Navigating Early Dialogue and LPRR Dossier Submission for Advanced Spinal Cord Stimulation Technology
This case study reflects our commitment to facilitating groundbreaking medical solutions' seamless integration into the complex world of reimbursement for a medical device company at the forefront of spinal cord stimulation technology. This technology seamlessly records and adjusts patient responses and aims to revolutionize long-term pain relief.
Paving the Way for Reimbursement Success: Early Dialogue and LPPR Dossier Submission
Our collaboration focused on guiding our client through the intricacies of the French reimbursement landscape, specifically about the LPPR (List of Products and Services Eligible for Reimbursement) dossier submission. This mission involved meticulous planning, execution, and engagement with authoritative bodies, including the HAS (the French Authority for Health).
Strategic Steps Toward LPPR Inclusion:
Our journey encompassed multifaceted stages:
- Early Dialogue Preparation: Commencing with an early dialogue with the HAS is a crucial step recommended to enhance the prospects of a positive appraisal.
- Simultaneous Submissions: Parallel submissions of the LPPR dossier to pivotal entities:
- CNEDiMTS Evaluation: Collaborating with the National Commission for Evaluation of Health Technologies within HAS for scientific assessments
- CEPS Consideration: Engaging the Economic Committee for Assessment of Health Products within the Ministry of Health for pricing determination
Meticulous LPPR Dossier Preparation:
Our strategic approach encompassed:
1.Early Dialogue Readiness: Meticulously preparing for early dialogue with the HAS to optimize engagement outcomes
2.Medico-Technical Dossier: Thoroughly compiling a comprehensive dossier for HAS/CNEDiMTS submission, covering:
o Technical Specifications
o Disease Description and Gravity
o Epidemiological Data
o Device Positioning in Therapeutic Management
o Bibliography Review
o Benefit-to-Risk Arguments
o Clinical Performance Analysis
3. Economic Dossier Preparation: Crafting an insightful economic dossier for CEPS/MoH submission, including financial insights and proposal justification
4. Clinical Expert Review: Engaging clinical experts for meticulous dossier review before HAS submission, ensuring medical accuracy and alignment
5.Ensuring documentation acceptance: ensuring seamless follow-up with both HAS and CEPS to secure proper documentation acceptance, navigating the approval journey with utmost precision.
