Digital Medical Devices in France: Overcoming Reimbursement Challenges
Despite the implementation of promising pathways like LATM and PECAN, designed to accelerate market access for digital medical devices (DMDs) in France, we remain far from achieving the ambitious objectives of the ๐๐ช๐จ๐ช๐ต๐ข๐ญ ๐๐ฆ๐ข๐ญ๐ต๐ฉ ๐๐ฐ๐ข๐ฅ๐ฎ๐ข๐ฑ 2023–2027. ๐ The plan aims to reach 50 PECAN applications by the end of 2026, yet the numbers tell a different story. ๐
Since the creation of these pathways:
๐ PECAN: At least 11 dossiers have been submitted, including 7 for telemonitoring solutions and 4 for DTx. Only 7 opinions have been issued, with just 3 receiving favorable outcomes.
๐ LATM: At least 16 applications have been submitted, with 9 decisions rendered and 6 favorable opinions.
๐ฒ๐๐ ๐ช๐๐๐๐๐๐๐๐๐ ๐๐ ๐ซ๐ด๐ซ ๐น๐๐๐๐๐๐๐๐๐๐๐๐: ๐ฐ๐๐๐๐๐๐๐ ๐๐๐๐ ๐๐๐ ๐ฏ๐จ๐บ ๐ฅ
The latest communication from the HAS* highlights recurring challenges faced by applicants:
โ ๏ธ Inconsistencies between claims and supporting clinical evidence.
โ ๏ธ Incomplete or irrelevant administrative documentation.
โ ๏ธ Lack of relevance and clarity in argumentation.
โ ๏ธ Inaccurate identification of the target population and comparators.
๐ฏ๐๐ ๐ด๐๐ ๐๐๐๐๐ ๐จ๐๐๐๐๐ ๐ช๐๐ ๐ฏ๐๐๐ ๐ ๏ธ
At Meditech Access, we specialize in simplifying the complex reimbursement process for digital medical devices, ensuring your application meets the stringent requirements of the HAS:
โ
Coherence: We ensure your clinical evidence aligns seamlessly with your claims.
โ
Completeness: Our experts guarantee your administrative documentation is thorough and relevant.
โ
Clarity: We craft clear and impactful arguments tailored to HAS standards.
โ
Accuracy: We help define precise and reliable literature review, target populations and comparators to strengthen your dossier.
By partnering with us, you can navigate the process confidently, avoiding common pitfalls while maximizing the potential for quicker, smoother, and successful reimbursement. ๐
Together, let’s accelerate the adoption of innovative digital health solutions and bring meaningful advancements to patients and the healthcare system in France! โค๏ธ๐ซ๐ท
#DigitalHealth
#MedTech
#PECAN
#LATM
#Reimbursement
#Innovation
Do not hesitate to contact us should you have any question.