Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas

ABSTRACT Objective. Health technology assessment (HTA) has been adopted by countries in order to improve allocative efficiency in their health systems. This study aimed to describe and analyze the HTA decision-making process in the Region of the Americas. Methods. A literature review was done to better understand the HTA situation in the Region. Also, in 2014 and 2015, individuals responsible for conducting HTA in countries of the Americas were identified and received a questionnaire on HTA and the decision-making process. Results. A total of 46 questionnaire responses were obtained, from 30 countries. The respondents were similar in terms of their institutions, main funding sources, and technology types assessed. Of the 46 respondents, 23 (50%) work for their respective ministry of health. Also, 36 (78%) undertake and/or coordinate HTA through coverage and reimbursement/pricing decisions and other HTA-related activities, while 24 (52%) use HTA for emerging technologies. While some countries in the Region have created formal HTA units, there is a weak link between the HTA process and decision-making. Most of the countries with recognized HTA institutions are members of the Health Technology Assessment Network of the Americas (RedETSA). Despite the advances in the Region overall, most countries in Central America and the Caribbean are still at the early stages of implementing HTA to support decision-making. Conclusions. Many countries in the Americas have benefited from the exchange and capacity-building opportunities within RedETSA. However, there are still many challenges to overcome in the Region in terms of the discussion and creation of HTA-related policies.

and impacts of health care technology. HTA also considers the clinical, social, ethical, and economic aspects in order to better inform health policymakers and improve the decision-making process in the area (3,4).
The use of HTA has increased worldwide, enabling coverage decisions to be evidence-based and improving efficiency in resource allocation. The assessment takes into account several aspects, such as efficacy, safety, efficiency, social and legal issues, and ethics (3)(4)(5)(6)(7). Technology assessment can be carried out at any point during the product's life cycle, and it can serve different purposes. These include advising a regulatory agency about the authorization and use of a technology, supporting coverage decisions, advising clinicians and patients about the proper use of a health technology, and guiding disinvestment decisions (8).
Recent years have seen considerable growth in the availability of drugs, diagnostic tools, telemedicine, and surgical equipment. These changes are often associated with positive results, such as improvements in health, quality of life, treatment, organization, and delivery (4,5). However, the arrival of new technologies and drugs has also produced negative repercussions. The increasing cost of health technologies, exacerbated by public expenditure constraints, is a reality that threatens health care systems in many countries (9). In a number of cases, health expenditures have grown faster than the gross domestic product (GDP) has, leading to difficult compromises between rising patient expectations and limited resources. As a result, decisionmakers are constantly seeking to enhance efficiency. According to an assessment performed by the medical journal Prescrire in 2015, only 8 out of the 87 new drugs assessed were described as "a real advance" or "offers an advantage" (9). The remaining 79 drugs tested were either damaging to health or could not be proven safe, due to insufficient documentation (9). Despite the appeal of new technologies and products, assessment is crucial in order to evaluate the value that a technology adds.

Health technology assessment in the Region of the Americas
In the Americas, the health sector reforms of the 1990s encouraged health equity and inclusion by establishing legal rights to health protection. Indeed, many countries have established social and welfare reforms to reduce poverty and expand access to nutrition, education, and health. The Region's health systems have used social health insurance or tax-based financing to extend health care services through benefit packages (10,11). This push toward achieving universal health reinforces the role of HTA in Latin America and the Caribbean, especially in a period when health systems are under pressure from increasing costs and declining budgets (11).
Recognizing the importance of this issue, in September of 2012, the Member States of the Pan American Health Organization (PAHO) adopted Resolution CSP28.R9, titled Health Technology Assessment and Incorporation into Health Systems. The resolution encouraged Member States to establish decision-making processes to incorporate health technologies based on HTA; to use HTA to inform public health policies, including public health system coverage decisions; to develop clinical guidelines and protocols for new technologies; and to actively participate in the Health Technology Assessment Network of the Americas (RedETSA) (3,6). RedETSA has 33 members in 16 countries: Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Honduras, Mexico, Panama, Paraguay, Peru, and Uruguay. PAHO serves as the secretariat of the organization (6). Passage of that resolution was one in a series of recent advances in the institutionalization of HTA in the Americas, which will be discussed later in this article.
The aim of this article is to describe and analyze the HTA decision-making process in the Region of the Americas and to establish a baseline for future impact assessments in the Region. We excluded papers published before 2000 and also ones written in a language other than English, Portuguese, or Spanish. All the articles selected included information about decision-making processes, HTA capacity, and the different uses of HTA to inform decisions in the countries of the Americas.

METHODS
From March to July of 2014, a crosssectional study was performed in the countries and territories selected for the Advance-HTA project in the Region of the Americas: Bahamas, Barbados, Belize, Bermuda, Costa Rica, Dominica, Dominican Republic, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua, Panama, Saint Lucia, Sint Maarten, Suriname, Trinidad and Tobago, and Venezuela. PAHO focal points in each country were asked to identify the individuals and/or institutions responsible for conducting HTA in their countries and to send them invitations to participate in the study. If no individual or institutions were identified, the PAHO focal point in that country was then invited to participate in the study and receive the survey. RedETSA focal points in Costa Rica and El Salvador also received the questionnaire.
Potential participants received both a PDF copy of the questionnaire (titled "HTA and the Decision-Making Process in Emerging Settings") and a Survey-Monkey Web hyperlink to the same questionnaire. The questionnaire was divided into five sections: i) Introduction/ Country Settings; ii) Use of HTA in the Country; iii) Decision-making Process; iv) Implementation of the Decision; and v) HTA and Decision-making: Future Challenges. A copy of the questionnaire is available from the authors.
The survey had been piloted in three Caribbean countries from January to February 2014. And, before that, the survey had been sent to the London School of Economics and to NICE International for feedback on its content and wording. (Established in 2008 by the United Kingdom's National Institute for Health and Clinical Excellence (NICE), NICE International offers advice to governments and governmental agencies overseas on building capacity for assessing and interpreting evidence to inform health policy and on designing and using methods and processes to apply this capacity to their local country setting.) In order to obtain a more complete overview of the Region of the Americas, during February through September of 2015, the survey was sent to these other PAHO Member States: Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Paraguay, Peru, and Uruguay.
All contact with survey respondents was made via email. As needed, email reminders were sent to possible respondents, asking them to complete the survey. In addition, when there were contradictory answers provided by different respondents from the same country, the respondents were contacted for clarification. The identity of all the respondents has been kept confidential.

Literature search
For the literature search, PubMed and LILACS were used in order to obtain a better idea of the range of publications on HTA and decision-making in the Region of the Americas. Annex 1 shows the number of references found for each country, before the exclusion process. Among the countries in the Americas, Canada, Brazil, Argentina, Mexico, Colombia, and Chile have published the most on the subject.
After excluding duplicates and search items that were not related to the study's objectives, as indicated by their title or abstract, a total of 226 articles were selected. After the full-text reading, a total of 137 references were considered.

Survey on the decision-making process
Responses from 30 of 38 countries and territories were obtained, with a total of 47 questionnaires received. One respondent had left the survey blank, so 46 answers were considered valid (Table 1). Antigua and Barbuda, Aruba, the Bahamas, Curaçao, Dominica, Grenada, Saint Kitts and Nevis, and Saint Vincent and the Grenadines did not participate in this study. The country with the most responses was Costa Rica (5), followed by Argentina and Brazil, with 4 responses each, and Colombia, with 3 responses.
Out of the 46 respondents, 26 of them (57%) were institutional member of RedETSA. As shown in Table 2, there is homogeneity in the characteristics of the respondents. Most belong to similar institutions, share comparable sources of funding for HTA, and assess the same type of technology. Twenty-three (50%) work for their respective ministry of health (MoH), 5 (11%) for a regulatory agency, and 4 (9%) for social security. Fourteen (30%) stated that they work for some other institution, such as a hospital, university, or international health organization.
The most common activity performed by respondents was undertaking HTA (37%), followed by the coordination of HTA activities (28%) ( Table 2). Other activities included coverage/reimbursement decisions (13%), pricing decisions (13%), the development of clinical guidelines based on HTA (13%), and other things (17%). The use of HTA throughout a technology's life cycle was concentrated in emerging technologies (52%), followed by established or widespread practice (30%). HTA was less commonly used for technology with declining use (9%).
In the region of the Americas, 13 of the 30 countries that responded to the questionnaire have established HTA bodies or organizations: Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Mexico, Peru, Uruguay, and Venezuela. (Bolivia established its national HTA committee after the initial questionnaire period, while this article was being prepared.) For Canada, the only respondent was a representative from INESSS, an independent organization that reports to Quebec's Minister of Health and Social Services. All the respondents with established HTA bodies or organizations are RedETSA members, except for Venezuela.
Of the 46 respondents, 39 of them (85%) reported carrying out assessments on pharmaceuticals, followed by medical devices (n = 33; 72%), and medical procedures (n = 22; 48%). Of the 46 respondents, 23 (50%) answered that there are no guidelines on how to perform HTA in their country, and 31 (67%) used HTA reports that had been carried out in other countries to guide their decisionmaking. Furthermore, 59% (n = 27) answered that there is no legislation in place to ensure that decision-making is supported by HTA. Despite this, 16 out of those 27 respondents (59%) without official legislation in place reported that HTA findings are still used in decisionmaking processes. Of the 46, 18 (39%) also stated that there are no mechanisms for monitoring or evaluating the HTA recommendations.
Cost-effectiveness thresholds were identified in 5 of the 30 countries. In Costa Rica, Ecuador, and Peru, the cost-effectiveness threshold is estimated to be three times the gross domestic product (GDP) per capita, whereas in Chile and Mexico, it is one times the GDP per capita. Chile's value was officially established in the Chilean Economic Evaluation Methodological Guideline, published in 2013.
When questioned about the main barriers that arise in the HTA decisionmaking process in their countries, 18 of the 46 respondents (39%) mentioned organizational/institutional barriers, 14 (30%) a lack of human resources, and 12 (26%) a lack of funding.
Among the 26 respondents that are members of RedETSA, 18 of them (64%) stated that there are methodological guidelines for conducting HTA in their countries. In addition, 14 of the 26 (54%) reported that there is no legislation to ensure that decision-making is supported by HTA. However, of those 14 that reported there is no such legislation, 11 of them (79%) reported using HTA findings despite there being no formal legislation, and 10 of the 26 (38%) stated they had reported not having any mechanisms for monitoring and evaluating the HTA recommendations, 4 of them (20%) stated they have some mechanism, and the other 8 respondents (40%) were unsure or did not respond. Of the 20, 8 of them (40%) indicated that they use HTA reports developed in other settings in their decision-making processes. The nonresponse rate for this question was significantly higher for non-RedETSA members (40%) than for RedETSA members (0%), a point that will be addressed later in this article.
The main barriers that arise in the decision-making process for HTA were also analyzed from the perspective of RedETSA membership (Figure 2). Among the 26 respondents that were members of RedETSA, 11 of them (42%) stated that organizational/institutional barriers are the main impediments to decisionmaking, followed by a lack of human resources (8 of 26, or 31%) and a lack of financial resources (7 of 26, or 27%). For the 20 non-RedETSA members, the most common barrier reported was lack of financial resources (12 of 20, or 60%), followed by organizational/institutional barriers (8 of 20, or 40%) and human resources (6 of 20, or 30%). All the RedETSA members responded to this question, while the non-RedETSA members had a noticeably high nonresponse rate of 35%.

DISCUSSION
Our literature review showed that scientific production on HTA and the decision-making process has been scarce for Central American and Caribbean countries, but widespread in Canada and Brazil.
Although advances have occurred in the Region of the Americas in the discussion and formulation of policies related to the HTA process, there are still many obstacles to overcome, as indicated in Figure 2. Among the respondents that were not RedETSA members, a high percentage of them did not answer the survey question on the main barriers in the decision-making process on HTA. This could be explained by the fact that they are in the early stages of HTA implementation and/or that the HTA-related questions were not applicable to their current context.
Despite the substantial progress seen in recent years in the Region, in some countries the implementation of HTA remains at a low level. Of the 30 countries that participated in the study, 25 said they performed some kind of HTArelated activity, but only 13 of them have officially established formal HTA bodies, such as an agency, institute, commission, or unit (Table 3). Institutionalization is essential for highlighting obligations and ethical responsibilities, establishing transparent processes, and identifying stakeholders involved in the chain that empowers decisionmakers. All of the formal HTA bodies, except the one in Venezuela, are members of RedETSA. RedETSA seeks to strengthen, increase, and promote the evaluation process for technologies in the Americas and to allow the exchange of information. These kinds of assistance from RedETSA could explain the significant improvements made by some of the countries in the Region.
The involvement of stakeholders and governance and decision-making bodies can substantially affect the impact of HTA. As indicated in Table 3, countries without an official HTA entity can still have HTA activities performed through universities, institutes, nongovernmental organizations, hospitals, and independent units that appreciate the value  In Panama, although there is no official HTA body, the CSS carries out some HTA activity for decisions on pricing, coverage, and reimbursement in its own system. In Paraguay, the health ministry conducts systematic reviews for the development of applications for decisionmaking in telemedicine.

FIGURE 1. Health technologies assessed in the Region of the Americas among countries that are members of the Health Technology Assessment Network of the Americas (RedETSA) (n = 26) and those that are not members (n = 20), 2014 -2015
Our study showed that there is a gap between the conclusions reached through HTA and decision-making in the Region of the Americas. Despite most countries performing some kind of HTA activity, 57% of respondents stated that there is no legislation to promote the use of HTA in the decision-making process. The four countries with related legislation are all members of RedETSA: Brazil, Chile, Colombia, and Uruguay. However, Brazil is the only country where the use of HTA in decision-making is mandatory. Thirty-nine percent of respondents indicated that there were no guidelines for conducting HTA in their countries, but 11% did not answer this question. Sixty-two percent said they used HTA reports that had been produced in other jurisdictions to help in their decisions, which agrees with findings from other authors (15)(16)(17)(18)(19)(20)(21). HTA work produced in different contexts is usually adapted to the local situation in order to be used in the decision-making process. When properly done, this saves time and money, prevents inefficiencies and duplication, and enables the transfer of knowledge between different situations (15,(22)(23)(24)(25).
The monitoring and evaluation (M&E) of health technology incorporation is also a challenge. Monitoring is defined as the routine tracking and reporting of priority information about a policy, program, or project. It provides information on the level of implementation of each product. Evaluation is the systematic collection of information about these courses of actions (policy/program/ project).
In many health care systems, M&E is strategically used to achieve the desired results of a policy, program, or a project by making the correct decisions (26). In our research, 39% stated that there are no M&E mechanisms in place to assess the impact of HTA.
Cost-effectiveness evaluations are used to assess health technologies and help decisionmakers to evaluate what they receive in return for the money they spend on health care. Explicit or implicit thresholds (above which technology is considered cost-ineffective for the health care system) are also sometimes used in decision-making. At the time of our study, Chile was the only country in the Region to have an established threshold in a legal document, of one GDP per capita (27). However, by the time this paper was prepared, Uruguay had approved legislation requiring the use of thresholds for the economic evaluation of medicines. In addition, several countries have adopted an unofficial reference value, including one GDP per capita in Mexico and three GDPs per capita in Costa Rica, Ecuador, and Peru. (In Costa Rica, the threshold only applies to the Central Pharmacotherapy Committee of the Costa Rican Social Security Fund.) As mentioned earlier in this article, there are barriers to overcome in the Americas for HTA and decision-making. With the survey question regarding barriers, all the RedETSA members answered it, but 35% of the non-RedETSA members did not answer it. For the nonmembers, this might be explained by the lack of awareness concerning the decision-making processes in their countries or their unfamiliarity with HTA issues.
The barriers for implementing HTA are well known. Organizational and institutional difficulties were mentioned by 41% of the respondents, showing that substantial changes related to organizational issues are required. In addition, 30% indicated a lack of human resources, and 4% pointed to insufficient financial means. The HTA process depends on qualified human resources, given the correlation that exists between highly skilled personnel and evidence-based decisions (28). The communications obstacle appears to have been overcome for   RedETSA members (with 0% saying it is a barrier), indicating that network's accomplishments in information sharing.

Conclusions
In recent years, there have been clear advances in the institutionalization of HTA in the Region of the Americas, both at a regional and national level (Annex 2). Between the submission of the questionnaires and the preparation of this article, the Region experienced further advances.
These included Uruguay's approval of a cost-effectiveness threshold for the economic evaluation of health technologies, the creation of an HTA institute in Peru, and the establishment of an HTA commission in Bolivia. Furthermore, a proposal for the creation of an HTA agency was submitted to the Senate in Argentina in July 2016 and is expected to be approved. Also, in Mexico, a standard has been approved that defines the linkages between CENETEC, the Price Commission, and the General Health Council, with the aim of improving decision-making.
Despite progress in the discussion and creation of policies concerning HTA processes and HTA institutionalization in the Americas, there is still a lot to be accomplished. The main gap to be addressed is the lack of explicit links between HTA activities and the incorporation of health technologies into health systems.
There are significant differences in the level of implementation of HTA for decision-making in the Americas among the RedETSA members when compared to the nonmembers. Significant progress has been achieved in HTA implementation: some countries have formed HTA units and utilize HTA at some point in the decision-making process. More advances have been made in RedETSA countries than in nonmember countries. This could indicate that RedETSA countries have benefited from the exchange and capacitybuilding opportunities available through this regional network.
The regional inequality in HTA development highlights the importance of the information gathered on the use of HTA in the decision-making process throughout the Americas. Implementing HTA processes is expected to produce substantial benefits in all countries, especially in Central America and the Caribbean, where most countries are at the early stages of implementing HTA to support decision-making.
Fortalecimiento y ejecución de la evaluación de las tecnologías sanitarias y del proceso de toma de decisiones en la Región de las Américas