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 Mantovani 2,5 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
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)
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 Type of study Naturalistic, multicentre, longitudinal Cost of Illness study, adopting the societal point of view Patients and Any CHD adult patient (>18 years) consecutively accessing a setting Gastroenterology Unit (Ospedali Riuniti, Bergamo and Ospedale Policlinico Federico II, Napoli) Time horizon 6 months before the enrollment in the study • Clinical, Health Related Quality of Life (EQ-5D), Data • 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
the “ COME ” Study Results 1,088 patients enrolled 62.0% male, age range 19-90 (median=59,5) HCC Cirrhosis OLT Chronic Hepatitis 85 (7,8%) 222 (20,4%) 652 (60,0%) 129 (11.9%) HCV Other HCV HBV Other HCV HBV Other HCV HBV Other 53,1% 46,9% 52,3% 19,0% 28,7% 64,6% 14,6% 20,8% 26,4% 20,9% 52,8% HBV Other 33,9% 13,0% HCV: 50,6% Co-inf: 1,3% HBV: 27,9% Others: 21,5%
Results Direct costs according to main condition € 400.00 € 300.00 € /patient/month € 200.00 € 100.00 € 0.00 OTHER hepatitis HBV HCV (includes Cirrhosis HCC OLT hepatitis hepatitis HBV-HCV (N=222) (N=85) (N=129) (N=221) (N=346) co- infection) (N=85) outpatient 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
Results Direct costs according to main condition € 2 400.00 € 2 200.00 € 2 000.00 € /patient/month € 1 800.00 € 1 600.00 € 1 400.00 € 1 200.00 € 1 000.00 € 800.00 € 600.00 € 400.00 € 200.00 € 0.00 OTHER hepatitis HBV hepatitis HCV hepatitis (includes HBV- Cirrhosis HCC OLT (N=221) (N=346) HCV co- (N=222) (N=85) (N=129) infection) (N=85) 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
Results Direct costs according to main condition € 125.00 € 100.00 € /patient/month € 75.00 € 50.00 € 25.00 € 0.00 OTHER hepatitis HBV HCV (includes Cirrhosis HCC OLT hepatitis hepatitis HBV-HCV (N=222) (N=85) (N=129) (N=221) (N=346) co- infection) (N=85) 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
Results Direct costs according to main condition € 2 600.00 € 2 400.00 € 2 200.00 € 2 000.00 € 1 800.00 € /patient/month € 1 600.00 € 1 400.00 € 1 200.00 € 1 000.00 € 800.00 € 600.00 € 400.00 € 200.00 € 0.00 OTHER hepatitis HBV hepatitis HCV hepatitis (includes HBV- Cirrhosis HCC OLT (N=221) (N=346) HCV co- (N=222) (N=85) (N=129) infection) (N=85) 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 outpatient 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
HCV: Total costs the “ COME ” Study Results 2500 2000 € /patient-month 1500 1000 500 0 Liver HCV Sample Hepatitis OTHER Hepatitis HCV Cirrhosis HCV HCC HCV Transplantation (Other Hepatitis HCV 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
Direct costs: Responder vs Non Responder to AV treatment Results € / month Direct Costs (HCV) Responder (N=48) Non Responder (N=39) HEPATITIS 150.0 109.8 98.5 100.0 EURO 64.6 63.5 50.0 15.3 13.1 9.7 13.1 7.1 5.9 8.6 4.0 3.4 0.0 0.0 Conventional Unconventional Hospitalizations Outpatient Formal caregiving Travelling Total drug treatment treatment medical visits and accommodation examinations Direct Costs (HCV) Responder (N=6) Non Responder (N=21) OTHER=OLT+HCC+CIRRHOSIS 1000 805.8 800 € 3.703,2 vs 9.669,6 / yr EURO 600 510.1 400 308.6 136.5 200 124.1 105.6 100 18.7 21.3 23.8 30.7 13.6 16.8 13.2 0 Conventional Unconventional Hospitalizations Outpatient Formal caregiving Travelling Total drug treatment treatment medical visits and accommodation examinations
the “ COME ” Study Results HBV: Total costs 2000 1800 1600 1400 € /patient-month 1200 1000 800 600 400 200 0 Liver HBV Sample Hepatitis OTHER Hepatitis HBV Cirrhosis HBV HHC HBV Transplantation (Other Hepatitis HBV 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 0 27 4.32 Traveling/accomodation 12.76 12.81 27.6 49.65 60.83 20
Indirect Costs according with Patient condition Results Loss of productivity* 3.5 3 2.5 2 Days/patient/month 1.5 1 0.5 0 HBV HCV Other Cirrhosis HCC OLT hepatitis hepatitis hepatitis (N=222) (N=85) (N=129) (N=221) (N=346) (N=85) Informal caregiver's loss of 0.12 0.18 0.14 0.64 0.77 1.21 productivity (days) Patients'loss of productivity 0.27 0.43 0.23 1.09 0.98 1.78 (days) * 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
Results HRQoL quality of life EQ-5D-5L No Problems Slight Problems Moderate Problems Severe Problems Extreme Problems 0.8 0.5 0.3 0.4 0.7 100% 3.0 2.7 3.4 3.6 4.7 11,9 9.1 10.1 6.8 25,9 13.6 % 29,6 18.9 39,1 % 13.5 % 47,9 15.4 % 75% % 22.5 24.6 50% 87.3 74.1 70.5 60.7 52.1 25% 0% Mobility Self-Care Usual-Activities Pain/Discomfort Anxiety/Depression
Conclusions This study provides with an exhaustive picture of the burden of 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)
Conclusions 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 550,00 € /month/pt in PNC patients 1.300,00 € /month/ pt in HCC patients 1.450,00 € /month/pt in OLT patients
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
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