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Transferability of HTA results Prof. Dr. Andrés Pichon-Riviere IECS-Instituto de Efectividad Clínica y Sanitaria Profesor de Salud Publica, Universidad de Buenos Aires

Transferability of HTA results · Transferability of HTA results Prof. Dr. Andrés Pichon-Riviere IECS-Instituto de Efectividad Clínica y Sanitaria Profesor de Salud Publica, Universidad

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Transferability of HTA results

Prof. Dr. Andrés Pichon-Riviere IECS-Instituto de Efectividad Clínica y Sanitaria

Profesor de Salud Publica, Universidad de Buenos Aires

Contenidos • Introducción al tema •Experiencias de transferabilidad en la región •Conclusiones

Definiciones Generalizability Whether the results from a given study apply to other settings Transferability The extent to which the results from a given study can be adapted to apply to other settings.

Por que es un tema relevante? • No hay recursos suficientes para hacer todos los estudios

en todos los lugares

• Frecuentemente los tomadores de decisión necesitan adaptar o interpretar datos de otras jurisdicciones/países

• Los estudios presentados por la industria para solicitar cobertura suelen incluir datos y/o modelos provenientes de otros países

• Demografía y epidemiología de la enfermedad

• Precios relativos

• Práctica clínica / tasas de uso

• Distribución y disponibilidad de los recursos sanitarios

• Incentivos a profesionales / instituciones

• Utilidades de los estados de salud

Hay varios factores que difieren entre los países y que es esperable que impacten en los resultados

Los decisores sanitarios están utilizando documentos de evaluación de tecnologías sanitarias de otros países

Source: Pichon-Riviere A, Augustovski F, Rubinstein A, Martí SG, Sullivan SD, Drummond MF. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010 Oct;26(4):421-7.

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

Los decisores reportaron que en el 76% de los casos en que

debieron utilizar un reporte de ETS para tomar una decisión

el reporte había sido realizado en otro país

Al utilizar reportes de otros países la

información que consideraron más

útil fue la información sobre:

•Descripción de la tecnología

•Seguridad

•Eficacia y Efectividad

Les resultó menos útil y aplicable la

información sobre:

•Implicancias éticas y legales

•Impacto presupuestario

•Evaluación económica

•Aspectos organizacionales

76%

Resultados (2) – Tomadores de Decisión

From their own countries, 24%

From Latin American

countries, 23%

From other

regions (eg Europe, North

America, Australia), 53%

Origin of HTA reports used in decision making

Source: Pichon-Riviere A, Augustovski F, Rubinstein A, Martí SG, Sullivan SD, Drummond MF. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010 Oct;26(4):421-7.

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

From other regions (eg

Europe, North America,

Australia), 80%

From Latin American

countries, 20%

Origin of HTA reports used as an input /source for HTA

Researchers (HTA “doers”) reported using HTA reports from other

jurisdictions as an input/source when elaborating local HTA reports in 64%

of the situations

When using reports from other

jurisdictions they found more

useful/adaptable the information

regarding:

•Description of the technology

•Safety

•Efficacy/Effectiveness

•Method. of systematic review

•as an aid in the comparisons of results

•as a starting point from which to

develop a new report

Less useful/adaptable

•Ethic/legal/social implications

•Budget impact

•Organizational issues

•Economic evaluation

Researchers – use of HTA from other jurisdictions

Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6.

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

33% of the researchers reported having adapted an HTA

report to the local setting.

In 75% of the cases the reports adapted came from other

regions and just 25% where reports from other Latin American

countries.

From Latin American countries,

25%

From other regions (eg

Europe, North

America,

Australia), 75%

Origin of HTA reports used for adaptation

Researchers – “adaptation” of HTA reports from other jurisdictions

Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6.

CHALLENGES FACED BY DECISION MAKERS FROM MIDDLE INCOME COUNTRIES IN TRANSFERRING ECONOMIC EVALUATIONS FROM OTHER JURISDICTIONS Michael Drummond1, Federico Augustovski2 , Zoltán Kaló3, Bong-Min Yang4, Andres Pichon-Riviere2, Eun-Young Bae5, Sachin Kamal-Bahl6

• Interviews with representatives of decision-making bodies from jurisdictions in Asia, Central and Eastern Europe with at least one year’s experience of using economic evaluations

• Representatives of the relevant organizations were interviewed in South Korea, Taiwan, Thailand, Croatia, Hungary, Poland, Slovakia, Argentina, Brazil, Colombia, Mexico and Uruguay

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

Uses of economic evaluations (N=number of organizations)

7

12

8

3

2

0

2

4

6

8

10

12

14

General information for thehealth care system

To inform reimbursement orcoverage decisions

To inform price negociationsor decisions

To develop clinical guidelines Other

Ways in which the results from studies conducted in other jurisdictions are used?

(N=number of organizations)

8

4

2 2

1

3

5

1

0

2 2

6

0

1

2

3

4

5

6

7

8

9

General background To check the validity of the data orassumptions in the local dosser from

the manufacturer

To compare the conclusions in thelocal dossier with the conclusions in

other jurisdictions

As a basis for making a local decision,based on the foreign study's

recommendations

Often Sometimes Never

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

Which categories of data from foreign studies are most often used in submissions you receive? (N= number of responses)

7

9

0 0

5

2

0

8

3

4

0 0

1

6

0 0

1

2

3

4

5

6

7

8

9

10

Data on epidemiology ofdisease or baseline risk

Data of relative treatmenteffect

Data on resource use Unit costs/prices Health state preferencevalues/utilities

Often Sometimes Never

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

Figure 5 Which categories of foreign data do you consider to be transferable? (N= number of responses)

3

8

0 0

1

6

1

6

1

8

0 0

3

8

0 0

1

2

3

4

5

6

7

8

9

Data on epidemiology of diseaseor baseline risk

Data of relative treatment effect Data on resource use Unit costs/prices Health state preferencevalues/utilities

Often Sometimes Never

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

Adaptation of foreign models by the organizations studied (N= Number of responses )

2

3

4

5

2

0 0

1

2

3

4

5

6

Without any adaption to the model structure to reflect local circumstances With adaptation to reflect local circumstances

Often Sometimes Never

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

OBSTACLES TO TRANFERRING ECONOMIC EVALUATIONS FROM OTHER

JURISDICTIONS

Number of times

mentioned

Other practice patterns, or the availability of facilities, are often different in my

jurisdiction 10

The current standard of care/ relevant comparator is often different in my

jurisdiction 9

Studies are often conducted in countries with a higher GDP, so the results do not

apply in my jurisdiction 8

Studies are often badly reported, or not enough details are given 8

It is often difficult or impossible to obtain an electronic copy of the model 7

The patient population is often different in my jurisdiction 6

Often, it is not possible to find local data to re-populate the model 6

Studies often have methodological deficiencies 5

Decision-makers in my jurisdiction much prefer a locally designed study 5

Studies often use methods that are too advanced for decision-makers in my

jurisdiction 4

Other obstacles (please list and rank) 3

Lack of local technical capability 1

. Decision-makers in my jurisdiction much prefer non-data driven arguments 1

Different resources & costs used in other jurisdictions 1

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

Skills accessible to the organization surveyed (N=number of organizations)

11

10

8

10

9

0

2

4

6

8

10

12

Physicians/clinical specialists Pharmacists Epidemiologists Health economists Medical statisticians

Use of International Resources

• Websites frequently consulted; NICE, CRD(York), CADTH, SMC, PBAC

• Very little use of transferability checklists (eg Eunethta checklist)

• Very little use of studies undertaken in other countries in the region

Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014

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

HEE methodological guidelines in Latin America

Countries with HEE

guidelines

Brazil, Colombia,

Cuba and Mexico

MERCOSUR:

Argentina, Brazil,

Paraguay and

Uruguay

Grupo Andino:

Bolivia, Chile,

Colombia, Ecuador,

Peru, Venezuela

Most of these guidelines 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.

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

What these guidelines say about the use of data, models and information from other jurisdictions? MEXICO: If information from international sources or from clinical trials from different contexts is used, appropriate adjustments must be considered in relation to differences in resource use. Data should be validated and adjusted in relation to local practice, besides having into consideration the differences in resource use between routine practice and that developed for research purposes. BRAZIL: QALYs. It is preferable that local utilities are used. If these are not available can be used international sources. CHILE - Modeling section: If the model was developed and validated abroad (or in another context), its use for national reality must be justified and the model should be calibrated with national data CHILE – Costs section: When data on cost of resources is not available at the local level can be considered ultimately using international evidence. In these cases must include the (descriptive and quantitative) analysis regarding the generalizability and transferability potential. In all cases, the choice of methodologies, and assumptions must be clearly justified.

Welte R, Feenstra T, Jager H y Leidl R. A Decision Chart for Assessing and Improving the Transferability of Economic Evaluation Results Between Countries. Pharmacoeconomics 2004; 22 (13): 857- 876

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

Conclusion In Latin America is commonplace to deal with the issue of transferring analysis or data from other jurisdictions The use and adaptation of HTAs from other jurisdictions can be a valuable tool to overcome the scarcity of local information and the lack of time and resources to generate evidence in the short term. As the use of economic evaluations to inform reimbursement and coverage decisions increases in middle income countries, it will be increasingly important to ensure improved practices in evaluating and conducting transferability of foreign data. Inadequacies in dealing with transferability issues may lead to inappropriate coverage decisions and the inefficient use of healthcare resources.

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

In the short and medium term: •Define/Agree on methodologies to rigorously assess the degree of transferability

• Invest in local data generation for those categories of data normally considered to have low transferability, such as unit costs, health state preference values and epidemiological data.

•As the number of HTA organizations in LA increases, they could collaborate more fully within their region, since the transferability of economic evaluations within the region is likely to be greater than that between regions. (eg multi country economic evaluations)

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

Thank you!

Andres Pichon-Riviere MD MSc PhD

[email protected]

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

Source: Pichon-Riviere A, Augustovski F, Rubinstein A, Martí SG, Sullivan SD, Drummond MF. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010 Oct;26(4):421-7.

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

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

Muchas gracias!

Andres Pichon-Riviere MD MSc PhD

[email protected]

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

All respondents consider that using HTA reports from other jurisdictions is

potentially very useful. This potential was considered to be higher for HTA

reports from Latin America.

They consider it useful to:

•Improve the decision making process

•Fewer resources needed

•Obtain results faster

•Avoid duplication of work

General section about transferability: responses from HTA “users” and “doers”

Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6.

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

Main barriers than limit the transferability of

HTA reports:

For HTA reports from Latin America

• Low quantity of HTA reports available

• Lack of guidelines/methods on how to adapt HTA reports

• Poor methodological quality

• Lack of transparency in the HTA reports published

For HTA reports from other regions

• Differences in health care costs

• Different epidemiological contexts

• Different health care systems

5.3

6.6

0

1

2

3

4

5

6

7

HTA reports from other regions (eg Europe, North America, Australia)

HTA reports from Latin American countries

Barriers for transferability: Poor methodological quality

p<0.01

Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6.

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

Main barriers than limit the transferability of

HTA reports:

For HTA reports from Latin America

• Low availability of HTA reports

• Lack of guidelines/methods on how to adapt HTA reports

• Poor methodological quality

• Lack of transparency in the HTA reports published

For HTA reports from other regions

• Differences in health care costs

• Different epidemiological contexts

• Different health care systems

5.1

7

0

1

2

3

4

5

6

7

8

HTA reports from other regions (eg Europe, North America, Australia)

HTA reports from Latin American countries

Barriers for transferability: Low quantity of HTA reports available

p<0.01

Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6.

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

Main barriers than limit the transferability of

HTA reports:

For HTA reports from Latin America

• Low quantity of HTA reports available

• Lack of guidelines/methods on how to adapt HTA reports

• Poor methodological quality

• Lack of transparency in the HTA reports published

For HTA reports from other regions

• Differences in health care costs

• Different epidemiological contexts

• Different health care systems

7.25

6

0

1

2

3

4

5

6

7

8

HTA reports from other regions (eg Europe, North America, Australia)

HTA reports from Latin American countries

Barriers for transferability: Different epidemiological contexts

p<0.01

Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6.

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

Main barriers than limit the transferability of

HTA reports:

For HTA reports from Latin America

• Low quantity of HTA reports available

• Lack of guidelines/methods on how to adapt HTA reports

• Poor methodological quality

• Lack of transparency in the HTA reports published

For HTA reports from other regions

• Differences in health care costs

• Different epidemiological contexts

• Different health care systems

7.6

6.5

0

1

2

3

4

5

6

7

8

HTA reports from other regions (eg Europe, North America, Australia)

HTA reports from Latin American countries

Barriers for transferability: Different healthcare costs

p<0.01