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Reimbursement strategy

Market Access Strategy for Medical Devices in Europe

Strategic recommendations on the topic of market access pathways for medical devices and IVD tests

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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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Initiated and published mini-HTAs in Norway since early 2025

Norway has a national framework for introducing new health technologies within the specialist health service, known as the "New Methods" framework. This framework ensures that all innovations undergo a formal Health Technology Assessment (HTA) before receiving funding approval. 

The framework operates on two levels: 

  • National level with decisions based on HTAs and made by the four Regional Health Authorities jointly;
  • Local (hospital) level, where decisions are made based on the mini-HTAs performed locally in the hospital.

Between January 1 and July 1, 2025, three new mini-HTAs were initiated in relation to MedTech:

  • Rezum (water vapor) for the treatment of benign prostatic hyperplasia;
  • Pharmacogenetic testing (CYP2C19/CYP2D6) in patients treated with selective serotonin reuptake inhibitors (SSRIs);
  • Strategies for hepatocellular carcinoma screening when ultrasound is inadequate.

During the same period, 11 mini-HTAs were published, including cardiovascular, e-health, gastrointestinal,  men’s health, and spine areas. Some examples are provided below:

  • Pulmonary vein isolation with Pulsed Field Ablation;
  • Temporary nitinol implant for minimally invasive treatment of benign prostatic hypertrophy;
  • Endoscopic spine surgery.

The full details in Norwegian 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.