A National Strategy for the Elimination of Hepatitis B and C Phase Two Report (2017) / Chapter Skim
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Appendix A: Population Health Impact and Cost-Effectiveness of Chronic Hepatitis B Diagnosis, Care, and Treatment in the United States
Appendix A: Population Health Impact and Cost-Effectiveness of Chronic Hepatitis B Diagnosis, Care, and Treatment in the United States
Pages 203-234
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From page 203... ...
-related deaths, a Markov model was constructed with disease progression estimates, liver transplantation, and background mortality rates. Age-specific HBsAg prevalence was estimated by race, ethnicity, and nativity, and a 2015 study cohort was constructed from age-group prevalence of HBsAg, HBeAg, chronic active hepatitis, and cirrhosis.
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accounts for 95 percent of the deaths and causes 80 percent of hepatocellular carcinoma, the most common type of liver cancer worldwide. Among the estimated 400 million people living with chronic viral hepatitis, 250 million have CHB, which carries a 15 to 25 percent risk of premature death from liver cirrhosis and liver cancer without care and antiviral treatment.
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The aim of this study is to model the potential population health impact of increasing CHB diagnosis, care, and treatment in reducing the risks of hepatocellular carcinoma, cirrhosis, and HBV-related deaths in the United States and the cost-effectiveness of the various target scenarios compared with current practice. MATERIALS AND METHODS Overview We developed a Markov model to simulate long-term outcomes, such as cirrhosis, hepatocellular carcinoma, and CHB-related death, under each scenario.
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, disease activity is defined by an elevation of ALT >2 ULN or evidence of significant histological disease plus elevated HBV DNA above 2,000 IU/mL for HBeAg– and above 20,000 IU/mL for HBeAg+. In the model once people with inactive CHB develop active hepatitis, depending on the level of care and treatment they receive, they would be less likely to develop liver-related complications such as hepatocellular carcinoma and cirrhosis.
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. We assumed that the effectiveness for both these drugs were similar and are equally effective in prevention progression from chronic active hepatitis to cirrhosis in both HBeAg+ or HBeAg– patients and they are used as first line treatment in the United States.
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Raffetti et al., 2016 To HBV-related All ages 0.11 (0.09-0.14) Thiele et al., death 2014 From active CHB, HBeAg– To inactive CHB, All ages 1.6 (0.0-11)
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death year 3 To HBV-related All ages 14.7 (11.8-17.6) death year 5 NOTE: CHB = chronic hepatitis B; HBeAg = hepatitis B e antigen; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCC = hepatocellular carcinoma; HCV = hepatitis C virus.
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The primary goal of antiviral treatment is to suppress replication of HBV, thereby preventing progression to cirrhosis and reducing the risk of hepatocellular carcinoma. Based on recent findings, we assumed that it was possible to develop hepatocellular carcinoma while on treatment, but with a 50 percent reduction in the rate decrease from natural history (Arends et al., 2015; Marcellin et al., 2013)
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. An assumption in the model pertaining to costs was that patients achieving seroconversion from the CHB active state continued to incur annual costs for CHB management.
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$11,964 $11,964-$14,364 Annual monitoring $710 $347-$1,390 Chronic hepatitis B $1,483 $154-$5,956 Cirrhosis $4,414 $154-$5,408 Decompensated cirrhosis $11,690 $3,735-$28,256 Hepatocellular carcinoma $46,538 $22,443-$67,321 Liver transplantation 1st year $159,220 $127,376-$191,064 Liver transplantation 2nd year $22,820 $18,256-$27,384 Health state utilities Active CHB 0.85 (0.80-0.92) Cirrhosis 0.87 (0.78-0.88)
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TABLE A-4 Scenario Analysis Rates Treatment Rate Among Treatment Adherence to Adherence to Scenario Diagnosed Received HBV Care Eligible Patients Monitoring Treatment Natural History -- -- -- -- -- Current Practice 34.6%a 33.3%b 45%c 35.1%d 85%e HHS 2020 Target 66% 33.3% 45% 35.1% 85% HHS 2020 Target + Improved Rx 66% 80% 80% 35.1% 85% Hypothetical Scenario 80% 80% 80% 80% 95% WHO 2030 Target 90% 90% 80% 100% 100% Idealistic (Utopian) 100% 100% 100% 100% 100% NOTE: HBV = hepatitis B virus; HHS = Department of Health and Human Services; WHO = World Health Organization.
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Table A-7 shows the baseline population distributions for the entry of the Markov model. If the current diagnosis, care, and treatment practices remain unchanged, as many as 6 percent of the 2015 CHB cohort will have developed hepatocellular carcinoma, 10.31 percent will have developed cirrhosis, and 9.40 percent will have died from HBV-related deaths by year 2030 (see Table A-8)
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2,018,251 (0.63%) NOTE: CHB = chronic hepatitis B; CI = confidence interval; HBeAg = hepatitis B e antigen; HBsAg = hepatitis B surface antigen.
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+ U.S. + Foreign Foreign Age Group All Foreign Born Foreign Born U.S.
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TABLE A-7 Baseline Population Distribution for the Entry of the Markov Model of Chronic Hepatitis B in the United States Scenario Current HHS 2020 HHS + Hypothetical WHO 2030 Practice Target Improved Rx Scenario Target Idealistic Model Entry Health State D35/C33/T45 D66/C33/T45 D66/C80/T80 D80/C80/T80 D90/C90/T80 D100/C100/T100 Inactive (monitor) 8.9% 17.0% 40.7% 49.4% 62.5% 77.2% Active HBeAg+ treatment 0.2% 0.3% 1.4% 1.6% 2.1% 3.2% Active HBeAg– treatment 0.9% 1.6% 7.0% 8.5% 10.8% 16.7% Cirrhosis treatment 0.2% 0.3% 1.3% 1.5% 1.9% 3.0% Natural history inactive 68.3% 60.2% 36.4% 27.8% 14.7% 0.0% Natural history active HBeAg+ 3.0% 2.9% 1.9% 1.6% 1.1% 0.0% Natural history active HBeAg– 15.8% 15.0% 9.6% 8.1% 5.9% 0.0% Natural history cirrhosis 2.8% 2.7% 1.7% 1.4% 1.0% 0.0% NOTES: D35/C33/T45, 35% diagnosed, 33% in care, 45% in treatment when treatment is appropriate; D66/C33/T45, 66% diagnosed, 33% in care, 45% in treatment when treatment is appropriate; D66/C80/T80, 66% diagnosed, 80% in care, 80% in treatment when treatment is appropriate; D80/C80/T80, 80% diagnosed, 80% in care, 80% in treatment when treatment is appropriate; D90/C90/T80, 90% diagnosed, 90% in care, 80% in treatment when treatment is appropriate; D100/C100/T100, 100% diagnosed, 100% in care, 100% in treatment when treatment is appropriate.
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in 15 Years Scenario HHS + Hypothetical WHO 2030 HHS 2020 Improved Rx Scenario Target Idealistic Cumulative Reduction Target D66/C33/T45 D66/C80/T80 D80/C80/T80 D90/C90/T80 D100/C100/T100 Hepatocellular carcinoma cases 2.66% 12.16% 25.66% 34.83% 47.66% Cirrhosis cases 1.55% 12.60% 33.65% 44.71% 63.23% HBV-related death 4.46% 19.14% 36.38% 50.42% 69.78% NOTE: HBV = hepatitis B virus; HHS = Department of Health and Human Services; WHO = World Health Organization.
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ETV ICER for total cohort -- $46,717 $46,387 $29,216 $41,212 $41,532 (compared to current practice) TDF 219 NOTE: CHB = chronic hepatitis B; ETV = entecavir; HBV = hepatitis B virus; HHS = Department of Health and Human Services; ICER = incremental cost-effectiveness ratio; QALY = quality-adjusted life year; TDF = tenofovir; WHO =World Health Organization.
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The solid line represents the cost-effectiveness frontier, those strategies that are potentially cost-effective, and the dotted line represents the WTP, which is a $100,000/QALY. HHS = Department of Health and Human Services; QALY = quality-adjusted life year; WHO = World Health Organization; WTP = willingness to pay.
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Monte Carlo probabilistic analysis recalculates expected values in the Markov model numerous times and is used to understand the uncertainties on the model results. The results were sensitive to several
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, and the probability of transitioning from inactive CHB to hepatocellular carcinoma, from seroclearance to hepatocellular carcinoma, from inactive to active CHB, from inactive CHB to seroclearance, from active hepatitis to hepatocellular carcinoma, and from hepatocellular carcinoma to HBV-related death (see Figures A-6, A-7, A-8, A-9, A-10, and A-11)
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. If the idealistic scenario was to be left out of the competing scenarios, the WHO 2030 target is the most optimal scenario at a willingness to pay threshold of $100,000.
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current practice versus HHS 2020 target.
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FIGURE A-9 Tornado analysis (ICER) current practice versus hypothetical scenario.
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FIGURE A-11 Tornado analysis (ICER) current practice versus idealistic scenario.
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114,197 123,465 152,993 172,822 228,392 266,642 ICER for total cohort -- $34,083- $37,272- $17,781- $28,874- $30,083 (compared to current practice) 54,518 49,109 38,569 49,435 49,176 NOTE: HHS = Department of Health and Human Services; ICER = incremental cost effectiveness ratio; QALY = quality-adjusted life year; WHO = 227 World Health Organization.
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DISCUSSION This is the first study undertaken to model the population health impact and cost-effectiveness of increasing CHB diagnosis, care, and treatment in the United States. The study found implementing programs that would substantially increase rates of CHB diagnosis, care, and viral suppressive therapy with the potent and low-resistance medications can prevent 19 to 70 percent of the HBV-related deaths in 15 years depending on the rates achieved.
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According to the National Cancer Institute, liver cancer screening in high-risk patients does not result in reduction in mortality although screening with twice a year ultrasound for early detection of hepatocellular carcinoma is recommended by AASLD for HBsAg+ persons who are at increased risk. The model did not calculate the potential survival benefit of liver cancer screening among CHB patients that received care and the potential survival benefit of antiviral therapy in hepatocellular carcinoma patients.
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2015. Entecavir treatment does not eliminate the risk of hepatocellular carcinoma in chronic hepatitis B: Limited role for risk scores in caucasians.
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2008. Natural history of chronic hepatitis B: Special emphasis on disease progression and prognostic factors.
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2011. Adherence to chronic hepatitis B treatment guideline recommendations for laboratory monitoring of patients who are not receiving antiviral treatment.
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2014. Population health impact and cost-effectiveness of monitoring inactive chronic hepatitis B and treating eligible patients in Shanghai, China.
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2013. Entecavir treatment reduces hepatic events and deaths in chronic hepatitis B patients with liver cirrhosis.
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