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Early value dossiers for medical technologies

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Public consultation on the telemonitoring guidelines open in Italy

On June 10, 2024, the National Agency for Regional Health Services (AGENAS) announced an online public consultation on the draft of the “Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring” aiming to collect feedback and additional insights to enhance the quality of the document and to achieve the following objectives:

  • Outline the requirements that a Medical System must meet to ensure interoperability with the Regional Telemedicine Infrastructure, as mandated by the Ministerial Decree of September 21, 2022. This includes ensuring appropriate levels of certification and security;
  • Provide an overview of the characteristics, requirements, recommendations, and standards that need to be considered when defining an evolutionary path for Medical Systems.

The Guideline is intended primarily for manufacturers and distributors of medical devices as well as health organizations/authorities and regions/autonomous provinces.

The consultation is open from June 10, 2024, to June 29, 2024. Participants should complete a questionnaire available on the EUsurvey platform in Italian and English.

More details in Italian and English can be found here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.