Recommendations about add-on reimbursement for medical devices in France in August 2022

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in August 2022. One recommendation was published in relation to the registration for devices in the List of reimbursable products and services. The opinion concerns men’s health area.

The first step in the assessment is the clinical (actual) benefit (SA), which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value (ASA) is graded on a scale from I (major) to V (absent) for claimed indications, which supports the pricing decisions.

Only one recommendation was published, and it related to men’s health technology group: Absorbable synthetic hydrogel spacer for the prevention of rectal toxicity from curative external radiotherapy for prostate cancer in low-risk or intermediate-risk patients PACEOAR by BOSTON SCIENTIFIC (application for registration; sufficient actual benefit; level IV of clinical added value)

See the details in French here.

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