M EAN ANNUAL COST OF PATIENTS HOSPITALIZED FOR CHRONIC HEPATITIS C IN F RANCE THE HEPC-LONE STUDY -...

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Costs associated to hospital stays in each liver disease stage were added up and a mean annual cost per patient estimated, according to the following formula: Mean annual cost per patient per liver disease stage As only inpatient deaths are captured into the PMSI, estimated outpatient deaths were imputed, based on published literature 1,2 . Corrected mean annual cost per patient per liver disease stage For each patient and for each stage, cumulative time in days was calculated, as stated in Figure 1. To populate cost-effectiveness analysis, cost for each health state considered within the model should be assessed. The objective of the HEPC-LONE study was to estimate the mean annual cost of adult patients hospitalized for Chronic Hepatitis C (CHC) in France, stratified by liver disease stage. The PMSI represents a comprehensive collection of all inpatient stays in France, intended to analyze hospital activity. However, it also allows economic research with some limitations to be considered: neither all clinical characteristics are gathered, nor outpatient costs (treatment, consultations, sick leave…). Based on the different types of hospital stays gathered, CHC patients are mainly managed in acute care (MCO units), which represents more than 98% of the total stays. Due to the conservative scope of the ENCC and the non consideration of some ancillary activities linked to transplantation (as suggested by a recent article on renal transplant 3 ), these mean annual costs might be underestimated. On the other hand, these estimates are similar to those observed by Deuffic-Burban et al. recently published 4 , even though comparison is challenging due to methodological differences. However, in the current study, F0-F3 stage mean annual costs estimate (€1,107) appears to be higher than Deuffic- Burban et al. ‘s one (€280 to 340). Here are expressed the mean annual cost of F0-F3 patient hospitalized for CHC (which include hospital expensive drugs). Since F0-F3 patients are more frequently managed as outpatient, this estimate should be weighted to get a mean annual cost of F0-F3 patient. References 1. Septfons A, Gautier A, Brouard C, et al. Prévalence, morbidité et mortalité associées aux hépatites B et C chroniques dans la population hospitalisée en France, 2004-2011. Bull Epidémiol Hebd. 2014;(12):202-9. 2. Gisquet E., Aouba A., Aubry R et al. Où meurt-on en France ? Analyse des certificats de décès (1993-2008). December 11th, 2012.Bulletin Epidemiologique Hebdomadaire. 3. Sainsaulieu Y, Sambuc C, Logerot H, et al. [Cost of a renal graft: medico-economic analysis of the amount reimbursed by the National health insurance to finance the preliminary and peripheral step of renal transplantation]. Nephrol Ther. 2014 Jul;10(4):228-35. 4. Deuffic-Burban S, Schwarzinger M, Obach D, et al. Should we await IFN-free regimens to treat HCV genotype 1 treatment-naïve patients? A cost-effectiveness analysis (ANRS 95141). J Hepatol. 2014 Jul;61(1):7-14. MEAN ANNUAL COST OF PATIENTS HOSPITALIZED FOR CHRONIC HEPATITIS C IN FRANCE THE HEPC-LONE STUDY PGI-12 Abergel A. 1 ; Rotily M. 2 ; Gaudin A-F. 3 ; de Léotoing L. 2 ; Vainchtock A. 2 ; Akremi R. 3 ; Branchoux S. 3 1. Department of hepato-gastroenterology, Estaing Hospital, Clermont-Ferrand , France; 2. HEVA, Lyon, France ; 3. Bristol-Myers Squibb, Health Economics & Public Health, Rueil-Malmaison, France. ISPOR 17 th Annual European Congress – 8-12 November 2014 - Amsterdam, The Netherlands This study was funded by Bristol-Myers Squibb. 26,162 patients were hospitalized for CHC (Figure 2). Patients were 56±13.5 years old on average, 62% were male. 54% of patients were hospitalized with F0- F3 fibrosis, 30% with cirrhosis, 17% with hepatocellular carcinoma and 7% with liver transplant. Hospital stays Patients Estimate of mean annual costs of patients hospitalized for CHC after correction were: €1,107 for F0-F3 fibrosis; €2,104 for compensated cirrhosis; €10,400 for decompensated cirrhosis; €11,739 for hepatocellular carcinoma; €62,098 for 1st year of liver transplant and €7,449 for subsequent year (Figure 3). Mean annual cost per patient hospitalized for CHC stratified per liver disease stage 58,405 hospital stays considered as directly related to CHC were extracted from the PMSI-MCO between 2010 and 2012; 743 additional hospitalizations were extracted from PMSI SSR/HAD. Non- complicated CHC (F0-F4 stages) accounted for 47% of all stays, as Table 1. Distribution of hospital stays according to liver disease stage. Figure 2. Distribution of patients according to liver disease stage. Figure 3. Distribution of the mean annual cost per patient according to liver disease stage. Nb of stays % F0-F3 Fibrosis 20,875 35% Compensated cirrhosis (F4 fibrosis) 6,990 12% Decompensated cirrhosis 11,570 20% Hepatocellular carcinoma 13,090 22% Liver transplant (1st year of management) 1,743 3% Liver transplant ( ≥ 2nd year of management) 4,880 8% Total 59,148 100% INTRODUCTION METHOD RESULTS CONCLUSION 6. Calculation of duration in each liver disease stage 7. Calculation of the mean annual cost per patient per liver disease stage 1 st hospital stay 2 nd hospital stay x th hospital stay Start date End date Date of the first hospital stay for CHC during the study period flagged in the PMSI Date of the 1 st stay with another liver disease stage, or Date of inpatient death, or Censoring (December 31 st 2012) Cumulative time (in days) LIVER DISEASE STAGE 2010 PMSI MCO – SSR – HAD 2012 Figure 1. Calculation of cumulative time at any liver disease stage. 8. Correction of the mean annual cost to take into account outpatient deaths stated in Table 1. Considering the evolution of the disease, patients could be assigned to several liver disease stages. Study period: January, 1 st 2010 to December, 31 st 2012. Data extraction: - From the PMSI-MCO (French Medical Information System - Medicine, Surgery, Obstetric units) database during the study period. - Patient tracking in the PMSI SSR & PMSI HAD databases (post-acute care & hospitalizations at home: alternative management of care). All public-private hospital stays with chronic viral hepatitis C (ICD-10 code: B18.2) as principal, related or significantly associated diagnosis. Hospital stays not related to CHC, based on ICD-10 codes and clinical procedures (“classification commune des actes médicaux”, CCAM) & medical review. Patients under 18 years of age. Viral co-infected patients (HBV and HIV). Based on ICD-10 & CCAM codes: F0-F3 fibrosis Compensated cirrhosis (F4 fibrosis) Decompensated cirrhosis Hepatocellular carcinoma Liver transplant (1st year of management) Liver transplant (2nd year of management) Hospital production costs (ENCC, French national cost studies) 2013 value (Euro). 1. Data source 2. Inclusion criterion 3. Exclusion criteria 4. Allocation to liver disease stage 5. Valuation of the hospital stays 14,252 4,195 3,648 4,459 635 1,301 - 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 F0-F3 Fibrosis Compensated cirrhosis Decompensated cirrhosis Hepatocellular carcinoma Liver transplant (1st year of management) Liver transplant (≥ 2nd year of management) €7,449 €62,098 €11,739 €10,400 €2,104 €1,107 €- €10,000 €20,000 €30,000 €40,000 €50,000 €60,000 €70,000 Liver transplant ( ≥ 2nd year of management) Liver transplant (1st year of management) Hepatocellular carcinoma Decompensated cirrhosis Compensated cirrhosis F0-F3 Fibrosis

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MEAN ANNUAL COST OF PATIENTS HOSPITALIZED FOR CHRONIC HEPATITIS C IN F RANCE THE HEPC-LONE STUDY - Poster ISPOR 2014, Amsterdam

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Page 1: M EAN ANNUAL COST OF PATIENTS HOSPITALIZED FOR CHRONIC HEPATITIS C IN F RANCE THE HEPC-LONE STUDY - ISPOR 2014, Amsterdam

Costs associated to hospital stays in each liver disease stage were added up and a mean annual cost per patient estimated, according to the following formula:

Mean annual cost per patient per liver disease stage

As only inpatient deaths are captured into the PMSI, estimated outpatient deaths were imputed, based on published literature1,2. Corrected mean annual cost per patient per liver disease stage

For each patient and for each stage, cumulative time in days was calculated, as stated in Figure 1.

To populate cost-effectiveness analysis, cost for each health state considered within the model should be assessed. The objective of the HEPC-LONE study was to estimate the mean annual cost of adult patients hospitalized for Chronic Hepatitis C (CHC) in France, stratified by liver disease stage.

The PMSI represents a comprehensive collection of all inpatient stays in France, intended to analyze hospital activity. However, it also allows economic research with some limitations to be considered: neither all clinical characteristics are gathered, nor outpatient costs (treatment, consultations, sick leave…).

Based on the different types of hospital stays gathered, CHC patients are mainly managed in acute care (MCO units), which represents more than 98% of the total stays.

Due to the conservative scope of the ENCC and the non consideration of some ancillary activities linked to transplantation (as suggested by a recent article on renal transplant3), these mean annual costs might be underestimated. On the other hand, these estimates are similar to those observed by Deuffic-Burban et al. recently published4, even though comparison is challenging due to methodological differences. However, in the current study, F0-F3 stage mean annual costs estimate (€1,107) appears to be higher than Deuffic-Burban et al. ‘s one (€280 to 340). Here are expressed the mean annual cost of F0-F3 patient hospitalized for CHC (which include hospital expensive drugs). Since F0-F3 patients are more frequently managed as outpatient, this estimate should be weighted to get a mean annual cost of F0-F3 patient.

References 1. Septfons A, Gautier A, Brouard C, et al. Prévalence, morbidité et mortalité associées aux hépatites B et C chroniques dans la population hospitalisée en France, 2004-2011. Bull Epidémiol Hebd. 2014;(12):202-9. 2. Gisquet E., Aouba A., Aubry R et al. Où meurt-on en France ? Analyse des certificats de décès (1993-2008). December 11th, 2012.Bulletin Epidemiologique Hebdomadaire. 3. Sainsaulieu Y, Sambuc C, Logerot H, et al. [Cost of a renal graft: medico-economic analysis of the amount reimbursed by the National health insurance to finance the preliminary and peripheral step of renal transplantation]. Nephrol Ther. 2014 Jul;10(4):228-35. 4. Deuffic-Burban S, Schwarzinger M, Obach D, et al. Should we await IFN-free regimens to treat HCV genotype 1 treatment-naïve patients? A cost-effectiveness analysis (ANRS 95141). J Hepatol. 2014 Jul;61(1):7-14.

MEAN ANNUAL COST OF PATIENTS HOSPITALIZED FOR CHRONIC HEPATITIS C IN FRANCE

THE HEPC-LONE STUDY PGI-12 Abergel A.1 ; Rotily M.2 ; Gaudin A-F.3 ; de Léotoing L.2 ; Vainchtock A.2 ; Akremi R.3 ; Branchoux S.3

1. Department of hepato-gastroenterology, Estaing Hospital, Clermont-Ferrand , France; 2. HEVA, Lyon, France ; 3. Bristol-Myers Squibb, Health Economics & Public Health, Rueil-Malmaison, France.

ISPOR 17th Annual European Congress – 8-12 November 2014 - Amsterdam, The Netherlands

This study was funded by Bristol-Myers Squibb.

26,162 patients were hospitalized for CHC (Figure 2). Patients were 56±13.5 years old on average, 62% were male. 54% of patients were hospitalized with F0-F3 fibrosis, 30% with cirrhosis, 17% with hepatocellular carcinoma and 7% with liver transplant.

Hospital stays

Patients

Estimate of mean annual costs of patients hospitalized for CHC after correction were: €1,107 for F0-F3 fibrosis; €2,104 for compensated cirrhosis; €10,400 for decompensated cirrhosis; €11,739 for hepatocellular carcinoma; €62,098 for 1st year of liver transplant and €7,449 for subsequent year (Figure 3).

Mean annual cost per patient hospitalized for CHC stratified per liver disease stage

58,405 hospital stays considered as directly related to CHC were extracted from the PMSI-MCO between 2010 and 2012; 743 additional hospitalizations were extracted from PMSI SSR/HAD. Non-complicated CHC (F0-F4 stages) accounted for 47% of all stays, as

Table 1. Distribution of hospital stays according to liver disease stage.

Figure 2. Distribution of patients according to liver disease stage.

Figure 3. Distribution of the mean annual cost per patient according to liver disease stage.

Nb of stays % F0-F3 Fibrosis 20,875 35% Compensated cirrhosis (F4 fibrosis) 6,990 12% Decompensated cirrhosis 11,570 20% Hepatocellular carcinoma 13,090 22% Liver transplant (1st year of management) 1,743 3% Liver transplant (≥ 2nd year of management) 4,880 8%

Total 59,148 100%

INTRODUCTION

METHOD

RESULTS

CONCLUSION

6. Calculation of duration in each liver disease stage 7. Calculation of the mean annual cost per patient per liver disease stage

1st hospital stay

2nd hospital stay xth hospital stay

Start date End date Date of the first hospital stay for CHC during the study period flagged in the PMSI

•Date of the 1st stay with another liver disease stage, or •Date of inpatient death, or • Censoring (December 31st 2012)

Cumulative time (in days)

LIVER DISEASE STAGE

2010 PMSI MCO – SSR – HAD 2012

Figure 1. Calculation of cumulative time at any liver disease stage.

8. Correction of the mean annual cost to take into account outpatient deaths

stated in Table 1.

Considering the evolution of the disease, patients could be assigned to several liver disease stages.

• Study period: January, 1st 2010 to December, 31st 2012.

• Data extraction: - From the PMSI-MCO (French

Medical Information System -Medicine, Surgery, Obstetric units) database during the study period.

- Patient tracking in the PMSI SSR & PMSI HAD databases (post-acute care & hospitalizations at home: alternative management of care).

All public-private hospital stays with chronic viral hepatitis C (ICD-10 code: B18.2) as principal, related or significantly associated diagnosis.

• Hospital stays not related to CHC, based on ICD-10 codes and clinical procedures (“classification commune des actes médicaux”, CCAM) & medical review.

• Patients under 18 years of age.

• Viral co-infected patients (HBV and HIV).

Based on ICD-10 & CCAM codes:

• F0-F3 fibrosis • Compensated cirrhosis (F4 fibrosis) • Decompensated cirrhosis • Hepatocellular carcinoma • Liver transplant (1st year of management) • Liver transplant (≥ 2nd year of management)

• Hospital production costs (ENCC, French national cost studies)

• 2013 value (Euro).

1. Data source

2. Inclusion criterion

3. Exclusion criteria

4. Allocation to liver disease stage

5. Valuation of the hospital stays

14,252

4,195 3,648 4,459

635 1,301

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

F0-F3 Fibrosis Compensatedcirrhosis

Decompensatedcirrhosis

Hepatocellularcarcinoma

Liver transplant(1st year of

management)

Liver transplant (≥ 2nd year of management)

€7,449

€62,098

€11,739

€10,400

€2,104

€1,107

€- €10,000 €20,000 €30,000 €40,000 €50,000 €60,000 €70,000

Liver transplant (≥ 2nd year of management)

Liver transplant (1st year of management)

Hepatocellular carcinoma

Decompensated cirrhosis

Compensated cirrhosis

F0-F3 Fibrosis