International Perspective of Comparative Effectiveness ... · Factors Currently Influencing...
Transcript of International Perspective of Comparative Effectiveness ... · Factors Currently Influencing...
International Perspective of Comparative Effectiveness Research
Danyi Zhang, MDPresident & Chief Medical Officer
VitalStrategic Research [email protected]
November 5-6, 2012Comparative Effectiveness Research Summit
Evolution of Outcomes Research
Evidence‐based Population Health and Medicine
CER Governing Bodies Around the World
NICE High Health Authority
Pharmaceutical Benefits Advisory
Committee (PBAC)
Joint Federal
Committee (JFC)
Agency for Healthcare
Research and Quality (AHRQ)
Ministry of Science
Health Insurance ReviewAgency (HIRA)
Comparative Effectiveness Research in Emerging Markets
How is CE governed and funded?
Who enforces the recommendations, if at all?
Has the information led to changed medical practices or altered costs?
Who decides what topics to address?
Who conducts analyses?
What are the primary data sources/techniques?
How is information disseminated?
Russia
Different parts of Russia have used CE information to make resource allocation decisions and improve technical efficiency
The current system of resource allocation is highly centralized and heavily hospital‐oriented
CE offers a means to improve alocative efficiency by reducing hospitalization, expanding the outpatient drug benefit, and setting professional standards for best practice
Brazil
Relys on CE to help ensure the accessibility of the services promised in the benefit package Uses the NICE guidelines as the first step in a process to ensure the availability of the services in the benefit packageMinistry of Science reviews the NICE guidelines in the context of the country’s medical care system, Brazilian health economists evaluate the cost of the NICE recommendations in the Brazilian contextThis information, in combination with the requests of physicians, hospital managers, and patient advocates, is presented to the Minister of Health for a final decision on what should be included in the final benefit package. Once a drug or device is included in the benefit package, the expectation is that it will be available to all patients
KoreaIn 2007, Korea abandoned reference pricing and switched to a positive drug listing system that calls for price negotiation based on evidence of comparative clinical and cost‐effectiveness (value‐based pricing). The shift highlighted the need to link decision making to evidence generation. In response,Health Insurance Review Agency (HIRA} became the government body In 2008 national medical research institute (NECA) was charged with undertaking research to address HIRA needs.Preliminary discussions indicate decision‐maker interest in both head‐to‐head trials and claims analyses as well as in methods research, including social value elicitation from the Korean population and adaptation of QALY or another outcome measure to the Korean setting
China, Taiwan, Thailand
China Taiwan Thailand
Survey (participant) 12 6 8
Population (million) 1,347.4 23.3 65.5
Total Health
Expenditures: % of GDP
4.3 6.5 4.1
•GDP per capita: International Monetary Fund (IMF), World Economic Outlook (WEO) Database, April 2012 edition•Health expenditures: Word Bank•Population: http://en.wikipedia.org/wiki/List_of_countries_by_population
Factors Influencing Decision Making
Factors Currently Influencing Decisions
Q1 Efficacy and safety data gained from RCT
Q2Novelty of the heath technology (e.g., branded
vs. generics, 1st vs. 2nd or 3rd in the same
class)
Q3Comparactive effectiveness vs. other health
technologies for the same indication
Q4Evidence gained from Real‐World
observational or non‐interventional studies
Q5 Evidence gained from medical chart reviewQ6 Patient QoL or PRO
Q7Patient affordability or cost burden of the
medical product
Q8Whether the product is list on reimbursement
list
Q9Medical guideline, treatment pathway, or
expert recommendation
Q10 Public or private insurance coverage
Q11Chemical, biological vs. traditional or
alternative medicine
For physicians when
making medical choices
For Payer/Gov. /HTA experts/Academic
when making reimbursement or coverage
decision
Payer/Gov./Expertsphysician
Score 1 to 5, least to most influencing
Other Factors Influencing Decision Making
What other factors healthcare
providers
are currently using or
will evaluate upon making medical
decision?
• Local existing practice pattern• Clinical risk (may result in over‐
treatment)
• Price• Cost‐effectiveness• Patient’s preferences• Patient’s compliance to a
treatment (inconveniences, AEs)
• Physician’s personal experience• Physician’s income vs. work load
What other factors government
payers
are currently using or will
evaluate upon making
reimbursement decision?
• Epidemiological importance• Patient’s reactions• Absolute price level• Cost‐effectiveness/economic
considerations/budget impact
• Political considerations• Psychological consideration
(e.g., palliative cancer
treatment)
• Location of manufacturer
(China; related to local
economy)
• Potential mis‐use or over‐use
Knowledge of Comparative Effectiveness Research (CER)
Familiar with
CER?
CER should be the
most important
factor for HTA?
Resources in
obtaining CER
analysis evidence
Steps to
implement CER
into routine
practice
YES: IIIIIIIIII 10YES: IIIIIIIIII 10NO: IIIIIIIIIIII 12NO: IIIIIIIIIIII 12
Communication
(incl. high quality
publications) with
physicians and
payers on the CER
results
Studies with local
data
Reliability of
evidence
Clinical guidelines
Studies
supplied
by
sponsors
YES: IIIIIIII 8YES: IIIIIIII 8NO: II 2NO: II 2DonDon’’t know: IIIIIIIIIIII 12t know: IIIIIIIIIIII 12
To answer
WHAT works
for WHOM in
what
circumstances
CER is real‐
world study,
should be
considered
alongside withRCT results.
Current regulatory requirements and submission process in reference to HTA
Current fo
cus is on
efficacy an
d safety.
HTA is cur
rently not
required.
RCT results are
required. HTA is
encouraged.
Evidence on safety and
efficacy are required.
HTA is only used in the
step of National Listing
of Essential Medicine (NLEM).
For NDA application
Future trends of HTA process, role, and impact within the next 1 to 3 and 5 to 10 years
National HTA Models• Mostly mentioned: UK (NICE) and Australia• Many mentioned Canada• One Chinese physician mentioned Italian model
Most Chinese
respondents think
China’s situation is more
complicated and needs
to find its own way.
HTA
Model
Why CER is needed in China?
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Clinical effectiveness evidence for treatment used in specific Chinese population and environment is needed ‐ ethnic background, traditional medicine, domestic generics, policy, health insurance, economic status
Rapid increase in new medicines or device entering from global sources brings challenge in making proper medical choice without evidence in comparative effectiveness
Clinicians and medical associations demand more clinical outcomes data collected from real‐world to determine gaps from guidelines, unmet needs, patient preference, and patient compliance
Government payors are increasingly interested in clinical effectiveness and cost effectiveness evidence to inform reimbursement policies
China Cardiometabolic Registries (CCMR)
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Organized by Chinese Medical Doctor Association, Supported by MOH, Funded by Industry
CCMR – Ongoing Studies
Visit: www.clinicaltrial.gov
for more information17
3B (Completed)
CCDC(Ongoing)
3B Extension
(Ongoing)NEW2D (Initiated)
Nationwide Assessment
of Cardiovascular Risk
Factors: Blood Pressure,
Blood Lipid, and Blood
Glucose, in Chinese
Patients with Type 2
Diabetes
Comprehensive Cohort
Study in Type 2
Diabetes with High Risk
of CVD in China
A Comprehensive
Longitudinal Cohort
Study in Type 2
Diabetes with High Risk
of CAD in China
Evaluation of
Effectiveness of
Treatment Paradigm
for Newly Diagnosed Type 2 Diabetes
Patients in China
25,000 Patients 1,000 Patients 5,000 Patients 5,000 Patients
No Follow‐up 12 Month Follow‐up 3 year Follow up 1 year follow up
Endocrinologists
CardiologistsNephrologists
Endocrinologists Endocrinologists
Cardiologists
Nephrologists
Endocrinologists
Cardiologists
Internists
Merck Roche Merck BMS
CCMR - Pathway to Quality Real World Clinical Research
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CMDA –CCMR
ESC –Euro Heart Survey
ACC ‐NCDR
Supported by MOH Based on Europe and US experienceAiming to serve China, Asia and the world
China National Disease Registry
Registry Study Data Center
To SponsorProduct DevelopmentSafety InformationProduct Utility
To HospitalQuality ManagementClinical Pathway Guideline Adherence
To ResearcherPublicationsEducation MaterialCareer Development
【Statistical Analysis and Report】
EMR + eCRF
19
China Outcomes Research and Evidence Based Medicine Summit (CORE)
2011 CORE
2012 CORE
2013 CORE
2012 CORE Summit Attendance
Attendee Distribution
China
Japan
Australia
Singapore
United States
France