HANDS-ON SUPPORT AT NATIONAL, REGIONAL AND LOCAL LEVEL

• Contact plan : appointment setup, presence at the meeting and drafting of the meeting minutes

• Coordination with clinical experts, CRO, methodologists if additional evidence collection is required to secure reimbursement

• Shaping of clinical practice guidelines and HTA body guidelines

• Translation of payer value proposition into reimbursement dossier

• Drafting and submission of reimbursement dossier (HTA dossier)

  • FOR FRANCE : application dossier for brand-name registration or generic registration on the positive list at national level (LPPR), for registration on the intra-DRG positive list, for enlistment at hospital level, for triggering of an early access scheme or derogatory scheme (Forfait Innovation, RIHN, Article 51, PHRC, PRME, “ATU DM”...), for registration of a new procedure code, for DRG-split, for supplement creation...

  • FOR BELGIUM: application dossier for registration on the List and associated Nominative Lists if any, application for coverage with evidence development (ACL, Application Clinique Limitée), for the modification of the Nomenclature of physician’s services (procedure code creation), for alternative funding at national or hospital level (case by case funding)... 

  • FOR SWITZERLAND: request for CHOP code creation, for SwissDRG creation or DRG-split, for outpatient fee-for-service adaptation (TARMED/TARCO), for supplementary payment (ZE) creation, for enlistment on the positive list (OPAS/KLV document), for coverage with evidence development...

• Assistance after funding request submission, during the evaluation process, during the hearing phase and during price/tariff negotiation.

• Regulatory assistance for France (notification to ANSM, “code unique”...),   for Belgium (distributor’s registration with FAMHP/FAGG/AFMPS, notification of device’s reference)...