Estimating cost-effectiveness associated with all-oral regimen for chronic hepatitis C in China.
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ABSTRACT: Background
All-oral regimens are associated with higher effectiveness and shorter treatment duration for chronic hepatitis C. Given its superior effect and enormous patients in China, clinicians or patients may be compelled to consider delaying treatment for all-oral regimen.Objective
To estimate cost-effectiveness of delaying treatment for all-oral regimen in the subsequent years under different assumptions about their price and efficacy compared with standard of care in China.Methods
A state-transition Markov model was developed to estimate lifetime costs and quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio (ICER) and net monetary benefit (NB) were calculated. And sensitivity analyses were also performed to assess the impact of uncertainty.Results
For treatment naive patients with Genotype 1, immediate treatment with all-oral regimen under assumed cost and efficacy at present was cost-effective compared with peginterferon α-2a (PegIFN) regimen at present with an ICER of $12536 per QALY gained and a positive NB of $6832 at a willingness-to-pay threshold of $21209. And it was more than 95% likely to be cost-effective if weekly drug cost was less than $1000. Moreover, patients delaying treatment for all-oral regimen in the 1st year were associated with increase in QALYs of 0.62 and increase in cost of $10114 compared with initiating PegIFN regimen at present, which resulted in a positive NB of $3115.Conclusion
From a payer perspective, all-oral regimen is associated with good long-term health and economic benefit for treatment-naive patients infected with HCV genotype 1. Particularly, if all-oral regimen would become available at lower price in the future, delaying treatment for all-oral regimen may be a good choice for patients in China.
SUBMITTER: Chen H
PROVIDER: S-EPMC5381915 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC5892899 | biostudies-literature
Project description:BackgroundHepatitis B surface antigen clearance or seroconversion is rarely achieved for patients using nucleoside analogs or pegylated interferon alpha monotherapy approaches. Several recent studies have confirmed the benefit of a combination of these two approaches for selected chronic hepatitis B patients. However, few reports have investigated long-term outcomes or health economic evaluation for hepatitis B surface antigen clearance. The aim of this study was to perform a cost-effectiveness analysis of the long-term use of this combination strategy among selected hepatitis B e antigen-negative patients.MethodsDrawing on experience in China, we used a Markov model to simulate disease progression among a population of hepatitis B e antigen-negative chronic hepatitis B patients with surface antigen levels of ≤1,000 IU/mL through a discrete series of health states. We compared nucleoside analog monotherapy to the combination strategy over a prolonged period. We measured lifetime costs, quality-adjusted life-years and incremental cost-effectiveness ratios.ResultsThe combination therapy produced 15.8 quality-adjusted life-years, and cost US dollars (USD) 45,032 per patient. The monotherapy gave 13.9 quality-adjusted life-years, and had a cost of USD 52,064. The incremental cost-effectiveness ratio of the monotherapy (USD -3,755 per quality-adjusted life-year) did not obtain extended dominance over combination therapy. The most cost-effective option was combination therapy among patients with hepatitis B surface antigen levels of ≤10 IU/mL, which had the lowest calculated cost of USD 35,318 and most quality-adjusted life-years (16.7).ConclusionsA long-term combination treatment strategy for selected hepatitis B e antigen-negative chronic hepatitis B patients may prolong quality-adjusted life-years compared with nucleoside analog monotherapy. Chronic hepatitis B patients with a hepatitis B surface antigen level of ≤10 IU/mL were the most cost-effective population under this strategy.
| S-EPMC8506536 | biostudies-literature
Project description:ObjectiveTo explore the expected long-term health and economic outcomes of telaprevir (TVR) plus peginterferon alfa-2a and ribavirin (PR), a regimen that demonstrated substantially increased sustained virologic response (SVR) compared with PR alone in adults with chronic genotype 1 hepatitis C virus (HCV) and compensated liver disease in the Phase III studies ADVANCE (treatment-naïve patients) and REALIZE (relapsers, partial responders, and null responders to previous PR treatment).Study designA decision-analytic model was developed to assess the cost-effectiveness of TVR+PR vs. PR in the United States (US).MethodsPatients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. Clinical data (patient characteristics, SVR rates, and adverse event rates and durations) were obtained from ADVANCE and REALIZE. Health-state transition probabilities, drug and other costs (in 2012/2013 US dollars), and utility values were obtained from the trials, published studies, and publicly available sources. Outcomes were discounted at 3% per year.ResultsRegardless of treatment history, patients receiving TVR+PR were projected to experience fewer liver-disease complications, more life-years, and more quality-adjusted life-years (QALYs) than patients receiving PR. In prior relapsers, TVR+PR was dominant, with lower total medical costs and more QALYs. For the other patient subgroups, incremental costs per QALY gained were between $16,778 (treatment-naïve patients) and $34,279 (prior null responders). Extensive sensitivity analyses confirmed robust model results.ConclusionsAt standard willingness-to-pay thresholds, TVR+PR represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US. Future analyses are needed to compare TVR+PR with all existing HCV treatment options.
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| S-EPMC5218507 | biostudies-literature
Project description:Background: Hepatitis C virus (HCV) genotype 1 is the most prevalent HCV infection in China. Sofosbuvir-based direct antiviral agent (DAA) regimens are the current mainstays of treatment. Sofosbuvir/velpatasvir (SOF/VEL) and sofosbuvir/ledipasvir (SOF/LDV) regimens became reimbursable in China in 2020. Thus, this study aimed to identify the optimal SOF-based regimen and to inform efficient use of healthcare resources by optimizing DAA use in treating HCV genotype 1. Methods and Models: A modeling-based cost-utility analysis was conducted from the payer's perspective targeting adult Chinese patients with chronic HCV genotype 1 infection. Direct medical costs and health utilities were inputted into a Markov model to simulate lifetime experiences of chronically infected HCV patients after receiving SOF/LDV, SOF/VEL or the traditional strategy of pegylated interferon (pegIFN) + ribavirin (RBV). Discounted lifetime cost and quality adjusted life years (QALYs) were computed and compared to generate the incremental cost utility ratio (ICUR). An ICUR below the threshold of 31,500 $/QALY suggests cost-effectiveness. Deterministic and probabilistic sensitivity analyses were performed to examine the robustness of model findings. Results: Both SOF/LDV and SOF/VEL regimens were dominant to the pegIFN + RBV regimen by creating more QALYs and incurring less cost. SOF/LDV produced 0.542 more QALYs but cost $10,390 less than pegIFN + RBV. Relative to SOF/LDV, SOF/VEL had an ICUR of 168,239 $/QALY which did not meet the cost-effectiveness standard. Therefore SOF/LDV was the optimal strategy. These findings were robust to linear and random variations of model parameters. However, reducing the SOF/VEL price by 40% would make this regimen the most cost-effective option. Conclusions: SOF/LDV was found to be the most cost-effective treatment, and SOF/VEL was also economically dominant to pegIFN + RBV. These findings indicated that replacing pegIFN + RBV with DAA regimens could be a promising strategy.
| S-EPMC8695807 | biostudies-literature
Project description:To assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment.This study uses a health economic model to estimate the cost-effectiveness of treating previously untreated and treatment experienced chronic hepatitis C patients who have severe and end stage renal disease with the elbasvir-grazoprevir regimen versus no treatment in the French context. The lifetime homogeneous markovian model comprises of forty combined health states including hepatitis C virus and chronic kidney disease. The model parameters were from a multicentre randomized controlled trial, ANRS CO22 HEPATHER French cohort and literature. 1000 Monte Carlo simulations of patient health states for each treatment strategy are used for probabilistic sensitivity analysis and 95% confidence intervals calculations. The results were expressed in cost per quality-adjusted life year (QALY) gained.The mean age of patients in the HEPATHER French cohort was 59.6 years and 56% of them were men. 22.3% of patients had a F0 fibrosis stage (no fibrosis), 24.1% a F1 stage (portal fibrosis without septa), 7.1% a F2 stage (portal fibrosis with few septa), 21.4% a F3 stage (numerous septa without fibrosis) and 25% a F4 fibrosis stage (compensated cirrhosis). Among these HCV genotype 1 patients, 30% had severe renal impairment stage 4, 33% had a severe renal insufficiency stage 5 and 37% had terminal severe renal impairment stage 5 treated by dialysis.Fixed-dose combination of direct-acting antiviral agents elbasvir and grazoprevir compared to no-treatment.EBR/GZR increased the number of life years (6.3 years) compared to no treatment (5.1 years) on a lifetime horizon. The total number of QALYs was higher for the new treatment because of better utility on health conditions (6.2 versus 3.7 QALYs). The incremental cost-utility ratio (ICUR) was of €15,212 per QALY gained for the base case analysis.This cost-utility model is an innovative approach that simultaneously looks at the disease evolution of chronic hepatitis C and chronic kidney disease. EBR/GZR without interferon and ribavirin, produced the greatest benefit in terms of life expectancy and quality-adjusted life years (QALY) in treatment-naïve or experienced patients with chronic hepatitis C genotype 1 and stage 4-5 chronic kidney disease including dialysis patients. Based on shape of the acceptability curve, EBR/GZR can be considered cost-effective at a willingness to pay of €20,000 /QALY for patients with renal insufficiency with severe and end-stage renal disease compared to no treatment.
| S-EPMC5854359 | biostudies-literature
Project description:Background and aimsChronic hepatitis C (HCV) is a liver disease affecting over 3 million Americans. Liver biopsy is the gold standard for assessing liver fibrosis and is used as a benchmark for initiating treatment, though it is expensive and carries risks of complications. FibroTest is a non-invasive biomarker assay for fibrosis, proposed as a screening alternative to biopsy.MethodsWe assessed the cost-effectiveness of FibroTest and liver biopsy used alone or sequentially for six strategies followed by treatment of eligible U.S. patients: FibroTest only; FibroTest with liver biopsy for ambiguous results; FibroTest followed by biopsy to rule in; or to rule out significant fibrosis; biopsy only (recommended practice); and treatment without screening. We developed a Markov model of chronic HCV that tracks fibrosis progression. Outcomes were expressed as expected lifetime costs (2009 USD), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER).ResultsTreatment of chronic HCV without fibrosis screening is preferred for both men and women. For genotype 1 patients treated with pegylated interferon and ribavirin, the ICERs are $5,400/QALY (men) and $6,300/QALY (women) compared to FibroTest only; the ICERs increase to $27,200/QALY (men) and $30,000/QALY (women) with the addition of telaprevir. For genotypes 2 and 3, treatment is more effective and less costly than all alternatives. In clinical settings where testing is required prior to treatment, FibroTest only is more effective and less costly than liver biopsy. These results are robust to multi-way and probabilistic sensitivity analyses.ConclusionsEarly treatment of chronic HCV is superior to the other fibrosis screening strategies. In clinical settings where testing is required, FibroTest screening is a cost-effective alternative to liver biopsy.
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