On July 26, 2022, the ISPOR 2022 Patient Representatives Roundtable – Latin America convened 33 stakeholders from Latin America representing government agencies, payers, patient-centered organizations, health economics, and research institutions. Discussions centered on critical considerations for effective social participation in health technology assessment (HTA) and patient journey mapping.
Presentations on current social engagement in HTA
Representatives from Brazil and Colombia presented their perspectives on patient economics in HTA. Many Latin American countries lack an established evaluation process; therefore, countries like the ones presented serve as trailblazers for other nations.
The first presentation highlighted Brazil's strengths of a universal healthcare system and a robust public sector. Social participation in healthcare decision-making is guaranteed by a law passed in 2011 which created the National Committee for Health Technology Incorporation (CONITEC). The Committee advises the Brazilian Ministry of Health in incorporating, evaluating, and developing clinical guidelines. Although Brazil is advancing in its HTA processes, there is still a lack of transparency about which methodologies are used for evaluating patients and qualitative contributions, a common thread discussed in other regions of Latin America. Improvement is needed in the evaluation process to determine what to do with the information collected from lived experiences and opinions of patients, caregivers, and health professionals other than reports or Word Clouds. Patient organizations articulate that public opinion contributions and evaluations must contain evidence-based data that can influence decision-making. There is inconsistent evaluation methodology impacting the credibility of the process as a whole.
The second presenter showcased one of Colombia’s HTA agencies that helps standardize clinical practices to increase healthcare quality and create a sustainable system that gives room for innovation, equality, and efficiency. In 2020, the agency surveyed 185 organizations of all health conditions and successfully worked with 48 in the creation of a manual. The manual establishes recommendations to guarantee the effective participation of patients and their organizations in all stages of the health technology assessment process, getting involved in an assertive, organized, informed, effective, and objective manner in obtaining results.
A study by the agency found that HTA patient participation is determined by expectations, feasibility, experience, and knowledge among actors. Although spaces are created for patient voices, patients do not know what happens to the collected data. If expectations are high that the information will be helpful, it will create the incentive for feasible action. Some patients felt their voices were not considered legitimate sources of information. The manual content includes criteria for participation, mechanisms, and possible scenarios to achieve increased patient participation. The next steps involve the implementation of the manual, determining how to measure impact, defining the results, and improving conflicts of interest.
Key considerations and takeaways during breakout discussions
Roundtable representatives were divided into three breakout groups to share insights on the strengths, weaknesses, threats, and opportunities of social participation in HTA. Participants identified when and how patient groups and associations should be involved to add value to the HTA process.
Strengths of social participation in HTA
Social participation in HTA creates empowered and informed patients. It allows for a better understanding of patient needs and a broader perspective in each evaluation process where patients can provide real-world data. Some Latin American countries have created their own procedural manuals. Unfortunately, many countries that do not have a manual must begin from scratch, which takes a lot of skill, resources, and stakeholder buy-in. It was recommended that these countries follow established guidelines to develop their own manual and draw on the strengths of the nations that have trailblazed the path forward. Participants agreed that an excellent project would be to create standards for Latin America, which each country could later adapt to its own healthcare system and priorities. Other strengths include expanding the right to healthcare, creating patient registries, and the ability to build bridges between users (patients) and those who make public health decisions.
Weaknesses of social participation in HTA
The most common weakness of social participation in HTA voiced by all groups was the lack of technical knowledge and real-world evidence (RWE) to make solid contributions taken seriously for evaluation. There is also a lack of technical preparation in patient organizations to meaningfully participate in discussions with policymakers. In addition to lacking technical knowledge, many countries have minimal evaluation standards. No structure guarantees adequate patient information, how patients are selected, and what is expected of them. There are no selection criteria for patient representatives or manuals that offer methodologies or ways to measure outcomes. Patients’ misunderstanding of the HTA process and scientific terminology leaves them feeling intimidated and hesitant to participate. A roundtable representative shared that some patients think that because of their intervention, other patients will access the same technology. Still, it is far from that, so the patient feels deceived.
Opportunities for social participation in HTA
People are increasingly looking for institutions with well-defined processes they can trust, especially after the COVID-19 pandemic. Because of this, institutions are beginning to open up to the HTA process, allowing the possibility of creating workgroups, improving transparency in decision-making, and the opportunity to contribute a different perspective. Roundtable representatives said they would like to involve academia and other trained professionals who can share scientific perspectives.
Threats to social participation in HTA
The most common threat in all roundtable discussions was the political environment in each country. There are constant fluctuations in legislation and institutions. The lack of state continuity creates instability when new officials do not respect the plans and commitments of the previous administrations. Conflicts of interest and lack of transparency remain top concerns. Most of the decision-making positions are held by the payers themselves. Bureaucracy and corruption threaten social involvement and contribution to HTAs.
When and how patient groups and associations should be involved in HTA
Roundtable representatives agreed that patients should be involved at all process stages. The participation of patients should not only be heard but should be a part of the entire decision-making process. Patient groups and associations can add value to the HTA process by increasing disease education, providing testimonies, and educating patients about clinical trials. Groups can also propose technologies to evaluate and actively engage in health policy. A starting point can be to promote ISPOR workgroups.
Acknowledgments
This summary was developed by Alejandra Murillo, BS. We would like to thank the Chair of the ISPOR Patient Representatives Roundtable – Latin America for his direction and leadership – Gustavo San Martin, Chief Executive Officer of Amigos Multiplos pela Esclerose (AME). We thank all speakers and attendees for their participation and valuable contributions.