The global commercial strategy must spell out a defined regional approach for Latin America as early as possible. Treatment outcomes and pay-for-therapeutic value are new concepts to key countries in Latin America considered when determining reimbursement, so having well defined target market access and pricing strategies are critical strategic components for sponsors to achieve acceptable levels of return on investment. In particular payers want evidence of therapeutic value against existing therapies, or a convincing Health Technology assessment for novel treatment to better define reimbursement. Traditionally companies do not include requirements from payers routinely integrated into clinical and regulatory planning. The consequence is that many new health treatments fail to achieve their commercial potential in reasonable time. Pay-per-therapeutic value is a global trend that has quickly taken off in Latin America.

At Axis HealthCare our local experts look to identify key clinical, technical, logistical, or regulatory concerns that must be clearly addressed to ensure an eventual commercial advantage as early as in phase III of the developmental process. We combine evidence from the global developmental process with local economic evaluation, pricing, and reimbursement to ensure strategic market access on a country by country basis. So we lay the foundation for what will ultimately quantify the regional differentiation of product value and effectiveness as part of the global and regional product development:

  • Evaluate in-market healthcare value and research over existing therapies.
  • For new therapies with unmet needs, Axis HealthCare can perform regional/country evidence-based compound/indication prioritization.
  • Define a regional / countrywide product profile with corresponding label claims.
  • Define market access, qualitative and quantitative pricing and reimbursement strategy.
  • Work to ensure that clinical trial protocol design supports local market access opportunities.