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- Analysis of the pricing and reimbursement scenario in Italy for the specific disease area/ indication
- Strategic evaluation of available evidence in support of the value proposition
- Identification of needs/opportunities for evidence generation, and design/follow-up of relevant studies
- Preparation/adaptation of Market Access plans and Stakeholder engagement plans
- Definition and implementation of Access strategies at national and regional level
- Design or adaptation of pharmacoeconomic/Health economics evaluations and models (budget impact, CE/CU, cost of illness…)
- Drafting, validation and submission of the national pricing and reimbursement dossier
- Innovation status: independent GRADE evaluation; preparation of innovation status dossier
- Design and implementation of tailored Managed Entry Agreements
- Definition, testing and implementation of the negotiation strategy: negotiation scripts, mock negotiations; participation in F2F hearings
- Support in designing and implementing successful regional access strategies (including preparation of core regional dossier and Region-specific forms, and follow-up of requests up to inclusion)
