Launch Excellence

 

 

  • 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)