question Is universal hepatitis c virus (hcv) screening for all US adults over the age of 18 and specific screening for hcv among people who inject drugs cost-effective in limiting hcv infection?
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findings in this economic evaluation study, hcv screening for people who inject drugs in the us. uu. increased quality-adjusted life years (qalys) by 0.23 (ie, approximately 3 months), with a cost-effectiveness ratio of $45,465 per qaly. universal hcv screening increased each qaly overall by 0.01, with an incremental cost-effectiveness ratio of $291,277 per qaly.
Which means that the findings of this study suggest that HCV screening in people who inject drugs may be a cost-effective intervention to combat HCV infection, which would decrease the risk of untreated hcv infection and liver-related problems. mortality.
importance Between 2 and 3.5 million people are living with chronic hepatitis C virus (HCV) infection in the United States, the majority of whom (approximately 75% ) are not aware of their illness. Despite the availability of effective HCV treatment in the early stages of infection, HCV will cause thousands of deaths in the next decade in the US. uu.
aim to investigate the cost-effectiveness of universal screening for all US adults over the age of 18 for HCV in the US. uu. and the specific screening of people who inject drugs.
design, setting, and participants this simulated economic evaluation used cohort analysis in a markov model to perform a monte carlo microsimulation test of 10,000 participants to assess the cost-effectiveness of hcv screening programs , and compared screening programs targeting people who inject drugs with universal screening of adults aged 18 years and older. data was analyzed in December 2019.
exposures per quality-adjusted life year (qaly).
main results and measures cost per qaly gained.
Results In a 10,000 monte carlo microsimulation trial comparing a baseline of 40-year-olds (men and women) and people who inject drugs in the united states, it was estimated that HCV screening and treatment increase total costs by $10,457 per person and increase qalys by 0.23 (approximately 3 months), giving an incremental cost-effectiveness ratio of $45,465 per qaly. In addition, universal HCV screening and treatment is estimated to increase total costs by $2,845 per person and increase qalys by 0.01, providing an incremental cost-effectiveness ratio of $291,277 per qaly.
Conclusions and Relevance The findings of this study suggest that HCV screening in people who inject drugs may be a cost-effective intervention to combat HCV infection in the US. HCV infection and liver-related mortality.
the exact number of people in the us is unknown. uu. who are currently infected with the hepatitis c virus (hcv) (presence of hcv rna), but it is estimated that there are more than 2 million people and up to 3.5 million people. 1,2 the majority of people with hcv infection (approximately 75%) are unaware of their infection because few symptoms are evident in the early stages of the disease.3,4 however, 70% to 85% of acute hcv infections become a chronic disease .5 chronic hcv infection is the leading reason for liver cirrhosis and hepatocellular carcinoma and the leading cause of liver transplantation .6 hcv causes nearly 40% of all chronic liver disease and is among the most common indications for liver transplantation in the united states.7, 8 Between 2003 and 2014, 20,782 adults with chronic HCV underwent liver transplantation.8 HCV infection accounted for approximately 18,000 deaths in the us. uu. in 2016,9,10 and mortality related to hCV infection exceeds all other deaths from infectious diseases combined.11
Most people with HCV in the United States are people born between 1946 and 1964 (i.e. baby boomers).12 However, due to the slow disease progression of hepatitis C, the disease can remain undiagnosed for decades.12 Infection rates among people who inject drugs (pwid) range from 30% to 90%, depending on frequency and duration of use, accounting for approximately 60% of all cases of hcv in the united states.13-17 in 2011, the number of adults and adolescents (us population aged 13 and older) who injected drugs in their lifetime was reported to be approximately 6.6 million people . hcv.4 sharing needles among pwid is a key risk factor for hcv transmission in prisons and jails in the united states.19 inmates in correctional institutions account for up to one-third of all cases of hepatitis c in the united states.20,21 Compared to an infection rate of 1% for the general US population, HCV infect ion rates are particularly high in correctional institutions, ranging from 17.4% to 23.1%.20,21 of every 10 million people who pass through correctional settings each year have an undiagnosed hcv infection; over 90% of these individuals are discharged into the general population.22-24 at any one time, these individuals may have little contact with the health care system and, as a result, play a prominent role in the spread of hcv in American communities.23-26
hcv treatment can be very effective, especially if hcv is diagnosed early in infection.27 existing research shows that universal hcv screening in developed countries is effective.28-30 previous studies on the cost-effectiveness of hcv screening in the united states examined voluntary screening, specific population groups (eg, baby boomers, pregnant women, blood donation volunteers, and screening performed in primary care settings US), or older forms of treatment.31-35 However, few studies have evaluated the cost-effectiveness of HCV screening in the US. uu. account for recent and highly effective treatment regimens for hcv. In addition, the cost of new drugs is relatively lower than that of older drugs; HCV treatment prices have been cut by about half. In the absence of such knowledge, the cost-effectiveness of universal and targeted screening for HCV remains uncertain.
The main objective of this study was to evaluate and compare the cost-effectiveness of screening for people who inject drugs with a universal HCV screening program for adults aged 18 years and older, taking into account the most effective and recent medical treatments for hcv.
This study was carried out on the basis of structured reports of economic evaluations of health interventions in accordance with the guide of consolidated standards of reports of economic evaluation of health (cheers). targeted screening for pwid. the common rule exempts this study from institutional board review because no human participants were involved.
This study was conducted using a Markov decision analysis model of HCV natural history and progression to assess the cost-effectiveness of HCV screening in the US population. The Markov model used in this study, based on the natural history of HCV according to empirically calibrated models, clinical features, and published literature,37-39 shows disease progression for a person with HCV infection using a 10-year horizon (Figure 1) . The base case at screening and diagnosis was considered to be 40 years old, which is approximately the median age in the United States.
Disease progression was described in terms of the metavir score, a liver biopsy staging system that assesses the severity of liver fibrosis.40 Metavir scores assess the degree of scarring or fibrosis of the liver, ranging from f0 (no fibrosis) to f4 (cirrhosis). health states were classified into 2 main stages of disease progression: fibrosis progression stages f0 to f4 and progression without fibrosis after stage f4. health states included healthy (no hcv), no fibrosis (f0), portal fibrosis without septa (f1), portal fibrosis with few septa (f2), numerous septa without cirrhosis (f3), compensated cirrhosis (f4), decompensated cirrhosis , hepatocellular carcinoma, post-hepatocellular carcinoma, liver transplant, and post-liver transplant.40-42 Without treatment, patients in the f0 state may experience spontaneous hcv clearance and return to an hcv-free state in the f0 state. otherwise, patients may progress to the next stage of disease severity (Figure 1). patients who receive treatment and achieve a sustained virologic response will progress to recovered states depending on the severity of fibrosis. patients with compensated cirrhosis who are not treated will progress to hepatocellular carcinoma or decompensated cirrhosis and may receive liver transplants. Because natural death can occur while a patient is in any state, the probability of natural death in the Markov model is based on American life tables.43 Death from the disease can occur in the final stages of progression. no fibrosis. people can be reinfected at the same rate (1%) as the general population during and after successful treatment and, if reinfected,44 will begin fibrosis progression from the f0 state. Distribution of initial fibrosis status was based on existing literature.45 Fibrosis transition rates (Table 1) vary with age and were based on published literature for HCV in the United States, with possible transitions occurring every 12 months.37,39,44
The treatment regimen included in this analysis was a combination of glecaprevir and pibrentasvir, used to treat chronic HCV genotypes 1, 2, 3, 4, 5, or 6 without cirrhosis or with compensated cirrhosis. the treatment protocol is 3 tablets (100 mg glecaprevir and 40 mg pibrentasvir) taken daily for 8 weeks. the treatment is highly effective, with a 98% success rate.46 the regimen is not effective for people with advanced cirrhosis (ie, decompensated cirrhosis).
HCV-related direct medical costs included in the study are listed in Table 1. Medication costs in this study were based on wholesale acquisition cost, which is an estimate of the list price of the drug. manufacturer and does not include discounts or rebates, and covered the duration of treatment.47 Health status medical costs, which are the cost of treatment based on disease severity and progress, were obtained from the literature published in a annual period.37,48,50 the costs considered included visits (inpatient and outpatient), diagnostic and laboratory tests, medical services, emergency department service place and pharmacy.44,48 the total cost of the liver transplant Obtained from US organ and tissue transplant cost estimates. uu. provided by a previous study.49 The cost of an HCV test was assumed to cost $140 based on existing literature.50 Finally, the cost of not having HCV was assumed to be $0. Costs were adjusted for inflation to 2019 US dollars using the US Consumer Price Index. UU., when it was necessary.51
The main outcome of this study was the gain in quality-adjusted life years (qalys) and incremental cost-effectiveness ratios (icers) were calculated. Costs were discounted at 3% per year based on the recommendations of the US Panel on Cost-Effectiveness in Health and Medicine.52,53 US Centers for Disease Control and Prevention (CDC) life tables were used for natural mortality rates of the united states population .43 this study was conducted in 2019 and data were analyzed in december 2019. the baseline for the analysis was a 40-year-old person in the united states. A cost-benefit analysis was performed using a societal perspective to assess and compare the status quo with HCV screening in 2 scenarios: annual screening of the total population (universal screening) and PWID-specific screening. ICERs were calculated by dividing the difference in the expected costs of each scenario by the difference in their effectiveness (ie, qaly). the screening scenario is based on a 60% chance of hcv infection in the population of people who inject drugs versus a 1% chance in the universal screening scenario.54%.13-17
To determine the expected rates of liver-related mortality, HCV infection, and liver transplantation in the 2 screening scenarios, a Monte Carlo microsimulation of 10,000 trials was performed. A Monte Carlo microsimulation performs repeated random sampling to obtain results in a process that cannot be easily estimated or performed. The Monte Carlo microsimulation used in this study estimated the effects of screening if the HCV screening program were scaled to 10,000 people. The microsimulation calculated the results 10,000 times, each time using a different set of random values of the model’s probability functions to calculate the grand totals of liver-related mortality, HCV infection, and liver transplantation for a sample of 10,000 people in a group of 10- year horizon.
Sensitivity analyzes were performed to measure and assess the uncertainty derived from the model assumption. sensitivity analyzes recalculated results under alternative assumptions and used a range of probabilities and values rather than a specific probability and value to determine the association of one variable (i.e., reinfection rate, infection rate for both the general population as for infected people, cost of hcv treatment) with the results. the treeage pro healthcare 2019 statistical package (treeage software inc) was used for all analyses.
Table 2 presents icers of costs of qalys gained for pwid-targeted screening and universal screening compared to the status quo determined by the Markov model. the pwid screening scenario is based on a 60% chance of hcv infection in this population. in table 2, the cost per qaly of pwid detection is $2,311.50 vs. $915.70 for status quo. relative to the status quo, screening and treating the population of infected people is estimated to increase total costs by $10,457 per person on average for a 10,000 monte carlo microsimulation trial, resulting in an increase in qalys of 0.23 (approximately 3 months) over its expected useful life. The icer in this scenario is estimated at $44,815 per qaly earned, which is less than $50,000 per qaly value.55 This means that this scenario is profitable.
Table 2 also presents the results of universal screening for all US adults in which 1% of the population has HCV infection.54 the cost per qaly of universal screening is $392.70 vs. 14, $40 for status quo. Relative to status quo, HCV infection for the entire US population is estimated to increase total costs by $2,845 and shows a very small increase in qalys of 0.01. The ICER for universal screening is estimated at $291,277 per qaly earned, which is more than $50,000 worth of qaly. this means that this scenario is not profitable.
The results of a Monte Carlo microsimulation analysis of 10,000 trials showed that screening for pwid versus current status is estimated to reduce liver-related mortality by 88 deaths and new infections by 8,754. In addition, the model estimated that the number of liver transplants declines at age 18 over a 10-year horizon. results from a monte carlo microsimulation analysis of 10,000 trials showed that universal screening versus status quo is estimated to reduce liver-related mortality by 1 death and new infections by 3,053 over a 10-year horizon. /p>
The results of the two-way sensitivity analysis for people engaged in hiv infection showed that, based on the assumption that 60% of people with hiv infection have hvc infection and the reinfection rate is 1%, the cost of hcv drug treatment could rise from $26,400 to $29,054 per pwid and icer would still be less than $50,000 per qaly, meaning hcv screening would still be cost-effective (figure 2). In addition, HCV screening for pwid is estimated to be cost-effective over a wide range of HCV infection rates. Given the cost of HCV drug treatment of $26,400 per patient, the HCV infection rate could drop to 40% and freezing would still be less than $50,000 per qaly; hcv screening would still be cost-effective. furthermore, based on the assumption that 60% of people who contract the virus have hcv infection and that hcv drug treatment costs $26,400 per patient, the reinfection rate could increase to 3.5% and the icer would still be less than $50,000 per qaly and hcv screening would still be profitable.
Universal HCV screening could be cost-effective across a range of HCV infection rates and HCV drug treatment costs. For example, if the cost of HCV drug treatment were reduced from $26,400 to $13,200 per patient and the infection rate increased to 10%, freezing would be less than $50,000 per qaly and HCV screening would still be cost-effective. furthermore, if the infection rate increased to 4% and the cost of hcv drug treatment decreased to $2,640 per patient, ice would be less than $50,000 per qaly and hcv screening would still be cost-effective.
Figure 3 shows the associations of independent variations in the probability of HCV infection, the cost of anti-HCV drug treatment, the probability of a new HCV infection, and the cost of medical treatment by disease stage. The result of the tornado diagram indicates that the cost of pharmacological treatment against HCV and the probability of HCV infection are the most influential parameters in the model.
This study examined the cost-effectiveness of universal hcv screening and targeted screening of adult pwid populations for the united states using monte carlo microsimulation analysis. This analysis used recent data on the efficacy and costs of the pan-genotypic regimen of glecaprevir and pibrentasvir as a treatment for chronic HCV, which costs about half the price of older treatments. our results showed that hcv screening for pwid is cost-effective at an icer of $44,815 per qaly. In addition, Monte Carlo microsimulation results for a PWID population showed that screening and treatment were associated with preventing at least 88 HCV-related deaths and reducing new infections by 8,754 cases relative to HIV status. current. The proposed strategy was associated with the avoidance of HCV-related deaths and new infections by 99% and 83%, respectively. In this scenario, HCV detection in people who were tested was associated with an 18-fold reduction in the number of liver transplants. however, universal screening for the entire us adult population. uu. was not profitable in our analysis.
Our study findings for HCV-targeted screening of infected individuals were consistent with results from screening high-risk populations reported in other countries, including the Netherlands, Canada, Japan, and the United Kingdom.28 -30.56 previous hcv studies projections in the united states are mixed. HCV screening is reported to be cost-effective when HCV prevalence is high in the total population or in primary care settings.31,32 Some studies did not support widespread HCV screening in average-risk adults.34 Rather, Other studies have suggested that broad screening for the general population may be cost-effective.57,58 For example, Eckman et al58 reported that single universal screening of adults was cost-effective in increasing quality-adjusted qalys. however, the cost of treatment for advanced stages of the disease was considerably lower, and the drug regimen examined was different from and substantially lower in cost than the glecaprevir and pibrentasvir regimen examined in our study. A 2018 study59 from the United States Preventive Services Task Force (USPSTF) recommended screening for HCV infection in adults aged 18 to 79 years.13 However, the USPTF recommendation is based on the effectiveness of screening for improve health outcomes and not profitability analysis.
Most previous studies examining the cost-effectiveness of HCV screening used data on specific populations or pharmaceutical treatment protocols older than those currently available.31-35 Few studies have evaluated the cost-effectiveness of HCV screening in I know. introduced effective treatments against hcv.
In our study, a combination of glecaprevir and pibrentasvir was examined as pharmacological treatment of early-stage HCV. it is a highly effective regimen that is inexpensive relative to older drug protocols, costing $26,400 for an 8-week treatment period. however, despite the lower cost, screening all US adults was not found to be cost-effective in our analysis, resulting in a freeze of almost $300,000 per qaly.
Our study also looked at the cost-effectiveness of HCV screening targeting the population of infected people. the prevalence of hcv infection among people who inject drugs is very high, estimated to range from 30% to 90%.13-17 address hcv infection among people who inject drugs by Diagnosing and treating the infection early can prevent many HCV-related complications and deaths in the United States and substantially reduce health care costs. our study did not examine how pwid detection can best be performed. for example, routine screening of incarcerated populations can be effective.22 however, ineffective or costly screening programs for people with disabilities will limit the potential cost-effectiveness that we report in our analysis.
Our study has limitations. In the Markov model, the potential HCV reinfection was assumed to be 1%, which is the probability of infection for the general population. however, HCV reinfection rates are higher among people who inject drugs (11%).60 In addition, our model included only direct medical costs. Indirect costs related to HCV treatment can be significant, such as patient mental health status and caregiver costs. we use wholesale acquisition costs, which are frequently used in economic analysis because they are reasonably transparent and consistent.61 Direct cost estimates were obtained from published sources and may not fully reflect actual treatment costs for a region or system. physician in particular within the usa uu. . finally, our model assumes that people complete the 8-week drug treatment regimen if they are diagnosed. To the extent that people do not complete the regimen, our analysis may overstate the cost-effectiveness of screening.
Injection drug use is a key risk behavior for HCV infection, resulting in an infection rate among people who inject drugs of 30% to 90%. If left untreated, HCV infection can progress to liver cirrhosis and ultimately death. New drug protocols have been developed to successfully treat HCV, and this study examines the cost-effectiveness of screening for infected people and universal screening for the US adult population. uu. The results of our analysis, using an ICER of $50,000 per qaly as the cut-off point, suggest that HCV screening that is tailored to pwid people is cost-effective in avoiding premature deaths and liver transplants associated with progression of disease. hcv disease.
Accepted for publication: June 24, 2020.
Published: September 3, 2020. doi:10.1001/jamanetworkopen.2020.15756
open access: This is an open access article distributed under the terms of the cc-by license. © 2020 tatar m et al. never open network.
Corresponding Author: Moosa Tatar, MA, Department of Population Health Sciences, University of Utah, 295 Chipeta Way, 1N492, Salt Lake City, Utah 84108 ([email protected] utah.edu).
Author contributions: mr. tatar and dr. wilson had full access to all study data and assumed responsibility for the integrity of the data and the accuracy of the data analysis.
concept and design: tatar, keeshin, mailliard.
data acquisition, analysis or interpretation: tatar, keeshin, wilson.
manuscript writing: tatar, wilson.
critical review of the manuscript for important intellectual content: all authors.
statistical analysis: Tatar.
administrative, technical or material support: keeshin.
supervision: keeshin, wilson.
Conflict of Interest Disclosures: dr. mailliard reported receiving grants from gilead sciences and abbvie outside of the submitted work. no other disclosures were reported.