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Event Overview: Latin America’s rapidly expanding and maturing healthcare markets are undoubtedly a fantastic opportunity for pharmaceutical and medical device companies. The reality, from a market access perspective, is that Latin America is a group of markets with vastly different market access environments. Several markets have well-established HTA and the infrastructure to carry this out; several markets are in the early stages of HTA implementation; several markets continue with International Reference Pricing and the remainder are a mixture of reimbursed and out-of-pocket payment healthcare markets. With a strong and growing private insurer market superimposed on top of all this, the complexity of this region requires a complex solution.

Payers in the region (health plans, sick funds & insurers, payers, health technology assessors, hospital financial management & health department officials) are faced with cost-containment challenges like never before, combined with the consumer expectation for improved healthcare delivery across the region. This is forcing Latin American payers & HTAs to make difficult choices regarding what medical procedures to fund and what expensive medications to reimburse. No longer are “me too” drugs that have achieved regulatory approval simply approved for reimbursement at high prices. Recent advances however, in the sophistication of HTA analysis and modeling, flexible pay for performance models, risk-sharing and value-based pricing schemes, have become increasingly important to mitigate payer risk and allocate financial resources to the areas of pressing need and bring high value, essential medicines and medical devices to the Latin American market.

Pharmaceutical and medical device companies need to use a variety of market access approaches to bring their products to these dynamic markets. A one size- fits-all approach is destined to fail and fit-for-purpose local expertise is essential to deliver the appropriate value message to the appropriate stakeholders in each market. Several markets will require sophisticated value dossiers and thorough levels of economic and clinical outcomes evidence which are at a similar standard as to larger HTAs such as NICE (UK) & HAS (France) which may surprise many pharma and device companies who are naïve to the region.

Increasingly regulators, payers, HTAs and healthcare systems in Latin American countries are requiring sophisticated evidence of clinical and economic value. Clinical studies increasingly need to be performed on local populations to reflect local conditions and are requiring not just quality data showing clinical benefit, however health economic endpoints also often need to be achieved as health-technology assessment (HTA)becomes more advanced in many countries. Generating real world evidence via observational studies and the use of patient registries is one of the fastest growing areas of pharmaceutical R&D. Such post-marketing studies are becoming increasingly important as regulatory agencies demand more long-term data which demonstrates efficacy, safety and quality. The medical and clinical affairs unit plays a decisive role in generating this vital evidence and this stream will present solutions to the challenges companies face in generating high-quality evidence which will communicate a compelling value argument to all necessary stakeholders in Latin America.