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IECS - Instituto de Efectividad Clinica y SanitariaInstitute for Clinical Effectiveness and Health Policy

December 2013

La aplicación de la evaluación de Tecnologías de Salud y las evaluaciones económicas en la definición de los Planes de

Beneficios en Latinoamérica

Prof Andrés Pichon-Riviere MD MSc PhD

A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar)

HTA in LA

• HTA was and is formally used to shape benefit packages in several countries

•Clear trend reflecting the importance that LA healthcare systems pay to the concept of incorporating new technologies that are good value for money.

• The region needs to increase drug and technology access, but also intensify cost-conscious measures.

• Some LA countries have already been in this HTA process for ten or more years with institutional structures dedicated to HTA. HTA has influenced different aspects of the health system in these countries, from coverage or pricing decisions of individual health technologies to the definition of package benefits or structural decisions about the health system in general. This is particularly true in the case of Brazil, Mexico, Chile, Colombia and Uruguay.

Pichon-Riviere - Instituto de Efectividad Clínica y Santaria (www.iecs.org.ar)

Health technology assessment• Eficacy / Effectiveness• Safety• Costs• Cost-Effectiveness / Cost-Utility• Budget impact • Social-ethical impact• Organizational impact• Impact on innovation / industrial development• Impact in the health care system

• Values

Assessment

Appraisal


Health Economic Evaluation methodological guidelines in Latin America

Countries with HEE guidelinesBrazil, Colombia, Cuba and Mexico

MERCOSUR: Argentina, Brazil, Paraguay and Uruguay

Grupo Andino: Bolivia, Chile, Colombia, Ecuador, Peru, Venezuela


HEE methodological guidelines in Latin AmericaBrazil, Colombia, Cuba and Mexico(and soon in Argentina, Uruguay, Chile, Costa Rica, Peru, Paraguay, among others) •Existing HEE guidelines in the region set high methodological standards, broadly similar to guidelines from developed countries

•Most of them were produced or are being sponsored by the public government, suggesting their interest in going in that direction regarding decision making of new and existing technologies for reimbursement and financing purposes.

•Still not clear how the information provided by the EE will be used and by whom and which are the values that will be used in the decision making process.

• Important to achieve in the future more homogeneous requirements across countries

Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar)

Until a few years ago…..

• Countries have struggled to manage scarce resources and provide basic care.

• Rationing has been largely implicit. Newer and more expensive technologies were not even considered. They were available, at very high prices, for a small proportion of the population.

• LA countries were not explicitly taking into account cost-effectiveness to make decisions about purchase and coverage of health technologies.

• This situation created a high price tolerance for innovative drugs, which were available only for the few patients who could afford them, often at higher prices than in developed countries.


Nowadays…..

• The current situation is no longer sustainable in a scenario where the region wants to move towards universal coverage, and also willing to include within its coverage access to innovative therapies,

• Countries in the region are already suffering this pressure. Once products are approved for marketing authorization citizens can sue for access. This right to healthcare, enforced through the courts, is currently creating a significant budget problem for health care systems at the National, state or municipal level.


Brasil (desde el año 2011)

URUGUAY - Decreto del P. E. de 2010

Los medicamentos que se prevea brindar bajo la cobertura financiera del FNR sólo podrán ingresar al Formulario Terapéutico de Medicamentos si previamente cuentan con:

a)informe Comisión Técnica Asesora que establezca evidencia científica suficiente e indicaciones

b) informe de evaluación económica que establezca adecuada relación costo/efectividad

c) informe de impacto presupuestal que acredite sustentabilidad financiera del protocolo de cobertura

d) informe favorable de la Comisión Asesora del FTM

Los laboratorios que presenten nuevos medicamentos en vistas a suincorporación al FTM deberán presentar evaluaciones económicas realizadas de acuerdo a las guías fármaco-económicas más aceptadas.


CHILE


Type of EE presented by the sponsor of the technology

“Acceptability” criteria

Cost-minimization New technology should be cost saving

Cost-effectiveness & Cost-utility New technology should be dominant (more effective & less costly)ORThe ICER should be below one GDP per capita per life year gainedORThe ICER should be below one GDP per capita per QALY gained

Costo-benefit The internal rate of return should be at least two percentage points higher than the internal rate of return of the CETES (Federal Treasury certificates)

MEXICO2011 New Guideline and “acceptability” criteria for inclusion of new drugs

Willingness to pay for a QALY (Quality Adjusted Life Year)

Mexican Cost per QALY threshold = one GDPpc per QALY

(GDPpc: Gross Domestic Product per capita)

(other countries in LA accept the WHO reference of 1 to 3 GDP per DALY)

• What can be the effect of applying these thresholds in the Latin America?

• In the past, new and expensive technologies were not routinely covered by public health systems. In this context governments, with few exceptions, did not care for the price of new technologies (these new technologies were available at a high cost only for those few who could afford them).

• But as the region moves towards universal coverage the price of new technologies will be increasingly important.

SueciaPIBpc U$ 57.714USA = 0,8 PIBpc

UKPIBpc U$ 38.974USA = 1,2 PIBpc

EspañaPIBpc U$ 31.985USA = 1,5 PIBpc

FranciaPIBpc U$ 42.379USA = 1,1 PIBpc

AustraliaPIBpc U$ 61.789USA = 1,1 PIBpc

CanadaPIBpc U$ 50.334USA = 1,0 PIBpc

Rango PIBpc (respecto a USA)

Europa–USA–Canada–Australia: 0,8 a 1,50,0

5,0

10,0

15,0

20,0

25,0

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4

0,8 1,5

SueciaPIBpc U$ 57.714USA = 0,8 PIBpc

UKPIBpc U$ 38.974USA = 1,2 PIBpc

ArgentinaPIBpc U$ 10.942USA = 4,4 PIBpc

PeruPIBpc U$ 6.018USA = 8,0 PIBpc

EspañaPIBpc U$ 31.985USA = 1,5 PIBpc

FranciaPIBpc U$ 42.379USA = 1,1 PIBpc

AustraliaPIBpc U$ 61.789USA = 1,1 PIBpc

CanadaPIBpc U$ 50.334USA = 1,0 PIBpc

EcuadorPIBpc U$ 4.496USA = 10,7 PIBpc

ChilePIBpc U$ 14.394USA = 3,3 PIBpc

MexicoPIBpc U$ 10.047USA = 4,8 PIBpc

BrasilPIBpc U$ 12,594USA = 3,8 PIBpc

BoliviaPIBpc U$ 2.374USA = 20,3 PIBpc

ColombiaPIBpc U$ 7.104USA = 6,8 PIBpc

Rango PIBpc (respecto a USA)

Latino América: 3,3 a 20,3

Europa–USA–Canada–Australia: 0,8 a 1,50,0

5,0

10,0

15,0

20,0

25,0

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4

3,3 20,3 0,8 1,5


0 20000 40000 60000 80000 100000 120000 140000 160000

Bolivia

Brasil

Peru

Argentina

Colombia

Chile

Uruguay

Canada

Finland

UK

USA

ICER: cost per QALY ($US)

Table 3 - Results per country and scenario. Life years, Quality Adjusted Life Years, Costs and Incremental Cost effectiveness Ratios. Discount rate of 5%, currency 2012 US dollars. Argentina Bolivia Brazil Chile Colombia Peru Uruguay NT Tzb Diff NT Tzb Diff NT Tzb Diff NT Tzb Diff NT Tzb Diff NT Tzb Diff NT Tzb Diff

Base case LYs 10.1 11.03 1.0 9.4 10.29 0.9 9.8 10.69 0.9 10.2 11.24 1.0 10.0 11.01 1.0 9.8 10.77 0.9 10.1 11.07 1.0

QALYs 8.1 8.7 0.6 7.6 8.1 0.5 7.9 8.4 0.6 8.3 8.9 0.6 8.1 8.7 0.6 7.9 8.5 0.6 8.1 8.7 0.6

Costs (thousands) 12.2 57.2 45.0 20.1 56.2 36.1 9.1 69.9 60.8 16.6 50.2 33.6 94.3 140.9 46.6 21.0 52.2 31.2 14.9 39.6 24.7

Cost/Utility (ICER) 77,273 70,202 110,283 55,928 80,590 55,821 42,104

COST EFFECTIVENESS AND COST UTILITY OF TRASTUZUMAB IN THE ADJUVANT TREATMENT OF EARLY HER2-POSITIVE BREAST CANCER IN SEVEN LATIN AMERICAN COUNTRIES: IMPLICATIONS FOR PATIENT ACCESS. Andres Pichon-Riviere (1); O. Ulises Garay (1); Federico Augustovski (1); Carlos Vallejos (2); Leandro Huayanay (3); Maria del Pilar Navia Bueno (4); Alarico Rodriguez (5); Cidley de Oliveira Guioti (6).


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


NOTES:Gross Domestic Product per capita (GDP pc) come from World Bank 2010.

FIGURE 3 - Cost effectiveness acceptability curves. Cost per QALY thresholds expressed as number of GDPs per capita

1 2.5 4 5.5 7 8.5 1011.5 13

14.5 1617.5 19

20.5 2223.5 25

26.5 2829.5 31

32.5 3435.5 37

38.5 4041.5 43

44.5 4647.5 49

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Brasil Bolivia

Argentina Chile

Colombia Perú

Uruguay

Cost per QALY thresholds expressed as number of GDPs per capita

Probability of being cost effective


Table 4 - Incremental cost effectiveness ratios expressed in terms of GDP per capita and threshold price of trastuzumab (440mg vial) to be cost effective under a willingness to pay thresholds of 1 GDP per capita per QALY (2012 US dollars) Country Argentina Bolivia Brasil Chile Colombia Peru Uruguay GDP pc $ 9.124 $ 1.979 $ 10.710 $ 12.431 $ 6.240 $ 5.401 $ 11.633

ICER as GDP/QALY 8,5 35,5 10,3 4,5 12,9 10,3 3,6

Current Tzb price $ 2.696 $ 2.260 $ 3.743 $ 2.099 $ 3.264 $ 1.981 $ 1.565

Max Tzb Value 1 GDPpc $ 350 $ 95 $ 400 $ 500 $ 340 $ 225 $ 475

Notes: GDP: gross domestic product; GDPpc: gross domestic product per capita; QALY: quality adjusted life years; Tzb=Trastuzumab; ICER= Incremental Cost Effectiveness Ratio; All values are expresed in US current dollars of 2012, are discounted with a 5% rate adn the GDPs per capita come from World Bank 2010. Exchange rates= Argentina $/US$ = 4,67; Bolivia $/US$ = 6,86; Brazil $/US$ = 1,84; Chile $/US$ = 476,5; Colombia $/US$ = 1.775,0; Perú $/US$ = 2,89; Uruguay $/US$ = 19,10 - International Monetary Fund 2012 (WEO outlook database)

PERUCurrent cost of one 440 mg vial of trastuzumab: USD 1,981

At this price, the cost-efectivenness of trastuzumab is 10.3 GDP per capita per QALY.

If Peru sets a willingness to pay per QALY threshold similar to that of Mexico (1 GDP per capita), trastuzumab should cost USD 350 instead of USD 1,981 to be considered cost effective.

Budget constrained health care

system

New technologies-Benefits gained-Additional Cost

Displaced services-Benefits forgone-Resources released

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

Cost-Effectiveness Thresholds in Latin America?

Adaptado de Drummond M. Seminario Internacional de Evaluaciones Económicas. Buenos Aires, 2012

Opportunity cost


Health benefit package (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 to the benefit package.

This limit is imposed by the constrained health care budget

Nueva Tecnología Sanitaria

Costo-efectividad U$D 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 forgone

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 loosed “health” and loosed efficiency(

Cost-saving (e.g. polio-sabin vaccination)

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 in the limit, e.g. U$D 8,000 or 10,000 per QALY)


Conclusions 1

• Until recently, LA countries were not explicitly taking into account cost-effectiveness. This situation created a high price tolerance for innovative drugs, which were available only for the few.

• The role of cost-effectiveness information in LA is becoming more important to support price negotiations and to decide whether or not to incorporate health technologies into health benefit packages.

• It is expected that many countries in the region will begin to consider a threshold between one and three GDP per capita per QALY or Life Year (as recommended by the WHO and similar to those explicitly or implicitly used in developed countries).


Conclusions 2

• Under this scenario, if global pricing policies continue to set similar prices internationally, it will be very unlikely for innovative drugs to be cost-effective in LA

• This inevitably entails similar or higher ICERs in current dollars, and much higher ICERs and less cost-effective results in terms of GDPPC.

• Therefore LA countries may not incorporate these new pharmaceuticals, unless they adopt significantly higher cost-effectiveness thresholds, such as 5 or 10 or more GDPPC per QALY, which does not sound reasonable or sustainable.


Conclusions 3

• Therefore LA will need to negotiate prices more related to countries’ income. One way out of this impasse would be to apply differential pricing, based on local assessments of value for money. The implication is that rich countries would pay higher prices than poorer ones.

• To improve the affordability of key drugs and health technologies while maintaining incentives for innovation is a challenge for rich and poor countries alike.

• Meeting this challenge is a joint responsibility of pharmaceutical companies, in applying differential pricing and governments, that would need to resist from international reference pricing and parallel trade of pharmaceuticals.


Thank you!

Andres Pichon-Riviere MD MSc [email protected]

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