the COME Study Results Stefano Fagiuoli 1 , Luciana Scalone 2,3 , - - PowerPoint PPT Presentation

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Costs and Quality of Life in Patients with Chronic Liver Diseases: the COME Study Results Stefano Fagiuoli 1 , Luciana Scalone 2,3 , Roberta Ciampichini 2 , Francesco Fusco 2 , Laura Gaeta 1 , Anna Del Prete 1 , Ivan Gardini 4 , Lorenzo G

SLIDE 1

Costs and Quality of Life in Patients with Chronic Liver Diseases: the “COME” Study Results

1 Ospedali Riuniti, Bergamo 2 CHARTA Foundation, Milan 3 CESP, Research Center of Public Health, University of Milano Bicocca, Monza 4 EpaC Onlus, Liver Patient Association 5 CIRFF, Center of Pharmacoeconomics, Federico II University of Naples, Naples

Stefano Fagiuoli1, Luciana Scalone2,3, Roberta Ciampichini2, Francesco Fusco2, Laura Gaeta1, Anna Del Prete1, Ivan Gardini4, Lorenzo G Mantovani2,5

SLIDE 2

Background and Aims:

The burden of Chronic Liver Diseases (CHDs) is little known. Information on the Burden of CHDs, which includes:

Impaired level of patients’ health and wellbeing,
Direct medical and non medical costs spent by patients and third party payer,
Loss of productivity due to absenteism and reduced working efficieny

is still currently little known Most of pharma-economic analysis are base solely on direct medical costs (Drugs and/or Hospital Charges)

SLIDE 3

Background and Aims:

We aimed to assess the socio-economic burden of CHDs in Italy Direct Costs (medical and non medical) Loss of productivity (days of work/study/everyday activities) Health Related Quality of Life (HRQoL)

SLIDE 4

Materials and Methods

Type of study Naturalistic, multicentre, longitudinal Cost of Illness study, adopting the societal point of view Patients and setting Any CHD adult patient (>18 years) consecutively accessing a Gastroenterology Unit (Ospedali Riuniti, Bergamo and Ospedale Policlinico Federico II, Napoli) Time horizon 6 months before the enrollment in the study Data

Clinical, Health Related Quality of Life (EQ-5D),
Resource consumption (direct costs)
Medical: (related to hepatic disease) conventional drug and unconventional

treatment (e.g., homeopathy, herbal medicines, vitamins, etc), hospitalization for reasons attributable to hepatic condition, outpatient medical visits and diagnostic examinations

Non Medical: formal (paid) assistance, travelling and/or accommodation
Loss of productivity (indirect costs)
Results are expressed as €/patient-month (direct costs) and

days/patient-month (loss of productivity).

Patients’ HRQoL was assessed with the EQ-5D questionnaire and is

reported as percentage of patients with problems

SLIDE 5

the “COME” Study Results

1,088 patients enrolled 62.0% male, age range 19-90 (median=59,5)

HCV 53,1%

Chronic Hepatitis

652 (60,0%)

HBV 33,9% Other 13,0%

Cirrhosis

222 (20,4%)

HCC

85 (7,8%)

OLT

129(11.9%)

HCV 52,3% HBV 19,0% Other 28,7% HCV 64,6% HBV 14,6% Other 20,8% HCV 26,4% HBV 20,9% Other 52,8%

HCV: 50,6% HBV: 27,9% Others: 21,5% Co-inf: 1,3%

Other 46,9%

SLIDE 6

Direct costs according to main condition Results

HBV hepatitis (N=221) HCV hepatitis (N=346) OTHER hepatitis (includes HBV-HCV co- infection) (N=85) Cirrhosis (N=222) HCC (N=85) OLT (N=129)

utpatient visits/examinations

€ 16.91 € 17.48 € 14.89 € 25.46 € 23.61 € 8.23 Conventional: antiviral therapy € 239.16 € 156.32 € 24.81 € 47.95 € 62.82 € 150.57

€ 0.00 € 100.00 € 200.00 € 300.00 € 400.00

€/patient/month

SLIDE 7

Direct costs according to main condition

Results

HBV hepatitis (N=221) HCV hepatitis (N=346) OTHER hepatitis (includes HBV- HCV co- infection) (N=85) Cirrhosis (N=222) HCC (N=85) OLT (N=129) Hospitalizations € 40.08 € 34.90 € 132.49 € 260.48 € 999.84 € 1 483.93 Conventional, excluding antiviral therapy € 1.64 € 3.63 € 11.73 € 99.14 € 75.10 € 917.90

€ 0.00 € 200.00 € 400.00 € 600.00 € 800.00 € 1 000.00 € 1 200.00 € 1 400.00 € 1 600.00 € 1 800.00 € 2 000.00 € 2 200.00 € 2 400.00

€/patient/month

SLIDE 8

Direct costs according to main condition Results

HBV hepatitis (N=221) HCV hepatitis (N=346) OTHER hepatitis (includes HBV-HCV co- infection) (N=85) Cirrhosis (N=222) HCC (N=85) OLT (N=129) travelling/accomodation € 12.85 € 12.65 € 13.47 € 38.45 € 41.21 € 79.53 Formal caregiving (assistance) € 1.96 € 3.22 € 2.66 € 9.19 € 9.28 € 17.77 Unconventional therapy € 8.40 € 10.89 € 11.27 € 22.61 € 17.30 € 16.77 € 0.00 € 25.00 € 50.00 € 75.00 € 100.00 € 125.00

€/patient/month

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Direct costs according to main condition Results

utpatient visits/examinations

€ 16.91 € 17.48 € 14.89 € 25.46 € 23.61 € 8.23 Hospitalizations € 40.08 € 34.90 € 132.49 € 260.48 € 999.84 € 1 483.93 Unconventional therapy € 8.40 € 10.89 € 11.27 € 22.61 € 17.30 € 16.77 Conventional, excluding antiviral therapy € 1.64 € 3.63 € 11.73 € 99.14 € 75.10 € 917.90 Conventional: antiviral therapy € 239.16 € 156.32 € 24.81 € 47.95 € 62.82 € 150.57

€ 0.00 € 200.00 € 400.00 € 600.00 € 800.00 € 1 000.00 € 1 200.00 € 1 400.00 € 1 600.00 € 1 800.00 € 2 000.00 € 2 200.00 € 2 400.00 € 2 600.00

€/patient/month

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Hepatitis OTHER Hepatitis HCV Cirrhosis HCV HCC HCV Liver Transplantation HCV HCV Sample (Other Hepatitis not included) Conventional drug treatment 184.06 160 111.7 83.63 781.26 181.25 Unconventional treatment 9.31 10.9 24.03 18.71 18.28 14.84 Hospitalizations 65.5 34.4 228.54 952.12 1302.73 242.64 Outpatient medical visits and examinations 16.29 17.38 26.87 26.21 8.42 19.64 Formal caregiving 2.14 3.17 7.21 11.24 17.32 5.67 Traveling/accomodation 13 12.6 35.05 39.86 106.13 25.71

500 1000 1500 2000 2500 €/patient-month

the “COME” Study Results

HCV: Total costs

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64.6 7.1 4.0 13.1 0.0 9.7 98.5 63.5 5.9 13.1 15.3 3.4 8.6 109.8

0.0 50.0 100.0 150.0

Conventional drug treatment Unconventional treatment Hospitalizations Outpatient medical visits and examinations Formal caregiving Travelling accommodation Total

EURO

Direct Costs (HCV) HEPATITIS

Responder (N=48) Non Responder (N=39)

100 13.2 124.1 16.8 23.8 30.7 308.6 136.5 18.7 510.1 21.3 13.6 105.6 805.8

200 400 600 800 1000

Conventional drug treatment Unconventional treatment Hospitalizations Outpatient medical visits and examinations Formal caregiving Travelling accommodation Total

EURO Direct Costs (HCV) OTHER=OLT+HCC+CIRRHOSIS Responder (N=6) Non Responder (N=21)

€ / month

Results

Direct costs: Responder vs Non Responder to AV treatment € 3.703,2 vs 9.669,6 / yr

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Hepatitis OTHER Hepatitis HBV Cirrhosis HBV HHC HBV Liver Transplantation HBV HBV Sample (Other Hepatitis were not included) Conventional drug treatment 135.33 240.8 239.68 347.8 1632.5 370.62 Unconventional treatment 10.98 8.56 13.43 17.04 5.8 9.31 Hospitalizations 53.75 39.72 208.15 712.64 219.5 105.61 Outpatient medical visits and examinations 16.89 16.84 22.35 7.43 9.18 16.59 Formal caregiving 3.07 1.95 3.49 27 4.32 Traveling/accomodation 12.76 12.81 27.6 49.65 60.83 20

200 400 600 800 1000 1200 1400 1600 1800 2000 €/patient-month

the “COME” Study Results

HBV: Total costs

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Results

Loss of productivity* * It is reported as mean days lost from work/doing everyday activities per patient-month. Loss of productivity includes both paid work and unpaid activities, e.g., from students and housewives

HBV hepatitis (N=221) HCV hepatitis (N=346) Other hepatitis (N=85) Cirrhosis (N=222) HCC (N=85) OLT (N=129) Informal caregiver's loss of productivity (days) 0.12 0.18 0.14 0.64 0.77 1.21 Patients'loss of productivity (days) 0.27 0.43 0.23 1.09 0.98 1.78

0.5 1 1.5 2 2.5 3 3.5 Days/patient/month

Indirect Costs according with Patient condition

SLIDE 14

Results

HRQoL quality of life

74.1 87.3 70.5 60.7 52.1 13.5 6.8 15.4 22.5 24.6 9.1 4.7 10.1 13.6 18.9 3.0 3.4 2.7 3.6

0.3 0.4

0.7 0.5 0.8

0% 25% 50% 75% 100%

Mobility Self-Care Usual-Activities Pain/Discomfort Anxiety/Depression

EQ-5D-5L

No Problems Slight Problems Moderate Problems Severe Problems Extreme Problems

25,9 % 29,6 % 47,9 % 39,1 % 11,9 %

SLIDE 15

Conclusions

This study provides with an exhaustive picture of the burden

f CHDs in Italy, considering the point of view of:

The Third party payer (NHS, for direct medical costs) Patients (HRQoL, productivity loss and some direct costs) Families (loss of productivity)

SLIDE 16

Conclusions

550,00 € /month/pt in PNC patients 1.300,00 € /month/ pt in HCC patients 1.450,00 € /month/pt in OLT patients The more advanced the Liver disease, the higher are the Global Costs, increasing from a mean of 300,00 €/month/pt for CH, up to

SLIDE 17

Conclusions

CHD generates High Costs to the Healthcare System The use of effective treatments in the Early Stages of Liver Diseases appears necessary when aiming at:

Costs and Quality of Life in Patients with Chronic Liver Diseases: the “COME” Study Results

Stefano Fagiuoli1, Luciana Scalone2,3, Roberta Ciampichini2, Francesco Fusco2, Laura Gaeta1, Anna Del Prete1, Ivan Gardini4, Lorenzo G Mantovani2,5

Background and Aims:

The burden of Chronic Liver Diseases (CHDs) is little known. Information on the Burden of CHDs, which includes:

is still currently little known Most of pharma-economic analysis are base solely on direct medical costs (Drugs and/or Hospital Charges)

Background and Aims:

We aimed to assess the socio-economic burden of CHDs in Italy Direct Costs (medical and non medical) Loss of productivity (days of work/study/everyday activities) Health Related Quality of Life (HRQoL)

Materials and Methods

treatment (e.g., homeopathy, herbal medicines, vitamins, etc), hospitalization for reasons attributable to hepatic condition, outpatient medical visits and diagnostic examinations

days/patient-month (loss of productivity).

reported as percentage of patients with problems

the “COME” Study Results

1,088 patients enrolled 62.0% male, age range 19-90 (median=59,5)

Chronic Hepatitis

652 (60,0%)

Cirrhosis

222 (20,4%)

HCC

85 (7,8%)

OLT

129(11.9%)

HCV: 50,6% HBV: 27,9% Others: 21,5% Co-inf: 1,3%

Direct costs according to main condition Results

Direct costs according to main condition

Results

Direct costs according to main condition Results

Direct costs according to main condition Results

the “COME” Study Results

HCV: Total costs

€ / month

Results

Direct costs: Responder vs Non Responder to AV treatment € 3.703,2 vs 9.669,6 / yr

the “COME” Study Results

HBV: Total costs

Results

Loss of productivity* * It is reported as mean days lost from work/doing everyday activities per patient-month. Loss of productivity includes both paid work and unpaid activities, e.g., from students and housewives

0.5 1 1.5 2 2.5 3 3.5 Days/patient/month

Indirect Costs according with Patient condition

Results

HRQoL quality of life

EQ-5D-5L

Conclusions

This study provides with an exhaustive picture of the burden

The Third party payer (NHS, for direct medical costs) Patients (HRQoL, productivity loss and some direct costs) Families (loss of productivity)

Conclusions

550,00 € /month/pt in PNC patients 1.300,00 € /month/ pt in HCC patients 1.450,00 € /month/pt in OLT patients The more advanced the Liver disease, the higher are the Global Costs, increasing from a mean of 300,00 €/month/pt for CH, up to

Conclusions

CHD generates High Costs to the Healthcare System The use of effective treatments in the Early Stages of Liver Diseases appears necessary when aiming at:

 Reducing worsening of Patient’ Health  Reducing both Direct and Indirect Costs