Expert Review of Pharmacoeconomics & Outcomes Research Downloaded from informahealthcare.com by University of Southern California on 03/13/15 For personal use only.
Editorial
Institutionalizing health technology assessment for priority setting and health policy in Latin America: from regional endeavors to national experiences Expert Rev. Pharmacoecon. Outcomes Res. 15(1), 9–12 (2015)
Federico Augustovski Author for correspondence: Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina and Faculty of Medicine, School of Public Health, University of Buenos Aires (UBA), Buenos Aires, Argentina [email protected]
Andrea Alcaraz Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina
Joaquin Caporale Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina
Sebastia´n Garcı´a Martı´ Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina
Andre´s Pichon Riviere Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina and Faculty of Medicine, School of Public Health, University of Buenos Aires (UBA), Buenos Aires, Argentina
In this paper, we provide a short summary of recent trends and key issues regarding the current status of health technology assessment (HTA) in Latin America. Initially, we describe worldwide and region-wide initiatives that foster the institutionalization of HTA for decision making and health policy in our region. Then, we describe some countries in the region that are worth mentioning for their application of HTA at a national level. The target audiences are those researchers and decision makers interested in following HTA in our region.
Health technology assessment (HTA) for priority setting and health policy has received an increased importance in Latin America (LA) during the past years. This paper aims to depict selected regional hot topics and trends. Recently, a large number of researchers and decision makers (over 740) have attended ISPOR 4th Regional Latin America Conference held in Buenos Aires with over 400 scientific presentations; two of its leading topics are addressed herein [1,2]. We initially describe regional and worldwide initiatives that foster the institutionalization of HTA in LA, and then refer to unique experiences of some countries in the application of HTA at national levels. It is evident that LA has experienced significant advances in the past 10 years. A clear example and a leading case in the world has been the endorsement of Resolution CSP28.R9 in 2012 Pan American Health Conference by all Pan American Health Organization (PAHO) member states [3]. This is the first example in the world of a region-wide HTA initiative being approved and promoted by all
countries in the region. Additionally, PAHO is also promoting HTA Network of the Americas (RedETSA), the regional HTA network officially launched in 2011, which involved 13 member countries [4]. Collaborative international initiatives promoting HTA and consolidating the interaction between HTA technical (assessment) and decision making (‘appraisal’) components have been recent key stimuli for LA countries. A good example of this is the PAHO ProVac initiative (Promotion of Evidence-Based Decision Making for the Introduction of New & Underutilized Vaccines) and its focus on the incorporation of economic evaluations for health care decision making at the country level [5]. There are many ProVac tools being currently tested in 29 countries in LA and the Caribbean, and the current aim is to replicate them in other regions of the world (EURO, EMRO, AFRO). The collaboration works closely with LA regional Centers of Excellence and Ministries of Health and contributes to local capacity building in member states.
KEYWORDS: health technology assessment • Latin America • outcome research • pricing policies • priority setting
informahealthcare.com
10.1586/14737167.2014.963560
Ó 2015 Informa UK Ltd
ISSN 1473-7167
9
Expert Review of Pharmacoeconomics & Outcomes Research Downloaded from informahealthcare.com by University of Southern California on 03/13/15 For personal use only.
Editorial
Augustovski, Alcaraz, Caporale, Garcı´a Martı´ & Pichon Riviere
Consolidation of information repositories related to HTA and collaboration in the HTA process across countries are interesting initiatives. There are some examples of HTA and economic evaluation networks and organizations in which LA countries could increase their involvement or whose models may be of interest to replicate in the region. These include global networks such as INAHTA, HTAi and ISPOR and also regional networks such as EUnetHTA (European Network for Health Technology Assessment), HTAsiaLink (network to support collaboration between Asian HTA agencies), EuroScan (International Information Network on New and Emerging Health Technologies), ProVac and especially RedETSA. Some initiatives are worth mentioning, mainly those aimed at facilitating information sharing among HTA agencies and avoiding work duplication, as well as the platforms developed by some of these networks to promote shared production and use of HTA. Some experiences could be replicated or extended to our region, such as consolidation of information repositories related to HTA or collaboration in the HTA process across countries. Good international examples are the EUnetHTA initiatives such as the Planned and Ongoing Projects (POP) database, which avoids duplication and promotes information sharing among HTA agencies; the HTA Core Model, a methodological framework for shared production and use of HTA; the Evidence database on new technologies (EVIDENT Database), aimed at sharing information on coverage and assessment status [6]. The region faces significant challenges in the consolidation and explicit linking between HTA and decision making. Regarding the right-to-health litigation issue, related to the provision of health technologies, a recent systematic review that included 30 studies found that judgments were frequently in favor of plaintiffs in countries such as Colombia (75–87%), Costa Rica (89.7%) and Brazil (70–100%). In Colombia, most of the lawsuits were filed for benefits included in the Compulsory Health Plan, and the mean annual increase in drug expenditure was 68% in 2003–2009, for a total cost of around US $300 million in 2009 [7]. The interaction between health care and judicial systems is growing in our region since most countries in LA guarantee health care as a universal right within their national constitutions. There is a very interesting World Bank initiative called Priority Setting and Constitutional Mandates in Health aimed at filling in the many gaps existing between norms (de jure) and their implementation (de facto). Since universal coverage contemplates three factors: who is covered, which services are covered and the proportion of costs covered, oftentimes it is very difficult to reach a fair ruling since funds will never be able to cover 100% of the population for 100% of the costs and 100% of the needed services. Each country fills the ‘cube’ in its own way, trading off the proportion of services and the proportion of the costs to be met from pooled funds [8]. Litigation is usually prevalent when there is no adequate access to health services, either to gain access to prioritized/essential services or others [9]. Therefore, instead of 10
an outcome-oriented focus, a more process/rights-oriented focus should be sought to overcome many prejudices and barriers between the judicial parts and health professionals and to promote more fluent communication among key stakeholders. Many aspects in this process should be addressed, such as disagreement, reasonableness of the prioritized services, individual autonomy and conflict of interests. Three countries are good examples of collaboration between HTA and the legal system: Brazil with its Cochrane Center providing evidence to the legal system, Costa Rica with an initiative to start a similar system and Uruguay for the creation of a health litigation database. At the national level, HTA is often used to strengthen decision making or as a tool to inform pricing and coverage policies. Some selected examples in this regard are Argentina, Brazil, Chile, Colombia, Mexico and Uruguay [2]. Argentina has developed two strategies for strengthening institutional linkages in relation to HTA. The first one was the establishment of the Coordinating Unit for Health Technology Evaluation and Implementation (UCEETS) in 2009 [10], which gathers different actors from the regulatory agency (ANMAT), from the national Ministry of Health (MoH) offices and representatives of the public health sector. With this framework, the current challenge seems to be the achievement of cooperation with all stakeholders (from the general public, technology producers to academia and NGOs) and the implementation, consolidation and expansion of an efficient prioritization strategy with explicit rules for technology incorporation at different health care levels and sectors. In the case of Brazil, the National Commission for the Incorporation of Technologies (CONITEC) created in 2011, within the Unified Health System (SUS) (Law 12401/11) [11], aims to advise on the incorporation and management of health technologies into the public system (SUS). It is formed by MoH offices and also has patient representation. An interesting example was the incorporation of trastuzumab for the treatment of HER2-positive breast cancer. CONITEC decision was favorable only at initial and locally advanced cancer stages, but after a price negotiation (with a 44.8% reduction) as well as the requirement of two new presentations (60 and 150 mg). Additionally, the MoH decided to produce this drug locally under a public/private initiative as an example of ‘technological transfer’ [12]. In Chile, HTA activities have been developed since the mid ’90s, but it was not until 2005, with the so-called Explicit Health Guarantees – AUGE/GES Universal Health Coverage plan (Law 19966) – that HTA began to be used to prioritize health conditions and technologies. The introduction of GES and its successive updating were significant examples of HTA use; however, the application of HTA encompasses the entire health system and Chile is working toward the institutionalization of a system-wide HTA process [13]. In January 2013, the HTA Commission was created aiming to propose a model to support decision making considering the duality of the Chilean health system and its many challenges. Another interesting Expert Rev. Pharmacoecon. Outcomes Res. 15(1), (2015)
Expert Review of Pharmacoeconomics & Outcomes Research Downloaded from informahealthcare.com by University of Southern California on 03/13/15 For personal use only.
Institutionalizing HTA for priority setting & health policy in LA
initiative in this country is the recent publication of national guidelines for economic evaluations [14]. Regarding Colombia, there is a positive and mandatory package since 1993 for social insurance called Mandatory Health Plan (POS) with nearly 96% coverage. POS was not updated regularly and there were many differences between the two subsystems, the contributive and subsidized regimes, generating inequities in access. As a consequence, there was a high rate of litigation to gain access to health technologies. An independent, public/private HTA agency (Instituto de Evaluacio´n Tecnolo´gica en Salud) was created in 2012, with incumbencies related to clinical practice guidelines, systematic reviews, economic evaluations and budget impact analysis to inform MoH decisions. A technology prioritization system was constructed based on the definition of 15 criteria (using the EVIDEM framework, with 13 EVIDEM criteria and two locally generated criteria) [15,16] and piloted in 2013. Mexico has a heterogeneous access to health technologies. The health technology adoption process has different phases and consists of five steps [17]: the regulatory authorization (COFEPRIS), sectorial inclusion by the General Health Council (CSG) in the basic ‘Cuadro Ba´sico’ list, institutional inclusion, negotiation and procurement by funders/buyers, and utilization by providers. The use of HTA is mostly confined to the public sector inclusion. Moreover, different approaches based on explicit and implicit rules coexist in the prioritization process. The Cuadro Ba´sico list and ‘Cata´logo de Insumos,’ and the benefit package for popular health insurance – Seguro Popular – are examples of use of explicit prioritization rules. But this coexists with waiting References 1.
2.
3.
Augustovski F, Pichon Riviere A, Lemgruber A, et al. First plenary session: Assigning regional priorities & the use of HTA & economic evaluations in Latin America: how far have we come? Available from: www.ispor.org/Events/ EventInformation.aspx?eventid=41&p= 145#plenary [Last accessed 18 March 2014] Lazovsky J, Petramale C, Castillo Riquelme M, et al. Second plenary session: HTA as a tool to inform pricing and coverage policies in the national context: case studies from Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay. Available from: www.ispor.org/Events/ EventInformation.aspx?eventid=41&p= 145#plenary [Last accessed 18 March 2014] Pan American Health Organization - World Health Organization. Resolution CSP28.R9: Health Technology Assessment and incorporation into Health System. 28th Pan American Sanitary Conference. 64th Session of the Regional Committee. Washington, D.C., USA, 17-21 September 2012. Available from: www.paho.org/hq/index.
informahealthcare.com
4.
Editorial
lists and shortages in social insurance institutions, and implicit rules also play an important role in access. Currently, Mexico is working on a health system reform based on universal coverage, and moving toward a single fund financing and a unique package of benefits [18]. Finally, the Highly Specialized Medical Procedures (FNR) from Uruguay is responsible for ensuring equal and universal access to procedures and high cost drugs. In this context, HTA in combination with economic evaluation and budget impact analysis is used to decide formulary incorporations and utilization norms. These norms and decisions are reviewed periodically and also have external independent audits. It is also noteworthy that they have monitored the outcomes and impact of the established treatments with real-world registries at the individual level since 2010 [19]. As has been shown, LA is moving forward toward the institutionalization of HTA in the decision-making process. There are many overarching themes that encompass region-wide initiatives and experiences and many lessons to be learned from local experiences of several countries. Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
php?option=com_content&view= article&id=7022&Itemid=1&lang=es [Last accessed 30 October 2013]
8.
The World Health Report. Health Systems Financing: The path to universal coverage. WHO Press; Geneva, Switzerland: 2010
Pan American Health Organization. Lanzamiento de la Red de Evaluacio´n de Tecnologı´as Sanitarias (REDETSA). Available from: www.paho.org/col/index. php?option=com_content& view=article&id=1180:lanzamiento-de-la-redde-evaluacion-de-tecnologias-sanitariasredetsa&catid=767&Itemid=554 [Last accessed 30 October 2013]
9.
Cubillos L, Escobar ML, Pavlovic S, Iunes R. Universal health coverage and litigation in Latin America. J Health Organ Manag 2012;26:390-406
10.
Ministerio de Salud de Argentina. Resolucio´n 458/2009. Evaluacio´n de Tecnologı´as Sanitarias. Available from: www.msal.gov.ar/pngcam/tecnologias2.htm [Last accessed 3 October 2013]
11.
Fernanda de Freitas Castro G. A Judicializac¸a˜o Da Sau´de Em Minas Gerais: Uma Avaliac¸a˜o Dos Processos Judiciais Relacionados Aos Procedimentos Ambulatoriais E Hospitalares No Perı´odo 1999-2009. Universidade Federal de Minas Gerais. Programa de Po´s-Graduac¸a˜o em Sau´de Pu´blica. Belo Horizonte – MG. 2013. Available from: www.bibliotecadigital. ufmg.br/dspace/bitstream/handle/1843/ BUBD-9C4GUV/ disserta__o_fernanda_castro.pdf?sequence=1
12.
Petramale C. Case studies from Brazil. Available from: www.ispor.org/conferences/
5.
Andrus JK, Walker DG. Evidence base for new vaccine introduction in Latin America and the Caribbean. Vaccine 2013; 31(Suppl 3):C2-3
6.
European network for Health Technology Assessment (EUnetHTA). www.eunethta.eu/ [Last accessed 23 October 2013]
7.
Reveiz L, Chapman E, Torres R, et al. Right-to-health litigation in three Latin American countries: a systematic literature review. Rev Panam Salud Publica 2013;33: 213-22
11
Editorial
Augustovski, Alcaraz, Caporale, Garcı´a Martı´ & Pichon Riviere
BuenosAires0913/presentations/2nd_ Plenary_Petramale.pdf [Last accessed 18 March 2014]
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Castillo-Riquelme M, Santelices CE. Fundamentos para la Institucionalizacio´n de ETESA en Chile. Rev Med Chile 2014; 142(Suppl 1):S50-4 Castillo M, Castillo C, Loayza S, Aravarena M. Guı´a metodolo´gica para la evaluacio´n econo´mica de intervenciones en salud en Chile. Departamento de Economı´a de la Salud, Subsecretarı´a de Salud Pu´blica, Ministerio de Salud de Chile. Available from: http://desal.minsal.cl/ DOCUMENTOS/PDF/2013/GUIA%20EE %20FINAL%20marzo-2013.pdf [Last accessed 3 October 2013]
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Goetghebeur MM, Wagner M, Khoury H, et al. Evidence and Value: impact on Decision Making-the EVIDEM framework and potential applications. BMC Health Serv Res 2008;8:270
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Castro Jaramillo H. Case Studies from Colombia. Available from: www.ispor.org/ conferences/BuenosAires0913/presentations/ 2nd_Plenary_Castro_Jaramillo.pdf [Last accessed on 18 March 2014]
Gonzalez Pier E. Case studies from Mexico. Available from: www.ispor.org/conferences/ BuenosAires0913/presentations/ 2nd_Plenary_Gonzalez_Pier.pdf [Last accessed 18 March 2014]
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Rodrı´guez A. Case studies from Uruguay. Available from: www.ispor.org/conferences/ BuenosAires0913/presentations/ 2nd_Plenary_Rodriguez.pdf [Last accessed on 18 March 2014]
Catalina Gutie´rrez S, Ursula G, Ana Lucı´a M, Adriana A. Procesos de priorizacio´n explı´cita en salud: Un enfoque siste´mico. Series de notas te´cnicas sobre procesos de priorizacio´n de salud. Notas te´cnicas # IDB-TN-407. BID 2012. Available from: http://idbdocs.iadb.org/
Expert Rev. Pharmacoecon. Outcomes Res. 15(1), (2015)
Editorial
Institutionalizing health technology assessment for priority setting and health policy in Latin America: from regional endeavors to national experiences Expert Rev. Pharmacoecon. Outcomes Res. 15(1), 9–12 (2015)
Federico Augustovski Author for correspondence: Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina and Faculty of Medicine, School of Public Health, University of Buenos Aires (UBA), Buenos Aires, Argentina [email protected]
Andrea Alcaraz Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina
Joaquin Caporale Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina
Sebastia´n Garcı´a Martı´ Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina
Andre´s Pichon Riviere Institute for Clinical Effectiveness and Health Policy, Ravignani 2024 (1414) Buenos Aires, Argentina and Faculty of Medicine, School of Public Health, University of Buenos Aires (UBA), Buenos Aires, Argentina
In this paper, we provide a short summary of recent trends and key issues regarding the current status of health technology assessment (HTA) in Latin America. Initially, we describe worldwide and region-wide initiatives that foster the institutionalization of HTA for decision making and health policy in our region. Then, we describe some countries in the region that are worth mentioning for their application of HTA at a national level. The target audiences are those researchers and decision makers interested in following HTA in our region.
Health technology assessment (HTA) for priority setting and health policy has received an increased importance in Latin America (LA) during the past years. This paper aims to depict selected regional hot topics and trends. Recently, a large number of researchers and decision makers (over 740) have attended ISPOR 4th Regional Latin America Conference held in Buenos Aires with over 400 scientific presentations; two of its leading topics are addressed herein [1,2]. We initially describe regional and worldwide initiatives that foster the institutionalization of HTA in LA, and then refer to unique experiences of some countries in the application of HTA at national levels. It is evident that LA has experienced significant advances in the past 10 years. A clear example and a leading case in the world has been the endorsement of Resolution CSP28.R9 in 2012 Pan American Health Conference by all Pan American Health Organization (PAHO) member states [3]. This is the first example in the world of a region-wide HTA initiative being approved and promoted by all
countries in the region. Additionally, PAHO is also promoting HTA Network of the Americas (RedETSA), the regional HTA network officially launched in 2011, which involved 13 member countries [4]. Collaborative international initiatives promoting HTA and consolidating the interaction between HTA technical (assessment) and decision making (‘appraisal’) components have been recent key stimuli for LA countries. A good example of this is the PAHO ProVac initiative (Promotion of Evidence-Based Decision Making for the Introduction of New & Underutilized Vaccines) and its focus on the incorporation of economic evaluations for health care decision making at the country level [5]. There are many ProVac tools being currently tested in 29 countries in LA and the Caribbean, and the current aim is to replicate them in other regions of the world (EURO, EMRO, AFRO). The collaboration works closely with LA regional Centers of Excellence and Ministries of Health and contributes to local capacity building in member states.
KEYWORDS: health technology assessment • Latin America • outcome research • pricing policies • priority setting
informahealthcare.com
10.1586/14737167.2014.963560
Ó 2015 Informa UK Ltd
ISSN 1473-7167
9
Expert Review of Pharmacoeconomics & Outcomes Research Downloaded from informahealthcare.com by University of Southern California on 03/13/15 For personal use only.
Editorial
Augustovski, Alcaraz, Caporale, Garcı´a Martı´ & Pichon Riviere
Consolidation of information repositories related to HTA and collaboration in the HTA process across countries are interesting initiatives. There are some examples of HTA and economic evaluation networks and organizations in which LA countries could increase their involvement or whose models may be of interest to replicate in the region. These include global networks such as INAHTA, HTAi and ISPOR and also regional networks such as EUnetHTA (European Network for Health Technology Assessment), HTAsiaLink (network to support collaboration between Asian HTA agencies), EuroScan (International Information Network on New and Emerging Health Technologies), ProVac and especially RedETSA. Some initiatives are worth mentioning, mainly those aimed at facilitating information sharing among HTA agencies and avoiding work duplication, as well as the platforms developed by some of these networks to promote shared production and use of HTA. Some experiences could be replicated or extended to our region, such as consolidation of information repositories related to HTA or collaboration in the HTA process across countries. Good international examples are the EUnetHTA initiatives such as the Planned and Ongoing Projects (POP) database, which avoids duplication and promotes information sharing among HTA agencies; the HTA Core Model, a methodological framework for shared production and use of HTA; the Evidence database on new technologies (EVIDENT Database), aimed at sharing information on coverage and assessment status [6]. The region faces significant challenges in the consolidation and explicit linking between HTA and decision making. Regarding the right-to-health litigation issue, related to the provision of health technologies, a recent systematic review that included 30 studies found that judgments were frequently in favor of plaintiffs in countries such as Colombia (75–87%), Costa Rica (89.7%) and Brazil (70–100%). In Colombia, most of the lawsuits were filed for benefits included in the Compulsory Health Plan, and the mean annual increase in drug expenditure was 68% in 2003–2009, for a total cost of around US $300 million in 2009 [7]. The interaction between health care and judicial systems is growing in our region since most countries in LA guarantee health care as a universal right within their national constitutions. There is a very interesting World Bank initiative called Priority Setting and Constitutional Mandates in Health aimed at filling in the many gaps existing between norms (de jure) and their implementation (de facto). Since universal coverage contemplates three factors: who is covered, which services are covered and the proportion of costs covered, oftentimes it is very difficult to reach a fair ruling since funds will never be able to cover 100% of the population for 100% of the costs and 100% of the needed services. Each country fills the ‘cube’ in its own way, trading off the proportion of services and the proportion of the costs to be met from pooled funds [8]. Litigation is usually prevalent when there is no adequate access to health services, either to gain access to prioritized/essential services or others [9]. Therefore, instead of 10
an outcome-oriented focus, a more process/rights-oriented focus should be sought to overcome many prejudices and barriers between the judicial parts and health professionals and to promote more fluent communication among key stakeholders. Many aspects in this process should be addressed, such as disagreement, reasonableness of the prioritized services, individual autonomy and conflict of interests. Three countries are good examples of collaboration between HTA and the legal system: Brazil with its Cochrane Center providing evidence to the legal system, Costa Rica with an initiative to start a similar system and Uruguay for the creation of a health litigation database. At the national level, HTA is often used to strengthen decision making or as a tool to inform pricing and coverage policies. Some selected examples in this regard are Argentina, Brazil, Chile, Colombia, Mexico and Uruguay [2]. Argentina has developed two strategies for strengthening institutional linkages in relation to HTA. The first one was the establishment of the Coordinating Unit for Health Technology Evaluation and Implementation (UCEETS) in 2009 [10], which gathers different actors from the regulatory agency (ANMAT), from the national Ministry of Health (MoH) offices and representatives of the public health sector. With this framework, the current challenge seems to be the achievement of cooperation with all stakeholders (from the general public, technology producers to academia and NGOs) and the implementation, consolidation and expansion of an efficient prioritization strategy with explicit rules for technology incorporation at different health care levels and sectors. In the case of Brazil, the National Commission for the Incorporation of Technologies (CONITEC) created in 2011, within the Unified Health System (SUS) (Law 12401/11) [11], aims to advise on the incorporation and management of health technologies into the public system (SUS). It is formed by MoH offices and also has patient representation. An interesting example was the incorporation of trastuzumab for the treatment of HER2-positive breast cancer. CONITEC decision was favorable only at initial and locally advanced cancer stages, but after a price negotiation (with a 44.8% reduction) as well as the requirement of two new presentations (60 and 150 mg). Additionally, the MoH decided to produce this drug locally under a public/private initiative as an example of ‘technological transfer’ [12]. In Chile, HTA activities have been developed since the mid ’90s, but it was not until 2005, with the so-called Explicit Health Guarantees – AUGE/GES Universal Health Coverage plan (Law 19966) – that HTA began to be used to prioritize health conditions and technologies. The introduction of GES and its successive updating were significant examples of HTA use; however, the application of HTA encompasses the entire health system and Chile is working toward the institutionalization of a system-wide HTA process [13]. In January 2013, the HTA Commission was created aiming to propose a model to support decision making considering the duality of the Chilean health system and its many challenges. Another interesting Expert Rev. Pharmacoecon. Outcomes Res. 15(1), (2015)
Expert Review of Pharmacoeconomics & Outcomes Research Downloaded from informahealthcare.com by University of Southern California on 03/13/15 For personal use only.
Institutionalizing HTA for priority setting & health policy in LA
initiative in this country is the recent publication of national guidelines for economic evaluations [14]. Regarding Colombia, there is a positive and mandatory package since 1993 for social insurance called Mandatory Health Plan (POS) with nearly 96% coverage. POS was not updated regularly and there were many differences between the two subsystems, the contributive and subsidized regimes, generating inequities in access. As a consequence, there was a high rate of litigation to gain access to health technologies. An independent, public/private HTA agency (Instituto de Evaluacio´n Tecnolo´gica en Salud) was created in 2012, with incumbencies related to clinical practice guidelines, systematic reviews, economic evaluations and budget impact analysis to inform MoH decisions. A technology prioritization system was constructed based on the definition of 15 criteria (using the EVIDEM framework, with 13 EVIDEM criteria and two locally generated criteria) [15,16] and piloted in 2013. Mexico has a heterogeneous access to health technologies. The health technology adoption process has different phases and consists of five steps [17]: the regulatory authorization (COFEPRIS), sectorial inclusion by the General Health Council (CSG) in the basic ‘Cuadro Ba´sico’ list, institutional inclusion, negotiation and procurement by funders/buyers, and utilization by providers. The use of HTA is mostly confined to the public sector inclusion. Moreover, different approaches based on explicit and implicit rules coexist in the prioritization process. The Cuadro Ba´sico list and ‘Cata´logo de Insumos,’ and the benefit package for popular health insurance – Seguro Popular – are examples of use of explicit prioritization rules. But this coexists with waiting References 1.
2.
3.
Augustovski F, Pichon Riviere A, Lemgruber A, et al. First plenary session: Assigning regional priorities & the use of HTA & economic evaluations in Latin America: how far have we come? Available from: www.ispor.org/Events/ EventInformation.aspx?eventid=41&p= 145#plenary [Last accessed 18 March 2014] Lazovsky J, Petramale C, Castillo Riquelme M, et al. Second plenary session: HTA as a tool to inform pricing and coverage policies in the national context: case studies from Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay. Available from: www.ispor.org/Events/ EventInformation.aspx?eventid=41&p= 145#plenary [Last accessed 18 March 2014] Pan American Health Organization - World Health Organization. Resolution CSP28.R9: Health Technology Assessment and incorporation into Health System. 28th Pan American Sanitary Conference. 64th Session of the Regional Committee. Washington, D.C., USA, 17-21 September 2012. Available from: www.paho.org/hq/index.
informahealthcare.com
4.
Editorial
lists and shortages in social insurance institutions, and implicit rules also play an important role in access. Currently, Mexico is working on a health system reform based on universal coverage, and moving toward a single fund financing and a unique package of benefits [18]. Finally, the Highly Specialized Medical Procedures (FNR) from Uruguay is responsible for ensuring equal and universal access to procedures and high cost drugs. In this context, HTA in combination with economic evaluation and budget impact analysis is used to decide formulary incorporations and utilization norms. These norms and decisions are reviewed periodically and also have external independent audits. It is also noteworthy that they have monitored the outcomes and impact of the established treatments with real-world registries at the individual level since 2010 [19]. As has been shown, LA is moving forward toward the institutionalization of HTA in the decision-making process. There are many overarching themes that encompass region-wide initiatives and experiences and many lessons to be learned from local experiences of several countries. Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
php?option=com_content&view= article&id=7022&Itemid=1&lang=es [Last accessed 30 October 2013]
8.
The World Health Report. Health Systems Financing: The path to universal coverage. WHO Press; Geneva, Switzerland: 2010
Pan American Health Organization. Lanzamiento de la Red de Evaluacio´n de Tecnologı´as Sanitarias (REDETSA). Available from: www.paho.org/col/index. php?option=com_content& view=article&id=1180:lanzamiento-de-la-redde-evaluacion-de-tecnologias-sanitariasredetsa&catid=767&Itemid=554 [Last accessed 30 October 2013]
9.
Cubillos L, Escobar ML, Pavlovic S, Iunes R. Universal health coverage and litigation in Latin America. J Health Organ Manag 2012;26:390-406
10.
Ministerio de Salud de Argentina. Resolucio´n 458/2009. Evaluacio´n de Tecnologı´as Sanitarias. Available from: www.msal.gov.ar/pngcam/tecnologias2.htm [Last accessed 3 October 2013]
11.
Fernanda de Freitas Castro G. A Judicializac¸a˜o Da Sau´de Em Minas Gerais: Uma Avaliac¸a˜o Dos Processos Judiciais Relacionados Aos Procedimentos Ambulatoriais E Hospitalares No Perı´odo 1999-2009. Universidade Federal de Minas Gerais. Programa de Po´s-Graduac¸a˜o em Sau´de Pu´blica. Belo Horizonte – MG. 2013. Available from: www.bibliotecadigital. ufmg.br/dspace/bitstream/handle/1843/ BUBD-9C4GUV/ disserta__o_fernanda_castro.pdf?sequence=1
12.
Petramale C. Case studies from Brazil. Available from: www.ispor.org/conferences/
5.
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Expert Rev. Pharmacoecon. Outcomes Res. 15(1), (2015)
