS Improvement published the MedTech Funding Mandate (MTFM) policy for 2022/23, which will come into force on April 01, 2022. The MTFM launched in 2021 to support NICE-approved and cost-saving devices, diagnostics, and digital products. Commissioners must fund technologies included in MTFM.

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.