International Decision Support Initiative

Amanda GlassmanCenter for Global Development

http://www.cgdev.org/publication/priority-setting-health-building-institutions-smarter-public-spending

What is the problem?

• Growth and demand for health care• Inertial ad hoc resource allocation with great opportunity cost

for health– Historical, input-based budgets– Budget available for allocation only drugs and devices

• Pile-up of low-cost, potentially high value technologies and interventions known to be highly cost-effective, not at scale.

• Wasteful spending on known ineffective interventions despite scarce resources

• Inequitable access to services and technologies driven by vested interests– MIDDLE-INCOME PROBLEM!

3

Distorted priorities cost lives

• Avastin paid for for all indications (incl FDA unlicensed ones)

• Regional variation in immunization with parts of the country with <50% coverage

Colombia

• >50% of insulin budget goes to analogues• Switching to human insulin can double the number of

patients on treatmentKyrgyzstan

• 40-50% of eligible patients NOT on treatment in Africa• 2nd and 3rd line ART for <5% of patients, consumes one

fifth of the total ART budgetHIV

Why: competing priorities & interests at many levels in ad hoc or inertial process of resource allocation = implicit priority-setting

5

Many ‘priorities’… …Many interests

MSF asks India to make affordable hepatitis C medicines as Natco resists expensive US drug patent•12-04-2014 •By Sehat •Bookmark

6

Even in the most developed system, politics are constantly in play

• Source: BBC website http://news.bbc.co.uk/1/hi/health/5063352.stm

Source: Andrés Pichon-Riviere , 2013. La aplicación de la evaluación de Tecnologías de Salud y las evaluaciones económicas en la definición de los Planes de Beneficios en Latinoamérica

Efficacy is global but cost-effectiveness and affordability (and preferences/values) are local

7

Cost-utility of Trastuzumab expressed as number of GDP per QALY

0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0

Bolivia

Brasil

Peru

Argentina

Colombia

Chile

Uruguay

Canada

Finland

UK

USA

Cost-utility of Trastuzumab (cost per QALY) as GDP per QALY

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

What can be done?

Effective and explicit Priority Setting

Health Intervention &Technology Assessment

9

What can be done: Defining health benefits plans (that will work to set priorities in practice)

– Minimum attributes:• Links to resource allocation and financing• (Completely) or partially constrains products and services available

through health system– OR: Guarantees that “at least” X will be available

• Comprises a portfolio of products and interventions– Not a single technology, not a vs. b

– Not:• Ad hoc rationing or implicit resource allocation (using budget until

$ runs out then user fees or no provision, or constraining supply capacity)

• Negative list (useful in their own way, but not a benefits plan)

But there is a serious capacity gap…

Despite increasing political commitment to UHC, priority-setting capacity for low- and middle-income countries is

limited and uncoordinated

5

InstitutionsEstablished

processes, legal frameworks…

Evidence and data

Epidemiology, political

economy, cost-effectiveness…

Human resourcesPolicymakers, technicians, clinicians…

The capacities required for effective priority-setting

Better Decisions for Better Health

Better Health

Effective do-er

partnerships

Strongercountry

institutions

Better decisions

Practical support and knowledge

products

Evidence-informed, transparent, independent,

consultative decision making processes

More efficient and equitable resource allocation decisions

with trade-offs made explicit

Demand-driven supportPolicy-informed knowledge products

Accountable institutions and processes protect politicians from vested interests and

help defend tough choices

11There is a complex translation process between “better decisions” and “better health” depending on the link between decisions and budgets, budgets and payments/transfers, transfers and delivery system, readiness and effectiveness of delivery and implementation and also the validity and reliability of the original data informing the analysis.

How can we make it happen?

• A Public-Public Partnership• Practitioner-to-practitioner; Government-to-

Government across HICs and LMICs• With a view to influencing major players such as

GAVI and the Global Fund whose decisions matter

A growing network of partners sharing the same principles

We are committed to partnerships with academic, public sector and international development

groups from across the world, and supporting regional hubs for priority-setting.

14

Can making health benefits explicit help?

• Maximize health, enhance value for money:– WDR93, CMH2001, GH2035– Thai HTA for UC package

• Realize rights:– Chile’s guarantees; Mexico’s entitlement

• Purchase care from providers:– Most payer-provider splits, RBF systems

• Budget expansions or as input to fiscal transfer systems’ capitations– Canada

• Cut costs:– Troika in Portugal and Cyprus

• Reduce waste:– Negative lists or do-not-do

• Enhance equity and reduce care variations• Improve provider accountability to patients and payers• Introduce greater evidence into public spending decisions• Incentivize the development of cost-effective new technologies

Source: Glassman & 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

Many LMICs have established explicit health benefits plans in both health insurance schemes and tax-funded systems

15

Low- and Middle-Income Countries with Health Benefit Plans

There are lots of ways to set explicit priorities, not mutually exclusive. Health benefits plans are one strategy.

Strengths Method Weaknesses• Allows policy-makers and immunization

program managers to make evidence-based decisions

National Immunization

Technical Advisory Group

• Absence of outcome indicators matched to policy-making processes

• Does not consider budget impact• Limited to vaccines/immunizations

• WHO Model List is frequently updated• Relatively easy to set up, given WHO Model

List (150+ countries have an EML) Essential Medicines List

• Generally non-binding to clinicians or even payers

• Process is often ad hoc• Does not guarantee availability of

medicines listed• Does not consider budget impact• Minimal dedicated staff at WHO (2 people)

• Provide guidelines to providers on best practices based on evidence

Clinical Guidelines / Do-not-do Lists

• Generally non-binding to clinicians

• Provides a systematic appraisal of the properties, effects, or impacts of health ‘technology’

• Involvement of a wide range of professionals (policy-makers, care providers, academics, citizens, etc.)

• Can be used successfully to inform public reimbursement/coverage

Health Technology Assessment

• Can be a resource consuming undertaking• Limited, but increasing, international

guidance and experience• HTA can happen at the margin

• Could incorporate cost-effectiveness and HTA into funding decisions

• Can be a mechanism to reform budgeting and align funding with priority technologies and populations

• Explicit plans and lists can reduce costs

Health Benefits Plans

• Process is often ad hoc• Limited international guidance• Instances of known c/e interventions not

funded at scale, while examples of not c/e interventions receiving subsidy

• Incremental and baseline epi and costs of new interventions not known

17

Risks and mitigating strategies

• Bureaucratic overload, top heavy and forgetting about implementation/service delivery– “Design” of HBP is just the start

• Political costs of “saying no”, short-termism of health ministers, risk of political interference that would undermine benefits of HBP– Good process, transparency/sunshine, autonomous agencies with heads

appointed outside political cycle • Keeping reviewed and updated, avoid being frozen in time, or the risk of

adding on without corresponding resource allocation now and in future– Plan and staff for updates, explicitly link budgeting and payment to HBP

• Maintaining budget control, if you get budget impact wrong or create too much uncertainty, it’s hard to pull back as becomes entitlement (need to maintain discretion @ payer to some extent), also legacy and transition issues – Check interactions with payment incentives

• Tough to do comprehensively– No need to be comprehensive or exhaustive

18

19

Source: Glassman, Giedion, Smith (forthcoming)

Health Benefits Plans: On-Going Cycle of Inclusion and Exclusion

CONTEXT• Donors• Health system• Markets• Political institutions• Regime• Rights• Technology• Wealth

CONSIDER:• Data / M&E• Governance• Politics• Ethics• Communication,

communication, communication

1 SET GOALS and general

criteria

2OPERATIONALIZE

criteriaDEFINE

principles and methods

4 COLLECTnew

data/evidenceCOLLATE

existing evidence

5 APPRAISE evidence –

apply methods and criteria

3 SELECTtopics (triage)

6 DELIBERATE around appraisal,

evidence

7RECOMMEND /

DECIDE 8

ALLOCATE resources

9 IMPLEMENTpayment, mgt,

provision, measurement

10 ADJUST based on new data, learning,

feedback

20Adapted from IOM 2011

Step 1: defining high-level goals and criteria, a job for politicians and stakeholders

EconomicsMust protect people against impoverishmentMust be affordable now and in futureMust maximize the number of people with coverageMust address market failures that result in incomplete insurance

EthicsDistribution of public spending fair and transparentDuty to protect most vulnerableStewardship of limited resources requires attention to maximizing health benefitsMethods transparent, participatory, equitable, consistent, sensitive to value, responsive to new information, encouraging to innovation

EvidenceShould only support safe, medically effective Should provide best scientific evidence to clinical decision-makingShould address medical concerns of greatest importance to the “population”Should facilitate “right care to right patient in the right setting at the right time”

Population HealthShould facilitate efforts to improve population healthPrimary, secondary and tertiary prevention needs attentionAccess for the vulnerable must be assuredDisparities should be eliminated

HBP

POLI

TICS

Mus

t be

feas

ible

and

sus

tain

able

pol

itica

lly o

ver ti

me

21

Step 2: operationalize criteria and define analytical methods, a job for technocrats and academics with input from stakeholders

• Criteria start generic –”financial protection” “equity”- but then have to be operationalized– Separate list of high-cost care (that reflects preferences? that affects small

popns? that is source of OOP?); ex Mexico, Uruguay– Insurance theory: choose high-cost, unpredictable condition-treatment pairs?– Can sometimes be reflected in methods (ECEA, age weighting)

22

• Methods relate to several pieces of HBP decision-making, but can be set generically for each, always with relation to goals: – Methods to decide where to start or what next (next step: triage)?

• Elicit stakeholder priorities (health problems, for example) or values/preferences

• Approach the triage problem– Methods to conduct HTA/appraisal, budget impact analysis?

• Reference cases or methods manuals and guidelines (https://www.york.ac.uk/che/research/global-health/development-methods-guidelines/economic-evaluation-guidelines/; http://www.hiqa.ie/healthcare/health-technology-assessment/guidelines, for ex)

• CEA but beyond CEA too, incorporating constraints of all kinds in models (ie variability in supply capacity)

– Methods to make recommendations?• Decision rules, thresholds

Health benefit plan (basket of services) of an imaginary country where the Ministry of Health (many years ago) defined a cost-effectiveness threshold of U$D 10,000 per QALY in order to consider a technology as cost-effective and allow its incorporation into the benefit plan.

This limit is imposed by the constrained health care budget

New Technology

Cost USD: 5,000/QALY

Technologies that will be displaced offered

less “value for money”. The benefit gain from the new treatment is

greater than the benefit foregone

New health technology with

a cost-effectiveness ratio of U$D 25,000/QALY

Is the benefit gain from the new treatment greater than the benefit foregone through

displacement?No. Displaced technologies

offered better “value for money” (the healthcare system

loses “health” and efficiency

Cost-saving (e.g. polio-Sabin vaccine)

Very cost-effective (e.g. U$D 1,000 per QAL)

Relatively good cost-effectiveness (e.g. U$D 5,000 per QALY)

Cost-effective (e.g. U$D 7,500 per QALY)

Cost-effective (but at the limit, e.g. U$D 8,000 or 10,000 per QALY)

Source: Andrés Pichon-Riviere , 2013. La aplicación de la evaluación de Tecnologías de Salud y las evaluaciones económicas en la definición de los Planes de Beneficios en Latinoamérica

Source: Morten and Lauer forthcoming 2015, with some own added commentary. 24

MCDA CEA ECEA CBATechnically robust and justifiable.

Method is well-established outside the healthcare sector and popular within the healthcare sector. Several general (ie nonhealthcare specific) good practice guidelines exist, but there is not yet a strong body of healthcare specific guidelines.

Method is very well-established within the healthcare sector. Guidelines for good practice exist although methodological controversies remain.

Method is new and established guidelines on good practice do not yet exist.

Method is well-established outside the healthcare sector and popular within the healthcare sector. Several general (ie nonhealthcare specific) good practice guidelines exist, but there is not yet a strong body of healthcare specific guidelines.

Reflective of social values. In principle, method can take into account any possible social values, but care should be taken in structuring the criteria. [CE just another criteria or a hurdle?]

Methods assume that population health gain is the overriding objective.

Method reflects a key concern in LMICs where avoidance of catastrophic financial payments is important alongside population health gain.

Methods involve modelling all-welfare relevant consequences. Opponents argue that CBA embeds unacceptable value tradeoffs.

Easy to understand Ease of understanding is one of the principle selling points. However, understanding the meaning of weight is more subtle than is often appreciated.

Methods can be implemented at various levels of sophistication: more complicated models will be harder for lay people to engage with.

Same comments apply as in the case of CEA but with the proviso that some of the additional financial modelling (in particular the concept of insurance value) adds an additional layer of complexity.

Models can be very technical and expression of costs and benefits in monetary terms is often a stumbling block for lay engagement.

Have low cost of implementation.

Does not required specialised modelling resources but requires relatively intensive engagement from stakeholders to supply weights.

Can be done at varying levels of intensity, from “quick and dirty” to more expensive and robust analyses. Expansion path analysis at the population level involves bringing together clinical and epidemiological data which can be time-consuming.

Same comments apply as in the case of CEA but with the additional proviso that modelling of financial and payment aspects is required.

Same comments apply as in the case of CEA and ECEA but requires a more extensive modelling of welfare consequences.

Headaches for methods issues related to HBP in LMIC

• Incremental costs of introduction of new interventions and technologies not known, baseline costs and effectiveness not known

– What are we comparing to?

– Currently, few studies present probabilistic sensitivity analyses

• Procedural fairness problematic with respect to methods (Culyer & Lomas 2006):– Not: transparent (to all); consultative (for stakeholders); accountable (to payers, owners, politicians);

able to resolve disputes about evidence and methods, etc.

• International guidance limited, mostly c/e information from other contexts, lack of attention to budget impact

• Limited comparability between existing c/e studies– Poor adherence to key methodological specifications for measures such as DALYs

• Decentralized, fragmented purchasing can mean unexplained variations in the standard and costs of care

25

26

Step 3: Triage (aka scoping, topic selection, structuring decision problem), a job for technocrats in consultation with providers and political leaders

• Macro choices that frame scope of HBP, linked to goals:– By type of service or product– By population group

» How coverage choices interact with HBP (fragmented systems vs universal)

» Capacity to benefit» Appropriateness criteria

• Example: Avastin® in Ontario only prescribed for rectal cancer - up to 12 cycles

– By level of complexity or facility– By disease– By level of subsidy (co-payments, deductibles, coverage caps)

• Also: structuring coding of HBP products and interventions?– ICD, DRG, etc.– International coding system for public health and prevention?

For example:Uruguay: list organized by type of care, 1 unique list for low and medium level care, one list for high complexity-cost. Colombia: organized by type of services and associated products in chapters: ambulatory care, hospitalization, oral health, etc. Chile: by health conditions and care guidelines

27

Morten forthcoming, 2015

Triage strategies

• India: all services and products currently reimbursed by insurer (RSBY) are included in HBP; all new inclusions will follow new process

• Romania: eliminate all never-evaluated and/or experimental products as first step

• DR: eliminate all neighbors’ and NICE “no” products

• Thailand: eliminate product (glucosamine) from list for safety reasons

[CONTRAST THESE TO GREEK EXAMPLE!]

Source: Glassman & 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

Topic selection: lack of process is a common feature in 4 countries

28

HTA in selected middle-income countries: How and why topics are selected

Country/Entity 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 in Colombian Law

Uruguay/FNR/MoH• There is no formal process for topic selection• Both the MoH and the FNR define the topics, recent market access

drives choice

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

employed to address each criterion

29

Source: Andrés Pichon-Riviere , 2013. La aplicación de la evaluación de Tecnologías de Salud y las evaluaciones económicas en la definición de los Planes de Beneficios en Latinoamérica

Step 4: Data and evidence -- Whereas efficacy is global, cost-effectiveness and

affordability (and preferences/values) are local

Cost-utility of Trastuzumab expressed as number of GDP per QALY

0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0

Bolivia

Brasil

Peru

Argentina

Colombia

Chile

Uruguay

Canada

Finland

UK

USA

Cost-utility of Trastuzumab (cost per QALY) as GDP per QALY

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

30

Step 8: Allocate resources consistent with HBP content in every fiscal period

• Initial costing and capitation calculations, fit with budget availability overall

• Planning to adjust for inflation• Incorporating scale up over time in capitations/payments to lower-

capacity providers or local governments

• Dilemma of decentralization:– Provides multiple access points for interest groups – Sub-national governments make decisions but costs are covered by national

government• Moral hazard• Spending escalation

– National governments provide fixed payment to sub-national governments which pay full marginal costs

• Underfunding at the sub-national level, hardwires inequity• Examples Canada and Australia

31Source: Giedion and Guzman 2015, forthcoming.

Processes and institutions –the governance arrangements- that frame the cycle are as important as the cycle itself

Attribute Examples of good governance in HBP

Examples of poor governance in HBP

Accountability NICE is hold accountable by parliament and media on the recommendations it makes

In Mexico, there are no systematic adjustment processes for CAUSES or FPGCIn Colombia the executive branch doesn’t explain why certain inclusion decisions were made and whether the BP actually focuses on sanitary goals

Transparency In Chile, the costing update studies are published and publicly available

Colombia, the original technical priority-setting studies used to design the HBP were lost and nobody really knows how decisions are made and on what criteria.In Uruguay, none of the documents explaining how the universal package was designed is publicly available

Responsiveness Colombia periodically updates its benefits package

Dominican Republic has never updated its BP since its inception in 2001

32Source: Giedion and Guzman forthcoming

Good HBP Governance Checklist: Stability and Consistency of Institutions

Explicit statement of goals and criteria used to choose and adjust the benefits package, anchored in legal frameworks.

Explicit rules on how coverage decisions are made, anchored in existing legal frameworks.

Explicit institutional framework indicating specific responsibilities for making coverage decisions for different entities and government and independent bodies (define who does what and how different entities interact).

Explicit rules on how the priority setting framework can be modified. Monitoring and evaluation to make sure actual decisions are in line with

existing rules (more on this in the M&E chapter). Appeals mechanisms in place allowing actors to question decisions when

not in line with established rules. Earmarked resources to allow the adequate functioning of the existing

institutional framework.

33

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 – Systems have limited focus on outcomes of care, few incentives to make

connections, HBP is necessary but not sufficient

34

THANK YOU!

• CONTACT ME:– aglassman@cgdev.org– @glassmanamanda

• MORE RESOURCES:– Priority-setting in health: building institutions for smarter public spending

• http://www.cgdev.org/publication/priority-setting-health-building-institutions-smarter-public-spending

– International Decision Support Initiative @ NICE International• http://idsihealth.wordpress.com/ • Coming in 2015/6: “What services should health systems provide? Health benefits

plans in low- and middle-income countries” with Ursula Giedion and Peter Smith.

35

What’s already out there?

• European Health Management Association. (2014). "HealthBASKET (2004-2007 Finished)." Retrieved 7 August 2014, from http://www.ehma.org/?q=node/81.

• Schreyögg, J., T. Stargardt, et al. (2005). "Defining the “Health Benefit Basket” in nine European countries: Evidence from the European Union Health BASKET Project." Eur J Health Econ 6(Suppl 1): 2-10.; Stolk, E. A. and F. F. H. Rutten (2005). "The “Health Benefit Basket” in The Netherlands." Eur J Health Econ 6(Suppl 1): 53-57.; Mason, A. (2005). "Does the English NHS have a 'health benefit basket'?" Eur J Health Econ 6(Suppl 1): 18-23.

• IOM (2011). Essential Health Benefits: Balancing Coverage and Cost. Washington, DC.• Paris, V. (2014). Health Benefit Plans in OECD Countries. LAC webinar, May 15, 2014.• Giedion, U., R. Bitrán, et al., Eds. (2014). Health Benefit Plans in Latin America: a regional comparison.

Washington, DC, Inter-American Development Bank.• Mohara, A., S. Youngkong, et al. (2012). "Using health technology assessment for informing coverage

decisions in Thailand." J Comp Eff Res 1(2): 137-146. • Teerawattananon, Y. and V. Tangcharoensathein. Designing a reproductive health services package in the

universal health insurance scheme in Thailand: match and mismatch of need, demand and supply. HEALTH POLICY AND PLANNING; 19(Suppl. 1): i31–i39, 2004.

• Vargas, V. and S. Poblete (2008). "Health prioritization: the case of Chile." Health Aff (Millwood) 27(3): 782-792.

• González-Pier, E., C. Gutiérrez-Delgado, et al. (2006). "Priority setting for health interventions in Mexico's System of Social Protection in Health." The Lancet 368(9547): 1608-1618.

But also literature and experience in priority-setting and resource allocation in general is relevant, but not

tightly linked to process and practice of HBP…