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 𝘋𝘪𝘨𝘪𝘵𝘢𝘭 𝘏𝘦𝘢𝘭𝘵𝘩 𝘙𝘰𝘢𝘥𝘮𝘢𝘱 2023–2027. 📅 The plan aims to reach 50 PECAN applications by the end of 2026, yet the numbers tell a different story. 📉
Since the creation of these pathways:
📌 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.
📌 LATM: At least 16 applications have been submitted, with 9 decisions rendered and 6 favorable opinions.
𝑲𝒆𝒚 𝑪𝒉𝒂𝒍𝒍𝒆𝒏𝒈𝒆𝒔 𝒊𝒏 𝑫𝑴𝑫 𝑹𝒆𝒊𝒎𝒃𝒖𝒓𝒔𝒆𝒎𝒆𝒏𝒕: 𝑰𝒏𝒔𝒊𝒈𝒉𝒕𝒔 𝒇𝒓𝒐𝒎 𝒕𝒉𝒆 𝑯𝑨𝑺 🏥
The latest communication from the HAS* highlights recurring challenges faced by applicants:
⚠️ Inconsistencies between claims and supporting clinical evidence.
⚠️ Incomplete or irrelevant administrative documentation.
⚠️ Lack of relevance and clarity in argumentation.
⚠️ Inaccurate identification of the target population and comparators.
𝑯𝒐𝒘 𝑴𝒆𝒅𝒊𝒕𝒆𝒄𝒉 𝑨𝒄𝒄𝒆𝒔𝒔 𝑪𝒂𝒏 𝑯𝒆𝒍𝒑 🛠️
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:
✅ Coherence: We ensure your clinical evidence aligns seamlessly with your claims.
✅ Completeness: Our experts guarantee your administrative documentation is thorough and relevant.
✅ Clarity: We craft clear and impactful arguments tailored to HAS standards.
✅ 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. 🚀
Together, let’s accelerate the adoption of innovative digital health solutions and bring meaningful advancements to patients and the healthcare system in France! ❤️🇫🇷
#DigitalHealth
#MedTech
#PECAN
#LATM
#Reimbursement
#Innovation
Do not hesitate to contact us should you have any question.