Policy Analysis: Feasibility of Health Technology Assessment as a tool in making decisions on health in Colombia.

Transcription

1 Policy Analysis: Feasibility of Health Technology Assessment as a tool in making decisions on health in Colombia. MSc in Health Policy, Planning and Financing UNIVERSITY OF LONDON London School of Economics and Political Science / London School of Hygiene and Tropical Medicine Gerardo Andrés Lopez Benavides MD, MSc September 2011

2 TABLE OF CONTENTS 1. ABSTRACT p 4 2. INTRODUCTION 5 3. METHODOLOGY 6 4. POLICY ANALYSIS Context Situational Factors Structural factors Colombian Health System Operation Health Technology Assessment Cultural factors External and Exogenous Factors Resources and Funding Regional Health Technology Assessment and Pharmaceutical Referencing Context Conclusions for Colombia 4.2. Policy Process Agenda Setting Political Process Stakeholders Perspectives about the IETS General Perception Perspectives surrounding the need of a Health Technology Assessment Agency in Colombia Normative Effects of IETS decisions IETS and the System s Sustainability Interaction between the IETS, the MPS and other Government Agencies Interaction between the IETS, the Civil Society and Market-related interest 2

3 groups Policy Formulation Stakeholders participation Description of the Policy Content Conclusions on Agenda Setting 4.3. Policy Process Implementation Process after Policy Formulation Policy Communication Type of implementation Conclusions 5. DISCUSSION AND CONCLUSIONS Feasibility of IETS 5.2. Recommendations to enhance feasibility of IETS 5.3. Role of IETS 5.4. Application of HTA in the Colombian SHI System 5.5. Potential advantages and disadvantages of the policy 5.6. Conclusions 6. BIBLIOGRAPHY APPENDIX Section 1 Colombian Health System Analysis Section 2 Regional Health Technology Assessments And Pharmaceutical Referencing (5 countries) Section 3 General Stakeholder s Perspectives about HTA Section 4 Exhibits ANNEX Informed Consent Format for Interviews 8.2. Interview Questionnaire 3

4 1. ABSTRACT The growing concern of continuous increases in health care expenditure, particularly due to high-cost medicines reimbursement, as well as international trends, promotes the feasibility and a positive scenario to establish a means for Health Technology Assessment (HTA) in Colombia. Methodology: This policy analysis paper utilizes a literature review to support the context surrounding the Colombian Health System, focusing on HTA, and a regional perspective. Following, personal interviews were conducted to provide a description of the policy process of agenda setting and policy implementation, as well as stakeholders opinions about the establishment and functioning of such a HTA Agency. Results: Colombia s Health System sustainability is a major concern for policy-makers as well as stakeholders. Although there exists a comprehensive benefits package that provides a holistic coverage for main ill-health conditions, there are gaps in current regulation, structural and cultural factors, that allow health technologies and medications not proven of high-value-for money to be reimbursed by the Social Health Insurance System. Being the Government responsible for the System s leadership and regulation, it led the policy process from agenda setting to formulation, and is currently working on its implementation. During the policy process, various actors participated at different times and levels, and most agreed on the need of a HTA Agency to aid in the priority setting process. Key issues such as political will, autonomy and independence, sufficient financial and human resources, as well as a transparent communication process are depicted as essential to guarantee the feasibility in achieving its objectives. Conclusions: The establishment of a Health Technology Assessment Institute is not only viable, but also needed in the current development of the Colombian Health System. The feasibility is guaranteed by the support of the Government, Legislature, and most stakeholders, embedded in a regional and international enhancing environment. 4

5 2. INTRODUCTION The main objective of this paper is to analyse the Feasibility of Health Technology Assessment (HTA) as a tool in making decisions on health in Colombia. The Colombian Health System is currently experimenting uncontrollable increases in health care expenditure due to high off-list medications reimbursement. Although regulation exists, enforcement is difficult and even more so when health has been established as a principal constitutional right. Even though, the Health Technology Assessment Institute (IETS) was established by Law to aid in the process of deciding reimbursement, the regulation itself has not yet been enacted. Further legislation is still being developed, and therefore it becomes important to provide objective qualitative research and analysis to aid in the policy process to enhance the IETS s implementation success. The health decision-making process in Colombia is complex. Although the Ministry of Social Protection (MPS) is responsible for policy formulation and agenda setting, the process is fully scrutinized by the Ministry of Finance (MF) and other actors. The policy process involves previous proper stakeholder participation, and even though their inputs are not binding nor are they always summoned, their support is essential for a successful policy implementation. Since HTA is currently not widely used in Colombia, it is crucial to investigate among valid stakeholders their opinions about HTA, the IETS, and question about the critical factors that would make the IETS feasible in the Colombian scenario. In order to make a proper assessment, interviews were performed to relevant stakeholders which were divided in three main interest groups: Government, Civil Society, and Market-related. Structurally, the paper initially describes the Methodology used, followed by the Policy Analysis in a narrative format. In the Policy Analysis, first, a description of the context, including situational, structural, cultural, and exogenous factors are depicted. Second, the policy process of agenda setting is presented and analysed, taking into account the information gathered from the interviews. In this section, the political process, stakeholders perspectives about HTA-IETS, policy formulation, actors participation, and a description of the policy s content are presented. Third, aspects related to the policy implementation process are addressed. Fourth, discussion and conclusions are argued about the feasibility of the IETS, recommendations to enhance it, the role of the IETS, and the application of HTA in the Colombian Health System, ending with an analysis of the potential advantages and disadvantages of the Policy. 5

6 3. METHODOLOGY Literature Review Documents were collected and reviewed using multiple database searches, which included World Health Organization (WHO), Pan American Health Organization (PAHO), Organization for Economic Co-operation and Development (OECD), the World Bank, PubMed/Medline. The search terms used were (<country> AND Health System OR health care System, social care insurance OR health insurance, pharmaceutical strategy, reimbursement of pharmaceuticals, and health technology assessment). The publication dates were limited from 2000 to 2011, that were available in English, Spanish and Portuguese, and that were in the public domain. Additionally, the journals of Health Affairs, Value in Health, Pharmaco-economics, Health Policy and the International Journal of Technology Assessment in Health Care were hand-searched for relevant articles. Moreover, information available from the websites at the different Ministries and Government Agencies as well as non-published papers was analysed. Interviews Personal interviews were performed in Colombia with selected key opinion and decision-making leaders representing various stakeholder groups: Government, Civil Society and Market-related interest groups. The broad conception of priority setting and specifically the establishment of the IETS, enacted by Colombian Law 1438 of 2011 were addressed on an open-ended questionnaire. The survey was comprised on three sections (Annex 1). The first part evaluated the perception of different actors about the Health System s performance, and particularly in relation to high tech and new drug access. Moreover, the responsibility of Government agencies is assessed in terms of priority setting and resource allocation. The second part explored the stakeholder s opinions about the newly created IETS and its relationship to other Government Agencies, as well as non-government actors. The third part gathered information around the policy process, agenda setting, policy formulation and implementation of the IETS. Finally, the feasibility and issues that might be considered crucial for its success were assessed. The interviews were conducted in Spanish since it was the native language of the interviewees and researcher. To ensure technical functioning as well as relevance and understanding of the questions, two potential respondents were piloted. The interviews included twelve (12) key opinion and decision-making leaders on medicines reimbursements as well as relevant stakeholders. These involved representatives from three 6

7 main groups: Government (Ministry of Social Protection, and other Agencies), Civil Society (patient s representatives, academy, think tanks), and Market-related (pharmaceutical companies, health insurance companies, health-care providers, and physicians). The data gathered in the interviews was declared confidential and anonymous with respect to the respondent s personal identity. Therefore, no explicit quotations or references to particular stakeholders are mentioned. However, these opinions will be expressed according to the three main groups. Respondents were identified by previous personal and work related contacts. 4. POLICY ANALYSIS 4.1 CONTEXT In order to identify the main contextual factors that may have an effect on health policy, Leichter s way of categorizing them will be used: situational factors that relate to impermanent or transient conditions, which may have an impact on the policy; structural factors that are expressed as the relatively unchanging elements of the society; cultural factors, which may also affect the policy, and finally, international and exogenous factors, which lead not only to interdependence between states, but also influence countries sovereignty. All these factors are complex and unique and are needed to better understand the policy process (Leichter, 1979) Situational Factors Health Systems worldwide are generally operating under constrained budgets, irrespective of the nature of their financing mechanisms and wealth. Developed countries usually face high people s expectations about health care in relation to breadth, scope and depth of coverage (Mossialos and Dixon, 2002). Access to new and high technologies is hoped; however, various methods for rationing expenditure have been put in place, specifically related to health technology assessments in order to determine their expected value-for-money. In the case of developing countries, budget restrictions are even more important and possible focused primarily on achieving universal coverage while maintaining a somewhat comprehensive benefits package. Low-income countries are still struggling to find ways to sustainably fund their Health Systems focusing on basic coverage and donor aid (Evans et al., 2010). Colombia, as an upper middle-income country, has been focused on attaining universal coverage, practically achieved since it already reached nearly 95% of the population (Ministerio de la Proteccion Social, 2011b). 7

8 Currently, the main issue is most likely the System s sustainability, primarily due to the reimbursement approval of elements out of the benefits package, via legal actions, at the expense of the pre-determined Health System s budget. The judiciary System at local and regional levels have made decisions affecting the health sector, ordering the provision of services not explicitly included in the benefits package. According to Ombudsman s data there were more than 250,000 legal actions in the year 2005, and 35% were related to health care services (Orjuela et al., 2010). The total reimbursement for benefits out of the package has increased more than ten-fold, going from 1.2% of FOSYGA s (National Solidarity and Guarantees Fund) pooled funds in the period of , to 11.2% in 2008, and 17.6% in 2009 (Ministerio de la Proteccion Social, 2010). The current System s economic crisis has been attributed in part to the Constitutional High Court s ruling T-760 of 2008, which among other issues corroborated the citizen s right to health care services. It is noteworthy the exponential rise in claims evidenced between 2008 and 2009 after the ruling. In fact, the Ministry of Social Protection (MPS) reported that 86.9% of total costs in 2009 (COP $ 1,700 billion) corresponded to the reimbursement of non-covered benefits mainly in the contributory sub-system (Ministerio de la Proteccion Social, 2010). Nonetheless, the increased expenditure on these additional items, mainly new and high technology drugs and medical devices, have not been assessed to provide high-value-care. Pharmaceutical Expenditure The pharmaceutical division of the National Association of Industrials (ANDI) estimated that by the year 2007, the domestic medicines market represented around US $ 1,808 million, the majority of which was covered by national production. Moreover, the Colombian pharmaceutical market ranked fourth in the region following Brazil, Venezuela and Mexico. It was estimated that by year 2010, the institutional market (public and social insurance) would represent 52% of the total, which demonstrates the great expansion that the universal health insurance coverage has had. From the total of medicines sold in the institutional channel, 60% corresponds to branded medicines while 40% are generics. Both sub-systems, contributory and subsidized, cover all medicines prescribed for the patients in-hospital or ambulatory provided they are included in the positive medicines list of the benefits package (Giedion, 2010). Although drug pricing is regulated by free market competition, it has not been able to properly obtain affordable prices. In addition, Colombia provides health and access to health care as a constitutional and exercisable right, and thus citizens demand via legal actions, their noncovered medicines, procedures and devices. According to the MPS 2010, the approval rate of 8

9 these claims exceeded 98% (Ministerio de la Proteccion Social, 2010). In particular, reimbursement for non-covered medicines has been exponentially increasing (Appendix: Exhibit 1). In fact, figures from the MPS (Ministerio de la Proteccion Social, 2010) evidence that even though 99% of the medicines prescribed were in the positive list, mainly generics, it accounts for 55% of the total expenditure. (Appendix: Exhibit 2 & 3) Structural Factors In this section, the structural bases are described in reference to the Colombian Health System. First, a brief historical account of the health reform is presented, as well as the System s operation. Second, a view of the Pharmaceutical market and access to medicines is depicted. Finally, the evolution of the health technology assessment process is displayed Colombian Health System Colombia was the first upper middle-income country to introduce managed competition for its Health System by implementing a Reform in It changed the National Health Service managed by the state, to a market oriented Social Health Insurance (SHI) System. In 2000, The World Health Report ranked Colombia s Health System as the most responsive in Latin America, and number 22 in the world (World Health Organization, 2000). The main objectives were providing universal coverage and equal financial access to basic health care for all. Exhibit 4 (Appendix) evidences coverage growth. This Reform created a Mandatory Health Insurance System for the formal sector, which also offered informal workers the ability to contribute voluntarily (Contributory sub-system). Wagebased revenues are collected by health insurance funds and pooled at a national level, in a central fund named FOSYGA. Additional revenues from central Government are also deposited in this Fund. Formal employees and their dependents are entitled to choose their preferred Health Insurance Company (EPS). Resources from FOSYGA are devolved to each EPS via a capitated risk-adjusted mechanism. The EPSs are responsible for contracting services from Health Care Trusts (IPS). Currently, the legislation allows up to 30% of vertical integration between EPS and service providers (CONGRESO DE LA REPUBLICA DE COLOMBIA, 2011). For those in the informal sector, unemployed, and poor, there is a Subsidised Sub-System. The benefit ranges from complete to partial subsidy, depending on a score obtained from a proxymeans household survey (SISBEN) (Departamento de Planeacion Nacional, 2011) (Trujillo et al., 2005). The funding of this sub-system comprises national and local taxes plus an additional 9

10 1.5% solidarity tax from the contributory sub-system. All collected funds are pooled at the central level and redistributed as for the Contributory Sub-System (Appendix: Exhibit 5). The SHI scheme covers a standard benefits package that differs depending on the Sub- System (Appendix: Exhibit 6). It includes a comprehensive outpatient, inpatient and a set of services as well as an essential medicines positive list (Mejía et al., 2002). Furthermore, catastrophic events such as cancer, HIV-AIDS, renal failure and some transplants are also fully covered (CONGRESO DE LA REPUBLICA DE COLOMBIA, 2007) System Operation The MPS manages the entire System providing regulatory and oversight authority. The beneficiaries choose freely the insurance company and the FOSYGA pays a risk-adjusted premium under a capitation scheme for the contracted health plan. The insurance companies, in turn, select and negotiate with a network of providers based on prices, management of care and quality (Hsiao, 1995). Furthermore, external agencies supervise service provision and enforce regulation (Exhibit 7). 10

11 Exhibit 7 An analysis of the Colombian Health System may be observed in the Appendix - Section 1. Pharmaceuticals and Access The market of medicines is supplied by a well-developed national industry, accounting for around 70% of the total market. However, transnational companies control it since the domestic industry relies on imports of raw materials. The main actor involved in drug regulation is the CRES, and the reimbursement is through the SHI System based on the national list of essential drugs (Giedion, 2010). The benefits package includes essential medicines that are considered to provide cost-effective benefit for most ill-health conditions. This list was first established with the Reform of 1993 based on the existing one from the former Social Security Institute, which in turn reflected WHO s recommendations for essential medicines. Under the SHI System there are three means of obtaining medicines (IMS, 2010): 1. Drug prescription included in the essential medicines list 2. Drug prescription for medicines not included in the benefits package: 11

12 a. Through a Scientific-technical committee (CTC) ruling by the EPS. b. Via legal action (tutelas), the patient accesses the judiciary System filing a legal claim arguing a violation of the constitutional right to health and health care. This gap in current regulation to access non-covered medicines, seems to account for the uncontrolled and overwhelming increase in drug expenditure for the entire System Health Technology Assessment Worldwide there is a development of HTA to address the needs of the health care Systems (Velasco-Garrido et al., 2010). Currently in Colombia the main organization involved in HTA is the Technical Evaluations Committee of Medicines and Technology (CTMT), which functions as an advisory body of the National Council on Social Security in Health (CNSSS). Although there is no formal process for HTA, this organization is still responsible for incorporating scientific and economic evidence-based data for decision-making, until the transition is completed to the newly created Health Technology Assessment Institute (Oortwijn et al., 2010). HTA History in Colombia The evolution process of Health Technology Assessment in Colombia is divided described in five periods. 1) 1994 to Since the initial health reform, the Government established the Medicines Advisory Committee in 1994 and functioned until This committee was fundamentally in charge of establishing the essentials medicines list to be reimbursed by the System (Cubillos, 2006). 2) 1998 to In 1998, the CNSSS replaced it with the Technical Committee on Medicines, which established the operation rules and procedures as well as the Ethics code. Moreover, an amendment was made to include 16 new drugs for reimbursement and excluding 2. Efforts were primarily focused on medicines alone without clear evidence on which prioritization methodologies were used in relation to health technology assessments (Cubillos, 2006). 3) 2002 to In 2002, the National Council for Health and Social Security (CNSSS) created the Technical Evaluation Committee of Medicines and Technology (CTMT) whose main objective was to support the CNSSS adjusting and updating the benefits package to be responsive to current health care needs by using health technology assessment. This committee comprised ad-hoc specialists including clinicians, pharmacologists, epidemiologists, health economics and a representative of the MPS who chaired the committee. The majority of the 12

13 concepts were related to medicines, followed by devices and procedures. Scientific societies, providers, pharmaceutical companies and health insurance funds in that order, requested the concepts. One of the main tasks of the TECMT was the benefits package update proposal, which included medicines and procedures in The methodologies used for decisionmaking were: literature review of clinical evidence and economic evaluations. However, although the members were considered competent, a lack of an explicit methodology in the formulation of the concepts issued by the committee made difficult its reproduction in other scenarios or times (Cubillos, 2006). In 2004, the CTMT, alongside the MPS, and the Reform Support Program developed a document whose main proposal was the creation of a Health Technology Assessment Agency tied to an evaluation network. This would permit attainting Systematic and robust information about health technologies evaluation for Colombia. Nonetheless, this proposal was not implemented (Cubillos, 2006). 4) In 2007, by Law 1122 the CRES was created as an special, administratively, and technically autonomous unit, accountable to the MPS, and responsible for determining the benefits package s content, and also Health Technology Assessment. Since then, the CRES has been setting up its internal operating procedures, determining the risk-adjusted capitated premiums to be reimbursed to health insurance funds, and updating the benefits package, among other issues (Ley 1122). 5) 2011 to present. At the beginning of 2011, by enactment of Law 1438, the Government introduced a new reform of the Colombian SHI, and within it, created the current Institute for Technology Assessment in Health (IETS), whose implementation was delegated to the MPS (CONGRESO DE LA REPUBLICA DE COLOMBIA, 2011) Cultural Factors The importance of citizenship was enhanced by the new Constitution of 1991, and health was declared a constitutional right (CONGRESO DE LA REPUBLICA DE COLOMBIA, 1993). At the same time, a legal action mechanism named tutela was facilitated for the citizens to seek State intervention whenever they felt their constitutional rights might have been violated. In the following years, a ruling by the High Courts also established a direct correlation between health and access to health care. This ruling has had many positive and negative effects on citizen s behaviour, and has certainly affected the Health System s programmed budget. Although Colombia s Health System has a comprehensive defined benefits package for the 13

14 contributory sub-system, and a lesser one for the subsidized, there are many procedures, medical devices and pharmaceuticals that might not be reimbursed. Even though the Health Reform of 1993 established a periodic updating of new technological advancements in health, in reality this has not taken place. Thus, each year since then, legal actions have exponentially flooded the judiciary System claiming violation of their constitutional right to health and hence access to health care, mainly due to reimbursement denial of new high technology pharmaceuticals by health insurance companies (Ministerio de la Proteccion Social, 2011b). The impact of establishing health as a constitutional right as well as the High Courts decision of equalizing the concept of health and health care have had major impacts. On the one hand, positive effects on health outcomes may be reflected on improved life expectancy and reduced infant mortality rates (United Nations, 2010). On the other hand, negative effects related to uncontrolled pharmaceutical expenditure are severely affecting the health budget and compromising the entire System s sustainability International And Exogenous Factors In this section, a general characterization of resources and funding of Latin-American Health Systems is addressed in the first part. In the second part, a short description of the regional HTA and pharmaceutical panorama is depicted Resources and Funding The financial structure of the Health System accounts as the most important challenge for the countries in the region. Health System financing comes mainly from three sources: 1) general taxation, 2) contributions by workers, employers and the State, and 3) private spending. Moreover, out-of-pocket payments are still an important source of revenue. Altogether, health funding in the region represents an average of 6.6% of the GDP in Latin America and the Caribbean (Appendix Exhibit 11). On terms of Total Health Expenditure (THE) the region spent nearly US$ 505 (PPP) per capita on health, less than upper-middle income countries (US$ 707), and inferior when compared to high-income countries (US $ 3,848). The majority of countries are increasingly allocating more resources for health in the past decades, although important differences exist within the region (Giedion, 2010) Regional Health Technology Assessment and Pharmaceutical Referencing 14

15 At the global level, HTA is currently used to provide information for the decision-making process based on clinical and economic evidence (Sorenson et al., 2008), and in some countries like the UK, the term value-based-pricing is increasingly acknowledged by researchers (Kanavos et al., 2010a). However, HTA impact differs greatly depending on the country, although assessing the same drug. In a study of various HTA agencies from OECD countries, Kanavos 2010 states that although there is some cross over in terms of clinical, safety, and economic information considered by different HTA agencies, there are considerable disparities in the information required, interpretation of evidence, rigor of the appraisal process, and stated motivations for listing or not listing drugs (Kanavos et al., 2010b). At the regional level, Latin America is a region with increasing use and influence of HTA in decision-making with HTA members of INAHTA (International Network of HTA agencies) in four countries: Argentina, Brazil, Chile, and Mexico. In addition, HTA was formally used to determine the benefit packages in Argentina, Uruguay, and Chile. Furthermore, in countries like Brazil, Mexico, and Colombia there is a formal fourth hurdle System in place that requires evaluation of new technologies using HTA. (Pichon-Riviere et al., 2010), (Homedes and Ugalde, 2005), (Homedes et al., 2005). On the Appendix - Section 2, the behaviour surrounding medicine s expenditure and the existing HTA activities is depicted for some representative countries of the region: Argentina, Brazil, Chile, Costa Rica and Mexico. Moreover, a map of the Health System of these countries is displayed Context Conclusions For Colombia Currently, Health System s sustainability is a major concern due mainly to poor reimbursement control of medicines that are out of the benefits package, and lacking proof of providing highvalue-care. Colombia is an upper middle-income country where a SHI System has practically achieved universal coverage. Although there exists equity, efficiency and quality issues, a comprehensive benefits package provides a holistic coverage for main ill-health conditions. HTA awareness has evolved positively leading to the creation of the Health Technology Assessment Institute (IETS) in From the cultural aspect, the establishment of health and health-care as constitutional rights is having an enormous impact on the System s sustainability. 15

16 Although Health Systems differ in the region, pharmaceutical expenditure is a continuous growing concern and thus, several have already developed HTA at different levels. Brazil, Mexico and Argentina have formal HTA while Colombia is currently in the process of formalization. 4.2 POLICY PROCESS - AGENDA SETTING The process by which the IETS reached the Colombian political agenda, and became Law most likely followed Kingdon s three-stream model (Kingdon, 1984). The problem stream is clearly expressed by the incremental budget constraint, along with the sense of poor regulation and enforcement on medicines and medical devices, due in part to the lack of proper tools to make informed decisions and setting priorities. The policy stream, consisting of the on-going analysis of problems and proposed solutions, progressively lead to the IETS as a possible solution. However, the following caveats must be taken into consideration: technical feasibility questioned, may not necessarily be consistent with current social values and thus not publicly acceptable, but it seems to resonate well with the Government and politicians. In the politics stream, the change of Government together with the campaigns by interest groups favoured political will. As Kingdon s model predicts, the three streams came together under the opportunity window derived from the current financial crisis and the pressure to give the MPS a proper technical Agency that would provide credible evidence-based information taking into account clinical and cost-effective analysis of new technologies, which would facilitate the Ministry the exercise of proper and more efficient regulation. In the following paragraphs, a description of the political process is presented in relation to agenda setting Political Process The debate surrounding Health Technology Assessment is not a new issue in the Colombian political arena. Ever since the enactment of the Reform Law of 1993 the concept has been present as described in its articulate. As it was demonstrated in the Colombian HTA history, the assessment of health technology has been approached by different instances dependent from the MPS. Nonetheless, there has been a clear trend to promote the creation of an autonomous, specialized, independent, and technical 16

17 Agency to be in charge of formally and properly assess health technology. This Agency would provide the Government with evidence-based information to support the decision-making process with respect to resource allocation and priority setting in Health. In more recent times, particularly after 2004, concise recommendations were made to the MPS to establish such an Agency. However, these recommendations were kept under the table for the following years. By 2007, the enactment of Law 1122 created the CRES (Health Regulation Commission), and great expectations were set about the role of this institution: primarily in priority setting and health technology assessment as its main objectives. Nonetheless, adverse conditions such as lack of capacity and expertise, together with ineffectiveness to deliver the expected results, ended with many stakeholders manifesting their discontent, frustration, and low credibility of CRES. By the middle of 2008, the economic crisis of the Health System was triggered by a Constitutional Court ruling favouring legal actions whenever drugs, or other health-care related items, were not approved by the EPS, although prescribed by the physician. The ruling only took into account the constitutional right to health and health-care, irrespective of its inclusion on the benefits package or not proven cost-effectiveness. Moreover, multi-lateral corporations such as the Inter American Development Bank have exerted financial pressure, and international trends surrounding HTA promoted by England s National Institute for Clinical Excellence (NICE), both, which have accompanied the MPS with policy recommendations in the past few years, have favoured international influence of creating such Institute. The summation of the factors expressed above, together with the recent corruption scandals in the sector, have determined a positive environment for the creation of the IETS. Hence, the expectations about the Institute are high, and all stakeholders will surely closely monitor its performance Stakeholders Perspectives About The Health Technology Assessment Institute (IETS) General Perception The enactment of the IETS is perceived by the Government sector as a meaningful advancement of the Health System, required in articulating the various processes in health prioritization, and contributing to make informed decisions. Moreover, the model needs it to fill the existing gap in reliable technical information. However, there is a sector that believes the IETS might be redundant as and independent Agency, and it should depend directly from the 17

18 CRES. The Civil Society expressed their concern about its creation since the CRES has not fulfilled their expectations. Moreover, it is perceived as a bureaucratic public institution that may not balance properly the interest of all stakeholders, particularly since the academy is considered as an optional consulting agent. The Market-related interest groups believe that, as philosophical and technical concept, it is logical that an expert Institute determines the most adequate health technologies for the country. Although it is born from the need of a technical necessity, it may become a politized Agency and favour the interest of some sectors and not all. Furthermore, the creation of this type of public institutions obeys political pressures, and most of the time neither are nor properly conceived. However, if it achieves its objectives in the short and medium run, providing the CRES with the much-needed technical inputs, it might gain the necessary respect and credibility Perspectives surrounding the need of a Health Technology Assessment Agency in Colombia The different groups have opposed perceptions about the need of establishing a HTA Agency. On the one hand, the current Government believes that it is of paramount importance since it will fill the gap currently present in the CRES. However, other Government officials believe that the IETS is not necessary since the CRES already has the delegated responsibility, and has the resources to perform the task. This dissident group argues that having two institutions of this sort would imply duplication of functions and waste of resources. However, they agree that there may be a need to strengthen the CRES technically, and would compromise on creating a division to solely perform HTA. On the other hand, Civil Society members have contradicting opinions about the IETS. One group argues that the creation of new Institutes only correspond to increased bureaucracy. Another group considers it an important advancement of the Health System, and that it will provide much needed evidence-based information to make better decisions on health. The Market-related interest groups fully agree on the establishment of an independent, technical Institute to perform HTA, but taking into account the macro-economic impact. The IETS would provide the CRES with technical advise that would support its decisions. Moreover, the international panorama has demonstrated the need of an entity that plays the role of a mediator to balance social consensus, prioritization and, resource allocation. Furthermore, there is an imperative need to count with a high-level Government Agency that would determine reimbursement instead of the judges. 18

19 Normative Effects Of IETS Decisions An issue concerning a normative need versus an array of recommendations emanating from the Institute was raised. In that sense, the Government group offers two diverging views. On the one hand, the more radical wing strongly thought that the concepts issued by the IETS should definitely have a normative effect, and provide the CRES with technical support to formulate policies towards a more efficient System, and should be adopted via administrative Acts. On the other hand, a more patient-oriented group believed that perhaps the best approach should be more conservative, and the IETS should limit itself to a guidance role. One of the main reasons being that the medical field deals with patients, HTA is not a flawless science, and it changes with time. Furthermore, they promote the discourse of clinical guidelines and treatment recommendations without compulsory compliance, especially due to the fact that medical practice is normally embedded in uncertainty. Another sector offers a conciliatory perspective, arguing that the concepts from the IETS do not necessarily have to be norms of compulsory compliance, but they should have sufficient technical strength so whenever the decision-makers diverge from the recommendations, they would have to comprehensively justify the reasons of such decision. The Civil Society has two divergent positions. On the one hand, one sector believes that it would depend on the origin of the concepts. They would justify their compulsory compliance only provided the following criteria described. First, have a serious academic background, with an evidence-based decision. Second, the decisions must be uncontaminated with conflicts of interest, and provide solutions to the population based on cost-effectiveness. Third, they should have been scrutinized from the perspective of macro-economic feasibility, and the population s health needs, based on burden of disease and risk. Only then should they become norms, otherwise they should just be recommendations. On the other hand, another group expressed that the IETS concepts should only be recommendations to avoid politization, and not interfere with the doctor s professional autonomy. In their view, medicine should not be restricted by compulsory norms since the medical field is not conceived in that sense. The Market-related interest groups coincided on the fact that the concepts that might result from a serious work by the IETS should have a compulsory effect and become norms to be formulated by CRES. The latter being responsible for prioritization and establishing the contents of the benefits plan. Again, they emphasized on the fact that the decisions must be proven to be 19

20 transparent, independent, and based on certain scientific evidence-based information as well as cost-effectiveness Health Technology Assessment Institute (IETS) And The System s Sustainability In the view of the Government, the IETS definitely aids the System s financial sustainability and promotes good governance, offering CRES with technical tools to support their decisions. The Institute would provide the necessary elements for the different stakeholders to make informed decisions, particularly in an imperfect market where regulation is a cornerstone. Nonetheless, it is clear to these groups that the IETS is not a panacea, and thus not the only solution to the financial crisis. The Civil Society group believed that the IETS would not aid in pro the System s sustainability, until root-based issues are properly addressed. The rampant corruption is one of the big issues, along with Government Agencies incapable of proper follow up and sanctioning. Moreover, a more radical wing believes that as the IETS is currently conceived with the same economists perspectives searching only savings, the same bureaucrats maintaining the status-quo that holds them in power, and the Market-related interest groups trying to obtain their own benefits, the IETS would not prosper and sustainability would never be achieved. The Market-related interest groups argue that the IETS would contribute to the System s sustainability. Furthermore, the main goal of the Institute should be focused on addressing that issue; otherwise it would not have a real significance Interaction Between The IETS, The MPS And Other Government Agencies It is clear that the MPS has the responsibility of leading all the sector s activities, defining policy, objectives, norms, and level of decentralization around health. Other Government agencies such as INVIMA, CRES, SNS and the INS, each have their own role. INVIMA, the National Food and Drug Regulatory Agency, is in charge of inspection, surveillance and control. The Agency determines the entrance of new products into the Colombian market according to existing regulation. In the opinion of several stakeholders, being the INVIMA the port of entry, it should carefully review the entrance of new high technology drugs, medical devices, and other inputs taking into account the country s health needs, and not just guaranteeing product availability according to a free market. The CRES has the main responsibility of determining and periodically updating the benefits plan, based on information from the National Health Institute (INS), and the newly created IETS. The INS providing data about the population s epidemiological profile, burden of disease, as well as the main causes of morbidity and mortality. The latter, IETS, providing evidence-based 20

21 information to the CRES around new health-related products and technologies after screening them using HTA tools. The regulatory Agency in charge of surveillance and policy compliance of all System actors is the National Health Superintendence (SNS) Interaction Between The IETS, The Civil Society And Market-related Interest Groups There are different positions of the role that the Civil Society and the Market-related interest groups should play with the IETS. The Government group agreed on the participation of all stakeholders. Even if the IETS is purely a technical Agency, it should be an instrument to bring the people closer to the Government and procure more legitimate, transparent, collaborative and concerted decisionmaking. Moreover, the participating stakeholders should collaborate providing true and reliable information, as well as be clients of the IETS adopting its recommendations or norms. However, it is important to also acknowledge the fact that there are gaps among stakeholders due to asymmetry of information. In any case, there should exist a high level of inter-dependence since it is a System, and whatever one actor does in one sector affects another. Furthermore, if all actors actively participate, they can all be accountable for the System s performance. On another line of thought, the Civil Society believes that the academy, as well as scientific societies must be involved since they are the natural providers of evidence, knowledge, and real life experience of different technologies. Moreover, they expressed that even though the patients may have a gap in technical understanding, they should be involved and help refining and legitimizing the decisions. On the other hand, they think that the Market-related interest groups in general should not actively participate due to unavoidable conflicts of interest. Finally, the Market-related interest groups propose two perspectives. The first one dictates that there is an evident and insurmountable conflict of interest of these actors, and hence they should have no interference with the IETS and its decisions. The second one expressed a less radical stand in the sense that all stakeholders should participate, and in the case of the health insurance companies as well as the health-care providers, they should be aware of the process since they would be the recipients of the norms. The pharmaceutical industry should also be summoned in order to understand the scenarios, and accordingly establish prices to satisfy the new demands. 21

22 4.2.3 Policy Formulation The MPS was in charge of formulating the policy around the IETS along with other norms enacted in Law 1438 of Specifically the directorates of insurance, quality assessment and public health were directly involved in the formulation. The Ministry is also responsible for the further development of guidelines to operationalize the Institute and make it a reality. After policy formulation, international agents such as the Inter-American Development Bank, UK s NICE as a consultant, and other Colombian Agencies are currently supporting the process Stakeholders Participation The initiative lied in the hands of the Government, and tried to gather the views of most actors. However, the majority felt that even though they may have been heard, the reality is that their inputs were not taken into account. The Government group believes on the importance of community participation as well as the inputs from other stakeholders. They mentioned having facilitated a participative environment for Civil Society, as well as for the Market-related interest groups. Particularly in the implementation stage, various focal meetings have taken place. Furthermore, they argue that it is an on-going process, and actors will be called in due time to express their inputs. Nonetheless, certain Civil Society groups did not feel that even though some consultations were made, their views were not taken into account. However, some Market-related interest groups refer to have been approached in focal groups and partially consulted. In all cases, they expressed the need of a more active participation by all stakeholders, led by the Government, in search for legitimacy and social consensus Description Of The Policy Content In January 2011, Law 1438 was enacted as a Reform to the Social Security System in Health. Its objectives are mainly focused on universal coverage, entitlement portability, and equalization of the benefits plan, institutional strengthening, and financial sustainability. The System s financial sustainability is addressed, and with respect to financial control and priority setting, the Government established or renewed various Government Agencies. First, the Government established the National Observatory for Health (ONS) to monitor and provide epidemiological and relevant information; second, created the Technical Scientific Board of Peer Reviewers (JTCP), to assess clinicians on non-covered drug prescriptions (among others); third, empowered the MPS to define the Pharmaceutical Policy including medicines, medical supplies and devices, in order to optimize their utilization, avoid access inequity, and warrant quality. 22

23 Moreover, a new National Commission for Prices of Medicines and Medical Devices (CNPMD) was appointed to be in charge of price regulation. In this issue, the MPS will determine a price setting mechanism for medicines and devices and reimbursement will not exceed these ceilings. Furthermore, the MPS together with the Ministry of Finance also regulates drug reimbursement. By ministerial Resolution 3026 of 2011, the maximum prices to be reimbursed by the FOSYGA for medications not included in the benefits plan were established. prioritized by their reimbursement cost (Ministerio de la Proteccion Social, 2011a). These drugs have been The already existing INVIMA will continue with its activities related to quality assessment, efficacy, and drug and devices safety. Additionally, by 2012, the evaluation would include biotechnology and biological products. Finally, the Government empowered the MPS to create the Health Technology Assessment Institute (IETS), as a not-for-profit, public-private organisation, which would include, amongst others, the Colombian Academy of Medicine, and scientific societies. IETS will be in charge of developing evidence-based HTA, clinical guidelines and protocols to guide optimum use of medicines, devices, and medical procedures included in the benefits package. Its concepts are in the form of recommendations to Government Agencies concerned such as CRES, CTC, JNCP, SNS, as well as providers and health insurance companies. The Institute s main objectives include developing HTA based on safety, efficacy, effectiveness, utility, and the economic impact of the assessed technologies. IETS will make use of accredited centres for Health Technology Assessment at the national and international level. The scope of evaluation will include the use of technologies for prevention, diagnosis, treatment, and rehabilitation, and assess their possible impact on morbidity and mortality. Furthermore, the Institute will be in charge of designing evidence-based clinical guidelines and protocols, to be used as standards for service delivery by providers. In order to demonstrate transparency, IETS will publish its methods, and disseminate its results. The Institute will be responsible that HTA and clinical guidelines would promote quality improvement, safety, and cost-effectiveness. Both protocols and clinical guidelines for medicines, devices or procedures to be included in the benefits package will be consulted widely with health professionals, scientific societies, professional boards, and university health faculties. Currently, the MPS is still working on developing the proper way to determine how the Institute will function. An advisory group sponsored and financed in part by the Inter-American 23