Health systems face the challenge of improving population health in a context of budget constraints, limited information, and opposite views from stakeholders. These elements make decisions on health coverage more complex and demand a socially legitimate process (Reference Daniels1). Health technology assessment (HTA) as a multi-disciplinary field offers a comprehensive framework to support these difficult decisions (2–Reference Drummond, Schwartz and Jönsson4).
Since the 1970s, HTA has been adopted to inform decisions about coverage of healthcare interventions in many jurisdictions (Reference Banta5). In Latin America, important progress has been made in Mexico, Brazil, and Colombia (Reference Kuhn-Barrientos6). In Chile, elements of HTA were implemented alongside the Regime of Explicit Health Guarantees in 2005, the Chilean Health benefit plan (Reference Castillo-Riquelme and Santelices7;Reference Estado8), specifically the generation of clinical guidelines following the principles of evidence-based medicine for assessing efficacy and safety (Reference Estado8;Reference Ministerio9). In 2013, a National Commission of HTA formed by representatives of governmental entities proposed to create a national centralized institution, independent in its technical work but publicly funded, responsible for evidence assessment and elaboration of recommendations to the health authority (10). Unfortunately, this discussion has been conducted inside the institutions that depend on the health authority without any external consideration. The objective of this study is to explore and describe the viewpoints and beliefs of potential beneficiaries of HTA in Chile about its institutionalization. The main motivation is contributing to the discussion about the implementation of a legitimate HTA process in Chile.
METHODS
A qualitative study with a descriptive design, based on the discourse analysis model (Reference Jorgensen and Phillips L11) was performed. Participants were eligible if they were representatives of groups who have some grade of participation on the decision-making process: (a) technical groups (academics and scientific societies), (b) public and private decision makers related to acquisition of healthcare technologies and implementation of HTA (payers and healthcare providers), (c) civil servants interested in HTA (patient associations, consumer associations, and NGOs) or (d) congress representatives. The exclusion criterion was to have participated in the National Commission of HTA, whose opinions are reflected in their proposal (10).
The recruitment of interviewees followed a purposive sampling (Reference Polit and Hungler12;Reference Mays and Pope13) and the sample was defined a priori, based on the above criteria. We invited five representatives from each group due to the limited time and budget available, and they were contacted by email or telephone. Finally, eighteen face-to-face semi-structured interviews were conducted with nineteen participants (Supplementary Table 1). The 1-hour interviews were guided and recorded on the participants’ workplaces for a psychologist and a specialist in public health, and were transcribed by external social scientists. The data were analyzed using open coding. The aim of this strategy is to understand the phenomena “breaking down, examining, comparing, conceptualizing, and categorizing data”, to recognize their properties and dimensions (Reference Strauss and Corbin14). A coding system was generated from the content reported by interviewees for an expert data coder and discussed with the multidisciplinary research team to facilitate the analysis of divergent visions (Reference Mays and Pope13). As a result, a systematic triangulation of perspectives was performed to control bias alongside the analysis (Reference Flick15). The Research Ethics Committee of the Faculty of Medicine at Pontificia Universidad Católica de Chile approved this research project and suggested a verbal agreement from participants. All confirmed their willingness under the conditions explained at the beginning of the interview.
Table 1. Interview themes: open coding
RESULTS
The interviews provided viewpoints, which were categorized in three main areas. The categories and sub-categories are shown in Table 1.
Category 1: Principles to Guide HTA
Interviewees said the main criteria that should govern HTA are transparency and participation:
“It is not because participation and transparency are popular, but we are talking about a topic that has two aspects. . . First, health technologies are controverted, complex and have [sic] scientific uncertainty; and second, affect to several groups in different ways” (Healthcare provider)
The 89 percent agreed to consider all social groups influenced by these decisions. These groups are shown in Table 2. However, interviewees proposed different levels of participation. The 68 percent considered that patients and manufacturers have conflicts of interest, which might introduce bias. They should be restricted to provide information through qualitative methods, such as focus groups, opinion surveys, hearings, and Advisory Councils. Ninety-five percent mentioned that the process should be public and understood by all citizens, with clear rules, transparent management of funds, and disclosure of stakeholders’ conflicts of interest to improve credibility and legitimacy. Fifty-eight percent included equity as a principle to integrate a nondiscriminatory basis. Others perceived that HTA is only to estimate cost-effectiveness, and equity ought to be considered in subsequent instances of decision making. However, most participants said that installing this process would make the health system more equitable. Finally, some interviewees incorporated principles such as technical rigor, process based on evidence, efficient use of resources, and independence.
Table 2. Groups of stakeholders to be represented in HTA process.
* Eighteen interviews were conducted on nineteen Chilean representatives of stakeholders in HTA.
Category 2: Institutional Framework
The 84 percent proposed to create an autonomous public entity, which should link governmental, private, and nonprofit organizations:
“(the organization) will be autonomous, independent in their duties, lines of work, strategies, research and results; (...) If it is not autonomous, it will face political influences of powerful groups and stakeholders, affecting the outcome, which will produce damage to the country”
(Scientific society)
To ensure independence, they suggested the creation of a Board formed by social representatives. Some believed that any HTA model should be embedded in the health organizations processes and led by the Ministry of Health. Furthermore, the 68 percent thought in a Center for decision making, whereas 32 percent indicated that its scope should be limited to perform evaluations, studies, and formulate indications for use, that is, a Centre of collection of evidence.
Regarding its indications, half of participants believed that this institution should provide recommendations for public and private decision makers, becoming a national referent. Others believed that only compulsory mandates would safeguard decisions based on evidence and with strict scientific standards. Although, 68 percent supported an appealing process focused on technical aspects, others mentioned that it should be directed to decision makers or legal instances; thus, the process is not contaminated. They emphasized that a participative and transparent process will minimize prosecution of cases.
All agreed that the main duties of the institution should be guaranteed with public funds and the 32 percent considered a strict normative to incorporate private funds to avoid conflicts of interest. Finally, they also expressed the need of a law to safeguard the regulation of their processes and funds:
“According to our culture and tradition is through a law that this organization should be created to guarantee its stability over time and avoid changes. . . we have examples of good policies, that after being implemented, when the government changes, they are suspended and eliminated.”
(Public decision maker)
Category 3: Impacts of the implementation of this HTA institution
Participants acknowledged some challenges. Thirty-seven percent mentioned that Chile does not have human capacities to support this process, and it should be included as part of health professionals’ training. Another challenge is to make HTA a necessity for the country rather than a technical exercise. Also, some argued that HTA represents a cultural change, because it will modify the decision making:
“I think you will have resistance of technicians and politicians for implementing the model, because it will remove their power... If you do all with methodology and participation, you distribute power”
(Public decision maker)
With respect to benefits, 63 percent said HTA would allow decision planners to assign resources efficiently, improving public expenditure and avoiding overspending on the incorporation of technologies. Second, 53 percent said it will produce a systematization of the decision-making process and it will work as a filter, able to guarantee the use of scientific evidence as a requirement and to promote the enrichment of democracy. Finally, only 26 percent believed that the creation of an agency to guide HTA in Chile is a priority.
DISCUSSION
The study revealed a broad consensus on the need for an independent and publicly funded HTA body in Chile to support decisions on health coverage, which should be built based on two main principles: transparency and participation. In addition, the processes and institutional arrangement for this institution should be framed by law to make sure they will not be modified by pure political interests.
The study has some limitations that must be acknowledged. First, the small number of participants might have left out important considerations, but despite the sample size, we were able to account for saturation in the technical group and on topics such as participation, transparency, and autonomy. Another important concern is that the implementation of an HTA process should not be based only on perceptions of stakeholders; its definition also needs a normative analysis, which in many cases is the only way to solve irreconcilable but legitimate views. A final model can be built based on the convergence of these elements.
Although it could be argued that the results provided by this study were expected based on international experience (16–18), this remains as an empirical question given the local context. Thus, the relevance of the present piece of work is to provide scientific evidence, based on which health authorities can make progress in the implementation of a legitimate HTA process.
Overall, the results of this study are quite consistent with the proposal of the National Commission of HTA. The idea of building a new HTA institution is broadly supported and, therefore, the health authority should not wait more to initiate the construction of the normative framework. However, more work is needed to clarify exactly what the process should look like.
SUPPLEMENTARY MATERIAL
Supplementary Table 1: https://doi.org/10.1017/S0266462317000381
CONFLICTS OF INTEREST
The authors have no conflict of interest to declare during this research.
