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The Official News & Technical Journal Of The International Society For Pharmacoeconomics And Outcomes Research
LATIN AMERICA

Introduction and Conclusion by Diana Pinto MD, MHA, DSc, ISPOR Latin America Conference Program Committee Chair & Associate Professor of the Department of Clinical Epidemiology at Pontificia Universidad Javeriana School of Medicine & Research Associate, Fedesarrollo, Bogotá, Colombia


Pharmacoeconomics and Outcomes Research in Latin America - Argentina, Brazil, Chile, Colombia, and Mexico

Introduction
Pharmacoeconomics and outcomes research can play an important role in the quest towards improving the health of the Latin American people. This role is highlighted by the overview of health and health system characteristics and challenges shared by countries across the Latin America region [for further information please see the ISPOR Health Care Systems in Latin America Matrix at: http://www.ispor.org/conferences/Colombia0907/ISPOR_ LAProgramMatrix.pdf]. Overall in Latin America, we are characterized by a double-burden of disease: persistence or resurgence of infectious and parasitic diseases plus, an increasing incidence of chronic and degenerative diseases of developed countries. The percentage of non-communicable diseases is likely to increase as the region is on track towards meeting the health millennium goals (with the exception of maternal mortality) and also by the fact that the aging population is growing (Figure 1).

Figure 1
Figure 1. Latin America Health Profile

Furthermore, Latin American countries are increasingly exposed to factors related to the development of chronic disease. This will surely increase the demand for health services and will change the number and type of health interventions that need to be provided to the population. With regards to monetary expenditures, Latin America has substantial levels of spending with a regional average of about 7% of GDP. Per capita spending at the international dollar rate is around $550 - which is a value comparable to Eastern Europe and Central Asia. It is very unlikely these levels of spending will expand as budgets are heavily constrained, given most countries do not have a large tax basis to increase public spending, amongst other reasons. It is important to mention that pharmaceuticals account for a large share of spending in all countries, much of it accruing through households and out of pocket. The organization of most health systems across Latin America - with the exception of Costa Rica and Cuba - is characterized by social health insurance for the formally employed population, private insurance for the well to do, public insurance for the poor, or some combination. Since the 1990's, most countries have implemented health system reforms seeking increased coverage and access for vulnerable populations and efficiency in the delivery of health services. Also, there is a movement towards prioritization of public resources to specific population groups and disease categories, trying to make scarce public resources more efficient and effective. Another issue that concerns us is globalization. Globalization can be both a friend and foe to the extent that an increased rate of diffusion and adoption of new technologies can bring not only health enhancing interventions but can also bring a lot of trash. For example, it is shocking to see that in 2005, an evaluation of 2404 common treatments regarding available evidence of effectiveness found that 47% and 4% of treatments were rated as ineffective or likely to not be beneficial or even harmful, and for only 15% of common treatments did the evidence suggest some benefit (Figure 2).

Figure 2
Figure 2. Globalization: friend or foe? Source: Clinical Evidence, 2005 http://www.clinicalevidence.com/ceweb/about/knowledge.isp.

 

Pharmacoeconomics & Outcomes Research In Latin America - The Argentina Perspective
Federico Augustovski MD, MSc, Director of Health Economic Evaluations, Institute for Clinical Effectiveness and Health Policy (IECS), & President, ISPOR Argentina Local Chapter, Buenos Aires, Argentina

As in many Latin American countries, Argentina has a rather fragmented health sector. This is one of the main difficulties, shared by many western countries as well. Currently with a population of about 39 million, almost half is covered by the social security system, composed of more than 300 organizations or union-based insurance systems [1, 2]. About a third of the population has no insurance and is assisted by the public sector which is the federal system with 24 provincial different health care systems. About 10% of the population is covered by private insurance, such as HMO's or private health plans. In Argentina, like in Brazil with ANVISA, in the US with the FDA, or in Europe with the EMEA, Agencia Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is the regulatory body responsible for drug marketing and authorization. It depends on the Ministry of Health and requires evidence mainly on quality and safety. As most regulatory agencies, it only requires the three main hurdles for drug approval and marketing. It was only in recent years that the fourth hurdle began to be considered between the drug marketing authorization and the coverage of reimbursement of new pharmaceuticals or devices; it has been a recent movement, mainly undertaken in the social security and private sectors. Regarding the intentions of the country and the laws, a technical document published by Consejo Federal de Salud (the Federal Health Council, (COFESA), which is composed of all the provincial and central Ministers of Health, has set the scene for the health reform in the current period [3]. Among its many aims is one that, with the regulation of the health technologies, would propose the creation of a regulatory health agency in order to evaluate health technologies to design and implement clinical practice guidelines and to interact with other actors. This was supposed to have begun in 2006, but nothing has happened thus far.

The Institute of Clinical Effectiveness and Health Policy (IECS) is an academic NGO and is the main Argentinean health technology assessment agency and one of the few INAHTA members from Latin America. The Superintendence of Social Security - which depends on the Ministry of Health - is the regulatory body of social health insurance in Argentina. It regulates the coverage for about half of the population. In 1996, more than 10 years ago, it was responsible for setting the first mandatory benefit package which was called the Plan Médico Obligatorio (PMO). In 2000, IECS was called to critically revise the services included in this benefit package and after the first preliminary analysis it was concluded that a high percentage of the services should be revised to a former process of Health Technology Assessment (HTA). It was thought that the coverage of many services should be restricted to specific clinical conditions and it was necessary to define a formal and explicit process to adopt and incorporate new health technologies. As a result of this initial experience, 10% of the technologies were excluded because of lack of effectiveness and for two-thirds of them the coverage was limited to specific clinical conditions or patient groups [4]. In 2003, the Superintendence - with the collaboration of IECS - issued a guideline for submission for new technologies which required local data, not only in effectiveness and efficacy, but also about local cost-effectiveness and potential budgetary impact, as used in other parts of the world. This system of new technology submission was active until 2006 and more than 200 technologies were submitted through this process. However, in 2006 when the authority changed in the Superintendence, this system became inactive and has remained so for a little bit more than a year. Besides its activities with the Superintendence, IECS also established an HTA consortium composed of about 25 organizations comprised mainly of insurers but also national and local government Ministers of Health and organizations from the social security.

Argentina and the IECS also participate in technical cooperation activities with Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil or Fondo Nacional de Recursos in Uruguay. For Argentina specifically, the Institute provides HTA reports for the members of this consortium. These reports assist the organizations in the decision-making process of new technologies which are not covered or defined by the mandatory benefit package of the Superintendence. As an example of recent experience during 2003 through 2006, the Institute worked on 117 HTAs. In the first stage of the program, most of the documents were not complete HTAs or health economic evaluations. In most cases, they were brief documents that supported the decision that had to be made at that moment. Only 7% of the documents were complete HTAs that assessed technologies such as drug eluting stents, laparoscopic surgery, new antipsychotics and vaccines; 64% of the reports were rapid response documents that are mainly based on secondary sources of information such as HTA reports from other agencies, systematic reviews and meta-analysis, clinical practice guidelines and coverage policies from other countries. Twenty-three of them were brief technical documents that are more comprehensive reports based on a primary literature search and a critical review of the most up-to-date evidence. Interestingly in recent years, the number of reports on pharmaceuticals has been increasing from 8 or 12 reports per year in 2003 and 2004, to 21 reports in 2006. They represented only one-third of all the reports published in 2003 and now they represent almost half [5]. The Institute webpage receives nearly 10,000 visitors each month and has more than 5,000 registered users from more than 20 countries that receive a monthly HTA newsletter. In Argentina, the documents are used to define health coverage policies mostly by the 25 organizations that are members of this HTA consortium. This consortium is a mix of public and private institutions that together provide coverage to about half of the Argentinean population [6]. These HTA reports are also indexed in the Centre for Reviews and Dissemination database hosted by The University of York, in the INAHTA database and in the IECS local database.

Regarding decision-makers' attitudes and views, and regarding the use of HTA and economic evaluation, IECS undertook a qualitative research project that was part of the Nevalat initiative (Latin American Health Economic Evaluation Network) some years ago with the objective to evaluate health decision-makers' knowledge and attitudes about economic evaluations and whether HTA was increasingly used for decision-making [7]. It was a qualitative study design based on semi-structured interviews and focus groups which were used to explore how decision-makers belonging to different health sectors in Argentina implement research allocation decisions. Informants were mostly unaware of economic evaluation and its use in decision-making. The most important criteria they mentioned to adopt a treatment or coverage policies were evidence of effectiveness, social and stakeholder demand, or resource availability. Despite a general positive attitude, knowledge was rather limited in this audience. Cost considerations were widely accepted by purchasers and managers, but clinicians argued that they interfered with the patient/doctor relationship. Other barriers cited by the interviewees were: lack of confidence in the transferability of studies, the institutional fragmentation of the health care system. However the new situation created by the Argentinean economic crisis of 2001-2002 was cited as a favorable context for these rationing measures, though most of them were implicit. Although explicit priority setting was implemented by many purchasers and managers, HTA was not used as a priority setting tool in this context.

Another important factor in most countries is the pharmaceutical sector which is slowly encouraging the local use of health economic evidence and HTA activities, partly by fostering educational activities both in-house within the country or in the region, and also gathering key decision-makers for educational short courses, or short educational activities. It is also sponsoring local field studies. For example, IECS designed and maintain an Argentinean cost database that now has more than 1,000 service costs for the different health sectors of the country with more than 6,000 unit costs data and also is actively commissioning health economic evaluations - both local Argentinean health economic evaluations or as part of multi-country collaborative projects using either global models or models developed locally [8]. In summary, HTA demand increased importantly after Argentina's crisis, with overlapping needs from different stakeholders - both in the public sector, and in the social security sector. The private insurers have similar and overlapping demands which created fertile ground for the growth of HTA. The social security, the public and private sector decision-makers are becoming more aware of HTA and economic evaluation reports and their relevance to decision-making.

Nevertheless it can be concluded that HTA has had a limited albeit important impact to evaluate the efficiency of the services covered by the social health insurance in Argentina and further steps are needed to strengthen the formal link between HTA and decision-making and, importantly, to foster the adaptation of HTA into the local reality.

References
  1. Fuente: INDEC, Censo Nacional de Población, Hogares y Viviendas 2001.
  2. Indicadores Básicos. Argentina 2006. Organización Panamericana de la Salud. Ministerio de Salud de la Nación.
  3. Plan Federal de Salud. Ministerio de Salud de la Nación. http://www.msal.gov.ar/htm/site/pdf/Plan%20Federal%20de%20Salud.pdf
  4. Pichon-Riviere A, Augustovski F, Rubinstein A. Health Technology Assessment in Argentina: six years in perspective. Congress abstract - 3rd Annual Meeting Health Technology Assessmente International. HTAi 2006, Adelaide, Australia.
  5. Pichon-Riviere A, Augustovski FA, García Martí S, Rubinstein A. Assessment of New Pharmaceuticals by the Main Health Technology Assessment Agency in Argentina. Contributed Poster Presentation. ISPOR 1st Latin America Conference. Cartagena, Colombia. September 2007: page 201.
  6. Pichon-Riviere A, Augustovski FA, Garcia Marti S, Rubinstein A. Assessment of the Performance of an Hta Agency to Inform Policy Decisions in Argentina. Oral Presentation. 4th HTAi Annual Meeting, Barcelona, June 2007: page 116.
  7. Rubinstein A, Belizán M, Discacciati V. Are economic evaluations and health technology assessments increasingly demanded in times of rationing health services? The case of the Argentine financial crisis. Int J Technol Assess Health Care 2007;23:169-76.
  8. Pichon Riviere, A; Regueiro, A;Souto, A;Augustovski, F. Base de datos de costos sanitarios Argentinos / Health Care Costs Database - Argentina. http://www.iecs.org.ar/iecs-visor-publicacion.php?cod_publicacion=146&familia=8&origen_publicacion=buscador

Pharmacoeconomics and the Decision-making Process: The Brazilian Experience
Alexandre Lemgruber Msc, Brazilian Health Surveillance Agency, Office of Economic Regulation, Office of Economic Evaluation of New Technologies, Brasilia, Brazil

This following will summarize this subject from a government point of view, specifically from the point of view of the Brazilian Health Surveillance Agency - ANVISA. Although universities were the first institutions in Brazil to promote research and organize meetings on pharmacoeconomics, and industry has in the recent years become more and more interested in pharmacoeconomics and concerned about training programs, this article will focus on how pharmacoeconomics has been incorporated into the decision-making process in the Brazilian government. The following will also address what are the capacity- building strategies in Brazil, what is the national policy in this field, the importance of working on dissemination and finally, how Brazil has participated in international collaboration.

Prior to 2002, pharmacoeconomics was discussed only at the academic level. In November of 2002, ANVISA organized a meeting called the “International Experience in Pharmacoeconomics”. It was a starting point for discussion of pharmacoeconomics in the Brazilian government and there were representatives of 8 countries present who had experience in this field. The Brazilian government invited 150 decision-makers from federal, state and municipal levels, as well as representatives from universities and industry to discuss how to set an agenda for starting in pharmacoeconomics. For the first time, pharmacoeconomics was considered at the official level as part of the agenda, and the priorities that were set at that meeting were: applying pharmacoeconomics to regulation, capacity-building strategies, dissemination strategies, setting collaborative centers for government, and international cooperation.

From that starting point in 2002, important landmarks can be highlighted. In 2003 the Office of Economic Evaluation of New Technologies was made responsible for working with pharmacoeconomics within the Agency. In 2004, pharmacoeconomics was incorporated into the price regulation scheme for drugs. It was the first official use of pharmacoeconomics in Brazil. In 2005 a commission was nominated to propose a National Policy for Health Technology Management. In 2006 the first issue of the Brazilian Bulletin for Health Technology Assessment (the BRATS) was published, and the Commission for Health Technology Incorporation (CITEC) was created.

The following gives some information on the first regulation policy where the Brazilian government applied pharmacoeconomic concepts, the price regulation policy for new drugs. Price regulation policy is defined by the Pharmaceutical Price Council - CMED, which is formed by 5 ministries: Health, Finance, Justice, Industry and Civil House. The Minister of Health is the president of the council and ANVISA is the Executive Secretariat. ANVISA decides on the price of new drugs which can be reviewed by the Council. The Office of Economic Evaluation of New Technologies is responsible for technical support, and makes the recommendation about the ceiling price for new drugs. But why is the health agency involved with price regulation? In Brazil, the Agency has the mission of working to improve people's access to these technologies. In this model, the economic dimension plays a very important role in the regulatory framework. The pharmaceuticals have been the main focus of economic regulation to date (Brazil has just started gathering economic data on medical devices).

The prices of new medicines are defined based on clinical evidence and economic analysis. To get the premium price, the industry has to prove that the new medicine has clinical benefits over the comparator, the condition to be in the so called Category I. The premium price for a Category I medicine has a ceiling price that is the lowest price in 9 developed countries. If the industry cannot prove the benefit then it takes the price of Category 2 medicines, which are “me-too” drugs, and the price is decided based on cost-minimization analysis. Without going into details on the process of analysis, one can say that the key points of this analysis, after the dossier is submitted by the industry, are: the literature review, the choice of the right comparator, and then the cost-minimization analysis to define the ceiling price. The Office of Economic Evaluation of New Technologies and the Office of Economic Regulation then make the recommendation to the Executive Secretariat of CMED, which makes the decision on the ceiling price (within a deadline of 3 months after submission). So, one can say that there are two conditions to market a drug in Brazil: the registration, as usual, and then the price approval based on this model.

The following listings summarize the decision-making process for the pricing decisions, the criteria for the evaluation of new drugs and the main steps of the evaluation process:

The Decision-making Process: Pricing Decisions
  • Price Regulation Policies are defined by the Pharmaceutical Price Council, formed by 5 Ministries (Health, Finance, Justice, Industry and Civil House);
  • ANVISA is the Executive Secretariat: decides on prices of new drugs, which can be reviewed by the Council; and
  • The Office of Economic Evaluation of New Technologies is responsible for the technical support and for the recommendation about the prices of new drugs.
Price Regulation of New Drugs
  • Prices of new medicines are defined based on clinical evidence and economic analysis;
  • To get a premium price, the industry has to prove that the new medicine has clinical benefits over the comparator - Category I ;
  • The premium price for a Category I medicine has a ceiling: the lowest price in 9 developed countries; and
  • The prices of category II medicines (me-too) are decided based on costminimization analysis.
Main Steps
  • Economic dossier submitted by industry;
  • Choose of the right comparator;
  • Literature review;
  • Cost-minimization analysis;
  • Recommendation to the Secretariat; and
  • Marketing approval (deadline: 3 months after submission).

Moving forward, a new commission was created in 2006 and it was an important initiative from the Ministry of Health - it is called the Commission for Technology Incorporation (CITEC) and has 5 members - 3 from the Ministries of Health (the Secretary of Health Attention, the Secretary of Science & Technology and the Secretary of Disease Control); 1 from the National Agency of Supplemental Health (ANS - the agency responsible for regulating the private market, the Health Maintenance Organizations (HMOs)); and 1 from ANVISA. The Commission makes recommendations to the Minister of Health, who makes the final decision about incorporation. Pharmacoeconomic studies are mandatory if the new technology is more expensive than those already incorporated. Budget impact analysis is required as well. Brazil is one of the first countries in Latin America to establish the fourth hurdle to incorporate new technologies into the public system, but the implementation of the new rules has just begun.

In Brazil, the main actors in this process of discussing the evaluation and incorporation of technology in Brazil are as follows: 1) ANVISA is responsible for registration, economic evaluation and price regulation of new drugs based on health technology assessment; 2) ANS decides on the incorporation of new technologies in the private health sector; 3) The Secretary of Science & Technology is responsible for the health technology assessments in the Ministry of Health and the national policy on health technology management; 4) The Secretary of Health Attention is responsible for the coordination of CITEC; and 5) The Secretary of Disease Control has the responsibility for specific programs - for example, HIV. It is very important that each of the actors has his own responsibilities and that they are working in integration. The fact that they work together and are integrated to discuss the incorporation is a very interesting model, because it allows the sharing of responsibilities and allows for complementary abilities to result in responsible and informed decisions on evidence.

It is also very important to discuss a national policy. In the last two years Brazil has engaged in a discussion to set the process coordinated by the Secretary of Science & Technology. The public has made several contributions. The main direction of the policies were to have the decision-making process be based on evidence, to improve the process for incorporating new technologies, to encourage rational use of health technologies, to strengthen research, education and dissemination strategies, to strengthen the governmental institutions and to maintain the permanent dialogue between public and private institutions and civil society. This national policy is about to be approved by the Minister of Health.

Another major issue is capacity-building. Since 2003, ANVISA and the Ministry of Health have made several efforts to develop human resources in pharmacoeconomics and health technology assessment. ANVISA has a cooperation agreement with the Pan- American Health Organization (PAHO) to finance a permanent educational program targeted to civil servants at the federal and state levels and other health professionals.

One very important thing is to work on dissemination strategies, such as the Brazilian Bulletin for Health Technology Assessment (BRATS), the communication initiative of ANVISA, ANS and the Secretary of Science & Technology. The goal of this publication is to deliver reliable information about health technologies to decision-makers and to health professionals. The BRATS had 4 issues so far and is available at: www.anvisa.gov.br/divulga/newsletter/brats/ index.asp.

Finally, there is the importance of working in collaboration. ANVISA has been working in collaboration with HTA agencies and government bodies responsible for economic evaluation and pricing decisions. Among the international cooperation activities since 2003, can be highlighted: a) training programs in Canada and Spain; b) cooperation agreement signed between ANVISA and the Institute for Clinical Effectiveness and Health Policy (IECS) in Argentina; c) participation in some activities with the NEVALAT network; d) training programs in the Agency targeted to the countries that are interested in learning about the Brazilian experience; e) participation in the Health Technology Assessment Commission of Mercosul. It is very favorable that Brazil now has an ISPOR chapter. It is a very important initiative that helps in this process of sharing experience as the country tries to go further in this process of establishing pharmacoeconomics as an important tool in the decision-making process.

In conclusion, pharmacoeconomics plays a very important role in price regulation. It is now considered in the new incorporation rules and it is going to be part of the national policy. It is important to focus on capacity-building and we should seek cooperation among international institutions. There is a lot that has been done, and there is a lot to do in the upcoming years.

For further information, please email: alexandre.lemgruber@anvisa.gov.br.

Pharmacoeconomics & Outcomes Research in Latin America-Chile
Emilio Santelices Cuevas MBA, MD, President, Doctors for Chile & Anesthesiologist, Clinica Las Condes, Santiago, Chile

When we talk about pharmacoeconomics or the evaluation of results in Chile, it must be done in the context of what has occurred in the recent years - this means referencing the health reform framework that the country began approximately five years ago. It has been challenge, but this article will attempt to show what has been the foundation and some of the initial results of this reform, in order to better understand what is the desired future and vision to which we are contributing and collaborating in this new scenario in Latin America today. Chile is in a position much like other countries in Latin America. It is a country in an advanced demographic transition with health indicators which are among the most advanced in Latin America. It has a developed country pattern with a prevalence of chronic illness. On the other hand, it has regional and communal health disparities, for example, life expectancy can be 10 years less in one region than in another. Associated with this, there are growing costs, an increase in the demand for health care, inefficient management of resources and methodological failures in their allocation. However, when this reform was established in Chile, the government, together with the participation of some stakeholders, intended to achieve better health care goals in Chile. It is necessary to pay tribute to these predecessors because the health authorities at that time had the vision to make adequate interventions, face new challenges in relation to changes in demographics, reduce the inequality of health, and provide services according to the needs of the population. Chile faces the beginning of the current century with an imperative to maintain so-called standards, but to also advance these standards while doing justice to the reality in terms of the challenges that it faces today. This is how, in a very summarized way, four main legal aspects were defined as the reform framework, all of who are determined to guarantee access, opportunity, financial coverage, quality and over all focus on the patients. This article will only concentrate on one of the four legal aspects and which has received the greatest recognition.


Figure 1. Explicit Guarantees in Health Care

This legal aspect is called the GES (see Figure 1). This GES tells Chilean citizens: “Ladies and gentlemen of the Chilean state, from the time this law is announced, it will guarantee you health care attention, access, opportunity, financial coverage and quality”. This new condition included 56 pathologies that must be guaranteed in a protocol defining cost and time frame. These guarantees started a process of implementation that has been going on for three years and that is defined according to various priorities. It can succinctly be said that the analysis of this situation brings an account of 56 pathologies that corresponds at least to 60% of the burden of illness that the country has. Therefore, the message sent to citizens was that government and authorities were taking care of their future with regards to what health care involves and especially with regards to a well resourced distribution. Table 1 shows a partial list of those diseases that were included.

What happens in terms of results? There is currently a debate in Chile as a consequence of a series of problems that appeared regarding implementation. Perhaps the less evident problem, which if not adequately managed, could have a larger impact, is what concerns should have financial coverage. Regarding this issue, there are three studies - one of which was developed at the Physicians Corporation for Chile [Médicos para Chile]. This study corresponded to a preliminary study done before the system was put in place, which estimated a basic health care cost per subject of $86, then when the regime was already in place an independent consultant estimated that the real cost per subject was $105. As a result of this data, the main question is: Which is the real cost that the state will have to assume in the future? If the state estimated these costs because it has been determined that there are hidden demands and there are costs that have not been answered for, then there is a need to improve each of these health care protocols to bring the exact necessary health care procedures to the population, and therefore to estimate with certainty the real costs involved for this system. Having determined these challenges and having set up this reform, we can say that it cannot be timelier or necessarily challenging to take up the discipline of pharmacoeconomics in order to move Chile into the future. The World Bank made suggestions regarding investment in health at the end of 1993 to all the countries in Latin America to help them contain health costs that were increasing in an uncontrollable fashion. If we cannot make adequate forecasts of this spending, then we will not be able to accomplish this objective. Another concern is whether Chile needs to incorporate new diseases or whether it should work more in depth with the protocols for each of the diseases that are already listed. For example: For Miocardial Infarction disease the guarantee included only Streptokinasa treatment. The state realized that it was necessary to move toward the gold standard which is angioplasty treatment and that means a higher cost not previously evaluated. So how can Chile approach this issue of pharmacological protocols? Perhaps by using first treatment line or adequately improved tools of treatment? Which tool should be used to make assessments? These are questions that need to be answered. On the other hand, there is enough evidence that shows that there are currently new priorities that must be taken into consideration, which raises the concern of either needing to move along the pathway of curative medicine, or if to perform health interventions with preventive measures? Chile must assess preventive procedures to reduce negative factors like, obesity, non-exercise, and smoking. Finally, how can Chile incorporate the new technologies into this scenario? Each of these questions requires tools for analysis and the application of pharmacoeconomics as a main discipline.

The structural issues within other Latin American countries, whereas this portion focuses on the different objects within that structure, are also a concern. The biggest question remains is if Chile is ready? What is the level of knowledge knowledge and use of pharmacoeconomics and outcomes research in Chile? Chile is performing research, collecting information, and trying to establish technical criteria. However, the selection of priorities made by decision-makers usually does not take into consideration this area. We need to focus not only on working in this area, but also on exerting a strong influence to ensure that decisionmakers are truly informed on these issues. That is why at Médicos para Chile, in looking for health solutions in Chile, we asked: 'How prepared are we?' To answer this question, we made a very short survey of decision-makers in the private and public sectors at academia, to insurers, and at the pharmaceutical industry, in order to know the level of knowledge and the use of economic evaluation in health care. We asked: “Have you heard about pharmacoeconomics?” This was a very broad question and practically 1/3 of the respondents did not even know what pharmacoeconomics was; only one-fourth of them had attended congresses or seminars on these topics (Figure 2). As a result, we must say that we clearly have a problem on our hands. If we agree we have a huge challenge ahead of us, we need to also agree the gap between the critical mass of those who have to face this challenge and what is required in practice is also huge.


Figure 2. Knowledge of Pharmacoeconomics

Therefore, the work we have taken on ourselves in Chile is to move forward in this field of economic evaluation; that is why we believe the time has come to collaborate, with a clear idea on the provision of tools to the primary players - the insurers, the providers, the health care sector, health technology, and the pharmaceutical industry - so that all can work together to share knowledge, to help the decision-makers become appropriators of these tools, and to take this discourse as their own. We cannot remain just in the academic realm. If we cannot share and become the disseminators of these tools we will not turn them into a better health condition for our people. We need to collaborate in training and in creating tools and curricula that will bring this knowledge close to the physicians, clinicians, and decision-makers who are acting in the local scene. We need to work together in order to create and apply knowledge at a local level. It should not just be knowledge to feed scientific journals, but knowledge that can be grounded and can be brought to the people in the form of better care, quality and health (Figure 3).


Figure 3. Time of Collaboration

Pharmacoeconomics and Outcomes Research in Colombia
Rafael Alfonso MD, MS, Past-President Local ISPOR Chapter - Colombia, PhD Student - University of Washington, Seattle, WA, USA

Background
Colombia is the fourth largest country in Latin America and, like many other middle-income developing countries, it suffers from the double burden of chronic non-transmitted diseases - especially cardiovascular and metabolic - and infectious and transmittable diseases - especially in children and susceptible populations [1].

This situation increases the difficulty associated with making appropriate decisions pertaining to the allocation of scarce resources in the health care system. The current Colombian health care system is a product of the reform of “Law 100” in 1993, transforming the government based “National health system” to an insured system aiming to integrate the social security and public health sectors and to create universal access to the system, while bringing market pressures to bear on institutions to improve their efficiency. Colombia has three different regimes: “contributive” for employees and independent workers, “subsidized” for the poor, and “linked” (vinculados) for uninsured [2].


Figure 1. Outcome of CTMT reviews from 2003 to 2005

Insurers of the contributive regime (Entidad Promotora de Servicios-EPS) and of the subsidized regime (Aseguradoras del regimen subsidiado-ARS) contract with institutions and health care professionals, which can be public or private, to provide the health care services to patients.

The regulators of the system are headed by the Ministry of Social Protection and the Comité Nacional de Seguridad Social en Salud (CNSSS) which is the body that finally decides the benefits package that all Colombians receive according to the regime to which they belong (Table 1).

Individuals that belong to the contributive regime receive most of the benefits in the approved package, including catastrophic diseases. Subsidized individuals receive partial coverage in higher levels and usually by public providers. Obviously there are limits and access barriers in the system (i.e., currently the co-payment is around 30%) [3].;

One of the main accomplishments of the Colombian health system has been the increase in coverage of the population, from 23% before 1993 to around 75% in the second quarter of 2006 (39% subsidized and 36 % contributive regime). The government expects to increase this coverage even further in the next 4 years [4].

Decision-Making Process in the Benefits Package
In theory, the government, through the Ministry, the national scientific societies and patient associations can submit proposals for drugs, devices or procedures to be included into the mandatory benefits package (Plan Obligatorio de Salud), to the Quality Office at the Ministry of Social Protection. Once the submission is determined to be complete, it is reviewed by a committee called Comité Técnico de Medicamentos y Evaluación de Tecnología (CTMT), or the Technical Committee of Drugs and Technology Evaluation. The main functions of the committee are to recommend the inclusion or exclusion of drugs, devices or procedures from the health plan offerings; to ask the Ministry of Social Protection to provide the necessary information, studies or evaluation to support their recommendations; and to present at least one review of the entire list and manual of procedures and evaluations of technology, establishing the inclusions and exclusions, criteria and recommendations. The committee could: 1) seek independent advisors and reviewers on specific topics; 2) recommend the inclusion or exclusion of a procedure, drug or device; or 3) ask for a recommendation from the Ministry. In any case, they are not autonomous to change the health plan, and it is the CNSSS which makes the final decision which may follow or not follow the recommendations from the committee. The members of the CTMT include: a health professional specialist in pharmacology, a physician, an epidemiologist, two health professionals specializing in health economics, and a professional with knowledge in economics and health care costs.

The coordination of this committee is led by the director of the Quality Office at the Ministry of Social Protection. An additional permanent invitee to this committee is the representative of the Pan American Health Organization (PAHO) in Colombia.

The submission requires all the product information, including efficacy and safety profiles, and information to support the replacement of any of the drugs, procedures or devices that are available on the list at that time. Additionally, at least one local cost-effectiveness study should be provided according to the requirements. Before 2005 it was not required to have local cost-effectiveness studies, but after 2005 at least one local study is required.

In a review by L. Cubillos, a total of 55 submissions received by the committee between 2003 and 2005 were assessed, 31 (62%) were recommended to be included in the health plan, but only 16 (29%) were finally included. Thirteen (23%) were still pending on the decision by the CNSSS, and inclusion was not recommended for eleven (15 %). At the time of the review, the remaining had not yet received a decision (Figure 1).


Figure 1. Outcome of CTMT reviews from 2003 to 2005

These results from the CTMT showed that the frequency and number of meetings was below what was expected, there was not a standardized methodology to evaluate the information submitted, particularly for the health economics and outcomes research data, and the recommendations appear to lack consistency. Clearly, there was room for improvement and several groups have been working very hard to improve this process; as a result, a new law has been written, law 1122 of 2007, which has created the Comisión de Regulación en Salud (CRES) - or Health Regulation Commission. Currently, the new members include: the Ministry of Social Protection or his delegate, the Ministry of the Treasury or his delegate and five commissioners that are to be elected from a university, a clinical research center, a health economics research center, an association of health professionals and an association of patients. In general, members are expected to have a minimum of ten years worth of experience and expertise in the field of interest. The main functions of CRES are: 1) to define and adjust the basic health package; 2) to define and review the list at least once per year; 3) to define and review the premium or unit of payment per capita in each regime; 4) to establish and update payments and honoraria for health care providers; and 5) to report an evaluation of the health care system and issue recommendations to Congress. It seems that, on paper at least, this new body has more autonomy and additional decision-making influence than its predecessor was provided.

Decision-Making Process by Insurers
Decision-Making Process by Insurers At this point in time, each insurer has autonomy to provide any health technology not included in the basic package, yet they must assume the cost. There is not a specific structure or committee devoted to health technology assessment (HTA) for private insurers, and neither laws nor guidelines that they can follow. Nevertheless, a few insurers indicate that they have their own HTA procedure and methodology, but almost none are currently making decisions based on cost-effectiveness or health economic tools - or at least there are no reports or publications available from their decision-making process which suggests otherwise.

Pharmacoeconomics and Outcomes Research Education
After performing a review of approved educational programs in Colombia through the National System of Superior Education, of which there are only seven, with most of them at the Specialization (or bachelor's degree) level, no Masters-level or PhD programs were identified pertaining to pharmacoeconomics or health economics and/or outcomes research. The currently available programs have greater emphasis in administration and management compared to health economics itself, and there is very little emphasis on outcomes research topics. This was a “gap” identified through our analysis process. There are specific groups and scientific societies that have been created very recently such as ACOES (Asociación Colombiana de la Economía de la Salud), which was created in 2006 with great success. The first Congress of Health Economics was held in Bogota in November 2006. Also, the ISPOR Local Chapter was created in 2007, with 32 founding members and an ambitious development plan. Between these two scientific associations and several research groups, the knowledge and use of the health economics and outcomes research tools is expected to improve in the coming years.

Conclusions
In summary, pharmacoeconomics and outcomes research in Colombia are starting to emerge as important tools for decision-making in the health care system, nevertheless the lack of information and experience in these fields impede a higher impact.

The aim of academics, researchers and scientific groups should be to expand information systems with the help of insurers and providers, and to improve the data to help shape regulations and methodologies used by the new CRES. Finally, we must share current and future study findings by publishing the information and allowing the scientific community and other stakeholders the opportunity to scrutinize the results and to provide feedback on the process of continuing to learn as we advance.

References

  1. Boutayeb A. The double burden of communicable and non-communicable diseases in developing countries. Trans R Soc Trop Med Hyg 2006;100:191-9.
  2. Aiming for equity in Colombia's health system reform: Achievements and continuing challenges: International development research centre [homepage on the Internet]. [cited 8/9/2008]. Available from: http://www.idrc.ca/en/ev-118490-201-1-DO_TOPIC.html.
  3. Barón-Leguizamón G. Gasto nacional en salud de colombia 1993-2003: Composición y tendencias. Rev salud pública 2007;9:167-79.
  4. Ministerio de la proteccion social /Estadísticas del ministerio de la protección social [homepage on the Internet]. [cited 8/10/2008]. Available from: http://www.minproteccionsocial.gov.co/VBeContent/NewsDetail.asp?ID=14606&IDCompany=3.

Pharmacoeconomics & Outcomes Research In Latin America-Mexico
Guillermo Meléndez MD, MSc, Fundación Mexicana para la Salud & President, ISPOR México Local Chapter, México City, México

The current health system in Mexico is organized in such a way that the Ministry of Health regulates the different institutions who oversee the medical services in the country. The main institution is the IMSS (Instituto Méxicano de Seguro Social, or the Mexican Institute for Social Security) which covers employees and accounts for almost 50% of the population in the country. Then we have the ISSSTE [Instituto de Seguridad y Servicios Sociales para los trabajadores del Estado or the Security and Social Services for Civil Servants] which provides the medical services for the civil servants and accounts for about 11% of the population. The other big institution is the Ministry of Health by itself, attending to the worst-off, and this accounts for about 21%. So these 3 main institutions account for 80% of the country population receiving medical services. The rest are: the army, the marines, and PEMEX - which is the oil company run by the government and which, in wealthy times such as in 2007, they spend with less restrictions, but in other times they reduce the medical services budget significantly.


Figure 1. Mexico's Health System Organization

Then, there is the private medicine which is a kind of “out-of-pocket” medicine, along with the medical insurance companies, which have not grown very much in Mexico to date. All these health institutions depend on one General Health Council which is the council that decides or assesses the introduction of new drugs into the health system institutions. The General Health Council is composed of four different commissions and each commission is represented by one representative from the main institutions. The main mission for this General Health Council is to develop and update a national formulary and health goods catalogue for the best provisioning public institutions from the national health system in accordance with medical science and technology. This was released in May 2003 as the mission for the council. What happens in this General Health Council? How does it work? (see Figure 2)

Figure 2. How does the purchasing or acquisition process work?

Requirements for submission for a new drug to be assessed and approved as part of the formulary are: having the evidence of good manufacturing practices (either national or international); providing proof of clinical evidence or clinical efficacy and safety for the new technology; recently, in 2003 they required that pharmacoeconomic evidence be submitted demonstrating that there is more value for money for the institutions including the main new drug as compared to the current drugs that are already included in the national formulary; and some other special requirements that apply to transportation such as drugs that require refrigeration for instance. In May 2003, the health law in Mexico was changed and amended to require that - for the medical drugs, for diagnostic aids, for disposable materials, for medical devices and for equipment - an economic study be submitted by the manufacturers in order to be assessed for inclusion in the national formulary list.

Hence, any drug that has been assessed and approved in the national formulary will be included in this new catalogue, which is updated from time to time according to the order that the drug or any other device has been approved by the Council. Once the drug is approved by the General Council they have to go to the institutions. After that they have to resubmit to the institutions to be approved at each institution so even though the Council has approved the drug or device, they have to be re-approved by the institutions. Once they are approved by the institutions, they then start supplying the new technology to the government. The supplies enter intervening processes where manufacturers do not sell directly to the government, but through a distributor and bidding is held once or twice a year depending on the institution and the yearly spending. For medical drugs in Mexico, about $1.5 billion is spent, which is a significant amount for this country and it requires a more sensible process which necessitates the inclusion of pharmacoeconomics into the way decisions are made in the country. In summary, the purchasing and decision process is: the Council approves the national formulary catalogue of goods and sets the national price - a ceiling price is set for drugs and they cannot go further than that - but each institution is independent on the purchasing. For instance, in the case of IMSS, there are independent regions and each decides by region what to purchase from the manufacturers. But other institutions, smaller institutions, are mainly purchasing in a centralized way. There are two meetings a year for the purchase of any goods massively, and biddings are divided into national goods (mainly represented by generics), international goods (which are patent protected) and goods that were not included in the national formulary, but which are necessary for the institutions. They then have to go and bid and these innovators are sold to the system at mainly market demand prices. Currently, health technology assessment is at the very first stage where the drug or any other health technology is assessed to be included into the national formulary and anything further is not considered the health economic assessment at the biddings which are mainly driven by the price set before in the process.

National goods and bidding are pushing for lowest prices, and the international goods and bidding are pushing for global prices, and goods not included in the national formulary but required by the institutions, are sold at market prices. What are the problems with this system? Until last year, the level of knowledge of health economics within the Commissions' consultants was almost nonexistent. They continued making decisions with clinical evidence rather than health economics, and that was a problem because they were requesting health economics assessment when they were not able to do any assessment at all from the modeling and critical point of view, which led to more difficulties in interpreting what the health assessment was for that particular drug. Fortunately in the past year, this situation has significantly changed and new advisors with ample experience in health economics are now involved in drug assessment. There are more qualified government personnel doing health economics assessment and planning, but the rest of the commissions - for instance for the medical devices or disposable materials and diagnostic aids commissions - are still lacking clear regulations for all the parties in the system. The government has already been working on the pharmacoeconomic guidelines and they will soon be released. These guidelines will very clearly delineate the requirements for all parties and will improve the way the submission of new drugs is performed. Experts on health economics are using the initial assessment at the level of the General Health Council, but once the General Health Council has approved there are no other points where health technology assessment is done. Meetings are basically comprised for national manufactures and the price approved for international manufactures. There is no information or feedback about effectiveness of different drugs listed in the national formulary, as the institutional pharmacovigilance system works independently from the decision makers. There are an increasing number of drugs in the national formulary, but no drugs are being removed from the national formulary, so there are a consistently growing number of new drugs whilst keeping the old drugs on the list.

The other problem seen with this system is that all these institutions that are managing the health system in Mexico do not exchange or share information, neither with externals nor themselves. It has become very difficult to do external prices on the effectiveness of drug management. Other issues that have been identified are that institutions are lacking clinical guidelines to standardize the practices of treatment, and there are a great number of personal decisions by doctors in terms of the management of a particular disease. So, there is a need for standardizing protocols and guidelines for the management of critical diseases. In conclusion, the national formulary system should be updated in its whole. There are too many institutions in the system with different needs and purchasing capacities. Numerous decision-makers in the process (many that could be considered illiterate on health economics and the national education strategies) necessitate the important education of decision-makers on a day to day basis. Rules for bidding need to be updated to include the health economics assessment, and government databases should be shared with all the parties in order to understand how the institutions are making decisions on the spending of the budget.

Conclusion
The ISPOR 1st Latin America Conference provided many important lessons, beginning with the fact that there is definitely awareness of the need and benefits of pharmacoeconomics and outcomes research in the region, yet much more needs to be done in terms of capacity building and applying this tool to decision making. Governments are key audiences for pharmacoeconomics and outcomes research and currently are assuming some level of leadership in terms of trying to incorporate it into policy making. There are also many examples of private institutions striving to promote the use of pharmacoeconomics for decision-making. Thus, countries face the challenge of articulating public and private efforts towards the generation and uptake of pharmacoeconomics evidence for policy.

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