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SNIIRAM: PRIMARY AND
SECONDARY CARE RESOURCE
USE IN FRANCE – NATIONAL
CLAIMS DATA
Eric Van Ganse, Manon Belhassen
PharmacoEpidemiology Lyon (PEL)
Respiratory Medicine, Croix Rousse University Hospital, Lyon, France
UMR CNRS 5558, Claude-Bernard University, Lyon, France.
January 23, 2015
REG 2015 Winter summit
Maximising the Yield: Databases around the World Part I – Europe & Canada
INTRODUCTION
French Health Care System
Health Care System:
3
• Established in 1945
• World Health Organization (2000) : France provides "close to best
overall health care" in the world
• In 2005, France spent 11.2% of GDP on health care
• >75% of all health care expenditures are covered by government
funded agencies
Health Care System
4
• 46% of General Practitioners (GPs) still work in solo
practices and are ‘self-employed’, while drawing their
income from public funding
• the French National Health Service directly refunds all
patients >70% of all health care costs
• This reimbursement =100% in case of “expensive
long-term conditions”
SNIIRAM: PRIMARY AND
SECONDARY CARE
RESOURCE USE IN FRANCE
– NATIONAL CLAIMS DATA
Linkage between primary and
secondary care
6
• SNIIR-AM:
• SNIIRAM is the National Information System for the Health
Care Insurance (all systems)
• Implemented in 2004, SNIIRAM is a national database of
medical and HCP interventions (claims)
Linkage between primary and
secondary care
7
• The SNIIR-AM is the first information system based on
linkage between:
• Primary care data (GPs and Specialists, Community
Pharmacies,…)
• and…
• Secondary care data (Public & Private Hospitals)
Linkage between primary and
secondary care
8
• Data:
• On beneficiaries (individual data and anonymous) information,
ie medico-administrative (LTD number, occupational diseases,
discharge diagnoses from hospitals in ICD 10 codes, date of
pregnancy, …)
• On benefits: detailed identity of all acts, and dates
• On HCPs (individual data not anonymous): identifyer, gender,
age, medical specialty, type of practice, conventional status,
union affiliation, district
Linkage between primary and
secondary care
9
Limitations:
• The data model is complex : it reflects the rules of the
Social Security (reimbursement > research)
• Concepts and names are numerous and voluminous
• The time needed to access and process individual data
can be long.
Data Collection during the Hospital Stay
• FINESS
•Status : public / private
• Adress
• Patients ID (anonymised)
• Age
• Gender
• Main Diagnosis (DP), Related (DR)
& Associated (DAS)
(ICD-10)
• Acts (≈7 600 codes from the CCAM)
• Products « added »
10
• Mode of entry (home, A&E,…)
• ICU, neuro-vascular,…
• Mode of discharge (home, HAD, SSR,..)
Patients’
records
Hospital DataPatients Data
Medical Data
Data on Patient’s
Management
Financial Data
Linkage between primary and
secondary care
11
• EGB:
• The EGB is a cohort at the 1/97 of the beneficiaries of
the social security (national health insurance), whether
they have received healthcare reimbursements or not.
• It currently gathers together some 650,000
beneficiaries of the coverage for salaried workers,
other than civil servants and students (general
scheme), and should eventually cover all of the French
social security schemes over a 20-year period.
Linkage between primary and
secondary care
12
• This sample is used:
• to conduct longitudinal studies (individual medical histories)
• to trace the health care pathway of patients over long periods,
both in primary and secondary care
• to estimate the population protected by the social security as
well as the rate of access to health care and the characteristics
of individual healthcare expenditure.
Linkage between primary and
secondary care
13
• Strengths:
• EGB is a representative sample covered by all health
insurance plans
• Its rate of sampling, close to 1/100th allows to collect data on a
large population (about 650,000 people in the general
scheme), so answering many questions on the health behavior
of the population
• Thus, it is possible to monitor a population protected by LTD
such as diabetes (13,000 people in the EGB in 2007), severe
chronic respiratory failure (2,500 people) or AD (2,000 people)
Linkage between primary and
secondary care
14
• Limitations:
• The education level, income level, or occupational category of
beneficiaries, are missing.
• The sample contains information on the actual care reimbursed,
but self-medication or drugs prescribed but not purchased cannot
be measured.
• Similarly, it is impossible to verify whether absent refills (“gaps”)
are due to lack of prescriptions or to lack of purchase < patients,
as therapy prescribed but not dispensed is not listed in claims data
• No clinical information (examination of the patient by the
physician, results of laboratory tests or imaging)
• No diagnosis, unless seconday care or LTD (“algorithms”)
Linkage between primary and
secondary care
15
Access to the data:
• Since 2001, the CNIL has formalized the conditions of use of
the SNIIRAM: users must be formally and nominally
‘habilitated’ and all identifiers of individuals are irreversibly
anonymised before being stored
• The database of Social Security is considered to be secure.
• Today, access to EGB and SNIIR-AM are restricted to “public
teams” working at Universities or Research Institutions
• No way for a drug company to have direct access to the data
(hot debate)
THREE EXAMPLES OF
EGB AND SNIIR-AM
STUDIES
RATIO project
APSIs project
SINGULAIR project
RATIO project
RELATIVE EXPOSURE TO INHALED STEROIDS
(RATIO “ICS-TO-TOTAL ASTHMA THERAPY”)
Background
• Inadequate use of inhaled corticosteroids in asthma
(ICS) are a major cause of loss of asthma control and
unscheduled medical care
• In claims data, the “ICS-to-total-asthma-therapy” ratios
(R) have shown interest to identify asthmatics more at
risk of exacerbations, as a result of insufficient
exposure to ICS for their level of disease severity, and
hence, poor control.
Methods
• Patients aged<40, with ≥3 dispensings of anti asthma
drugs in 2005.
• The ICS-to-total-asthma-therapy ratio measured the
proportion of ICS units, out of the overall number of
respiratory drug units (prescribed/ dispensed) during a
12 month-period .
• According to ratio values, patients were classified into 3
groups:
• ICS non users (ratio=0%)
• Low-ICS-ratio group (0% < ratio <50%)
• High-ICS-ratio group (ratio ≥ 50%).
Methods
Outcomes
• Markers of asthma exacerbations: asthma-related
hospitalizations, visits to GPs, use of oral steroids
(OCS) or antibiotics (ATB)
Analyses
The outcomes were compared during a 12-month period
between:
• Non ICS users (R=0%)
• Low-ICS-ratio group (0<R<50%)
• High-ICS-ratio group (R≥50%).
Results
• Patients in the low-ICS-ratio group had higher rates of
asthma-related hospital admissions, and higher
dispensing levels of oral corticosteroids and antibiotics
than the other groups
R = 0%
N=404
0%<R< 50%
N=792
R ≥ 50%
N=966
p
≥ 1 asthma-related hospitalisation 0.50% 1.89% 0.21% 0.0007
≥ 1 dispensing of oral
corticosteroids (%)
34.6% 53.3% 42.2% <0.0001
Units of oral corticosteroids (mean) 0.5 1.2 0.9 <0.0001
≥ 1 dispensing of antibiotics(1) (%) 56.1% 71.1% 61.9% <0.0001
Units of antibiotics(1) (mean) 2.1 3.4 3.1 <0.0001
Medical visits (mean) 5.4 7.0 5.7 <0.0001
APSIs project
COMPARATIVE EFFECTIVENESS STUDY OF
ALLERGENS PREPARED FOR A SINGLE
INDIVIDUAL (APSIS) IN ALLERGIC CHILDREN
Background
• Allergic rhinoconjunctivitis (ARC) is a common disorder
with a prevalence of around 30% in the French population
middle-aged population
• ARC may facilitate the development of asthma
• Asthma is present in around 6% of the French population
with consequences on medical resource utilization and
quality of life
• Allergens Prepared for a Single Individual (APSIs) are an
anti-allergic therapy for patients with ARC
Objective
• To assess the effectiveness of APSIs in children.
Methods
• A population of rhinitis-treated children (aged 5-15 years) with
antihistamines and nasal therapy reimbursed between 2007
and 2010 was identified in the EGB database
• Among them, children initiating APSIs between 2010 and 2012
(index date) were identified
• Each child of the APSIs cohort was matched to a non-APSIs
child with rhinitis (APSIs initiation was taken as index date)
• The outcome was the costs of medical resource utilization
related to rhinitis and asthma of each cohort during 3 years
after APSIs initiation, not taking into account the cost of APSIs
Results
• A total of 585 APSIs children (24% with 3 years follow-up) were
identified (63% boys)
• The APSIs cohort was less expensive for the payer than the
reference cohort from the second year (on average 180€/child
in APSIs cohort against 230€/child in reference cohort)
• This difference increased during the 3rd year: APSIs children
saved on average 100€ compared to children of the reference
cohort.
• The differences were mainly due to lower expenses (50%)
related to asthma medications and hospitalizations in the
APSIs cohort
Results
SINGULAIR project
EFFECTIVENESS OF MONTELUKAST ON
ASTHMA CONTROL IN INFANTS
Background
• Montelukast 4mg (MTL-4) is an add-on therapy for
asthmatic infants
• French regulators have requested real-world evidence on
effectiveness of MTL-4 in infants (6-24 months)
Objective
• To compare the effectiveness of MTL-4, associated or not
with ICS, vs. ICS without MTL-4, on health outcomes of
infants with mild to moderate uncontrolled asthma
Methods
• We preselected infants receiving ≥2 consecutive dispensations
of respiratory drugs (R03 ATC classification) from 2010 to
2012, and presenting an exacerbation within 6 months of the
second R03 dispensing.
• Asthma exacerbation was identified by:
• asthma-related hospitalizations,
• dispensing of oral corticosteroids,
• addition of short-acting beta agonists to existing respiratory therapy,
• switch to a higher ICS dosage, or nebulized CS.
• Infants being treated with ICS without MTL-4 were compared to
those receiving MTL-4 on asthma control:
• the occurrence of a new exacerbation,
• the total number of exacerbations during the 6 months follow-up period
• asthma-related health care utilization
Results
Infants aged 6-24 months Number Percentage
With 2 dispensations of respiratory medications (R03) between
March 8, 2010 and December 31,2011
171,392 100 %
 With initial exacerbation (T0) 152,212 88.8 %
 With at least 6 months follow-up from T0 115,489 67.4 %
 MTL4-group 4,490 3.9 %
 ICS group 74,561 64.6 %
Results
• Time to occurrence of a new exacerbation was shorter in
ICS group (54.1 days) compared to MTL-4 group (57.7
days). In both groups, more than 3 out of 4 infants had at
least one exacerbation during follow-up.
• Total number of exacerbations during 6 months follow-up:
no statistical difference between MTL-4 and ICS.
Relative risk 95% CI p
Group
(MTL-4 vs ICS)
1,00 0,97 – 1,03 0,8617
Results - Health care utilization in both
groups (except for treatment therapy):
SNIIRAM/EGB: Overall Conclusions
• French databases are a useful tool to perfom
observational studies: SNIIRAM is one of the largest and
most complete dataset in the world
• Access and data management are complex, but results
are of interest!
• Contact : eric.van-ganse@univ-lyon1.fr

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SNIIRAM: PRIMARY AND SECONDARY CARE RESOURCE USE IN FRANCE

  • 1. SNIIRAM: PRIMARY AND SECONDARY CARE RESOURCE USE IN FRANCE – NATIONAL CLAIMS DATA Eric Van Ganse, Manon Belhassen PharmacoEpidemiology Lyon (PEL) Respiratory Medicine, Croix Rousse University Hospital, Lyon, France UMR CNRS 5558, Claude-Bernard University, Lyon, France. January 23, 2015 REG 2015 Winter summit Maximising the Yield: Databases around the World Part I – Europe & Canada
  • 3. Health Care System: 3 • Established in 1945 • World Health Organization (2000) : France provides "close to best overall health care" in the world • In 2005, France spent 11.2% of GDP on health care • >75% of all health care expenditures are covered by government funded agencies
  • 4. Health Care System 4 • 46% of General Practitioners (GPs) still work in solo practices and are ‘self-employed’, while drawing their income from public funding • the French National Health Service directly refunds all patients >70% of all health care costs • This reimbursement =100% in case of “expensive long-term conditions”
  • 5. SNIIRAM: PRIMARY AND SECONDARY CARE RESOURCE USE IN FRANCE – NATIONAL CLAIMS DATA
  • 6. Linkage between primary and secondary care 6 • SNIIR-AM: • SNIIRAM is the National Information System for the Health Care Insurance (all systems) • Implemented in 2004, SNIIRAM is a national database of medical and HCP interventions (claims)
  • 7. Linkage between primary and secondary care 7 • The SNIIR-AM is the first information system based on linkage between: • Primary care data (GPs and Specialists, Community Pharmacies,…) • and… • Secondary care data (Public & Private Hospitals)
  • 8. Linkage between primary and secondary care 8 • Data: • On beneficiaries (individual data and anonymous) information, ie medico-administrative (LTD number, occupational diseases, discharge diagnoses from hospitals in ICD 10 codes, date of pregnancy, …) • On benefits: detailed identity of all acts, and dates • On HCPs (individual data not anonymous): identifyer, gender, age, medical specialty, type of practice, conventional status, union affiliation, district
  • 9. Linkage between primary and secondary care 9 Limitations: • The data model is complex : it reflects the rules of the Social Security (reimbursement > research) • Concepts and names are numerous and voluminous • The time needed to access and process individual data can be long.
  • 10. Data Collection during the Hospital Stay • FINESS •Status : public / private • Adress • Patients ID (anonymised) • Age • Gender • Main Diagnosis (DP), Related (DR) & Associated (DAS) (ICD-10) • Acts (≈7 600 codes from the CCAM) • Products « added » 10 • Mode of entry (home, A&E,…) • ICU, neuro-vascular,… • Mode of discharge (home, HAD, SSR,..) Patients’ records Hospital DataPatients Data Medical Data Data on Patient’s Management Financial Data
  • 11. Linkage between primary and secondary care 11 • EGB: • The EGB is a cohort at the 1/97 of the beneficiaries of the social security (national health insurance), whether they have received healthcare reimbursements or not. • It currently gathers together some 650,000 beneficiaries of the coverage for salaried workers, other than civil servants and students (general scheme), and should eventually cover all of the French social security schemes over a 20-year period.
  • 12. Linkage between primary and secondary care 12 • This sample is used: • to conduct longitudinal studies (individual medical histories) • to trace the health care pathway of patients over long periods, both in primary and secondary care • to estimate the population protected by the social security as well as the rate of access to health care and the characteristics of individual healthcare expenditure.
  • 13. Linkage between primary and secondary care 13 • Strengths: • EGB is a representative sample covered by all health insurance plans • Its rate of sampling, close to 1/100th allows to collect data on a large population (about 650,000 people in the general scheme), so answering many questions on the health behavior of the population • Thus, it is possible to monitor a population protected by LTD such as diabetes (13,000 people in the EGB in 2007), severe chronic respiratory failure (2,500 people) or AD (2,000 people)
  • 14. Linkage between primary and secondary care 14 • Limitations: • The education level, income level, or occupational category of beneficiaries, are missing. • The sample contains information on the actual care reimbursed, but self-medication or drugs prescribed but not purchased cannot be measured. • Similarly, it is impossible to verify whether absent refills (“gaps”) are due to lack of prescriptions or to lack of purchase < patients, as therapy prescribed but not dispensed is not listed in claims data • No clinical information (examination of the patient by the physician, results of laboratory tests or imaging) • No diagnosis, unless seconday care or LTD (“algorithms”)
  • 15. Linkage between primary and secondary care 15 Access to the data: • Since 2001, the CNIL has formalized the conditions of use of the SNIIRAM: users must be formally and nominally ‘habilitated’ and all identifiers of individuals are irreversibly anonymised before being stored • The database of Social Security is considered to be secure. • Today, access to EGB and SNIIR-AM are restricted to “public teams” working at Universities or Research Institutions • No way for a drug company to have direct access to the data (hot debate)
  • 16. THREE EXAMPLES OF EGB AND SNIIR-AM STUDIES RATIO project APSIs project SINGULAIR project
  • 17. RATIO project RELATIVE EXPOSURE TO INHALED STEROIDS (RATIO “ICS-TO-TOTAL ASTHMA THERAPY”)
  • 18. Background • Inadequate use of inhaled corticosteroids in asthma (ICS) are a major cause of loss of asthma control and unscheduled medical care • In claims data, the “ICS-to-total-asthma-therapy” ratios (R) have shown interest to identify asthmatics more at risk of exacerbations, as a result of insufficient exposure to ICS for their level of disease severity, and hence, poor control.
  • 19. Methods • Patients aged<40, with ≥3 dispensings of anti asthma drugs in 2005. • The ICS-to-total-asthma-therapy ratio measured the proportion of ICS units, out of the overall number of respiratory drug units (prescribed/ dispensed) during a 12 month-period . • According to ratio values, patients were classified into 3 groups: • ICS non users (ratio=0%) • Low-ICS-ratio group (0% < ratio <50%) • High-ICS-ratio group (ratio ≥ 50%).
  • 20. Methods Outcomes • Markers of asthma exacerbations: asthma-related hospitalizations, visits to GPs, use of oral steroids (OCS) or antibiotics (ATB) Analyses The outcomes were compared during a 12-month period between: • Non ICS users (R=0%) • Low-ICS-ratio group (0<R<50%) • High-ICS-ratio group (R≥50%).
  • 21. Results • Patients in the low-ICS-ratio group had higher rates of asthma-related hospital admissions, and higher dispensing levels of oral corticosteroids and antibiotics than the other groups R = 0% N=404 0%<R< 50% N=792 R ≥ 50% N=966 p ≥ 1 asthma-related hospitalisation 0.50% 1.89% 0.21% 0.0007 ≥ 1 dispensing of oral corticosteroids (%) 34.6% 53.3% 42.2% <0.0001 Units of oral corticosteroids (mean) 0.5 1.2 0.9 <0.0001 ≥ 1 dispensing of antibiotics(1) (%) 56.1% 71.1% 61.9% <0.0001 Units of antibiotics(1) (mean) 2.1 3.4 3.1 <0.0001 Medical visits (mean) 5.4 7.0 5.7 <0.0001
  • 22. APSIs project COMPARATIVE EFFECTIVENESS STUDY OF ALLERGENS PREPARED FOR A SINGLE INDIVIDUAL (APSIS) IN ALLERGIC CHILDREN
  • 23. Background • Allergic rhinoconjunctivitis (ARC) is a common disorder with a prevalence of around 30% in the French population middle-aged population • ARC may facilitate the development of asthma • Asthma is present in around 6% of the French population with consequences on medical resource utilization and quality of life • Allergens Prepared for a Single Individual (APSIs) are an anti-allergic therapy for patients with ARC
  • 24. Objective • To assess the effectiveness of APSIs in children.
  • 25. Methods • A population of rhinitis-treated children (aged 5-15 years) with antihistamines and nasal therapy reimbursed between 2007 and 2010 was identified in the EGB database • Among them, children initiating APSIs between 2010 and 2012 (index date) were identified • Each child of the APSIs cohort was matched to a non-APSIs child with rhinitis (APSIs initiation was taken as index date) • The outcome was the costs of medical resource utilization related to rhinitis and asthma of each cohort during 3 years after APSIs initiation, not taking into account the cost of APSIs
  • 26. Results • A total of 585 APSIs children (24% with 3 years follow-up) were identified (63% boys) • The APSIs cohort was less expensive for the payer than the reference cohort from the second year (on average 180€/child in APSIs cohort against 230€/child in reference cohort) • This difference increased during the 3rd year: APSIs children saved on average 100€ compared to children of the reference cohort. • The differences were mainly due to lower expenses (50%) related to asthma medications and hospitalizations in the APSIs cohort
  • 28. SINGULAIR project EFFECTIVENESS OF MONTELUKAST ON ASTHMA CONTROL IN INFANTS
  • 29. Background • Montelukast 4mg (MTL-4) is an add-on therapy for asthmatic infants • French regulators have requested real-world evidence on effectiveness of MTL-4 in infants (6-24 months)
  • 30. Objective • To compare the effectiveness of MTL-4, associated or not with ICS, vs. ICS without MTL-4, on health outcomes of infants with mild to moderate uncontrolled asthma
  • 31. Methods • We preselected infants receiving ≥2 consecutive dispensations of respiratory drugs (R03 ATC classification) from 2010 to 2012, and presenting an exacerbation within 6 months of the second R03 dispensing. • Asthma exacerbation was identified by: • asthma-related hospitalizations, • dispensing of oral corticosteroids, • addition of short-acting beta agonists to existing respiratory therapy, • switch to a higher ICS dosage, or nebulized CS. • Infants being treated with ICS without MTL-4 were compared to those receiving MTL-4 on asthma control: • the occurrence of a new exacerbation, • the total number of exacerbations during the 6 months follow-up period • asthma-related health care utilization
  • 32. Results Infants aged 6-24 months Number Percentage With 2 dispensations of respiratory medications (R03) between March 8, 2010 and December 31,2011 171,392 100 %  With initial exacerbation (T0) 152,212 88.8 %  With at least 6 months follow-up from T0 115,489 67.4 %  MTL4-group 4,490 3.9 %  ICS group 74,561 64.6 %
  • 33. Results • Time to occurrence of a new exacerbation was shorter in ICS group (54.1 days) compared to MTL-4 group (57.7 days). In both groups, more than 3 out of 4 infants had at least one exacerbation during follow-up. • Total number of exacerbations during 6 months follow-up: no statistical difference between MTL-4 and ICS. Relative risk 95% CI p Group (MTL-4 vs ICS) 1,00 0,97 – 1,03 0,8617
  • 34. Results - Health care utilization in both groups (except for treatment therapy):
  • 35. SNIIRAM/EGB: Overall Conclusions • French databases are a useful tool to perfom observational studies: SNIIRAM is one of the largest and most complete dataset in the world • Access and data management are complex, but results are of interest! • Contact : eric.van-ganse@univ-lyon1.fr