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Cost-effective reimbursement analysis for medical technologies in Europe

Procedure coding, payment mechanism, reimbursement tariffs, policy, and HTA considerations in 34 EU countries

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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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Recommendations about transitional coverage of medical devices in France in January 2023

Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a pathway to obtain temporary reimbursement for CE-marked, presumably innovative medical devices intended for the treatment of rare or serious diseases or compensation for a disability. This mechanism allows reimbursement of medical devices for one year (with a possibility of renewal), with the goal of establishing additional evidence, before submitting an application for regular reimbursement via the List of Reimbursable Products and Services (LPPR).

In January 2023, the French National Authority for Health (HAS) released new recommendations about transitional coverage of medical devices and medical aids from the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) meetings.

Two positive opinions of the following devices were published:

  • Intermittent coronary venous sinus occlusion system PICSO by MIRACOR MEDICAL with the following indication: secondary prevention of complications of anterior myocardial infarction with ST-segment elevation by reducing the size of the infarction in patients over 18 years of age with the onset of symptoms within the last 12 hours and a Thrombolysis in Myocardial Infarction (TIMI)  flow of 0 or 1, in which percutaneous coronary intervention (PCI) is considered (link);
  • Aspiration/extraction system FLOWTRIEVER SYSTEM consisting of TRIEVER catheter and FLOWTRIEVER catheter by INARI with the following indication: treatment of pulmonary embolism in combination with anticoagulant therapy for patients with severe pulmonary embolism, at high risk of premature death in failure or contraindicated to thrombolysis, or at high intermediate risk of premature death with hemodynamic deterioration despite well-conducted anticoagulant treatment, in failure or contraindicated to thrombolysis, when surgical embolectomy is not possible and after advice from a multidisciplinary team (link).

See the details in French here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.