Chronic wounds

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 19147 of September 6, 2023, Tuscany Regional Healthcare has published assessments of four medical devices in the peripheral vascular and dermatology areas.

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 the fourth quarter of 2022, Health Technology Wales published three MedTech-related guidance (Left atrial appendage occlusion in patients with atrial fibrillation, continuous topical oxygen therapy, and virtual reality distraction therapy). Four Topic Exploration Reports were released as well (virtual wards, genetic testing for prostate cancer, autofluorescence imaging, and geniculate artery embolization); however, Health Technology Wales decided not to proceed with complete appraisals on these topics.

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.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 10778 of June 01, 2022, Tuscany Regional Healthcare has published assessments of nine medical devices in various therapeutic areas, such as cardiovascular and peripheral vascular areas, surgical procedures, orthopedics, and dermatology.

In May 2022, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (endoanchoring systems in endovascular aortic aneurysm repair, supercapsular percutaneously assisted total hip arthroplasty for osteoarthritis, personalized external aortic root support using mesh in people with Marfan syndrome), one Medical Technologies Guidance (Sleepio to treat insomnia and insomnia symptoms), and six Medtech innovation Briefings (ViewSite Brain Access System, Granulox for managing chronic wounds, AMBLor for identifying melanomas, Bladder EpiCheck for detecting bladder cancer recurrence, and others). No MedTech-related clinical guidelines were published.

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 June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

On January 28, 2021, the Innovation Committee at the Federal Joint Committee (G-BA) published the first overview of the 28 innovative projects on new forms of medical care that will be funded. The projects concerning the technologies belonging to the cardiovascular, eHealth, orthopedic, neurology, nephrology, and other technology groups received funding.

In January 2021, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (self-expanding implant insertion into the intersphincteric space for faecal incontinence and minimally invasive radical hysterectomy for early stage cervical cancer), two new medical technologies guidance (the PLASMA system for transurethral resection and haemostasis of the prostate, and the VAC Veraflo Therapy system for acute infected or chronic wounds), and six Medtech innovation briefings (Optilume for anterior urethral strictures, AI in mammography, AI for analyzing chest CT images, AcQMap for mapping the heart atria to target ablation treatment, and others). Also, two clinical guidelines were updated.

The report presents a summary of the reimbursement situation for the use of negative pressure wound therapy (NPWT) (procedure and medical aid) in Europe. The following clinical indications are considered: diabetic foot ulcer; venous leg ulcer; pressure ulcer. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.