Transferability of HTA results - Advance-HTA

Transcription

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
Hay varios factores que difieren entre los países y
que es esperable que impacten en los resultados
•
•
•
•
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
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.
Resultados (2) – Tomadores de Decisión
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
Origin of HTA reports used in decision making
From their own
countries, 24%
From other
regions (eg
Europe, North
America,
Australia), 53%
From Latin
American
countries, 23%
76%
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
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)
Researchers – use of HTA from other jurisdictions
Researchers (HTA “doers”) reported using HTA reports from other
jurisdictions as an input/source when elaborating local HTA reports in 64%
of the situations
Origin of HTA reports used as an input /source for HTA
From other
regions (eg
Europe, North
America,
Australia), 80%
From Latin
American
countries, 20%
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
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.
Researchers – “adaptation” of HTA reports from other
jurisdictions
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.
Origin of HTA reports used for adaptation
From Latin
American
countries,
25%
From other
regions (eg
Europe,
North
America,
Australia),
75%
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 PichonRiviere2, Eun-Young Bae5, Sachin Kamal-Bahl6
• Interviews with representatives of decisionmaking 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)
14
12
12
10
8
8
7
6
4
3
2
2
0
General information for the To inform reimbursement or To inform price negociations To develop clinical guidelines
health care system
coverage decisions
or decisions
Other
9
Ways in which the results from studies conducted in other
jurisdictions are used?
8
8
7
6
6
5
5
4
4
3
3
2
2
2
2
2
1
1
1
0
0
General background
To check the validity of the data or
To compare the conclusions in the As a basis for making a local decision,
assumptions in the local dosser from local dossier with the conclusions in
based on the foreign study's
the manufacturer
other jurisdictions
recommendations
Often
Sometimes
Never
Which categories of data from foreign studies are most often used in
submissions you receive? (N= number of responses)
10
9
9
8
8
7
7
6
6
5
5
4
4
3
3
2
2
1
1
0
0
0
0
0
0
0
Data on epidemiology of
disease or baseline risk
Data of relative treatment
effect
Data on resource use
Often
Sometimes
Unit costs/prices
Health state preference
values/utilities
Never
Figure 5 Which categories of foreign data do you consider to be transferable? (N=
number of responses)
9
8
8
8
8
7
6
6
6
5
4
3
3
3
2
1
1
1
1
0
0
0
0
0
0
Data on epidemiology of disease Data of relative treatment effect
or baseline risk
Data on resource use
Often
Sometimes
Unit costs/prices
Health state preference
values/utilities
Never
Adaptation of foreign models by the organizations studied
(N= Number of responses )
6
5
5
4
4
3
3
2
2
2
1
0
0
Without any adaption to the model structure to reflect local circumstances
Often
Sometimes
With adaptation to reflect local circumstances
Never
OBSTACLES TO TRANFERRING ECONOMIC EVALUATIONS FROM OTHER
JURISDICTIONS
Other practice patterns, or the availability of facilities, are often different in my
jurisdiction
The current standard of care/ relevant comparator is often different in my
jurisdiction
Number of times
mentioned
10
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
Studies often use methods that are too advanced for decision-makers in my
jurisdiction
5
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
4
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,
Skills accessible to the organization surveyed
12
11
10
10
10
9
8
8
6
4
2
0
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
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): 857876
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.
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)
Thank you!
Andres Pichon-Riviere MD MSc PhD
[email protected]
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.
Muchas gracias!
Andres Pichon-Riviere MD MSc PhD
[email protected]
General section about transferability: responses from HTA “users” and
“doers”
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
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
Barriers for transferability: Poor methodological quality
For HTA reports from other regions
• Differences in health care costs
• Different epidemiological contexts
• Different health care systems
6.6
7
6
5.3
5
4
3
2
1
0
HTA reports from other regions (eg
Europe, North America, Australia)
HTA reports from Latin American
countries
p<0.01
HTA reports:
• Low availability of HTA reports
Barriers for transferability: Low quantity of HTA reports available
8
7
7
6
5.1
5
4
3
2
1
0
HTA reports from Latin American countries
p<0.01
HTA reports:
Barriers for transferability: Different epidemiological contexts
8
7.25
7
6
6
5
4
3
2
1
0
p<0.01
HTA reports:
Barriers for transferability: Different healthcare costs
8
7.6
6.5
7
6
5
4
3
2
1
0
p<0.01

Transferability of HTA results - Advance-HTA

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