Wound dressing

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 26990 of December 18, 2023, Tuscany Regional Healthcare has published assessments of three medical devices in the peripheral vascular, orthopedic, and dermatology areas.

In November 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (extracorporeal shockwave therapy for calcific tendinopathy in the shoulder, balloon disimpaction of the baby's head at emergency cesarean, percutaneous ultrasound-guided microwave ablation for benign thyroid nodules, ab interno canaloplasty for open-angle glaucoma, tunnelled peritoneal drainage catheter insertion), and two new Medical Technologies Guidance (GreenLight XPS, Optilume). Also, one new clinical guideline was published, and one was updated.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in September 2022. Thirty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and medical aids.

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 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.

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

In February 2021, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Leukomed Sorbact for preventing surgical site infection) and seven new Medtech innovation briefings (PROPEL sinus implants, URO17 for detecting bladder cancer, Faecal microbiota transplant, DOAC Dipstick for detecting oral anticoagulants, CytoSorb for reducing the risk of bleeding during cardiac surgery, and others).

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.

The report presents a summary of the reimbursement situation for use of biologic and synthetic skin substitutes in Europe. The following clinical indications are considered: burns; chronic wounds (hypertrophic scar). 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.

The report presents a summary of the reimbursement situation for treatment of burns in Europe. The following types of treatment for burns of are considered: debridement of burn skin; dressing of burnt skin (including vacuum assisted closure device); placement of split-thickness skin autograft. 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.