BURDEN OF HEPATITIS C IN BULGARIA

Transcription

1 BURDEN OF HEPATITIS C IN BULGARIA Prof. Guenka Petrova Current patients` characteristics (according to national epidemiology data) Indicator % Value Total population Prevalence of HCV 1,5% People diagnosed with HCV infection (unofficial data) Proportion of patients, diagnosed with chronic HCV infection, receiving treatment (unofficial data) 1% 545 Proportion of patients with chronic HCV infection on antiviral treatment 37% 200 Patients with HCV 1a on antiviral treatment 10% 20 Patients with HCV 1b on antiviral treatment 90% 180 Patients with HCV 1a on antiviral treatment with cirrhosis 10 Patients with HCV 1b on antiviral treatment with cirrhosis

2 Schematic view of the HCV development in Bulgaria Approximate morbidity 1.5% ( души) 15-25% Spontaneous virus load Stable disease Chronic HCV year 75-85% 15-30% Up to 18 mill BGN (9 mill ) Cirrhosis (15,000 30,000 person) 2-4% Increasi ng cost to society Slow progression End stage: НСС, transplantation, death 3 Our studies Petrova G., J. Genov, M. Dimitrova, K. Pavlov. What is the cost of the bad control of chronic viral hepatitis. Sofia, ISPOR Bulgaria conference, March 2015 Dimitrova M., Petrova G., Genov J., Pavlov K., Mitov K., Savova A. COST ANALYSIS OF THE CHRONIC HCV-RELATED CIRRHOSIS IN BULGARIA. Value in health, 2015 Nov; 18 (3): A583 Dimitrova M, Petrova G, Kamusheva M, Savova A, Doneva M. Social Burden of Chronic HCV infection in patients with hepatocellular carcinoma. Value Health Nov; 18(7): A476 Petrova G., M. Dimitrova. Cost-effectiveness assessment of liver disease therapy. EASL conference, Budapest, JUNE,

3 1 st study Costs for real life therapy of patients with chronic HCV infection and cirrhousis Healthcare resources used for cirrhotic patients Medicinal products % utilization No of patients Dose/Therapeutic course Payer Ceftriaxone 41% х 1 g i.v. / 7-10 days Hospital Ciprofloxacin 38% x 500 mg i.v. / 7-14 days Hospital Terlipressin 4% days; 4x2 mg i.v. Hospital Esomeprasole 41% 124 2x1 fl. i.v. Hospital Albumin 44% days; 20-60g/ daily Patients Spironolactone+ Furosemide 38% 115 Spironolactone 200 mg/ daily; Furosemide mg/ daily for 6 months Patients Propranolol/Carvedilol (avg) 48% 145 Carvedilol 2x12,5-25 mg; Propanolol 3x40 mg/ daily for 1 year Patients Bands for endoscopic treatment 15% bands per package Patients Norfloxacin 10% mg/daily for 1 year Patients L-ornithine-L-aspartat 15% mg/ 6 months Patients Endosopic treatment 15% 45 NHIF Lactulose + L-ornithine-L-aspartat 14% mg NHIF Abdominal paracentesis 38% 115 NHIF Albumin up to 2 vails per patient 44% days; 20-60g/daily NHIF Hospitalizations 100% 301 NHIF 5 Total costs of treatment of cirrhosis/bgn/ Direct medical costs of NHIF Direct medical costs of hospital Direct medical costs of patients Total costs for 301 patients with cirrhosis for 3 years = BGN ( euro); Average cost per patient per 1 year- 1,343 BGN ( 687 euro) 6 3

4 2 nd study Prospective, real-life, observational study on demographic (age and sex), clinical (Child-Pugh stage, ascites, portal hypertension, esophageal varices, encephalopathy, etc) and data on utilized healthcare resources (cirrhosis drug therapy, therapy of cirrhosis-related complications, hospitalizations) were collected. Retrospective budget model, evaluated the total direct medical costs and indirect costs. Patients groups and subgroups patients with chronic HCV infection and cirrhosis, monitored in the University hospital Queen Joanna-ISUL for 3-year period ( ). - Patients were further divided into subgroups depending on the severity of the disease according to Child-Pugh. Healthcare resources - Healthcare resources were divided into three subgroups utilized by the National Health Insurance Fund (NHIF), the hospital and the patients. The subdivision was necessary because NHIF does not cover all healthcare services and there were expenditures made by the hospital and the patients, namely for the medicinal products and the medical supplies. Costs - Micro-costing approach based on the data for the utilized healthcare resources on hospitalizations, highly specialized interventions, drugs and medical supplies. 7 Demographic and clinical data Total number of patients 301 Males (76%) 228 Females (24%) 73 Follow-up duration (avg) months (12 months on avg) Severity of disease (Child-Pugh) on baseline - A (57,1%) 172 Severity of disease (Child-Pugh) on baseline - B (37%) 109 Severity of disease (Child-Pugh) on baseline - C (6,64%)

5 Complications and concomitant pathology Rate and type of complication, diagnosed at baseline No patients Ascites (38,2%) 115 Spontaneous bacterial peritonitis (10%) 30 Other infection (urological, pneumonia, soft tissue infections) - 30% 90 Encephalopathy (18,6%) 56 Esophageal varices 3-4 grade (incl. haemorrhage) (41,2%) 124 Esophageal varices 1-2 grade (58,8%) 177 Concomitant pathology Heart diseases (35,5%) Resources used Total number of hospitalizations 847 Number of hospitalizations due to decompensated liver disease/cirrhosis (Health service, covered by the NHIF) 386 Number of hospitalizations due to highly specialized interventions in gastro-intestinal disorders (Health service, covered by the NHIF) 281 Number of hospitalizations due to highly specialized interventions of the hepatobiliary system, pancreas and peritoneum (Health service, covered by the NHIF) 180 Average number of hospitalizations per patient 3 Average hospital stay (days) on first hospitalization per patient 17 Average time (months) of follow-up per patient

6 Concomitant diseases 20 N patients with cirrhosis and hepatitis 80 N patients with cirrhosis and hepatitis Out of 54 cirrhotic patients: 27 have only cirrhosis 27 have hepatitis and cirrhosis 12 with HBV and cirrhosis 11 with HCV and cirrhosis 1 with hepatitis В+С and cirrhosis 1 with hepatitis А 2 undefined Out of 123 patients with cirrhosis: 97 have only cirrhosis 23 have hepatitis and cirrhosis 15 are with HBV and cirrhosis 4 are with HCV and cirrhosis 1 are with hepatitis А+С and cirrhosis 3 сare unidentified 20 са били с ЧН 5 are with liver insufficiency and hepatitis 15 are with liver insufficiency and cirrhosis 11 3 rd Study - DALY DALY 1756,03 Life expectancy for male is 70 years and for female YLL 798,17 YLD 957, Ly et al 2012; 2. Perz 2006; 3. CDC 2013b; 4. Chen & Morgan 2006 N 1243;864;417 L 0,3472; 0,301; 0,2555 years над над 70 N Dead L health status loss 0,3472 0,301 0,2555 L cirrhosis 27 общо L - cirrhosis 97 общо L HCC 445 общо DW cirrhosis 0,194 0,194 0,194 DW HCC 0,508 0,508 0,508 DW hepatitis 0,75 0,75 0,75 L- years of life lost L surveillance

7 3 rd study Social burden of HCV in Bulgaria Years of life lost at the end of ,17 Years of life in disability - 957,86 DALY = 1 756, th study - Patients with HCV genotype 1a without cirrhosis 14 7

8 ICER and SA -HCV genotype 1a, no cirrhosis Strategy Cost Incr Cost Eff Incr Eff Incr C/E double and triple therapy 37063,6 0,53 new DAAs , ,9 0,98 0, ,5 15 Patients without cirrhosis genotype 1b 16 8

9 ICER and SA - HCV genotype 1b, no cirrhosis Strategy Cost Incr Cost Eff Incr Eff Incr C/E double and triple therapy 37063,6 0,53 new DAAs , ,9 0,99 0, o Discussion ICER The ICER of both new INF-free therapies is above the 3xGDP threshold for Bulgaria; The ICER for both new INF-free therapies is lower for patients without cirrhosis for both subgenotypes compared to patients with cirrhosis; The ICER for both new INF-free therapies is more favourable for patients with HCV genotype 1b compared to patients with genotype 1a. Limitations of the cost-effectiveness model Only direct medical costs for drug therapy were considered; Direct medical costs related to treatment of ADRs (anemia, skin reactions, depression) of the dual and triple therapy were not considered due to insufficient data for the therapeutic regimes and duration of treatment for the patients. Future possibilities Adding the cost of ADRs to the cost of therapeutic regime with dual or triple therapy will decrease the value of the ICER for the new INF-free therapies. 18 9

10 o Current practice in Bulgaria Positive Drug List (PDL) Both new INF-free regimes are included in the PDL with 100% reimbursement and will be paid by the National Health Insurance Fund (NHIF) from this year Due to changes in the legislation MAH are obliged to provide discounts to NHIF to keep reimbursement status The latter is expected to lead to further decrease in the values of the ICER for the new DAAs Telaprevir is excluded from PDL from this year National Health Insurance Fund As of the NHIF has published new criteria for treatment of adult patients with chronic HCV infection in compliance with EASL Guidelines and National Pharmacotherapeutic Guideline: - New INF-free therapeutic regimes are considered as I-st line therapy for patients with genotype 1 if available in Bulgaria - Treatment with new DAAs could be initiated only in patients with chronic HCV infection with METAVIR 03 and METAVIR 04 stage. Treatment of patients with METAVIR 02 could be only started after careful consideration of the specialist 19 - Double and triple therapy are treatment of choice only if patients are contraindicated for treatment with the new DAAs Conclusion Market access to innovative medicinal products Market/patient access to innovative medicinal products has improved since 2013 The NHIF has reconsidered its criteria for treatment adults with chronic hepatitis C infection in compliance with the international guidelines Currently priority to treatment is given only to patients at advanced stages of the disease NHIF will reimburse 100% the treatment with new DAAs for the next three years ( ) Financial risk-sharing agreements with MAHs are in force to reduce the financial burden on the NHIF budget In 2018 reconsideration on reimbursement status will be done Cost- Effectiveness of new DAAs in the Bulgarian healthcare setting Further observational studies are needed to assess the effectiveness of the new DAAs in real-world 20 and their cost-effectiveness 10

11 Thank you for your attention 11