Market Access

European market access challenges usually have acronyms: NICE, HAS, AMNOG, AIFA, and CIMP – which give evidence of the global megatrend for rigorous assessments in reimbursement decisions of health technologies (Health Technology Assessment (HTA)).

Market Access is however substantially more than ‘just’ submitting dossiers to the HTA institutions: client needs: health economics, policy and public affairs engagement, evidence generation and pricing for fruitful, landscape assessments, epidemiology, statistics to re-analyze studies, outcomes research and real-world data analyses, medical communication, health policy and health environment analyses, hospital reimbursement assessments, prizing and contracting strategies, payer access and knowledge and ‘sounding boards’ for fruitful discussions with decision makers.

All our services

• Development of overall strategy in European reimbursement incl. AMNOG, NICE, SMC, AIFA, HAS etc.
• Reimbursement Dossiers and HTA Submissions
• Strategic and technical support throughout the process, including early advice and post-submission support
• Development of all components of the dossier, or incorporate aspects developed elsewhere, including:
  • Systematic reviews of clinical literature
  • Systematic reviews of burden of illness, utility, and economic literature
  • Network and other meta analyses
  • Re-analyses of the clinical data according to reimbursable population
  • New utility research or resource use/cost estimation
  • Cost-utility models
  • Budget impact models (including, if requested, validation with payers)
• Real-world data analyses
• Epidemiology
• Sounding boards with decision-makers and payers
• Stakeholders (e.g. Key Opinion Leaders) selection/involvement
• Development of ‘objection handling’ and ‘Q&A documents’
• Development and support of written statements and oral hearings
• Implementation of trainings for oral hearings and statements