Tuesday, April 16, 2024

Key Recommendations on Medical Devices Reimbursement and Accessibility in France by HAS

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The French National Authority for Health (HAS) issued a series of important recommendations regarding the add-on reimbursement of medical devices and medical aids. These recommendations were the result of deliberations by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) and focused on the registration of medical devices in the List of Reimbursable Products and Services (LPPR). The guidance covered a range of devices, including those used in cardiovascular, peripheral vascular, and ophthalmological treatments, as well as various medical aids.

The assessment process for these devices begins with an evaluation of the clinical (actual) benefit (SA), which is categorized as either sufficient or insufficient. This initial assessment is crucial as it determines whether a device will be included in the LPPR list. If the clinical benefit is deemed sufficient, the device’s clinical added value (ASA) is then graded on a scale ranging from I (major) to V (absent). This grading is based on the device’s performance in claimed indications and plays a significant role in subsequent pricing decisions.

Highlights from HAS’s Recent Recommendations for LPPR Registration Applications

  1. Renal Denervation Catheter SYMPLICITY SPYRAL by Medtronic: This device was acknowledged to have a sufficient actual benefit and was assigned a level III of clinical added value compared to the absence of a therapeutic alternative.
  2. Paclitaxel Releasing Coronary Balloon RESTORE DEB by CARDIONOVUM: This product was found to have an insufficient actual benefit, which implies it may not be eligible for inclusion on the LPPR list.
  3. Aqueous Humor Drainage System XEN by ABBVIE: Similar to the RESTORE DEB, this device was also determined to have an insufficient actual benefit.

In addition to these specific devices, the HAS also made recommendations concerning other peripheral vascular devices and medical aids. These recommendations are part of a broader effort by the HAS to ensure that the French healthcare system provides support for medical devices and aids that offer substantial clinical benefits to patients.

Medical Devices

Ensuring Efficacy and Value in Medical Devices Reimbursement and Accessibility

The HAS’s rigorous evaluation process reflects its commitment to ensuring that medical devices reimbursed by the healthcare system are both effective and provide significant clinical value. This approach not only helps in optimizing healthcare spending but also ensures that patients have access to the most beneficial and innovative medical technologies. The decisions made by the HAS, particularly those regarding the clinical benefit and added value of medical devices, are critical in shaping the landscape of medical device availability and reimbursement in France.

In summary, the recommendations issued by the HAS are a vital component of the healthcare system in France, guiding the reimbursement and availability of medical devices and aids. These recommendations, based on detailed evaluations of clinical efficacy and added value, play a crucial role in ensuring that the French healthcare system remains sustainable while continuing to provide high-quality care to patients.


Resource: Med Tech Reimbursement Consulting, January 09, 2024

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