e-Health

In April and May 2023, it was announced that the Galician Agency for Health Technology Assessment (AVALIA-T) initiated several HTAs, including the evaluations in the e-health, nephrology and urology, men’s health, IVD, obstetrics and gynecology, pulmonary and airways, surgical procedures, and some other fields.

On April 28, 2023, the NHS Cancer Programme awarded £12.1 million to six innovations that improve the early detection and diagnosis of cancer. Awarded medical devices, in-vitro diagnostics, and digital health solutions are used to diagnose bowel, skin, liver, breast, ovarian, and esophageal cancer. They have proven their efficacy and clinical effectiveness and will be funded over the next 18 months to support rollout and real-world testing.

In March 2023, Health Technology Wales published an Evidence Appraisal Report (EAR) and Guidance on photobiomodulation for the prevention and treatment of oral mucositis. Furthermore, seven Medtech-related Topic Exploration Reports (TER) were published, including single-pulse transcranial magnetic stimulation and AI-assisted ultrasound for deep vein thrombosis; however, Health Technology Wales will proceed with a full appraisal on one topic only - digital wound management tools.

In late April, NHS Accelerated Access Collaborative introduced the Health Technology Navigation Pathway Tool to help innovators adopt new technologies into the NHS. The Tool breaks the innovation journey down into 25 steps, themed around the five key phases of the product lifecycle, from creation to commissioning and adoption. For each step, the schematic flowchart outlines key organizations to engage with, regulatory insights, best practice approaches, policies, guidelines, to-do lists, and required outputs.

In April 2023, the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) released three health technology assessments in the field of eHealth, including the assessment of Thermidas thermal imaging system as well as two comparison reports of Digi-HTA with NorDEC and DiGAV frameworks.

On March 31, 2023, the Ministry of Health and Prevention published the Decree in the Official Journal of the French Republic that defines an application process for the early coverage of digital medical devices for therapeutic purposes and medical telemonitoring by health insurance.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.

On March 24, 2023, the French National Authority for Health (HAS) announced a three-year experiment on the health economic evaluation of digital medical devices (DMD). This will allow manufacturers to voluntarily provide a budget impact analysis (indicating a cost-saving effect on the healthcare system) that can support the registration of their DMDs in the LPPR List and a pricing decision.

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.

In March 2023, two more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by sickness funds.

In February 2023, the Scottish Health Technology Group, SHTG, released three MedTech-related assessments: selective internal radiation therapies (SIRT) for treating primary hepatocellular carcinoma, Feeling Good app, store-and-forward teledermatology for triage of primary care referrals.

In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.