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Regulatory and HTA Landscape in Latin America
What are the Needs, Challenges, and Opportunities?
Hector Castro
Genentech
@genentech
D

ecision making in healthcare is a complex process that takes place along a continuum that moves from evidence generation to evidence review and deliberation, to decision making, and to communication of decisions made. In many low- and middle-income countries (LMICs), this process is often not systematic, deliberative, or transparent. This article highlights the links between Health Technology Assessment (HTA) and regulatory practices, including harmonization and collaborative efforts, in Latin America.

HTA Landscape in Latin America

HTA can be used for many different purposes, from priority setting to purchasing decisions to quality improvement of healthcare systems. In Latin America, HTA has mostly been used to inform health benefit packages and reimbursement. While interest in using HTA to inform purchasing for procuring vaccines and in delisting or disinvesting in technologies is growing, its use for quality improvement such as establishing quality outcome frameworks or pay-for-performance mechanisms has been limited.

Different countries are at different stages of developing HTA expertise, but the importance of HTA is increasing across Latin America. Some countries have little or no awareness of HTA as a policy solution to improve efficiency, transparency, and accountability of resource allocation. A few nations (e.g., Brazil and Colombia) have established mature HTA systems that inform value-based national healthcare. Others have already established (e.g., Argentina and Mexico) or are close to establishing or broadening the mandates (e.g., Chile and Peru) of their national HTA agencies.

Barriers to establishing HTA include lack of financial support, policy/political support, local capacity, data quality, and implementation strategy (see Figure 1). For example, in Colombia, major policy changes over the last decade have boosted HTA development; local policy support from governmental institutions has resulted in funding for capacity building at HTAs within the Institute of Health Technology Assessment (IETS).

a flow chart illustrating the barriers, facilitators and drivers fro establishing HTA
From Castro-Jaramillo HE et al, 2016. IJTAHC

Collaboration and Harmonization in Latin America HTA

Collaboration across countries among HTA agencies in Latin America is currently very limited. However, there has been a regional effort for harmonizing HTA through Red de Evaluación de Tecnologías Sanitarias de las Américas (RedETSA), the HTA network of the Americas. RedETSA has been working to strengthen local HTA capacities, establish an inventory of regional capabilities, and facilitate information sharing between different organizations.

In 2020, an international joint task group co-led by the International Network of Agencies for Health Technology Assessment (INAHTA) and Health Technology Assessment International (HTAi) published a new and internationally accepted definition of HTA. However, some authorities, regulators, payers, and stakeholders in Latin America continue to use outdated definitions of HTA to inform their decision-making. Therefore, development partners within the region need to advance and evolve the definition and application of HTA to reflect current international standards and best practices.

There have also been some global efforts to advance the institutionalization or establishment of HTA mechanisms in many LMICs. One organization has developed a roadmap, which outlines opportunities to align the processes of national regulators and HTA mechanisms, for establishing HTA in LMICs.

Regulatory-HTA Alignment

Most Latin American countries currently conduct HTA after regulatory approval of a therapeutic product. However, this is already changing in countries such as Brazil and Colombia through efforts to promote regulatory-HTA alignment by making pricing decisions closer (in time) to regulatory approval. While there have been attempts to mimic value-based market access models used in Europe, especially in Germany and France, their focus has been too narrow instead of encompassing the full product lifecycle, including horizon scanning, early collaboration and dialogue, pricing negotiations, or use of real-world evidence.

HTA agencies may have opportunities to align with regulators and leverage regulatory information, for example as early research transitions into product development, or by using information already submitted in the regulatory dossier for purposes of making HTA decisions. Reliance on cross-border HTAs is not common practice in the region, but there may be an opportunity to explore a “core” regional model like that of EUnetHTA in the EU.

Conclusion

While HTA in Latin America is mainly conducted post-approval, after the medicine is on the market, this is beginning to change. As regulatory and HTA systems become more thoroughly connected, HTA agencies will discover more opportunities to grow more proactive, integrated, and efficient. We can expect the HTA ecosystem in Latin America to become stronger, broader in remit, and mostly consist of country-based institutions within the next five to 10 years.
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