In the specialized area of Early Dialogues and Health Technology Appraisal Scientific Advice, Justin Stindt Consultants is a leading consulting agency in Pharma, Biotech, and Medtech market access. We specialize in guiding clients through scientific advice “Early Dialogues” with France’s Haute Autorité de Santé (HAS), crucial for meeting evidence requirements and enhancing the chances of favorable HTA appraisals and reimbursement.
Our team of experts provides strategic advice on clinical development, ensuring high-quality evidence generation for Health Technology Assessments. This includes handling queries related to clinical aspects and health economics, tailored to each project’s specific needs.
Additionally, we assist medical device manufacturers in pre-submission meetings with the CNEDiMTS, focusing on critical technical and regulatory aspects for dossier preparation. As a global consulting firm, Justin Stindt Consultants is dedicated to optimizing trial designs and improving market access potential for your products.
Early Dialogues France – HTA scientific advice by the French HAS to optimize your trial design and chances for reimbursement
In France, the Haute Autorité de Santé (HAS) offers free-of-charge early scientific advice on evidence-generation plans for new pharmaceuticals, medical devices, or diagnostic/interventional procedures through Early Dialogues (EDs). EDs are optional, free of charge, non-binding (both for HAS and the applicant), and confidential between the applicant and the HAS.
The objective of EDs is to provide pharma, biotech and medtech companies with recommendations on clinical development and support the generation of good quality evidence for proper Health Technology Assessments (HTAs). Questions related to health economics can also be addressed.
EDs pertaining to medical devices and diagnostic/therapeutic procedures also aim to guide companies to anticipate which data can be expected for special funding through the “forfait innovation” process.
Only requests fulfilling the following 3 eligibility criteria are considered:
- Product with a new mechanism of action in the disease
- Targeting an indication for which there is an unmet or insufficiently covered medical need
- The early dialogue can be finalized before the start of the pivotal clinical trials
There is a fast-track procedure including written feedback by the HAS in response to the briefing book submitted by the manufacturer and a standard procedure which involves a meeting with the HAS. For this meeting the manufacturer needs to prepare a presentation in addition to the briefing book. Our agency has experience with both procedures and can guide your company through the process.
Early Meetings and Pre-submission Consultations for Medical Devices
Prior to submitting the application to the CNEDiMTS, you may wish to arrange a meeting with the assessment department (note these are not members of the CNEDiMTS). Depending on the development status, two types of meetings are possible:
- Rencontres précoces (early meetings): The main objective of these meetings is to discuss questions about the methodology of the clinical study being considered
- Rendez-vous pré-dépôt (Pre-submission meetings): These meetings are set up specifically for medical devices in order to support manufacturers on the technical and regulatory aspects in the constitution or in the finalization phase of their dossier (field of the LPPR, content of the dossier in particular)
These meetings are free and confidential.
Justin Stindt Consultants is your agency to support you with engaging in Early Dialogues with the HAS in France
Justin Stindt Consultants is your agency with the right experts with extensive experience in engaging with the HAS, including facilitating early dialogue meetings for the development of optimal clinical development and evidence-generation plans. As a market access pharma service provider, our firm has helped many clients develop briefing books and presentations for HAS meetings.
Our experts not only prepare the materials for you but also attend the meetings upon your request, write meeting minutes and executive summaries and support you with embedding the advice into your pivotal trial design and further evidence generation plans. Many of our clients have found the Early Dialogues with the HAS very insightful and have adapted clinical trial protocols and statistical analysis plans to better meet the evidence needs of the HAS to maximize the chances of successful HTA endorsement.
Are you looking for a vendor to support you with early dialogues with the HAS in France? Then pick a supplier with a proven track record of developing and delivering briefing books and presentations for the HAS and accompanying clients to these scientific advice meetings. Contact our consultants today to learn how our agency can tailor our services to meet your unique needs and enable you to leverage the Early Dialogues scientific advice pathway.
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