Biologic and synthetic skin substitutes

Series
Dermatology
Status
Published
Date
Number of report
084

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The report presents a summary of reimbursement situation for use of biologic and synthetic skin substitutes in European countries.

Sample pages are provided for an older version of the report. Before delivery to the client, the report is updated to the current state (e.g., 2022 coding, tariffs, and policy considerations). 

The following clinical indications will be considered:

  • burns;
  • chronic wounds (hypertrophic scar).

The only reimbursement within public / statutory health insurance systems is considered.

Report includes essential information about reimbursement and national funding, including:

  • Brief overview of reimbursement system for medical devices
  • Procedure coding for technology
  • Diagnosis coding
  • Payment mechanism for technology
  • Reimbursement tariffs for technology
  • Restrictions in indications or scenarios for use of technology
  • Policy considerations by payers and policy-makers about technology

Reimbursement information is provided for the following geographies:

  • Austria
  • Belgium
  • Denmark
  • England (UK)
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Sweden
  • Switzerland

It is also possible to add analysis in Czech Republic, Finland, Hungary, Romania, Russia and Turkey.

Manufacturers of biologic and synthetic skin substitutes include:

  • Allergan (AlloDerm)
  • Anika Therapeutics (HYALOMATRIX)
  • Avita Medical (ReCell)
  • Eurosurgical (Pelnac)
  • Hans Biomed (SureDerm)
  • Integra LifeSciences (Dermal Regeneration Template)
  • MedSkin Solutions (MatriDerm)
  • MiMedx Group (AmnioFix, EpiFix, EpiBurn, AmnioCord, AmnioFill)
  • Modex Therapeutiques (EpiDex)
  • Olympus Terumo Biomaterials (Terudermis)
  • Organogenesis (Dermagraft, NuShield, Affinity, Apligraf)
  • Ortec International (OrCel)
  • Osiris Therapeutics (Grafix, Grafix PL prime)
  • Promethean LifeSciences (GammaGraft)
  • Regenicin (PermaDerm)
  • Smith & Nephew (Biobrane, Oasis, Oasis Ultra)
  • Stryker (DermACELL)
  • Vericel Corporation (Epicel)
  • Wright Medical (GRAFTJACKET)

Table of content is not available at the moment. Report is still ongoing.

06

Oct 2022

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.

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15

Jul 2022

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.

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31

May 2022

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.

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06

Jul 2021

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.

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18

Jun 2021

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.

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