PECAN, the new DiGa-like pathway in France. Har passerat
Onsdag 24 maj 2023 15:55 - 16:10 F5
Föreläsare: Ouassim NAIET EL GAIED
France has a long history of testing different programs to include innovation and digital health in the healthcare system.
Inspired by the German DiGA solution and the fast-track pathway for regular medical devices (PECT), they are in the process to introduce a pathway for conditional reimbursement (PECAN) while the missing evidence is generated. This new pathway will be available in 2023.
The scope of this is either:
- Remote monitoring solutions;
- Digital therapeutic (DTx).
The criteria to be eligible for this pathway are:
- Potential of a meaningful clinical benefit;
- Ability to close the evidence gap during the period of conditional reimbursement.
The reimbursement will cover a 12-months period and is conditioned by a permanent reimbursement dossier submission within 6 months of the start of the PECAN for digital therapeutic (DTx) and within 9 months for remote monitoring solutions.
During this presentation, we explain the key takeaways and how to optimize your chances to gain this new golden pathway. We will also share with you our feedback on innovative medical devices assessment and pricing.
Forskare (även studerande)
Exempel från verkligheten (goda/dåliga)
Ouassim NAIET EL GAIED Föreläsare
Market Access consultant
Highly qualified pharmacist with a Master's degree in international regulatory affairs and a university diploma in Market Access & Health Economics.
Ouassim is a Market Access expert specialized in digital health at MediTech Access, a French consulting firm at the forefront of the most important milestones for digital health reimbursement in France, including the remote patient monitoring experiment (ETAPES), the first HTA assessment dossiers for digital health solutions, and the new remote monitoring reimbursement and PECAN frameworks.
He is actually responsible for managing digital health projects at MediTech Access where he is dedicated to supporting startups and MedTech companies in gaining early access and/or reimbursement for their medical devices. Prior to joining MediTech Access, Ouassim managed early market access phases for connected medical devices at BioSerenity, a start-up specializing in cardiology, neurology, and sleep medicine. He was also a Market Access intern at Air Liquide Healthcare, where he was involved in the development of a digital solution in oncology.