Comment on the paper "Cost-effectiveness of sofosbuvir in hepatitis C genotype 1 infection in Germany: A reanalysis of published results".
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SUBMITTER: Muhlbacher AC
PROVIDER: S-EPMC7891755 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
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Comment on the paper "Cost-effectiveness of sofosbuvir in hepatitis C genotype 1 infection in Germany: A reanalysis of published results".
Mühlbacher Axel C AC Sadler Andrew A
PloS one 20210218 2
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Project description:BackgroundChronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used.ObjectiveTo estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States.DesignMonte Carlo simulation, including deterministic and probabilistic sensitivity analyses.Data sourcesRandomized trials, observational cohorts, and national health care spending surveys.Target population8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic).Time horizonLifetime.PerspectivePayer.InterventionSofosbuvir-based therapies, pegylated interferon-ribavirin, and no therapy.Outcome measuresDiscounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).Results of base-case analysisThe ICER of sofosbuvir-based treatment was less than $100,000 per QALY in cirrhotic patients (genotype 2 or 3 and treatment-naive or treatment-experienced) and in treatment-experienced noncirrhotic patients but was greater than $200,000 per QALY in treatment-naive noncirrhotic patients.Results of sensitivity analysisThe ICER of sofosbuvir-based therapy for treatment-naive noncirrhotic patients with genotype 2 or 3 infection was less than $100,000 per QALY when the cost of sofosbuvir was reduced by approximately 40% and 60%, respectively. In probabilistic sensitivity analyses, cost-effectiveness conclusions were robust to uncertainty in treatment efficacy.LimitationThe analysis did not consider possible benefits of preventing HCV transmission.ConclusionSofosbuvir provides good value for money for treatment-experienced patients with HCV genotype 2 or 3 infection and those with cirrhosis. At their current cost, sofosbuvir-based regimens for treatment-naive noncirrhotic patients exceed willingness-to-pay thresholds commonly cited in the United States.Primary funding sourceNational Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.
| S-EPMC4420667 | 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:BackgroundPrevalence of chronic hepatitis C virus (HCV) infection is high among incarcerated persons in the United States. New, short-duration, high-efficacy therapies may expand treatment eligibility in this population.ObjectiveTo assess the cost-effectiveness of sofosbuvir for HCV treatment in incarcerated populations.DesignMarkov model.Data sourcesPublished literature and expert opinion.Target populationTreatment-naive men with chronic, genotype 1 HCV monoinfection.Time horizonLifetime.PerspectiveSocietal.InterventionNo treatment, 2-drug therapy (pegylated interferon and ribavirin), or 3-drug therapy with either boceprevir or sofosbuvir. For inmates with short remaining sentences (<1.5 years), only no treatment or sofosbuvir 3-drug therapy was feasible; for those with long sentences (≥1.5 years; mean, 10 years), all strategies were considered. After release, eligible persons could receive sofosbuvir 3-drug therapy.Outcome measuresDiscounted costs (in 2013 U.S. dollars), discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.Results of base-case analysisThe strategies yielded 13.12, 13.57, 14.43, and 15.18 QALYs, respectively, for persons with long sentences. Sofosbuvir produced the largest absolute reductions in decompensated cirrhosis (16%) and hepatocellular carcinoma (9%), resulting in 2.1 additional QALYs at an added cost exceeding $54,000 compared with no treatment. For persons with short sentences, sofosbuvir cost $25,700 per QALY gained compared with no treatment; for those with long sentences, it dominated other treatments, costing $28,800 per QALY gained compared with no treatment.Results of sensitivity analysisHigh reinfection rates in prison attenuated cost-effectiveness for persons with long sentences.LimitationsData on sofosbuvir's long-term effectiveness and price are limited. The analysis did not consider women, Hispanic persons, or patients co-infected with HIV or hepatitis B virus.ConclusionSofosbuvir-based treatment is cost-effective for incarcerated persons, but affordability is an important consideration.Primary funding sourceNational Institutes of Health.
| S-EPMC4313741 | biostudies-literature
Project description:BackgroundNewer direct-acting antiviral therapies are increasingly becoming the therapy of choice in patients with hepatitis C virus (HCV) infection. Here, we report the safety and effectiveness of sofosbuvir/velpatasvir (SOF/VEL) and ledipasvir/sofosbuvir (LDV/SOF) in real-world cohorts in Germany.MethodsPatients initiated on SOF/VEL 12 weeks or LDV/SOF 8, 12 or 24 weeks regimens in a single German centre were included in this study. Data on treatment outcomes and adverse events (AE) were analysed in patients with available sustained virologic response 12 weeks after cessation of treatment (SVR12) information overall and by subgroups.ResultsThis study included 115 patients who received SOF/VEL from July-2016 to July-2017, and 249 patients who received LDV/SOF from November-2014 to September-2015. Overall, SVR12 was achieved in 99% of patients on SOF/VEL ± ribavirin 12 weeks independent of HCV genotype, treatment history, or cirrhosis status, and in 96% of patients treated with LDV/SOF 8 weeks or LDV/SOF ± ribavirin 12 or 24 weeks. In genotype 1 treatment-naïve, non-cirrhotic patients, ≥99% achieved SVR12 across SOF/VEL and LDV/SOF regimens. Likewise, 100% of genotype 3-cirrhotic patients on SOF/VEL ± ribavirin regimens achieved SVR12. Grade 3/4 AE were reported in 13 (5.2%) patients on LDV/SOF and in 1 (<1%) patient on SOF/VEL.ConclusionOverall, SOF/VEL and LDV/SOF achieved high SVR rates in a broad patient population. We showed the effectiveness of SOF/VEL as a pan-genotypic regimen, and regardless of treatment history or cirrhosis status. Use of such therapies improves outcomes and contributes towards the global efforts to eradicate HCV.
| S-EPMC6448908 | biostudies-literature
Project description:In clinical trials, sofosbuvir showed high antiviral activity in patients infected with hepatitis C virus (HCV) across all genotypes. We aimed to determine the cost-effectiveness of sofosbuvir-based treatment compared to current standard treatment in mono-infected patients with chronic hepatitis C (CHC) genotypes 1-4 in Switzerland. Cost-effectiveness was modelled from the perspective of the Swiss health care system using a lifetime Markov model. Incremental cost-effectiveness ratios (ICERs) used an endpoint of cost per quality-adjusted life year (QALY) gained. Treatment characteristics, quality of life, and transition probabilities were obtained from published literature. Country-specific model inputs such as patient characteristics, mortality and costs were obtained from Swiss sources. We performed extensive sensitivity analyses. Costs and effects were discounted at 3% (range: 0-5%) per year. Sofosbuvir-containing treatment in mixed cohorts of cirrhotic and non-cirrhotic patients with CHC genotypes 1-4 showed ICERs between CHF 10,337 and CHF 91,570 per QALY gained. In subgroup analyses, sofosbuvir dominated telaprevir- and boceprevir-containing treatment in treatment-naïve genotype 1 cirrhotic patients. ICERs of sofosbuvir were above CHF 100,000 per QALY in treatment-naïve, interferon eligible, non-cirrhotic patients infected with genotypes 2 or 3. In deterministic and probabilistic sensitivity analyses, results were generally robust. From a Swiss health care system perspective, treatment of mixed cohorts of cirrhotic and non-cirrhotic patients with CHC genotypes 1-4 with sofosbuvir-containing treatment versus standard treatment would be cost-effective if a threshold of CHF 100,000 per QALY was assumed.
| S-EPMC4431849 | biostudies-literature
Project description:ObjectivesA number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan.MethodA Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: treatment-naïve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2% was set for both cost and effectiveness.ResultsIncremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis.ConclusionsThe results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.
| S-EPMC6588956 | biostudies-literature
Project description:ObjectiveThis study aimed to estimate the cost-utility of sofosbuvir/velpatasvir (SOF/VEL) compared with other direct-acting antivirals (DAAs) in Chinese patients with hepatitis C virus (HCV).DesignA Markov model was developed to estimate the disease progression of patients with HCV over a lifetime horizon from the healthcare system perspective. Efficacy, clinical inputs and utilities were derived from the published literature. Drug costs were from the market price survey, and health costs for Markov health states were sourced from a Chinese study. Costs and utilities were discounted at an annual rate of 5%. One-way and probabilistic sensitivity analyses were conducted to test the impact of input parameters on the results.InterventionsSOF/VEL was compared with sofosbuvir+ribavirin (SR), sofosbuvir+dasabuvir (SD), daclatasvir+asunaprevir (DCV/ASV), ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) and elbasvir/grazoprevir (EBR/GZR).Primary and secondary outcomesCosts, quality-adjusted life years (QALYs) and incremental cost-utility ratios (ICURs).ResultsSOF/VEL was economically dominant over SR and SD. However, 3D was economically dominant compared with SOF/VEL. Compared with DCV/ASV, SOF/VEL was cost-effective with the ICUR of US$1522 per QALY. Compared with EBR/GZR, it was not cost-effective with the ICUR of US$369 627 per QALY. One-way sensitivity analysis demonstrated that reducing the cost of SOF/VEL to the lower value of CI resulted in dominance over EBR/GZR and 3D. Probabilistic sensitivity analysis demonstrated that 3D was cost-effective in 100% of iterations in patients with genotype (GT) 1b and SOF/VEL was not cost-effective.ConclusionsCompared with other oral DAA agents, SOF/VEL treatment was not the most cost-effectiveness option for patients with chronic HCV GT1b in China. Lower the price of SOF/VEL will make it cost-effective while simplifying treatment and achieving the goal of HCV elimination.
| S-EPMC7443302 | biostudies-literature
Project description:Sofosbuvir and ledipasvir, which have recently been approved for treatment of chronic hepatitis C virus (HCV) infection, are more efficacious and safer than the old standard of care (oSOC) but are substantially more expensive. Whether and in which patients their improved efficacy justifies their increased cost is unclear.To evaluate the cost-effectiveness and budget impact of sofosbuvir and ledipasvir.Microsimulation model of the natural history of HCV infection.Published literature.Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age, and fibrosis distribution in the United States.Lifetime.Third-party payer.Simulation of sofosbuvir-ledipasvir compared with the oSOC (interferon-based therapies).Quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs.Sofosbuvir-based therapies added 0.56 QALY relative to the oSOC at an ICER of $55 400 per additional QALY. The ICERs ranged from $9700 to $284 300 per QALY depending on the patient's status with respect to treatment history, HCV genotype, and presence of cirrhosis. At a willingness-to-pay threshold of $100 000 per QALY, sofosbuvir-based therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients. Compared with the oSOC, treating eligible HCV-infected persons in the United States with the new drugs would cost an additional $65 billion in the next 5 years, whereas the resulting cost offsets would be $16 billion.Results were sensitive to drug price, drug efficacy, and quality of life after successful treatment.Data on real-world effectiveness of new antivirals are lacking.Treatment of HCV is cost-effective in most patients, but additional resources and value-based patient prioritization are needed to manage patients with HCV.National Institutes of Health.
| S-EPMC4435698 | biostudies-literature
Project description:Around 1% of the world's population is infected with hepatitis C. The introduction of new direct-acting antiviral agents (DAAs) in 2014 has substantially improved hepatitis C treatment outcomes. Our objective was to evaluate the long-term cost effectiveness of DAAs in health care personnel (HP) with confirmed occupational diseases in Germany. A standardised database from a German statutory accident insurance was used to analyse the cost-effectiveness ratio for the DAA regimen in comparison with interferon-based triple therapies. Taking account of the clinical progression of the disease, a Markov model was applied to perform a base case analysis for a period of 20 years. The robustness of the results was determined using a univariate deterministic sensitivity analysis. The results show that treatment with DAAs is more expensive, but also more effective than triple therapies. The model also revealed that the loss of 3.23 life years can be averted per patient over the 20 years. Compared to triple therapies, DAA treatment leads to a higher sustained virologic response (SVR). Although this results in a decrease of costs in the long term, e.g., pension payments, DAA therapy will cause greater expense in the future due to the high costs of the drugs.
| S-EPMC7013637 | biostudies-literature
Project description:BackgroundChronic hepatitis C is a major public health burden. With new interferon-free direct-acting agents (showing sustained viral response rates of more than 98%), elimination of HCV seems feasible for the first time. However, as HCV infection often remains undiagnosed, screening is crucial for improving health outcomes of HCV-patients. Our aim was to assess the long-term cost-effectiveness of a nationwide screening strategy in Germany.MethodsWe used a Markov cohort model to simulate disease progression and examine long-term population outcomes, HCV associated costs and cost-effectiveness of HCV screening. The model divides the total population into three subpopulations: general population (GEP), people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM), with total infection numbers being highest in GEP, but new infections occurring only in PWIDs and MSM. The model compares four alternative screening strategies (no/basic/advanced/total screening) differing in participation and treatment rates.ResultsTotal number of HCV-infected patients declined from 275,000 in 2015 to between 125,000 (no screening) and 14,000 (total screening) in 2040. Similarly, lost quality adjusted life years (QALYs) were 320,000 QALYs lower, while costs were 2.4 billion EUR higher in total screening compared to no screening. While incremental cost-effectiveness ratio (ICER) increased sharply in GEP and MSM with more comprehensive strategies (30,000 EUR per QALY for total vs. advanced screening), ICER decreased in PWIDs (30 EUR per QALY for total vs. advanced screening).ConclusionsScreening is key to have an efficient decline of the HCV-infected population in Germany. Recommendation for an overall population screening is to screen the total PWID subpopulation, and to apply less comprehensive advanced screening for MSM and GEP.
| S-EPMC6889318 | biostudies-literature