1. 1

2. Image: DFID - UK Department for International Development/ CC Image: flickr user mtsofan/ CC Inertial, implicit and ad hoc resource allocation can result in low value and inequity versus 2

3. Competing interests in an ad hoc process drive these perverse choices 3

4. Explicit priority-setting can help achieve health goals Goal is universal coverage of highly c/e, pro-equity health benefits, not cost control and denial of care. Image: DFID - UK Department for International Development/ CC Image: Canadian Press) / CC versus 4

5. Huge health gains are possible Health spending growing, markets too Health technologies are rapidly diffusing Legal actions more common Forces converging to make explicit priority-setting necessary and possible 5

6. Cost-effectiveness of 108 health interventions evaluated in DCP2 Cost-effectiveness of HIV/AIDS interventions (DALYs per $1,000) For a given budget, there are large differences in obtainable health impact Source: DCP2, www.dcp2.org 6

7. Sources: World Bank, 2013; WHOSIS, 2013 Greater public health spend does not directly translate into health gains 7 Life Expectancy (Years) vs. Per Capita Public Spending on Health (PPP int. $), 2011

8. Source: WHOSIS, 2013 Per capita public spend is growing 8 Per Capita Public Spending on Health by Country (PPP int. $), 1995-2011 — Average — Trinidad & Tobago — Costa Rica — Panama — Uruguay — Guatemala — Nicaragua — Honduras — Bolivia — Argentina For the highest spenders, consistent growth began around 2003

9. Markets are growing too Source: Giedion (2011), from IMS, OveralI growth pharmamarkets 2010. http://www.pharmaphorum.com/2011/04/06/pharma-emergingmarkets- latin-america/; Avastin/Bevacizumab La Roche, annual report. 9

10. Legal actions are increasingly common Brazil: 240,000 federal cases in 2010 for a total of $550 million, only medicines Colombia: 40,000 cases a year; in 2009 litigation cost the public sector $300 million Source: Cubillos et al (2012) 10

11. Essential medicines lists Health benefits plans HTA agencies NITAG Current policy tools: 11

12. Note: List of Latin America & Caribbean countries are those included in the World Bank’s country and lending group (developing only) Source: WHO National Medicines List/Formulary/Standard Treatment Guidelines (http://www.who.int/selection_medicines/country_lists/en/), 2013http://www.who.int/selection_medicines/country_lists/en/ Most countries have a national essential medicines list (NEML) 12 Countries with NEMLCountries without NEML Argentina Belize Brazil Chile Colombia Dominican Republic Ecuador El Salvador Guyana Haiti Antigua and Barbuda Bolivia Costa Rica Cuba Dominica Grenada Guatemala Panama St. Lucia Honduras Jamaica Mexico Nicaragua Paraguay Peru St. Vincent and the Grenadines Suriname Uruguay Venezuela

13. Note: Analysis is preliminary Source: IMS MIDAS Medical Data, 2013 In many cases, the NEML does not effectively function as a priority- setting mechanism that assures value for money in system 13 Human Insulin Shares by Country (% of Total Prescriptions), 06/2013

14. 14 A growing number of countries making health benefits explicit in LAC (IDB 2014) Explicit BPNO explicit BP LAC=region most densely „populated“ with BPs Recent proliferation of BPs in the context of UHC and universal health insurance schemes

15. Role of benefits plans in priority-setting HBP as cornerstone for other health system functions HBP as deployed by payers/commissioners, monitored by regulators/legislators and used and contested by citizens Until now, in practice, HBP not mainly about maximizing health or financial protection, but instead: Equity and care variation corrections Budgeting and resource mobilization Contracting and commissioning 15

16. HBP Determines what services will be asked for from the provider network Determines the required amount of resources Can be a key tool of strategic purchasing Determines what human resources and infrastructure will be required Can be used as a starting point to design contracting and payment mechanisms Source: Ursula Giedion; Picture: center stone Notre Dame, Paris. May be seen as an expression of the right to health More than a list: a policy cornerstone - 16 - Increases accountability

17. Issues related to benefits plans Plans or lists with limited connection to budgets and beneficiaries Incremental costs of introduction of new interventions and technologies not known, baseline costs and effectiveness not known What are we comparing to? Procedural fairness problematic (Culyer & Lomas 2006): Not: transparent (to all); consultative (for stakeholders); accountable (to payers, owners, politicians); able to resolve disputes about evidence and methods, etc. Many instances of known c/e interventions not funded at scale, while examples of not c/e interventions receiving subsidy International guidance limited, mostly c/e information from other contexts, lack of attention to affordability 17

18. 18 Capitation payments for the benefits plan in DR US$, constant, 2001-2014 (source IDB 2014 ) Contributory regime Subsidized regime

19. 19 Launch of the Seguro Popular program Legal Reform for the creation of the System of Social Protection in Health Change of federal goverment Evolution of the benefit packages of Seguro Popular, 1996-2012 Source: For 2013, Sistema de Protección Social en Salud. Informe de Resultados, 2013, from a presentation by Eduardo Gonzalez Pier 2014. Mexico’s CAUSES grew from 91 to 266 interventions, while the capitation payment was only adjusted for inflation

20. Fuente: COST EFFECTIVENESS AND COST UTILITY OF TRASTUZUMAB IN THE ADJUVANT TREATMENT OF EARLY HER2-POSITIVE BREAST CANCER IN SEVEN LATIN AMERICAN COUNTRIES: IMPLICATIONS FOR PATIENT ACCESS. Andres Pichon-Riviere (1); O. Ulises Garay (1); Federico Augustovski (1); Carlos Vallejos (2); Leandro Huayanay (3); Maria del Pilar Navia Bueno (4); Alarico Rodriguez (5); Cidley de Oliveira Guioti (6). Bolivia is a middle-income country, but it would cost more than 38 times their annual GDP per capita to purchase a QALY with Trastuzumab

21. Source: Glassman and Chalkidou, “Priority-Setting in Health: Building institutions for smarter public spending,” a report of the Center for Global Development’s Priority-Setting Institutions for Global Health Working Group, 2012 Latin American countries with health technology assessment agencies (HTA) select topics on an ad hoc basis 21 HTA in selected middle-income countries: How and why topics are selected Country/EntityPrioritization process for topic selection Brazil/ANVISA/CITEC No formal process. The definition of priorities has been made through an Annual Workshop on Priorities Chile/CCA No formal process. Topic selection is carried out by the CCA Colombia/CRES No preestablished process for topic selection. In 2011 for the first time a more systematic process was used, but this has not been institutionalized Colombian Law Uruguay/FNR/MoH There is no formal process for topic selection. Both the MoH and the FNR define the topics Thailand/HITAP Representatives of four groups of stakeholders (health professionals, academics, patient groups, and civil society organizations) are appointed to sit on a panel overseeing intervention prioritization. Panel introduces six agreed criteria. A scoring approach with well-defined parameters and thresholds was employed to address each criterion.

22. Source: PAHO, Immunization in the Americas—2013 Summary ( http://bit.ly/1isVnEp ), 2014 http://bit.ly/1isVnEp Eleven countries have NITAG 22 CountryNumber of NITAG Meetings Panama Peru Mexico Chile Honduras El Salvador Cuba Argentina Colombia Uruguay Brazil Number of NITAG Meetings by Country (2012) In other countries, the NITAG did not meet in 2012 or information on the NITAG was not available

23. NITAG in LAC sometimes consider cost-effectiveness studies, but aspects of their quality can be improved 23 Weak methods or reporting related to equity, affordability, all comparators, clarity on currency conversion, price data, reporting ICER, stating conflicts of interest

24. Recommendations Better, more transparent data, methods and processes urgently needed Compliance with better practices in economic evaluation Adding, modifying or eliminating technologies or benefits necessarily means adjusting budgets and payments Process that is defensible in courts, and assures that people only get care that works to improve health Assuring fiscal sustainability Link priority-setting instruments –whether EML, HBP or HTA- to incentives for effectiveness in their delivery (the cornerstone) Systems have limited focus on outcomes of care, few incentives to make connections 24

25. Si no logramos priorizar bien, nos queda otro tipo de racionamiento con resultados perversos para la salud y la equidad Negar Criterios de exclusión (por ej edad limite para diálisis) Seleccionar Criterios para inclusión (por ej IMC por Orlistat) Defleccionar Cost shifting (por ej entre niveles de atencion) Disuadir Barreras al acceso (por ej co pago) Postergar Listas de espera Diludir Reducida cantidad y calidad  inequidad Terminar Frenar prematuramente el servicio Fuente: Klein, Day & Redmayne 1996

26. Priority-setting Entire decision-making process and context, including the legislative, regulatory, policy, payment, and reimbursement framework within which evidence is developed and used to inform public spending decisions. Reflects that priority setting …involves multiple actors and processes, and is based on inputs provided by health systems, the legal framework, and social values prevailing in each society… …leading to different types of outputs such as coverage decisions, guidelines, protocols, or other evidence-based recommendations that will be reflected in public budgets and spending for health. The specific system emerges from a country’s priority-setting starting point. Includes but does not refer only to the narrow technical and analytic function of assessing an individual technology or intervention (narrow HTA) 26

27. Seven core processes of priority- setting 1 Registration 2 Scoping 3 Cost-effectiveness analysis / HTA 4 Budget impact analysis 5 Deliberative process 6 Decision 7 Appeals, tracking and evaluation 27

28. Working group envisioned new or better support to countries and global funders via a consortium to: create and/or strengthen priority-setting processes and institutions for health benefits design and adjustment and/or decisions on new technology adoption in LMIC, in support of UHC identify, fund and implement priority-setting knowledge products that represent regional or global economies of scale guidance on methods for empirically-based c/e thresholds and decision rules guidance on data requirements and collection options benchmarked coverage and reimbursement decisions on new technologies joint assessments of new, potentially cost-effective technologies; joint efforts to cost and assess new clinical guidelines regional exchanges and cooperation clearinghouse, blogs of new papers and decisions, emerging issues in field and coping strategies, web portal of open data/methods/models, reports, etc. provide an international voice to give moral and technical support to the difficult politics and communication around priority-setting 28

29. What it shouldn’t be Not an entity that issues recommendations about specific technologies, or make decisions on behalf of countries Instead an independent source of expertise and voice in the service of the public interest Not advocating a single approach or solution to the organization of priority-setting Instead, pragmatic processes that evolve to reflect core functions Not an academic exercise or about a single academic discipline Instead, policy focused and multidisciplinary (clinical, economic, fiscal, social science, ethics, public) Not a brand-new institution At the service of payers and commissioners of all kinds, in the public interest 29

30. What’s happened since report was published 30 UN UHC Declaration HTAsiaLink second meeting, discussions with ASEAN New HTA entities in Colombia, Costa Rica, others Three Latin American HTA/p-s/benefits plans networks established and running, including REDETSA IDB Benefits Plan book released PAHO and WHO HTA Resolution HTAi Latin America meeting Establishment of the International Decision Support Initiative