In November 2023, the French National Authority for Health (HAS) unveiled pivotal recommendations concerning the reimbursement of supplementary medical devices and aids following deliberations within the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). This release encompassed seven specific recommendations targeting the inclusion of medical devices within the List of reimbursable products and services (LPPR), spanning various domains such as cardiovascular, nephrology, urology, and orthopedics.
Critical Evaluation of Clinical Benefit and Added Value
The assessment process hinges on the evaluation of the clinical benefit (SA) initially, categorized as either sufficient or insufficient, dictating potential incorporation into the LPPR list. For those deemed to possess sufficient benefit, the subsequent grading of clinical added value (ASA) operates on a scale ranging from I (significant) to V (non-existent) for the stipulated applications, significantly impacting pricing decisions.
Several instances of these recommendations delineate the scope of registration applications:
- Rate-controlled dual-chamber implantable cardiac pacemaker AMVIA SKY DR-T by BIOTRONIK: It was ascertained to possess sufficient actual benefit but manifested level V clinical added value in comparison to the EDORA 8 DR-T.
- Synthetic bone substitute AKTIBONE GRANULES by NORAKER: This substitute demonstrated sufficient actual benefit but registered level V clinical added value when contrasted against other synthetic bone substitutes and those incorporating animal-derived derivatives already listed within the LPPR.
- Adjustable hydraulic sub-urethral support implant for men ATOMS by AMI: This device was found to exhibit insufficient actual benefit.
Beyond these examples, additional recommendations pertained to various cardiovascular devices, orthopedic devices, and medical aids, underscoring the comprehensive nature of the assessment process conducted during the CNEDiMTS meetings.
Evaluating Medical Device Reimbursement in France
The insights gleaned from these recommendations not only inform decisions on device inclusion within the reimbursement list but also elucidate the perceived clinical benefits and added values across multiple medical domains. The meticulous evaluation process aids in delineating the efficacy and utility of these devices, thereby impacting their accessibility and affordability for patients within the French healthcare system.
Furthermore, these recommendations serve as a vital guide for manufacturers, clinicians, and stakeholders, providing clarity on the assessment criteria and standards essential for securing reimbursement and fostering innovation in medical device development. The nuanced assessments conducted by HAS through CNEDiMTS meetings continue to shape the landscape of medical device reimbursement in France, prioritizing patient welfare and therapeutic advancements.
Resource: Med Tech Reimbursement Consulting, December 07, 2023
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