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NTELLIGENCR E C O M M E N D A T I O N S & G U I D E L I N E S
Priority-Setting Institutions in HealthRecommendations from a Center for Global Development Working Group

Amanda Glassman �, Kalipso Chalkidou –, Ursula Giedion k, Yot Teerawattananon ', Sean Tunis §,

Jesse B. Bump �, Andres Pichon-Riviere “

Washington, DC, USA; Baltimore, MD, USA; London, United Kingdom; Bogota, Colombia; Nonthaburi,Thailand; and Buenos Aires, Argentina

A

The author

From the �

USA; §Cen

Kingdom; kHealth, No

University o

bstract

The rationing problem is common to all health systems––the challenge of managing finite resources to

address unlimited demand for services. In most low- and middle-income countries, rationing occurs as an

ad hoc, haphazard series of nontransparent choices that reflect the competing interests of governments,

donors, and other stakeholders. Yet in a growing number of countries, more explicit processes, with

strengths and limitations, are under development that merit better support. Against this background,

the purpose of the Center for Global Development Working Group, which is to examine how priorities

are set currently, and to propose institutional arrangements that promote country ownership and

improve health outcomes by more systematically managing this complex process of politics and eco-

nomics, is discussed. Current global and national priority-setting practices in low- and middle-income

countries, the potential for strengthened national institutions, and increased global support are

reviewed. Recommendations for action are provided.

A fundamental challenge for all health systems isto allocate finite resources across the unlimited de-mand for health services. This is a rationing prob-lem, regardless of whether it is explicitlyaddressed as such, because it requires active or pas-sive choices about what services are provided towhom, at what time, and at whose expense. Inevi-tably, some demand goes unmet, which is a sourceof the intense pressure to provide more serviceswithin any given resource envelope. Efforts to re-duce waste, increase quality, and improve efficiencyare all responses to this pressure. Expanding health-care costs are another reflection of the same forces.A recent Organisation for Economic Co-operationand Development (OECD) report [1] found thathealth spending growth exceeded economic growth

s have reported that they have no relationships relevant to the co

Center for Global Development, Washington, DC, USA; �Depar

ter for Medical Technology Policy, Baltimore, MD, USA; –N

Independent, Bogota, Colombia; 'Health Intervention and Tec

nthaburi, Thailand; “Health Technology Assessment and Econ

f Buenos Aires, Buenos Aires, Argentina. Correspondence: A. G

in almost all OECD countries over the past15 years. In the context of worsening fiscal posi-tions in the global recession and greater demandfor services because of aging populations, as wellas more complex and expensive health technologies,the pressure on OECD health systems to delivermore care with greater efficiency is unprecedented.

Policymakers and analysts working in low- andmiddle-income countries (LMIC) are concernedwith the same issues. In many middle-incomecountries, economic growth is also accompaniedby a greater proportion of gross domestic productdevoted to health. This has led to a significant in-crease in health spending, often because of costlytechnologies of marginal benefit while most of thepopulation remains without access to basic and

ntents of this article to disclose.

tment of International Health, Georgetown University, Washington, DC,

ational Institute for Health and Clinical Excellence, London, United

hnology Assessment Program, Department of Health Ministry of Public

omic Evaluations, Institute for Clinical Effectiveness and Health Policy,

lassman ([email protected]).

mailto:[email protected]

http://dx.doi.org/10.1016/j.gheart.2012.01.007

http://dx.doi.org/10.1016/j.gheart.2012.01.007

14 Glassman et al.

Priority-Setting Institutions in Health

G L O B A L H E A R T , V O L . 7 , N O . 1 , 2 0 1 2

M a r c h 2 0 1 2 : 1 3 – 3 4

highly cost-effective care. Many LMIC have em-ployed technical ‘‘priority-setting’’ approaches toargue for certain interventions over others. Theburden of disease approach, applied by the WorldHealth Organization (WHO) using the disabil-ity-adjusted life year (a standardized measure ofdisease burden), has been used to facilitate compar-isons of one health problem versus another. Cost-effectiveness analysis is another commonly invokedtechnique, for instance as used by the United King-dom’s Department for International Developmentin its ‘‘value for money’’ initiative. In general, theseapproaches are intended to maximize the impact(however defined) of health spending in LMIC,but because donors and others usually produce theirown analyses using their own methods, there is noconsensus on what should be prioritized.

The result of a myriad of actors championing akaleidoscope of ‘‘priorities’’ is confusion. Advocates,researchers, and policy makers have labeled almostevery disease, condition, medication, or interven-tion a ‘‘health priority.’’ From rotavirus to cardiovas-cular disease, from leishmaniasis to cervical cancer,from vaccines to palliative care, the gamut of healthneeds and possible responses are prominent on theagendas of various groups. Competing advocacy ef-forts are not new and are likely to remain a key fea-ture of the landscape. For instance, the recent UNHigh-Level Meeting on Non-Communicable Dis-eases [2] promoted at least 4 new conditions as glo-bal priorities, without recognizing the difficultreality that prioritizing some issues also meansdeprioritizing others. The problem is particularlyacute for policy makers in many LMIC because theydo not have institutional mechanisms that could as-sess various proffered ‘‘priorities,’’ evaluate politicaland economic constraints, and gather input from abroad range of stakeholders, including citizens.

In addition, many LMIC depend on external re-sources to finance their health systems, and manyalso rely on donors or other partners for technicalassistance or implementation support. This addsan international dimension to the already compli-cated matter of setting priorities because relianceon external financing and advice leaves countries’domestic policy processes open to outside influence.A common outcome is a negotiated set of prioritiesthat reflect some domestic needs and some techni-cal, political, and economic considerations definedlargely by the interests of donors. Few would arguethat this process is optimal.

Coping with tradeoffs in the prevention andtreatment of human immunodeficiency virus/ac-

quired immunodeficiency syndrome (HIV/AIDS)is among the most visible global rationing dilem-mas facing policy makers and donors. Only 36%of those needing antiretroviral therapy were receiv-ing treatment in Africa as of December 2009 [3].Countries must decide who will receive lifesavingantiretroviral therapy, when, and under what cir-cumstances. Yet in most cases, countries have notdefined explicit rationing criteria, leading to a non-transparent process rife with opportunities forabuse by those with influence and partially or com-pletely void of ethical considerations [4]. An Insti-tute of Medicine panel on the future of HIV/AIDSin Africa [5] acknowledged this problem, callingfor a ‘‘decision-making process for resource alloca-tion [that] incorporates robust safeguards not onlyagainst discrimination but also against arbitrary orself-serving exercises of power.’’

Potential conflicts over priorities are already verycomplicated within the domestic sphere. For in-stance, important drivers of costs in middle-incomecountries have been rights-based legal argumentsby which citizens have used the court system tocompel the provision of often-expensive therapies.This strategy has been used in some South Amer-ican countries where the right to health is en-shrined in constitutional law. In these instances,citizens have forced the expansion of state-providedservices, which leads to increased health systemexpenditures and/or cuts in other services. Thispractice will likely spread; civil society organiza-tions in Uganda recently sued the government over2 maternal deaths [6]. Because this strategy onlycompels the government to provide specific addi-tional services, it does not address wider implica-tions of how much should be spent, how theresources should be used, or what tradeoffs mightresult [7,8].

In many cases, health systems plan to provide farmore services than is possible under their existingbudgets, which creates the difficult problem ofrationing the provision of promised services. Manyplans have no budgets linked to the activities de-scribed in the plan. Ssengooba [9] illustrates thisquandary in Uganda, where a package of servicescosting $28 per capita was expected to be deliveredwith an $8 per capita actual expenditure. Moregenerally, governments in many LMIC tend topromise universal coverage to all those in need.For example, the constitution of Haiti states: ‘‘thestate of Haiti has the absolute obligation to guaran-tee the right to life, health and protection withoutdistinction’’ [10]. However, financial resources are


M a r c h 2 0 1 2 : 1 3 – 3 4Glassman et al. 15


so low that this commitment cannot be fulfilled inpractice. The lack of coherence between a limitlesspromise and limited resources leads to implicitrationing through waiting lines, low quality, ineq-uities, and other mechanisms.

The multiplicity of priorities and the lack ofinstitutional mechanisms at global and nationallevels to rationalize services and spending often re-sult in poor overall system performance, as mani-fested in low coverage levels for highly effectivehealth technologies, relatively excessive supply ofhigh-cost services with limited clinical advantages,inefficient and underused health facilities, inequi-table access to services, and ultimately poor healthoutcomes. Gains from reallocating toward morecost-effective health interventions can be substan-tial, illustrating the human and financial costs asso-ciated with weak and implicit rationinginstitutions. For example, a 2011 study by the Cen-ter for Global Health Research in India [11] esti-mates that a basic package of cost-effective healthcare would cost about one-half of current per capitapublic spending on health and reduce total deathsby 28%. For cardiovascular disease (CVD), Gazi-ano et al. [12] find that pharmacotherapy can becost-effective in low resource settings and thatCVD-related deaths could be reduced by up to50%. Yet in most countries, the rationing compro-mises of the current implicit priority setting mech-anisms are rarely made explicit to policy makers orthe citizens they serve.

In this paper, we begin with the argument thatfor any given budget, systematic approaches to pri-ority setting produce more health services and ulti-mately better health outcomes than do approachesthat are haphazard or largely ad hoc. The large lit-erature on priority setting shows widespread sup-port for this position. However, mostinvestigators have concentrated only on the techni-cal aspects of priority setting, such as quantifica-tions of the burden of disease or the cost-effectiveness of interventions. Although these tech-nical contributions constitute key potential inputsinto the process, priority setting is fundamentallya political exercise, because it involves the distribu-tion of benefits and responsibilities. As Reich [13]observed in his critique of the 1993 World Devel-opment Report (WDR), technical advancementsdo not automatically translate into political action.Our review of the field finds that the process bywhich countries move toward more systematic ap-proaches remains largely unanalyzed. Accordingly,we focus our attention on institutional mechanisms

that can help manage the politics of decision mak-ing by providing independent, technically soundassessments of health priorities and interventions.We begin by briefly reviewing global efforts to sup-port more systematic priority setting. We then re-view national-level institutions that have tried toincrease the influence of technical evidence in pri-ority-setting decisions. We discuss the evidenceand then identify important decisions and chal-lenges that arise when establishing and managingpriority-setting institutions. We conclude with rec-ommendations for how countries can move towardmore systematic priority setting to increase theeffectiveness of their health spending and promotebetter lives for their citizens.

G L O B A L E F F O R T S T O S U P P O R TP R I O R I T Y S E T T I N G

Global-level attempts to support priority settinghave been undertaken for at least 3 decades, butthese efforts have tended to focus on only a few as-pects of priority setting, such as gathering evidenceor creating methods, and have yet to result in broadimprovements via more systematic decision makingin LMIC. Perhaps the best-known of these pro-jects has been the World Bank’s 1993 WDR [14]and related literature, which was inspired by theOregon Health Services Commission’s effort toprioritize within the U.S. Medicaid program inthe late 1980s [15]. This work introduced the glo-bal health community to the use of cost-effective-ness criteria to determine which healthinterventions would be publicly financed––and byextension donor-financed. These investigators ar-gued that burden of disease estimates could becombined with a cost-effectiveness rank list ofinterventions to derive packages of services thatwould facilitate the largest improvement in healthas measured by disability-adjusted life years, forany given budget. Murray et al. [16] distinguishedbetween calculating these packages from a ‘‘groundzero’’––where the current budget is applied to thewhole of disease burden in the absence of currentlyfinanced health interventions––versus a ‘‘marginalexpansion’’––wherein a package would be con-structed with an additional or marginal increasein budget applied to the current disease burden.

Criticisms of this approach have focused on theweak data on which estimates of burden, cost, andeffectiveness relied; the value judgments implicit indisability-adjusted life year age weighting and dis-counting decisions; and treatment of equity issues

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[17], as well as the political difficulties associatedwith translating a ground zero package into a pub-lic budget based on historical inputs [18]. Further,early cost-effectiveness analysis only consideredhealth maximization as the priority-setting objec-tive; later work has highlighted the need for multi-dimensional priority-setting objectives, includingequity and fairness, financial protection, and exist-ing health system capacity. Beyond these consider-ations, policy implementation and adoption issueshave not been explored adequately.

Since the 1993 WDR [14], much work has fo-cused on regularly updating estimates of the globalburden of disease, injuries, and risk factors (1990,2000–2002, 2004 thus far; 2005 and 2010 projec-tions underway) via the Disease Control PrioritiesProject and a connected WHO/Institute for HealthMetrics and Evaluation collaboration [19]. Theavailability of this information has likely played arole in the increasing number of LMIC-focusedcost-effectiveness studies published in the peer-re-viewed literature, which now number in the thou-sands. But their application in practice to actualpriority-setting processes is likely to be very small.

Another growing area of activity relates to mod-els and tools that policy makers could use to designtheir own packages or identify priority interven-tions. For instance, the 1994 Health ResourceAllocation Model, by Murray et al. [16], is opti-mized for burden of disease, cost-effectiveness ofavailable health interventions, and available healthsystem infrastructure. Other examples includeWHO’s Choosing Interventions that are Cost-Effective (CHOICE) Project, which incorporatesinteractions between concurrent interventions andmodels the effect of scale on costs and effectivenessfor every intervention and every combination at dif-ferent levels of coverage [20,21]. The Lives SavedTool [22], developed by Johns Hopkins University,allows users to compare the health impact of alter-native coverage strategies over a period of time, butit does not model costs. The comprehensiveness ofthese models is growing. Evidence and Value: Im-pact on Decision Making (EVIDEM) combines amulticriteria decision analysis value matrix madeup of 15 quantifiable components of decision (qual-ity of evidence, disease, intervention, and econom-ics) with a qualitative tool including 6 ethical andhealth system-related components of decision,and pilots the tool for a single disease in SouthAfrica and Canada [23]. Baltussen et al. [24] usemulticriteria decision analysis to prioritize inter-ventions in 7 LMIC, concluding that methodolo-

gies like this ‘‘can have far-reaching andconstructive influences on policy formulation.’’Yet in all cases, the models remain in the literatureor in pilots, and have rarely been deployed to in-form ongoing policy-making processes.

The international community has also focusedon improving the quality and availability of epide-miological, demographic, use, cost, and effective-ness data that feed into burden of disease andcost-effectiveness estimations, most notably viathe Health Metrics Network [25], the Demo-graphic and Health Surveys [26], and the Multi-Indicator Cluster Surveys [27]. Nevertheless, basicstatistics on births, diseases, and deaths remainproblematic [28]. (According to the UN StatisticsDivision, only around 20% of African countriesprovided complete information on births anddeaths for at least 1 year in the 2003–2007 period[28].) Furthermore, little funding has gone toincentivize or support the regular, quality collectionof these data and their use in actual decision mak-ing. For example, in spite of the importance ofthese data for assessing cost-effectiveness, valuefor money, and the impact of their investments,neither the GAVI Alliance nor the Global Fundfor AIDS, Tuberculosis, and Malaria require stan-dardized reporting on total public expenditure onhealth, relevant disease epidemiology, and the localcosts of provision as pre-conditions to the receipt oftheir funding [29].

Among the few donor-sponsored initiatives todirectly strengthen evidence-based resource alloca-tion at the country level is the Supporting Indepen-dent Immunization and Vaccine AdvisoryCommittees Initiative (SIVAC). SIVAC buildsthe capacity of National Immunization TechnicalAdvisory Groups and, in some cases, provides sup-port to carry out cost-effectiveness studies in sup-port of new vaccine introduction or new vaccinetechnology [30]. However, the exclusive focus onvaccination creates its own challenges, as new vac-cines are not necessarily compared with the appro-priate counterfactual. For example, vaccines arefrequently compared with a ground-zero situa-tion––a vaccine versus no intervention––even whenscreening and/or treatment can be viable alterna-tives. Although these efforts could help prioritizingamong vaccines, they do not address prioritizationbetween vaccines and other options, which severelylimits their usefulness for national priority settingin health.

Another prioritization effort is the essentialmedicines list (EML). Defined as ‘‘those [medi-




cines] that satisfy the priority health care needs ofthe population’’ and launched in 1977, WHO––with the help of an international expert committeemade up mainly of clinical pharmacists––createslists of medicines ‘‘with due regard to disease prev-alence, evidence on efficacy and safety, and com-parative cost-effectiveness’’ to inform purchasingdecisions in the context of national health agendas.A model list––updated every 2 years based onapplications––is published online and frequentlyadopted (though not necessarily funded or pro-vided) by governments in developing countries.As of 2011, 156 countries have adopted versionsof the EML [31]. Whereas indicators to track ac-cess to essential medicines were only established in2009 and information on funding is not available, ameta-analysis of 679 published studies (mostlyfrom Sub-Saharan Africa) of variable design andquality reviewed medicines used in primary carein developing countries and found that the shareof all prescribed medicines that are included onan EML has increased over time [32]. However,this does not imply availability of all or indeed mostof the medicines listed on the EML. A study in In-dia looked at 5 essential medicines for children in-cluded on the EML, finding that 4 of 5 wereactually available in public facilities [33]. Conceptu-ally, the weaknesses of EML relate to its exclusivelyprimary care focus when many countries are seekinginternational advice on how to handle higher costmedications provided in hospitals, as well as the lim-ited linkages between the medicines included onEML and the benefits, costs, and affordabilityimplications of actually providing these medicines.Furthermore, EML have no local processes ofupdating or monitoring/evaluation attached. Final-ly, the EML approach has not been extended to de-vices, diagnostics, procedures, and other healthinterventions of increasing importance in LMIC.

In summary, global efforts to support nationalpolicy making have been limited to specific dis-eases, conditions, or types of technologies (suchas drugs or vaccines) and have focused on the gen-eration of global evidence, rather than generatingcountry-specific data, supporting country decisionmaking, building national institutions, or facilitat-ing exchanges and collaboration. Interestingly,although efforts are global in scope, none of the ac-tions mentioned directly help global funding agen-cies set priorities, in spite of a growing number ofnew technologies in the context of declining globalhealth resources and evidence of widespread use ofineffective or unnecessary services.

N A T I O N A L E F F O R T S T O S U P P O R TP R I O R I T Y S E T T I N G

We reviewed national-level attempts to make pri-ority setting more systematic to understand whatinitiatives and processes have been taken on coun-tries’ own initiatives and to see what links theremay be between these actions and some of theinternational research and data collection efforts.We find that national efforts to support explicitpriority setting in health have taken 2 main paths:health benefits plans or lists (HBP) and healthtechnology assessment (HTA) agencies. We revieweach separately.Health benefits plans. As discussed, the WorldBank’s 1993 WDR and the WHO’s Commissionon Macroeconomics and Health both recom-mended a basic package of cost-effective care inLMIC as a priority-setting mechanism for LMIC.Table 1 [34–96] shows that this recommendationwas influential; we identify at least 63 LMIC thathave established an explicit positive and/or nega-tive package, plan, or list of health interventionsto be funded by public resources, insurance, or so-cial security contributions (Table 1). AlthoughHBP are sometimes thought to pertain exclusivelyto health insurance schemes, HBP are being usedin all kinds of health systems, even those withoutpurchaser–provider splits, as a means to structureresource allocation and potentially improveaccountability, equity, enforcement of rights, andcontrol of spending. In some countries, these ben-efits packages have become some of the main driv-ers of public health expenditure and thereby a keytool for strategic purchasing of health services. Ina review of the 98 World Bank health projects ap-proved between 2009 and 2011, 31––about one-third––refer to plans to develop or support a healthbenefits package. In addition, HBP have been useddirectly by donors in fragile states such as Afghan-istan, Haiti, and South Sudan to contract withnongovernmental organizations for direct serviceprovision. It is likely that the proliferation ofHBP reflects the influence of recommendationsfrom the 1993 WDR and WHO’s Commissionon Macroeconomics and Health, which both rec-ommended a basic package of cost-effective carein LMIC as a priority-setting mechanism forLMIC. Table 1 shows that this recommendationwas influential.

Drawing on the existing literature, we find thatcountries face challenges with HBP, and we sum-marize the evidence. We note that a systematic

Table 1. LMIC with health benefits plans

World Bank country grouping Number Positive or negative list of health benefits

Eastern Europe and Central Asia 18 Health insurance schemes: Azerbaijan (SAMHI decree 2008) [34]; Bulgaria (NHIF 1998) [35];

Croatia (HZZO) [36]; Estonia (EHIF 2001) [37]; Georgia (SMIC 1996) [38]; Hungary (OEP

1992) [39]; Kyrgyz Republic (MHIF 1996) [40]; Lithuania (NHIF) [41]; Macedonia (HIFM) [42];

Moldova (MHI 2002) [43]; Poland (NFZ 2003) [44]; Romania (NHIF 2002) [45]; Russia (MHIF

1993) [46]; Slovenia (HIIS 1992) [47]

Tax-funded systems: Armenia (SHA 1998) [48]; Kazakhstan (MOH 2005) [49]; Slovak

Republic (MOH) [50]; Tajikistan (MOH 2007) [51]

Latin America and Caribbean 14 Health insurance schemes: Argentina (PMO 1997) [52]; Chile (AUGE) [53]; Colombia (POS

1993)[54]; Dominican Republic (SENASA 2002) [55]; Nicaragua (Listado de Prestaciones

Medicas Quirurgicas de Salud: Ursula Giedion, Personal Communication, February 27,

2012) [56]; Peru (PEAS 2009) [57]; Uruguaya (PIAS 2007) [58]

Tax-funded systems: Argentina (Plan Nacer 2005) [59]; Bolivia (SUMI 2003) [60]; Brazilb [61];

Honduras (IHSS 1995) [62]; Mexico (CAUSES 2001) [63]; Nicaragua (MINSA) [56]

Asia 8 Health insurance schemes: Lao People’s Democratic Republic (HEF 2008) [64]; Philippines

(PhilHealth 2006) [65]; Vietnam (HCFP 2003) [66]

Tax-funded systems: Cambodia (HEF 2000) [67]; China (NRCMS 2003) [68] ; India (NRHM

2005) [69]; Malaysia (MOH) [70]; Thailand (UCS 2001) [71]

Middle East and North Africa 16 Health insurance schemes: Egypt (HIO 1964) [72] Israel (NIII 1995) [73]; Lebanon (CNSS)

[74]; Malta (NHS 1956) [75]; Syria (NHIS 2010) [76]; Tunisia (CNAM 2007) [77]; United Arab

Emirates (Daman 2006) [78]; West Bank and Gaza (GHI) [79]; Yemenc [80]

Tax-funded systems: Bahrain (MOH 1979) [81]; Djibouti (MOH) [82]; Jordan (MOH 1965)

[83]; Morocco (AMO 2005) [84]; Oman (MOH) [85]; Qatar (SCH) [86]; Saudi Arabia (NHS) [87]

Sub-Saharan Africa 9 Health insurance schemes: Ghana (NHIS 2004) [88]; Kenya (NHIF 1998) [89]; Namibia

(NMBFd) [90]; Nigeria (NHIS 1999) [91]; Senegal (CBHI) [92]; South Africa (NHIe) [93];

Tanzania (NHIF 1999) [94]; Uganda (NHIf) [95]

Tax-funded systems: Zambia (MOH 1993) [96]

AMO = Compulsory Health Insurance; AUGE = Regime of Explicit Health Guarantees ; CAUSES = Catalogo Universal de Servicios de Salud; CBHI = Community-basedHealth Insurance; CNAM = La Caisse Nationale d’Assurance Maladie de Tunisie; CNSS = National Social Security Fund ; EHIF = Estonian Health Insurance Fund;GHI = Government Health Insurance ; HCFP = Health Care Pool Fund; HEF = Health Equity Funds; HIFM = Health Insurance Fund of Macedonia; HIIS = HealthInsurance Institute of Slovenia; HIO = Health Insurance Organization; HZZO = Croatian Institute of Health Insurance; IHSS = Instituto Hondureno de Seguridad Social;LPMQSS = ; MHI = Mandatory Health Insurance ; MHIF = Mandatory Health Insurance Fund (Kyrgyz Republic, Romania); MHIF = Mandatory Health Insurance Funds(Russia); MINSA = Ministerio de Salud; MOH = Ministry of Health ; NFZ = Narodowy Fundusz Zdrowia; NHI = National Health Insurance; NHIF = National HealthInsurance Fund; NHIS = National Health Insurance Scheme; NHS = National Health Service; NIII = National Insurance Institute of Israel; NMBF = National MedicalBenefit Fund; NRCMS = New Rural Cooperative Medical System; NRHM = National Rural Health Mission; OEP = National Health Care Fund/ Országos Egészségbiz-tosítási Pénztár; PEAS = Plan Esencial de Aseguramiento de Salud; PIAS = Plan Integral de Atención en Salud ; PMO = Compulsory Medical Plan; POS = PlanObligatorio de Salud; SCH = Supreme Council of Health; SENASA = Proceso de traspaso al Seguro Nacional de Salud; SHA = State Health Agency; SAMHI = StateAgency on Mandatory Health Insurance; SMIC = State Medical Insurance Company; SUMI = Seguro Universal Materno Infantil; UCS = Universal Coverage Scheme.a Benefits package was designed with a TA from the World Bank and AIF (U. Giedion and M. Dinarte, January 2012).b The lists are conditional on Department of Science and Technology (DECIT) evaluation.c In planning as of 2009.d In progress.e Being established in 2012.f Proposed.

18 Glassman et al.



M a r c h 2 0 1 2 : 1 3 – 3 4

plan-by-plan review would be required to docu-ment all the characteristics of these efforts.

� HBP sometimes rely on poor data, no local data, andno cost information. Ghana’s HBP and its contents,for example, were legislated before being costed[97]. HBP in Latin America do not take futuredemographic and epidemiological trends into account[98].� HBP are not always linked to available resources or

are unaffordable, leading to erosion of health andfinancial protection impact, as well as legal (and polit-ical) challenges. Chile’s Regime of Explicit HealthGuarantees (AUGE) only calculated the total cost

but never the additional cost required to provide guar-anteed benefits [99]. Mexico’s Catalogo Universal deServicios de Salud (CAUSES) grew from 91 interven-tions in 2004 to 266 interventions in 2008, whereasthe capitation payment associated with the packagewas only adjusted for inflation [100]. Where HBPhave worked to structure expenditures, they areaccompanied by changes in budgeting, from inputsto the packages, where input costs are wrapped upin the packaged interventions as in Colombia andMexico. Many high-income countries also have pack-ages––particularly the insurance systems of Europe,Australia, and Canada––but these are based on generalmajor disease category classifications usually accompa-




nied by more detailed benefits schedules with associ-ated fees (for example, a price attached to a diagnos-tic-related group, such as Medicare’s AmbulatoryPayment Classification).� Lacking data on the costs and effectiveness of existing

health system activities, HBP costs are generally cal-culated based on the ground-zero assumption, on aper capita basis rather than incrementally. This isthe case in Chile, Honduras, and Peru [101].� HBP can be vague, grouped in general categories with

no specificity (Kenya), or grouped by diagnosis ratherthan interventions such that anything can be provided(Peru) [102].� In some cases, there are no explicit criteria for defin-

ing the content of health plans, or––in some decen-tralized countries––plans vary by subnational entityand their financing depends on the wealth of that par-ticular locality. This is the case in China for varioushealth insurance programs [Z. Kun, October 2011],with consequences for care variation and equity. Incountries that split social health insurance from publicsector provision, there may also be multiple packagesof different breadth, height, and depth, also withimplications for equity. Similarly, criteria are oftenapplied in an erratic, inconsistent way.� HBP are often conceived as one-off exercises and no

arrangements are in place to update analyses based oninflation, new information, or technological develop-ments. Where updates occur and disinvestment deci-sions are taken, there are few methodologicalstandards.� Cost-effectiveness research is generally carried out

and funded separately from the policy-making pro-cess, and there can be limited relevance to and con-nection with coverage and reimbursement decisions.In China, for example, primary and secondaryresearch in health is funded separately by differentgovernment agencies, which makes it difficult fordecision makers to get well-coordinated evidence thataddresses their own questions [Z. Kun, October2011].� HBP are frequently designed by governments or con-

sultants in isolation, often as a part of developmentbank programs. The government of Jamaica recentlyissued a request for proposals with Inter-AmericanDevelopment Bank funding that called for the designof a HBP in 6 months’ time [103]. Colombia is anexample of a HBP designed by technocrats based oncost-effectiveness, later challenged by a regulatorybody [104]. Chile’s AUGE package of guaranteedservices was also delegated to technical staff at theMinistry of Health, with little opportunity for stake-holder or public input or review [105]. The legal con-testation of health benefits is spreading in LatinAmerica [Z. Kun, October 2011] and in South Africa[106,107]. Parliaments are also involved; in Colom-bia, Congress recently legislated public subsidy fortreatment of rare, orphan diseases without regard

for trade-offs or costs [108]. (Another work estimatedthat the cost of treating Fabry disease alone, whichwould benefit between 31 and 37 persons was equiv-alent to affiliating 664,000 additional people in thesubsidized regime of insurance [109].) Conflicts ofinterest of those participating in the evaluation oftechnologies and the design of HBP are generallyundeclared.� There is usually insufficient documentation of meth-

ods, processes, and actual decisions. In 2011, theInter-American Development Bank [103] reviewedcoverage decisions (decisions per se, criteria for deci-sions) for 20 high-cost drugs in 4 OECD and 4 LatinAmerican countries and encountered an almost totallack of systematic information supporting coveragedecisions in Latin America.� Finally, the lack of a consultative, transparent, multis-

takeholder process in HBP evidence evaluation,design, and adjustment is a prominent feature of effortsin LMIC. This is a troubling pattern given the ethical,political, and legal issues involved in the priority-set-ting process. In South Africa in 1999, for example, uni-versity researchers using evidence-based criteriadesigned an essential package of hospital benefits formedical schemes that was established in regulationwithout any alteration and no public debate [110].

Clearly HBP have had a mixed track record, buttheir frequency is an expression of a trend towardmore explicit rationing, motivated by growing pop-ulation demands and related legal, political, fiscal,and health concerns, as well as increasing emphasison results-based financing.Health technology assessment entities. Anotherapproach to priority setting has been the establish-ment of HTA entities to carry out clinical and eco-nomic evaluation and assessment of new medicaltechnologies and to guide reimbursement deci-sions, mainly in middle-income countries such asBrazil, Czech Republic, Colombia, Croatia, Esto-nia, Poland, Thailand, and Uruguay [110].(Whereas LMIC are the focus of this paper, theworking group also examined HTA processes inEuropean countries. All European countries havededicated national HTA agencies that exploit eco-nomic evidence as part of applications to includenew medicines for public reimbursement. This isparticularly so in the case of innovative productsor in situations in which the manufacturer is seek-ing a premium price [111]. Evidence used in HTAincludes the safety, efficacy, effectiveness, cost, so-cial, institutional, legal, and ethical implications ofnew technology adoption, although the precise useand methodology differs from agency to agency[112,113]. EUnetHTA, a European Commis-

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sion–funded initiative for promoting some stan-dardization of the methods for HTA across Eur-ope, has been fairly successful in raising awarenessand building a series of methodological tools tosupport those doing HTA in countries across Eur-ope. European experience also illustrates that manyHTA bodies involve a wide range of stakeholdersincluding decision makers, health professionals,academics, patient representatives, and laypersonsin the process [114,115]. Although agencies inmiddle-income countries did not initially connectHTA to the design of publicly funded benefitsplans or coverage decisions, the transparency andrigor of the methodologies used to analyze newtechnologies have increased the influence of HTAagencies on the uses of public funding and have ex-panded the assessment mandate beyond medicinesto devices, diagnostics, procedures, and otherhealth interventions. For example, although rec-ommendations are not binding, the NationalHealth Fund in Poland is obliged to request andconsider recommendations made by the HTAagency [110] and one of its first tasks was prepara-tion of a ‘‘basket of guaranteed services.’’ Thailand’sHealth Intervention and Technology AssessmentProgram (HITAP) is now formally part of theteam that designs the National Health Security Of-fice’s ‘‘universal coverage’’ package. In 2007, Koreamade the use of HTA mandatory in decision mak-ing on drug and healthcare reimbursement underthe Health Insurance Review Agency [116]. InBrazil, since mid-2011, new health technologiescan only be listed for funding within the publichealth system provided their security, efficacy,and cost-effectiveness have been demonstratedand assessed by the Comissao Nacional de Incorpo-racao de Tecnologias. Similarly, the country’s regu-latory agency National Health Surveillance Agency(ANVISA) decides prices of new entrant medica-tions based on comparative effectiveness. InColombia, starting in 2012, a HTA institute willprovide recommendations on whether evaluatedtechnologies should or should not be included inthe benefits package or whether, more generally,they should be financed with public resources. InMexico, HTA was made mandatory ahead of acoverage decision in 2011 [117].

Although a more systematic assessment of theimpact of each HTA agency is needed, the workinggroup found that the savings associated with just 2HITAP HTA-based recommendations––lateradopted by the Ministry of Health leadership––

have, in addition to saving lives, far exceeded theircumulative operating costs to date [118,119].

In spite of their promise, there are a number ofobstacles to the implementation of HTA in LMIC,similar to those observed in relation to HBP. First,evidence from Asia, Latin America, and Africa re-veals a severe shortage of local technical and analyt-ical research capacities for HTA compared with thecapacities of high-income countries where HTAhas long been used in policy decision making[120–122]. Second, the reviews of HTA reportsin LMIC found that the majority of the studieswere vulnerable to bias due to the poor quality ofscientific evidence available and deficient reportingfeatures [123]. This may be explained by an ab-sence of standard methodological and processguidelines and limited research infrastructure inmost LMIC [124–127]. Third, where HTA isnot built into coverage decision-making, HTA re-search is not usually directed toward major healthproblems because many HTA studies in LMICare funded by international organizations and phar-maceutical companies [128]. Given resource con-straints, HTA studies have to be prioritized andfocused on interventions that would assist decisionstargeting major health problems that could subse-quently have a large impact on population healthand spending. Fourth, political timing is often atodds with time requirements necessary to conducthigh-quality HTA [124] and supportive institu-tional infrastructure to take HTA decisions is miss-ing. Fifth, many studies find that HTA is a newdiscipline among health professionals and decisionmakers in LMIC and the lack of a clear under-standing of HTA among these potential userswas identified as a major barrier regarding the useof HTA in policy and practice [129]. Similarly,in an article on HTA agencies in Central and East-ern Europe, Sorenson et al. [130] identify obstaclesto HTA institutionalization as lack of capacity, lackof data, scoping difficulties, timeliness, and limitedorganizational infrastructure linking HTA findingsto decision making and implementation. Finally,there is an enduring challenge in connecting thetechnical assessment work to national policy-mak-ing and coverage decision processes [131].

As is immediately apparent from the 2 priority-setting pathways commonly in use in LMIC, HBPand HTA have much in common, using similarmethods of economic evaluation and criteria fordecision making, though sometimes applied totechnologies and services with different levels of




specificity. The growth of both of these policyinstruments in LMIC over the last decade is moti-vated by a range of factors, among them growingpopulation demands, increasing financial pressures(e.g., the IMF has recently established conditional-ity related to coverage decisions in publicly fundedhealth care in Romania under the second review ofthe Stand-By Arrangement [132]), greater avail-ability of new and generally higher cost technolo-gies, persistent inequities in health and coverage,and––perhaps––maturation in democratic pro-cesses. Further, HBP and HTA are converging inmiddle-income countries, with HTA agencies orunits being used to inform coverage decisions with-in HBP. HTA and HBP also have common limi-tations––data, local capacity, lack of legalframeworks, limited formal institutional structures,minimal stakeholder involvement, and sometimeslimited connections to coverage decision making.

D I S C U S S I O N

The Working Group on Priority-Setting Institu-tions for Health sees opportunities to support thecreation, strengthening, and maintenance of sys-tems in LMIC that inject objective assessment intodecision making on publicly funded health servicesand technologies. These systems can and do helpoptimize health outcomes by increasing the techni-cal content of difficult domestic political discus-sions that are often further complicated by donorpreferences, industry pressures, and other forces.In general, we found that country efforts to im-prove priority setting fell into 2 groups. Somehigh-capacity countries––all were middle-in-come––have established robust institutions to sup-port the priority-setting process. These countriesacted largely on their own initiative. Progress inother countries tended to mirror the state of glo-bal-level research, meaning that technical planshad been developed, but very little progress hadbeen made on managing the political process thatactually sets priorities.

After examining trends and characteristics inpriority-setting processes and institutions world-wide and building on the recommendation of Gie-dion et al. [133] to analyze priority setting as amultistep process from a systemic perspective, theworking group adopted a ‘‘7 + 7 framework’’ thatdescribes 7 principles (distilled from the original15 [134]) and 7 core processes of priority settingthat––if implemented, ideally under an explicit le-gal and institutional framework––could have the

potential to improve health for any desired levelof health spending, while channeling and manag-ing political, commercial, advocacy, and donorinterests via a fair process. Without a legal frame-work for setting up and using HTA, it is difficultto ensure enforceability or budget. Equally, if thecourts wish to enforce right-to-health legislation,but have no access to information and process re-lated to evidence appropriateness and affordability,decisions will not have intended effects.

Building on the collective experience of entitiescurrently using HTA to inform decisions, theworking group recommends that HTA systemgovernance follow 7 principles. It should be ethi-cally sound, scientifically rigorous, transparent,consistent, independent from vested interests, con-testable, and timely and enforceable [133,134].

The set of 7 processes that emerges from the 7principles is an ‘‘HTA system’’ whose level of dataand methodological complexity could be scaledaccording to country or funding agency circum-stances. In this usage, HTA system does not referexclusively to the technical and analytic functionof assessing an individual technology or interven-tion, but instead to the entire decision-makingprocess and context, including the legislative, regu-latory, policy, payment, and reimbursement frame-work within which evidence is developed and used.We therefore use a broad definition of HTA devel-oped by International Network of Agencies forHealth Technology Assessment [135]: ‘‘the sys-tematic evaluation of properties, effects, and/or im-pacts of health care technology. It may address thedirect, intended consequences of technologies aswell as their indirect, unintended consequences.Its main purpose is to inform technology-relatedpolicymaking in health care. HTA is conductedby interdisciplinary groups using explicit analyticalframeworks drawing from a variety of methods.’’Additionally, the term HTA system is chosen toreflect that priority setting involves multiple actorsand processes and is based on inputs provided bythe health systems, the legal framework, and thesocial values prevailing in each society, whereasthe process can lead to different types of outputssuch as coverage decisions, guidelines, protocols,or other evidence-based recommendations. Thespecific HTA system emerges from a country’s pri-ority-setting starting point: designing or adjustinga health benefits plan; establishing a positive ornegative list; trying to speed cost-effective medicalinnovations to patients; deciding whether to fi-nance a specific new technology or service.

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The 7 processes are:1. Registration. Registration or marketing

authorization is a first step in the priority-settingprocess. Just obtaining regulatory approval in thecountry is a first step toward availability and thepossibility of becoming a priority for public or do-nor spending. Some countries have used the regis-tration process to proactively speed access to goodvalue technologies, whereas others have been morepassive, letting the process be initiated by industryor donors. Increasingly, pharmacoeconomic evi-dence and clinical data are required for drug appli-cations [131]. Once a technology is registered in acountry, products diffuse quickly to those with theability to pay, creating immediate pressure for apublic-sector coverage decision. Off-license use isalso an issue. Off-license use can be good/necessary(as in pediatric medicines) or inappropriate (as inColombia and the recent decision to use a certainbrand of antiretroviral (ARV) as prophylaxis). Fur-ther, the potential for synergies between regulatorsand payers at the registration stage is large, giventhat security and efficacy of analyzed products areimportant evaluation dimensions.

2. Scoping. Depending on a country’s startingpoint, it will be necessary to identify and selectbroadly defined technologies for evaluation. A poorcountry may start from a major, underaddressedburden of disease, such as CVD, and examine pre-vention and treatment alternatives. In other cases, acountry may start from a costly device for which theincremental value for money is suspected to be lowthat, if funded, would potentially divert publicmonies from higher value uses, or a country mightstart with new technologies with great potential togenerate health improvements or cost savings. Gi-ven more limited resources, the scoping exercise isespecially challenging in LMIC where the numberof technologies outside lists or packages will belarge.

3. Cost-effectiveness. An analysis of the cost-effectiveness (CEA) or value for money of a tech-nology should be undertaken using widely acceptedmethods, tools, and systematic evidence reviews.This is the area where most global efforts to sup-port LMIC to date have centered, but they havenot gone far enough to generate and use local dataor to develop local cost-effectiveness thresholds.CEA should establish a comparative clinical benefitand an incremental cost-effectiveness ratio, ideallycombining local data on costs and use with interna-tional data on efficacy, thus adapting and translat-ing international evidence to local circumstances.

The identification of the appropriate counterfactualinformation should be given particular attention toavoid the zero-based scenario and to appropriatelyreflect the installed capacity of the health system.In addition, multiple quantitative criteria can bebuilt into the cost-effectiveness analyses to reflectboth health and nonhealth priorities in a country.For example, CEA can reflect equity considerationsvia differential weighting of different health statesat different ages, a concern for poverty reductionvia incorporation of financial protection criteria,and different discount rates given the time prefer-ences of a given society, among others. A prelimin-ary recommendation to adopt or not adopt isdeveloped based on CEA using a country-specificthreshold.

4. Budget impact. The budget impact of a preli-minary recommendation emerging from CEAshould be assessed. Budget impact analysis is a toolto predict the potential financial impact of theadoption and diffusion of a technology into ahealthcare system with finite resources. WhereasCEA addresses the additional health benefitsgained from investments in a technology, such asthe cost per additional disability-adjusted life yeargained, budget impact analysis addresses theaffordability of the technology, for example, thenet annual financial cost of adopting the technol-ogy for a finite number of years. This is essentialfor LMIC that have highly constrained fiscal re-sources in the health sector, yet is almost neverconducted as part of the introduction of new tech-nologies. A recent example is the adoption of thehuman papillomavirus vaccine by Rwanda [136].Tools such as the Marginal Budgeting for Bottle-necks can be adapted for this use [137].

5. Deliberative process. A deliberative processshould be run to examine the results of the CEA/budget impact analysis, hear from stakeholders,and consider more subjective decision criteria suchas the severity of conditions, the magnitude of indi-vidual health gain, the relative rarity of the diseasecondition, and trade-offs with ethical implications[138]. In processes worldwide, an appointed, amultidisciplinary committee that publicly disclosesconflicts of interest is tasked with making finaltechnology funding recommendations or decisions.Payers, providers, experts, industry/manufacturerrepresentatives, and, sometimes, patient or publicrepresentatives are included in the deliberation,though voting members may be limited to a subsetof the group. Culyer [139] describes the circum-stances, common in LMIC, that make the use of




deliberative processes in healthcare priority-settingnecessary and relevant:

. . .decisions have been delegated by a body with ademocratic mandate to one without it; evidence frommore than one expert discipline is involved; evidencefrom more than one profession is involved; stakehold-ers have conflicting interests; there are technical dis-putes to resolve and the evidence may bescientifically controversial; evidence gathered in onecontext is to be applied in another; there are issuesof outcome, benefits, and costs that go beyond theconventional boundaries of medicine; there is sub-stantial uncertainty about key values and risks thatneeds to be assessed and weighed; there are othersocial and personal values not taken into account inthe scientific evidence; there are issues of equity andfairness; there are issues of implementability andoperational feasibility involving knowledge beyondthat of the decision makers; and wide public and pro-fessional ‘‘ownership’’ is desired.

Setting up a fair, deliberative process around a technicalrecommendation for coverage allows for debate on theethical and equitable implications of decisions, such aswho will receive ARV given limited resources, while pro-viding a space for different interest groups to air concernsor bring new evidence to the table for consideration.

6. Decisions. Decisions should be guided by theresults of the evidence and recommendations pro-duced by the cost-effective, budget impact, anddeliberative processes. Recommendations shouldbe considered by the appropriate authority andwhen a coverage decision is made, it should belinked continuously to public budgets. Thoughseemingly self-evident, the HBP, as well as the na-tional health plan, experience suggests that manypolicies and plans remain aspirational and uncon-nected to budget, or there is a one-time connectionto budgets that can lead to erosion of effectivenessover time. Even though some advocate specifictechnology or program budget line items as thesolution to this issue [140], this approach is ulti-mately problematic as it is unconnected with indi-viduals entitled to receive a given intervention ortechnology. Depending on the setting, the decisionto fund/cover may be devolved by the payer (insur-ance fund or government) to the multistakeholdercommittee carrying out the interpretation of theevidence through the deliberative process or itmay remain, at least at the earlier stages of the pro-cess, the responsibility of the payer at either thecentral or local levels. In the latter case, the reasonsfor rejecting or deferring a positive or negative rec-ommendation ought to be made public and becontestable.

7. Appeals, tracking, and evaluation. Finally, acoverage decision and/or the underlying recom-mendation and associated analyses should be con-testable via an appeals process. This can rangefrom the ‘‘lighter’’ option of a public review thatcan be triggered by a select group of stakeholdersto a full-scale appeal, which may include formalresubmission of evidence and a public hearing. Itis important that the right balance is struck be-tween offering the opportunity to challenge a deci-sion publicly, potentially leading to its reversal, andensuring the overall process remains timely andinsulated from vested––commercial or profes-sional––interests that may, as they have access torelevant resources, be more likely to challenge ordelay unfavorable decisions. Finally, a more elabo-rate appeals process may be more relevant in set-tings where legal challenges and perceptions ofprocedural weakness have been common to the ex-tent it may reduce the chances of judicial reviewsand enhance stakeholders’ faith in the decision-making process.

Decisions are tracked and evaluated, in the pub-lic domain. The implementation (degree of uptake)and longer-term impact (in terms of health out-comes and/or budgetary impact) of decisions needto be monitored and reported. Uptake evaluationcan drive data collection systems that will in turnfeed into further, better targeted and better in-formed, updates of the guidance. They can alsoform the basis for performance assessment ofpurchasers and providers at the local level, throughhelping to identify the most appropriate and leastburdensome uptake metrics to be assessed. Finally,impact assessments can strengthen the case forusing evidence and independent processes to in-form coverage decisions, including in situationswhere additional investment is needed makingthe financial case for further investment, whichmay become increasingly important for bothglobal donors and LMIC Ministries of Finance.

A regular assessment of whether the processneeds repeating is also necessary. For example, inthe event of new safety data, the process would re-start at Step 1, or if new clinical or cost data be-comes available, the process could restart at Step3. Regular reviews and updates are critical in ensur-ing decisions are based on credible processes andup-to-date information.

There are a number of critical elements of arobust, sustainable HTA system that do not fit di-rectly within the processes described. Priority-set-ting decisions must be made in the context of

Figure 1. Application of the 7 · 7 framework using a real case study from the British NICE and NHS. Reprinted, with permission, from[141].

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legal, statutory, and regulatory policies that maysupport or undermine the ability to implementthese decisions. For that reason, there is often aneed to design HTA systems that are mindful ofthese contextual factors. In some cases, successfulimplementations of HTA-driven priority-settingpolicies require reconsideration of statutes and reg-ulations. Furthermore, because of the limited avail-ability of information about the comparativeeffectiveness of many health technologies and ser-vices, it will also be critical for the evaluation pro-cesses to be linked to systems for evidencedevelopment to address critical uncertainties inhigh-priority domains. Local or regional mecha-nisms for funding and implementing primary re-search will need to be organized to addresscritical uncertainties that arise in priority setting,so that the objective of policy making driven byeffectiveness and value can be more consistentlyachieved.

The HTA system, whether global or national,should help to increase the rigor and relevance ofevidence considered, provide a fair and transparentmechanism to manage the politics around resourceallocation, connect evidence-based decisions tobudgets, and create permanent institutional chan-

nels to consider resource allocation choices overtime. The Box [141] describes how the HTA sys-tem works in the British National Health Serviceusing the example of secondary prevention ofCVD (Fig. 1).

In Figure 1 and the following explanatory text,we apply the 7 · 7 framework using a real casestudy from the NICE and the British NationalHealth Service (NHS). Alongside countries suchas Canada, Sweden, New Zealand, and Australia,Britain has one of the best developed systems oftranslating evidence into policy. This need notmean that the NICE institutional standard is (orought to be) the model for other countries. Everycountry has to develop its own mechanism foridentifying priorities and acting on them based onevidence and values. Equally, our choice of exampleneed not imply that implementing the 7 · 7 frame-work is unattainable in a LMIC setting. Indeed,countries such as Thailand, China, and Brazil arebuilding similar mechanisms. We chose this exam-ple because it is (perhaps because of the accessibilityof NICE data and decisions and the fact they are inEnglish) one of the better-documented cases ofapplying the 7 · 7 framework to real policydecisions.

� Secondary prevention of CVD: an example fromthe British National Health Service.

In low-income countries, over 75% of people withcoronary heart disease or who had a stroke, did not re-ceive any of the 4 effective drug types (aspirin, beta-blockers, angiotensin-converting enzyme [ACE]inhibitors/angiotensin receptor blockers [ARBs], andstatins for myocardial infarctions; and aspirin, beta-blockers/diuretics/calcium channel blockers, ACEinhibitors/ARBs, and statins for stroke). For mid-dle-income countries, the rates varied from 50% toover 70%. The use of statins between high- andlow-income countries varied 20-fold, with the sick-est/highest risk group patients, receiving the leastcare. The investigators conclude: ‘‘although some pa-tients receive appropriate treatments when they accesshealth-care providers or hospitals, most do not receivebasic effective therapies long term, with many individ-uals receiving no preventive treatment Prevalence ofdrug use was substantially lower in less economicallydeveloped countries than it was in developed coun-tries, suggesting an urgent need for systematic ap-proaches to understand and rectify the causes of thelarge treatment gap in secondary prevention globally.’’

� Secondary prevention of myocardial infarctionusing pharmacological treatment.

1. Registration. The 4 drug classes recommendedfor secondary prevention of myocardial infarctionare: ACE inhibitor (or ARB, if intolerant) + aspirin(or an alternative antiplatelet) + beta-blocker + statin(unless there is a contraindication or side effects re-ported). All 4 drug classes have been registered inEurope with the European Medicines Agency(EMA) (and/or in the United Kingdom by Medicinesand Healthcare products Regulatory Agency[MHRA]), and all 4 are currently available in genericform at a price lower than the branded or brandedgenerics, with ARBs being the last class to lose patent(losartan was the first drug in its class to become gen-eric in March 2010, valsartan followed in 2011, andcandesartan and irbesartan in 2012).

2. Scoping.

a. According to Royal College of General Practi-tioners and National Collaborating Centre forPrimary Care [149], ‘‘the annual incidence ofmyocardial infarction for men aged between30 and 69 is about 600 per 100,000 and forwomen about 200 per 100,000. The BritishHeart Foundation (2004) has estimated thatthere are about 147,000 MIs per year in menof all ages in the UK and 121,000 in women,giving a total of 268,000 cases. In the UK,about 838,000 men and 394,000 women havehad a myocardial infarction at some point intheir lives.’’

b. Reducing mortality from cardiovascular diseaseand secondary prevention of myocardial infarc-tion (MI) are listed as key national priorities inthe NHS Operating Framework of 2007/2008[150] and the National Service Framework forCoronary Heart Disease: Winning the war onheart disease [151]. These nationally set prior-ities are important inputs in NICE’s workprogram.

3. Cost-effectiveness analysis. Based on publishedresearch [152], the incremental cost of offeringCVD medicines as secondary MI prevention, includ-ing the cost of the drugs and the visit to the primarycare center, was estimated at £514. The incrementalbenefit was estimated at 0.049 quality-adjusted lifeyears. Therefore, the cost per quality-adjusted life yearwas £10,816. Based on sensitivity analysis, pharmaco-logical secondary prevention is deemed to be cost-effective even if the overall cost of the interventionis twice as high as the estimated cost. Furthermore,the current levels (baseline) of offering secondary pre-vention at a primary care setting across the UnitedKingdom are at 11.3%. With a primary care centerlevel prevalence of MI of 0.75%, offering monetaryincentives to encourage secondary prevention alsobecomes cost-effective.

4. Budget impact analysis. Using prescription andprevalence data [153] from IMS and the nationalMyocardial Infarction Audit Project; tariffs/Diagno-sis-Related Group (DRG) costs; and unit costs fromthe British National Formulary and assumptions onthe likely proportion people on 2, 3, and 4 drug com-binations as practice changes over 1 year, the addi-tional annual net budget impact of rolling outsecondary prevention across the country for weighteddrug combinations ranged from £0.3m to £2.1m(starting from a baseline current cost estimate of£9.2m). The cost of all four combinations is £195.6per year per patient. Although the potential savingsfrom implanting secondary prevention were not quan-tified, an uncomplicated acute MI costs the NHSapproximately £3,500 and 24 h in the cardiac inten-sive care unit costs approximately £1,000 per day.

5. Deliberative process. A multidisciplinary commit-tee [154] of experts and lay people, all of whom abideby a conflict-of-interest policy, was convened byNICE as per the published NICE process of opera-tion [155] to discuss the evidence and make a recom-mendation as to whether the NHS ought toincentivize the pharmacological secondary preventionof MI. In addition to the clinical and economic data,the committee was presented with results of field-testing and stakeholder consultation. The minutes ofthe discussion and all the evidence was placed onNICE’s Website. The committee recommended thata new indicator is included in the NHS’s pay-for-per-




formance in primary care: ‘‘The percentage of patientswith a history of myocardial infarction (from 1 April2011) currently treated with an ACE inhibitor (orARB if ACE intolerant), aspirin or an alternativeanti-platelet therapy, beta-blocker and statin (unlessa contraindication or side effects are recorded).’’

6. Decisions. The NHS Employers’ organizationand the professional association of British generalpractitioners will make the final decision as to whetherpharmacological secondary prevention of MI willbecome part of the NHS’s P4P scheme for primarycare doctors across the country. During their annualnegotiations, the 2 parties can choose from a menuof indicators/activities evaluated and recommendedby NICE’s committees. For 2011/2012, the 2 partiesagreed to include the secondary prevention indicatorin the Pay for Performance (P4P) scheme [156].

7. Appeals, tracking, and evaluations. Compliancewith the P4P guidance (introduced in 2011) on sec-ondary prevention of MI will be assessed throughannual assessment of data collected through the onlineGeneral Practitioners Results Database and primarycare centers rewarded accordingly. In the meantime,there is evidence of uptake of NICE’s advice on sec-ondary prevention, with 95.5% of post-MI patientsreceiving at least one of the recommended medications[157]. In addition, data on CVD mortality is regularlycollected through the national audit (MyocardialIschaemia National Audit Project [MINAP]) andoverall NHS performance assessed against the 2011/2012 Outcomes Framework. Finally, cost of prescrib-ing and percentage of generic prescribing (also incen-tivized by NICE) for select drug classes such as ACEinhibitors and statins are monitored by region andbenchmarking data made publicly available throughNHS Prescription Services.

The recommendation and final decision are regu-larly reviewed as new clinical evidence emerges,including effectiveness and safety information, andalso as unit costs and utilization volumes may differfrom year to year or new pharmaceutical products areintroduced to the UK market. The clinical guidelineunderpinning the recommendation on secondary pre-vention is currently (2012) being reviewed. Thegrounds for the review include: (1) the fact that theantiplatelet agent clopidogrel has gone off patent inthe United Kingdom and new trial data showing thatARBs are of similar clinical effectiveness to ACEinhibitors and (2) combination of the 2 is not clinicallybetter than monotherapy [158].

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O B S T A C L E S A N D O P T I O N S F O R H T AS Y S T E M D E V E L O P M E N T

The working group has identified 6 major obstaclesto the further development of HTA systems in

LMIC and has developed a series of risk-mitigat-ing strategies:Scope is large and unmanageable; demands areurgent. As noted earlier, many benefits plans aredesigned under unreasonable time frames associ-ated with a window of opportunity for broaderhealth reform. That initial effort will result in a listand some notional cost but, to mitigate the risksassociated with this usual practice, efforts couldbe made, perhaps as part of the reform legislation,to ensure that a long-term institution be built,charged with updating and revising plans, coveragedecisions, or negative lists. As agencies that fre-quently provide technical assistance and fundingfor the development of benefits plans, the multilat-eral development banks can ensure that institutionsare part of the agenda for policy dialogue.

Further, starting small with a vision for scalingup is the most practical mitigating strategy. TheThai, Polish, and Colombian experiences suggestthat initially a small-scale effort will be most feasi-ble to build confidence on the approach and meth-odologies, to educate policy makers to createdemand, to train professionals and stakeholders in-volved in deliberations to prepare/oversee andunderstand the evidence, and to address 1 or 2key health burdens or technologies in an integralway. The SIVAC and Malaria Vaccine Initiative(MVI) programs are the seeds of such efforts thatneed to be connected with a permanent institu-tional entity, budget affordability assessments, andbudget decision making. Where the courts or con-gresses/parliaments have been active in legislatinghealth priorities, it will be vital to involve thesegroups in the designs of the processes and thesmall-scale pilots.Coping with capacity shortfalls. The capacity toactually carry out clinical and economic evaluationsis a major feasibility concern. However, whereascapacity to do these evaluations is many times lim-ited in-country, the entity could call for national–international partnerships to prepare core evidencepackages or simply contract out to a foreign univer-sity with expertise (as has been done in Poland insome cases). In parallel, as has been done in Thai-land, scholarships and sabbaticals can be arrangedto build more capacity in the medium term. Finally,capacity building driven by demand and within thecontext of a budding HTA system may be the mostefficient way of developing fit-for-purpose humanresources. This is what the Thai model has shownand is an experience shared by relatively resource-rich countries such as England where health eco-




nomic capacity burgeoned in response to the Brit-ish National Institute for Health and ClinicalExcellence’s (NICE) requests for evaluations.Understanding roles and responsibilities infragmented settings. Many countries struggle withexisting priority-setting arrangements that arefragmented among multiple agencies and individu-als. A baseline mapping of who does what isneeded in order to build a coordinated priority-set-ting policy and to understand whether a ‘‘new’’institution is required and where it should be posi-tioned or whether the institutional functionsshould be assumed by an existing entity. Such ananalysis has been carried out in Colombia duringthe preparatory phase of the design of a new healthtechnology evaluation institute [142].Can fair processes work in the context of weakgovernance and corruption? Given the emphasisof existing institutions on the role of expert andstakeholder committees to consider the evidenceand reach a recommendation, there is a worry thatsuch processes may be illegitimate if subject topolitical manipulation or if top leadership doesnot support the concept. Some ways to managethese threats are through: clearly defined proce-dural rules for engagement, conflict-of-interest dis-closures, and audits; elections within professionalbodies; and limiting voting rights to governmentand committee chairs. The roles of physicians’organizations have been mixed. Clinical engage-ment and leadership throughout priority-settingprocesses are essential but there is also a need toensure that professional and commercial interestsdo not capture the process of evidence assessmentand decision making. In many LMIC, for example,there is a need to distinguish between physician-led scientific associations and unions focused onwage negotiations.

However, it is worth noting that priority-set-ting entities supported by external donors alreadyexist in many low-income countries. At least 1priority-setting committee––the Country Coordi-nating Committee (CCM)––exists in every GlobalFund beneficiary country, including the mostimpoverished fragile states. The CCM is chargedwith setting priorities in disease control and pre-vention, consulting with stakeholders, and prepar-ing the country proposal, including the budget tothe Global Fund. Yet, in spite of adequate fund-ing and a mandate, the CCMs infrequently uselocally adapted cost-effectiveness and budget im-pact studies to decide on the optimal mix of tech-nologies, do not assess whether their budgets

reflect true costs or whether efficiencies can bemade, do not always assess the availability ofnew technologies that might be cost-saving ormore effective, sometimes fails to address therationing problem directly, and so on. The CCMsalso lack defined processes to carry out their func-tions. In at least in this context, it seems feasible tobuild out the capacity of CCMs to set priorities morerigorously and in consultation.

In the end, for any HTA/priority-setting activ-ity to gain traction within a country, there ought tobe a clearly articulated political demand and long-er-term political backing. Without such backing,any attempt to rationalize priority setting, buildcapacity, and generate data will be unlikely tosucceed.Intransigent data problems. In low-income set-tings particularly, there will be very limited datawith which to carry out clinical and economic eval-uations. Beyond the inevitable suggestion thatmore support be given to the production of thesedata (and asking for what is needed is a start), inthe interim, countries may need to rely on datafrom ‘‘similar’’ countries, efficacy and effectivenessestimates from studies conducted elsewhere, andassumptions about cost and use based on smallsamples and outdated demographic projections.Although this will be frustrating, problematic stud-ies may galvanize greater demand for measure-ment, and perhaps motivate donors to supportroutine, consolidated data collection and diseasesurveillance at scale. Alternatively, entities cancommission original data collection. A donor-funded project in India, for example, is collectingrepresentative data on costs in primary healthcareclinics as an input into a more accurate cost-effec-tiveness estimate and affordability analysis [143].Weak links to decision making. A final problemencountered in many HTA systems in high-in-come countries is the inefficiency with which theassessment programs are linked to decision mak-ing. More progress has been made recently, thoughfor many years, the technical production of HTAreports received only limited attention in coverage,benefit, or budgetary decisions. It is possible that asimilar phenomenon could occur in LMIC; inMalaysia, for example, whereas HTA conductedwithin the Ministry of Health on drugs has an im-pact on listing in the ministry’s formulary, HTA ondevices and practices has no impact on reimburse-ment decisions [144]. In a study in Latin America,policy makers identified the lack of a transparentand clearly defined link between HTA and the

28 Glassman et al.



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decision-making processes as a major barrier for theeffective application of HTA to resource allocationdecisions [145]. This risk is mitigated by the morepronounced fiscal pressures under which LMICoperate, lessons learned from the high-incomecountries, as well as potentially proactive globalsupport to an integral HTA system.

R E C O M M E N D A T I O N S

Based on this framing of an HTA system and itschallenges in different settings, the working grouprecommends direct, substantive support to the cre-ation and development of both global and domesticHTA systems. Within domestic actions, the work-ing group made a distinction between strategiesrelevant to middle-income countries and those rel-evant to low-income countries.

Global HTA facility. A global HTA facilityshould be created to provide sustained technicaland consultative support to global funding agenciesand LMIC governments. Global funders have anongoing need for rigorous economic evaluation oftechnologies to be funded, from antiretroviral med-ication to bed nets to determining the best strategyfor funding CVD prevention and multi-drug-resis-tant tuberculosis control. For example, a compari-son of least-cost equivalent antiretroviral therapywith the standard first-line regimens in 43 WHO‘‘3 by 5’’ focus countries finds that 59% of countriesuse drug combination regimens that are moreexpensive than available alternatives, demonstratingthe capacity for funders to achieve similar results ata reduced cost.

A Global HTA facility might also undertake theaccreditation of national HTA systems and evalua-tions. Building off the working group findings andrecommendations as well as instruments alreadydeveloped to assess clinical guidelines [146], stan-dards for a system could be developed that wouldestablish the full range of analytic and decision-making components of a working system. Func-tional and quality standards might include, amongother things, basic analytic skills sets, defined rela-tionship to decision-making authorities, transpar-ency, public engagement, appeals, HTA/regulatory alignment, appeals mechanisms, basicanalytical methods standards, or a link to researchpriorities. Donors such as the Global Fund couldrequire that accredited HTA systems be in placeand in use as conditions of grants and loans. Theglobal HTA facility could also track the healthand budget impact of coverage decisions in a selec-

tion of countries over time to inform futurereforms.

A global HTA entity could also derive econo-mies of scale in the generation and adaptation ofevidence dossiers, following toolkits and glossariesalready developed [124]. As new technologies comeonline, there is little need for each country to repeatcore analyses, but a great need to appropriatelyadapt HTA conducted in other countries to theepidemiological, cost and utilization profilesdomestically. Recent work on a geographic ‘‘trans-ferability checklist’’ for HTA will also be useful[147]. There are also great synergies in the sharingand benchmarking of coverage decisions amongcountries at similar levels of gross domestic productper capita, a simple strategy that could provide localdecision makers with the ammunition needed toadopt a new cost-effective technology, to tailorhigh-cost interventions to high-need subgroups,or to say no to inappropriate and expensive inter-ventions. This approach has been used by the In-ter-American Development Bank in the contextof a regional project and has been used to informcoverage decision-making during a 2010 updateof Colombia’s benefits plan [143,151]

Also, international funders, especially interna-tional organizations such as the World HealthOrganization, the World Bank, or multinationalpharmaceutical companies should be well awareof the difficulties in using HTA conducted in 1 set-ting for another setting, especially when the studiesinvolve economic parameters and social prefer-ences. Because when they commission economicevaluation studies, they are likely to use economicevaluations to inform policy decisions in multiplesettings. As a result, they should request the useof multinational trials for estimating clinical effi-cacy of the intervention, not only to introduce theintervention more widely, but also to provide forthe collection of local data used in local HTA.

The support of this facility would be guided by adeep, current knowledge of the history and bestpractices of HTA systems developed in other coun-tries, applying lessons learned in those situations toensure that best practices are replicated and com-mon mistakes are avoided. Above all, a tailored ap-proach to technical assistance, with practitioners ineach country relating directly to each other will beuseful and will help protect and enhance the inde-pendence and status of those charged with carryingout this very difficult task.

Direct support to LMIC. Direct support toLMIC that are creating or growing their own




HTA systems could take a number of forms. Exist-ing capacity-building efforts via evidence creation,tools, and methods could be more directly targetedto government counterparts charged with carryingout priority-setting work. Further, hands-on tech-nical pilots and demonstration projects––from therelevant starting point––would be a way to engagewith policy makers on real-time concerns. Adviceand financial support to generate data on effective-ness, efficacy, medical practice, and patient use pat-terns in-country have been highlighted as a priorityin Asia [148].

Coaching via procedural advice and knowledgeexchange among countries, facilitated by a globalfacility or a regional network, will also be essential.Exchanging examples of legislation, process guide-lines including conflict-of-interest management,handling of confidential data, stakeholder involve-ment, and overall governance and oversight canprevent ‘‘reinventing the wheel.’’ Providing supportto communications and public awareness-raisingcan also be useful to build stakeholder supportand demonstrate the commonality of problemsand solutions.

The working group made an important distinc-tion between low-income and high-income coun-tries, and the need to develop HTA systemoptions for low-income settings that would buildon bodies such as National Immunization Techni-

cal Advisory Groups and CCM that are in somecases already setting priorities for public and donorbudgets. Even in countries that only do HBP inthe context of results-based financing or perfor-mance-based contracting and/or where donors takea more direct role in priority setting, a version of anHTA system could be put in place, which wouldrelieve donors of the difficult technical and ethicaldecisions that are taking place implicitly, withoutadequate technical justification, and in the absenceof local participation.

Given the global economic outlook and antici-pated drops in aid, how LMIC spend their ownmoney will be a main determinant of the size andpace of health improvement in the future. Helpingcountries develop HTA systems that will increasevalue for money is a way forward.

A C K N O W L E D G E M E N T S

The authors acknowledge the members of the Priority-Setting Institutions for Health Working Group, whosemembership is described at http://www.cgdev.org/sec-tion/topics/global_health/working_groups/priority_set-ting_institutions. Working group members haveinformed the arguments and policy messages includedin this article, but have not yet reviewed the recommen-dations presented here, and are therefore not responsiblefor any errors and opinions.

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http://www.nice.org.uk/nicemedia/live/13071/50048/50048.pdf








http://www.nice.org.uk/media/742/32/QOFProcessGuide.pdf

http://www.nice.org.uk/media/742/32/QOFProcessGuide.pdf

http://www.bma.org.uk/images/summaryqofguidance2011_v3_tcm41-204734.pdf



http://www.nice.org.uk/usingguidance/evaluationandreviewofniceimplementationevidenceernie/searchernie/resultsummary.jsp?o=11008







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