Remdesivir and dexamethasone as tools to relieve hospital care systems stressed by COVID-19: A modelling study on bed resources and budget impact.

Remdesivir and dexamethasone are the only drugs providing reductions in the lengths of hospital stays for COVID-19 patients. We assessed the impacts of remdesivir on hospital-bed resources and budgets affected by the COVID-19 outbreak. A stochastic agent-based model was combined with epidemiological data available on the COVID-19 outbreak in France and data from two randomized control trials. Strategies involving treating with remdesivir only patients with low-flow oxygen and patients with low-flow and high-flow oxygen were examined. Treating all eligible low-flow oxygen patients during the entirety of the second wave would have decreased hospital-bed occupancy in conventional wards by 4% [2%; 7%] and intensive care unit (ICU)-bed occupancy by 9% [6%; 13%]. Extending remdesivir use to high-flow-oxygen patients would have amplified reductions in ICU-bed occupancy by up to 14% [18%; 11%]. A minimum remdesivir uptake of 20% was required to observe decreases in bed occupancy. Dexamethasone had effects of similar amplitude. Depending on the treatment strategy, using remdesivir would, in most cases, generate savings (up to 722€) or at least be cost neutral (an extra cost of 34€). Treating eligible patients could significantly limit the saturation of hospital capacities, particularly in ICUs. The generated savings would exceed the costs of medications.

Impact of Adding Oseltamivir to Usual Care on Quality-Adjusted Life-Years During Influenza-Like Illness.

OBJECTIVES: The ALIC4E trial has shown that oseltamivir reduces recovery time while increasing the risk of nausea. This secondary analysis of the ALIC4E trial aimed to determine the gain in quality-adjusted life-years (QALYs) associated with adding oseltamivir to usual primary care in patients presenting with influenza-like illness (ILI). METHODS: Patients with ILI were recruited during the influenza season (2015-2018) in 15 European countries. Patients were assigned to usual care with or without oseltamivir through stratified randomization (age, severity, comorbidities, and symptom onset). Patients' health status was valued with the EQ-5D and visual analog scale (VAS) for up to 28 days. Average EQ-5D and VAS scores over time were estimated for both treatment groups using one-inflated beta regression in children (<13 years old) and adults (≥13 years old). QALY gain was calculated as the difference between the groups. Sensitivity analysis considered the value set to convert EQ-5D answers to summary scores and the follow-up period. RESULTS: In adults, oseltamivir gained 0.0006 (95% confidence interval 0.0002-0.0010) QALYs, whereas no statistically significant gain was found in children (14-day follow-up, EQ-5D). QALY gains were statistically significant in patients aged ≥65 years, patients without relevant comorbidities, or patients experiencing symptoms for ≤48 hours. Using VAS and accounting for 28-day follow-up resulted in higher QALY gain. CONCLUSIONS: QALY gain owing to oseltamivir is limited compared with other diseases, and its clinical meaningfulness remains to be determined. Further analysis is needed to evaluate whether QALY gain and its impact on ILI treatment cost render oseltamivir cost-effective.

COVID-19 Treatments Sold Online Without Prescription Requirements in the United States: Cross-sectional Study Evaluating Availability, Safety and Marketing of Medications.

BACKGROUND: The COVID-19 pandemic has increased online purchases and heightened interest in existing treatments. Dexamethasone, hydroxychloroquine, and lopinavir-ritonavir have been touted as potential COVID-19 treatments. OBJECTIVE: This study assessed the availability of 3 potential COVID-19 treatments online and evaluated the safety and marketing characteristics of websites selling these products during the pandemic. METHODS: A cross-sectional study was conducted in the months of June 2020 to August 2020, by searching the first 100 results on Google, Bing, and Yahoo! mimicking a US consumer. Unique websites were included if they sold targeted medicines, were in English, offered US shipping, and were free to access. Identified online pharmacies were categorized as rogue, unclassified, or legitimate based on LegitScript classifications. Patient safety characteristics, marketing techniques, price, legitimacy, IP addresses, and COVID-19 mentions were recorded. RESULTS: We found 117 websites: 30 selling dexamethasone (19/30, 63% rogue), 39 selling hydroxychloroquine (22/39, 56% rogue), and 48 selling lopinavir-ritonavir (33/48, 69% rogue). This included 89 unique online pharmacies: 70% were rogue (n=62), 22% were unapproved (n=20), and 8% were considered legitimate (n=7). Prescriptions were not required among 100% (19/19), 61% (20/33), and 50% (11/22) of rogue websites selling dexamethasone, lopinavir-ritonavir, and hydroxychloroquine, respectively. Overall, only 32% (24/74) of rogue websites required prescriptions to buy these medications compared with 94% (31/33) of unapproved and 100% (10/10) of legitimate websites (P<.001). Rogue sites rarely offered pharmacist counseling (1/33, 3% for lopinavir-ritonavir to 2/22, 9% for hydroxychloroquine). Drug warnings were unavailable in 86% (6/7) of unapproved dexamethasone sites. It was difficult to distinguish between rogue, unapproved, and legitimate online pharmacies solely based on website marketing characteristics. Illegitimate pharmacies were more likely to offer bulk discounts and claim price discounts, yet dexamethasone and hydroxychloroquine were more expensive online. An inexpensive generic version of lopinavir-ritonavir that is not authorized for use in the United States was available online offering US shipping. Some websites claimed hydroxychloroquine and lopinavir-ritonavir were effective COVID-19 treatments despite lack of scientific evidence. In comparing IP addresses to locations claimed on the websites, only 8.5% (7/82) matched their claimed locations. CONCLUSIONS: The lack of safety measures by illegitimate online pharmacies endanger patients, facilitating access to medications without appropriate oversight by health care providers to monitor clinical response, drug interactions, and adverse effects. We demonstrated how easy it is to go online to buy medications that are touted to treat COVID-19 even when current clinical evidence does not support their use for self-treatment. We documented that illegitimate online pharmacies sidestep prescription requirements, skirt pharmacist counseling, and make false claims regarding efficacy for COVID-19 treatment. Health care professionals must urgently educate the public of the dangers of purchasing drugs from illegitimate websites and highlight the importance of seeking treatment through authentic avenues of care.

Economic impact of applying the AASLD-IDSA simplified treatment algorithm on the real-world management of hepatitis C.

BACKGROUND: The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommended in May 2019 that patients with hepatitis C virus (HCV) could be assessed for treatment initiation with a simplified treatment algorithm. This approach uses standard blood and fibrosis tests, rather than genotype testing, to guide the initiation of pan-genotypic direct-acting antiviral agents (DAAs) sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB) treatment. OBJECTIVE: To compare health care resource utilization (HCRU) and costs for patients who initiated treatment via the simplified vs nonsimplified algorithm (genotype testing). METHODS: We identified adults with commercial and Medicare Advantage coverage who were diagnosed with HCV who initiated SOF/VEL or GLE/PIB from July 1, 2016, through August 31, 2019, in a nationally representative US administrative claims database. The index date was defined as the first pharmacy SOF/VEL or GLE/PIB fill date. Continuous enrollment 12 months before and ≥6 months after index date was required. Patients with claims for hepatitis B, HIV, decompensated liver, or prior DAAs were excluded. Patients were propensity score-matched (1:1) and grouped as "simplified" or "nonsimplified." HCV-related HCRU and costs were compared for the post-matched groups. RESULTS: 3,539 HCV patients were included, and 16.6% initiated SOF/VEL or GLE/PIB via the simplified algorithm. Pre-matched treatments were SOF/VEL (52.8%) and GLE/PIB (47.2%). More than half (55.7%) of SOF/VEL and 44.3% of GLE/PIB patients started treatment via the simplified algorithm. HCV patients initiating via the simplified algorithm were more likely to be male (65.1% vs 60.6%; P = 0.041), commercially insured (53.3% vs 46.5%; P = 0.003), and in the Midwest (25.7% vs 19.3%; P < 0.001) vs nonsimplified patients. The nonsimplified group had more liver disease (52.1% vs 46.9%; P = 0.019), metabolic disorders (45.8% vs 39.2%; P = 0.003), and dyslipidemia (39.9% vs 35.4%; P = 0.041) vs the simplified group. Of the index prescriptions, 58.9% were written by gastroenterology or infectious disease specialists, and 68.1% (simplified) vs 75.4% (nonsimplified) had a specialist visit within 90 days prior to index DAA fill (P < 0.001). Matching resulted in 584 well-matched patients in each group. At post-match baseline, the simplified treatment group had significantly lower median (interquartile range [IQR]) HCV-related medical health care costs vs the matched nonsimplified group: $373 ($201-$684) vs $727 ($456-$1,185; P < 0.001). Median noninpatient/emergency department health plan-paid costs were also significantly lower in the simplified cohort ($257 vs $504; P < 0.001). During follow-up, medical HCV-related health care costs were similar across the groups. CONCLUSIONS: This study compared economic outcomes of HCV treatment initiation via the simplified and nonsimplified algorithms. The simplified approach resulted in lower use of health care resources, greater cost savings, and greater ability of patients to access care from both specialist and nonspecialist providers. While additional studies are needed, these early findings suggest a feasible path for simplified HCV treatment in real-world managed care settings. DISCLOSURES: Funding support for this study was provided by Gilead Sciences, Inc. Majethia, Lee, Mozaffari, Wolf, and Hsiao are employees of Gilead Sciences, Inc. Bunner and Chastek are employees of Optum Life Sciences, which received funding from Gilead Sciences, Inc. to conduct this study. Bunner owns stock in UnitedHealth group, parent company of Optum. A poster based on selected data from this study was presented at the AMCP 2021 Virtual Meeting, April 12-16, 2021.

Achieving end-to-end success in the clinic: Pfizer's learnings on R&D productivity.

Over the past decade, Pfizer has focused efforts to improve its research and development (R&D) productivity. By the end of 2020, Pfizer had achieved an industry-leading clinical success rate of 21%, a tenfold increase from 2% in 2010 and well above the industry benchmark of ∼11%. The company had also maintained the quality of innovation, because 75% of its approvals between 2016 and 2020 had at least one expedited regulatory designation (e.g., Breakthrough Therapy). Pfizer's Signs of Clinical Activity (SOCA) paradigm enabled better decision-making and, along with other drivers (biology and modality), contributed to this productivity improvement. These laid a strong foundation for the rapid and effective development of the Coronavirus 2019 (COVID-19) vaccine with BioNTech, as well as the antiviral candidate Paxlovid™, under the company's 'lightspeed' paradigm.

Cost-effectiveness and system-wide impact of using Hepatitis C-viremic donors for heart transplant.

BACKGROUND: The advent of direct-acting antiviral therapy for Hepatitis C (HCV) has made using HCV-viremic donors a viable strategy to address the donor shortage in heart transplantation. We employed a large-scale simulation to evaluate the impact and cost-effectiveness of using HCV-viremic donors for heart transplant. METHODS: We simulated detailed histories from time of listing until death for the real-world cohort of all adults listed for heart transplant in the United States from July 2014 to June 2019 (n = 19,346). This population was imputed using historical data and captures "real-world" heterogeneity in geographic and clinical characteristics. We estimated the impact of an intervention in which all candidates accept HCV+ potential donors (n = 472) on transplant volume, waitlist outcomes, and lifetime costs and quality-adjusted life years (QALYs). RESULTS: The intervention produced 232 more transplants, 132 fewer delistings due to deterioration, and 50 fewer waitlist deaths within this 5-year cohort and reduced wait times by 3% to 11% (varying by priority status). The intervention was cost-effective, adding an average of 0.08 QALYs per patient at a cost of $124 million ($81,892 per QALY). DAA therapy and HCV care combined account for 11% this cost, with the remainder due to higher costs of transplant procedures and routine post-transplant care. The impact on transplant volume varied by blood type and region and was correlated with donor-to-candidate ratio (ρ = 0.71). CONCLUSIONS: Transplanting HCV+ donor hearts is likely to be cost-effective and improve waitlist outcomes, particularly in regions and subgroups experiencing high donor scarcity.

Health care utilization and costs associated with direct-acting antivirals for patients with substance use disorders and chronic hepatitis C.

BACKGROUND: Patients with substance use disorders (SUD) and chronic hepatitis C virus infection (HCV) have limited access to direct-acting antivirals (DAAs) due to multilevel issues related to providers (eg, concern about reinfection); patients (eg, refusal); payers (eg, prior authorization); and health system structure, although clinical guidelines recommend timely DAA treatment for patients with SUD and HCV. Effects of DAAs on real-world health care utilization and costs among these patients is unknown. OBJECTIVE: To compare changes in medical service utilization and costs related to liver, SUD, and all-cause morbidity in patients with SUD and HCV treated with DAAs (DAA group) vs not treated with DAAs (non-DAA group). METHODS: We conducted a retrospective cohort study using MarketScan Commercial and Medicare Supplemental Claims databases (2012-2018) for newly diagnosed HCV treatment-naive adults with SUD. We used difference-in-differences analyses, stratified by cirrhosis status, to determine the adjusted ratio of rate ratio (RoRR) to assess the difference in the relative changes from the pre- to posttreatment periods between the 2 groups. RESULTS: 6,266 patients with SUD and HCV were identified. Of these patients who also had cirrhosis (n = 607), 49% (n = 298) initiated DAA therapy for HCV, whereas of those without cirrhosis (n = 5,659), 22% (n = 1,219) initiated DAAs. For patients with cirrhosis (n = 607), the liver-related costs decreased by $6,213 (95% CI = -$8,571, -$3,856) for the DAA group and $1,585 (95% CI = -$4,659, $1,490) for the non-DAA group. The relative decreases in the rate of liver-related costs were larger for the DAA group than for the non-DAA group, and the relative changes between groups were significantly different (RoRR = 0.37, 95% CI = 0.19-0.73). There was no difference in the relative changes after DAAs in the rate of SUD-related visits/costs or all-cause costs between the 2 groups. For patients without cirrhosis (n = 5,659), a similar association was observed. Besides, the relative decreases in the rate of SUD-related emergency department (ED) visits (RoRR = 0.54, 95% CI = 0.38-0.77); SUD-related long-term care visits (RoRR = 0.30, 95% CI = 0.13-0.73); all-cause ED visits (RoRR = 0.75, 95% CI = 0.64-0.88); and all-cause long term-care visits (RoRR = 0.36, 95% CI = 0.18-0.72) were larger in the DAA group than in the non-DAA group. CONCLUSIONS: DAAs are associated with a significant decrease in the rate of SUD-related ED visits and liver-related costs without increasing the rate of all-cause costs among patients with SUD and HCV, suggesting that the benefits of DAAs extended beyond liver-related outcomes, especially in this disadvantaged population. DISCLOSURES: Research reported in this publication was supported in part by the National Institute on Drug Abuse of the National Institutes of Health (K01DA045618). The funder did not have a role in the design, the execution, the analyses, the interpretation of the data, or the decision to submit the results of this study. The authors have no potential conflicts of interest.

Estimating the net value of treating hepatitis C virus using sofosbuvir-velpatasvir in India.

Recently developed direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV) have been groundbreaking for their high efficacy across disease genotypes and lack of severe side effects. This study uses a cost-of-illness (COI) approach to estimate the net value conferred by this class of drugs using the cost and efficacy of one of these novel drug combinations, sofosbuvir and velpatasvir (SOF/VEL), recently licensed for generic manufacture in India. This study considers COI of lifetime earnings lost by patients and potential secondarily infected individuals due to disability and premature death from HCV infection. Expected net benefits of treatment are substantial for non-cirrhotic (NC) and compensated cirrhotic (CC) patients (ranging from 5,98,003 INR for NC women to 1,05,25,504 INR for CC men). Increased earnings are not sufficient to fully offset cost of treatment for decompensated cirrhotic individuals but treatment may still be justified on the basis of the intrinsic value of health improvements and other treatment benefits.

Cost-effectiveness of a "treat-all" strategy using Direct-Acting Antivirals (DAAs) for Japanese patients with chronic hepatitis C genotype 1 at different fibrosis stages.

AIM: To evaluate the cost-effectiveness of therapeutic strategies initiated at different stages of liver fibrosis using three direct-acting antivirals (DAAs), sofosbuvir-ledipasvir (SL), glecaprevir-pibrentasvir (GP), and elbasvir plus grazoprevir (E/G), for Japanese patients with chronic hepatitis C (CHC) genotype 1. METHODS: We created an analytical decision model reflecting the progression of liver fibrosis stages to evaluate the cost-effectiveness of alternative therapeutic strategies applied at different fibrosis stages. We compared six treatment strategies: treating all patients regardless of fibrosis stage (TA), treating individual patients with one of four treatments starting at four respective stages of liver fibrosis progression (F1S: withholding treatment at stage F0 and starting treatment from stage F1 or higher, and three successive options, F2S, F3S, and F4S), and administering no antiviral treatment (NoRx). We adopted a lifetime horizon and Japanese health insurance payers' perspective. RESULTS: The base case analysis showed that the incremental quality-adjusted life years (QALY) gain of TA by SL, GP, and E/G compared with the strategies of starting treatments for patients with the advanced fibrosis stage, F2S, varied from 0.32 to 0.33, and the incremental cost-effectiveness ratios (ICERs) were US$24,320, US$18,160 and US$17,410 per QALY, respectively. On the cost-effectiveness acceptability curve, TA was most likely to be cost-effective, with the three DAAs at the willingness to pay thresholds of US$50,000. CONCLUSIONS: Our results suggested that administration of DAA treatment for all Japanese patients with genotype 1 CHC regardless of their liver fibrosis stage would be cost-effective under ordinary conditions.

Economic evaluation of remdesivir for the treatment of severe COVID-19 patients in China under different scenarios.

AIMS: The present study aimed to evaluate the cost-effectiveness of the 5-day remdesivir regimen compared with standard of care among severe COVID-19 patients in China, the evidence on which is essential to inform the necessity of securing access to remdesivir. METHODS: A dynamic transmission model that extended the susceptible-exposed-infected-recovered framework by incorporating asymptomatic, presymptomatic and waiting-to-be-diagnosed patients was constructed to conduct the cost-effectiveness analysis from the healthcare system perspective. To estimate epidemic parameters, the model was first calibrated to the observed epidemic curve in Wuhan from 23 January to 19 March 2020. Following the calibration, the infected compartment was replaced by 3 severity-defined health states to reflect differential costs and quality of life associated with disease gravity. Costs and quality-adjusted life year (QALY) outcomes of 9 million simulated people were accrued across time to evaluate the incremental cost-effectiveness ratio of remdesivir. As robustness checks, an alternative modelling technique using decision tree, additional epidemic scenarios representing different epidemic intensities, and 1-way parameter variations were also analysed. RESULTS: Remdesivir treatment cost CN¥97.93 million more than standard of care. Also, the net QALY gain from 5-day remdesivir treatment was 6947 QALYs. As such, the incremental cost-effectiveness ratio was CN¥14 098/QALY, substantially lower than the gross domestic product per capita threshold. The peak daily number of severe cases was 19% lower in the remdesivir treatment strategy. Overall, results were robust in alternative scenarios and sensitivity analyses. CONCLUSION: Given the cost-effectiveness profile, access to remdesivir for severe COVID-19 patients in China should be considered.

[Scientific research in times of pandemics.] / La ricerca scientifica in tempi di pandemia.

When a pandemic occurs, scientific research moves fast in order to achieve readily results, such as effective therapies to fight the SARS-CoV-2 and vaccines. But this high-speed science, engaged by the emergency and characterized by the explosion of online publications in preprint form not subject to scrutiny by peer reviewers, carries some risks. And it represents a challenge to maintain research integrity and to comply with those globally recognized standard principles of fairness. Competition and the pressure to publish immediately - a way of encouraging rapid data sharing - can favor the dissemination of incomplete if not erroneous results obtained from partial studies, which feed false news, such as the benefits of a drug, and illusory hopes. It is commonly through press releases that "speed science" disseminates information to an audience that wants to be informed and reassured. Financial and political interests often mix with the urgency to find solutions. Covid-19 has highlighted in particular the risk of a politicization of science at the expense of transparency.

Health care costs associated with chronic hepatitis C virus infection in Ontario, Canada: a retrospective cohort study.

BACKGROUND: High-quality estimates of health care costs are required to understand the burden of illness and to inform economic models. We estimated the costs associated with hepatitis C virus (HCV) infection from the public payer perspective in Ontario, Canada. METHODS: In this population-based retrospective cohort study, we identified patients aged 18-105 years diagnosed with chronic HCV infection in Ontario from 2003 to 2014 using linked administrative data. We allocated the time from diagnosis until death or the end of follow-up (Dec. 31, 2016) to 9 mutually exclusive health states using validated algorithms: no cirrhosis, no cirrhosis (RNA negative) (i.e., cured HCV infection), compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, both decompensated cirrhosis and hepatocellular carcinoma, liver transplantation, terminal (liver-related) and terminal (non-liver-related). We estimated direct medical costs (in 2018 Canadian dollars) per 30 days per health state and used regression models to identify predictors of the costs. RESULTS: We identified 48 239 patients with chronic hepatitis C, of whom 30 763 (63.8%) were men and 35 891 (74.4%) were aged 30-59 years at diagnosis. The mean 30-day costs were $798 (95% confidence interval [CI] $780-$816) (n = 43 568) for no cirrhosis, $661 (95% CI $630-$692) (n = 6422) for no cirrhosis (RNA negative), $1487 (95% CI $1375-$1599) (n = 4970) for compensated cirrhosis, $3659 (95% CI $3279-$4039) (n = 3151) for decompensated cirrhosis, $4238 (95% CI $3480-$4996) (n = 550) for hepatocellular carcinoma, $8753 (95% CI $7130-$10 377) (n = 485) for both decompensated cirrhosis and hepatocellular carcinoma, $4539 (95% CI $3746-$5333) (n = 372) for liver transplantation, $11 202 (95% CI $10 645-$11 760) (n = 3201) for terminal (liver-related) and $8801 (95% CI $8331-$9271) (n = 5278) for terminal (non-liver-related) health states. Comorbidity was the most significant predictor of total costs for all health states. INTERPRETATION: Our findings suggest that the financial burden of HCV infection is substantially higher than previously estimated in Canada. Our comprehensive, up-to-date cost estimates for clinically defined health states of HCV infection should be useful for future economic evaluations related to this disorder.

The impact of public coverage of newer hepatitis C medications on utilization, adherence, and costs in British Columbia.

BACKGROUND: Sofosbuvir and ledipasvir-sofosbuvir are both newer direct-acting antiviral agents for the treatment of hepatitis C. The high list prices for both drugs have led to concern about the budget impact for public drug coverage programs. Therefore, we studied the impact of public prescription drug coverage for both drugs on utilization, adherence, and public and private expenditure in British Columbia, Canada. METHODS: We used provincial administrative claims data from January 2014 to June 2017 for all individuals historically tested for either hepatitis C and/or human immunodeficiency virus. Using interrupted time series analysis, we examined the impact of public insurance coverage on treatment uptake, adherence (proportion of days covered), and public and private expenditures. RESULTS: Over our study period, 4,462 treatment initiations were eligible for analysis (1,131 sofosbuvir and 3,331 ledipasvir-sofosbuvir, which include 19 patients initiated on both treatments). We found the start of public coverage for sofosbuvir and ledipasvir-sofosbuvir increased treatment uptake by 154%. Adherence rates were consistently high and did not change with public coverage. Finally, public expenditure increased after the policy change, and crowded out some private expenditure. CONCLUSION: Public coverage for high-cost drugs for hepatitis C dramatically increased use of these drugs, but did not reduce adherence. From a health policy perspective, public payers should be prepared for increased treatment uptake following the availability of public coverage. However, they should not be concerned that populations without private insurance coverage will be less adherent and not finish their treatment course.

Cost-Effectiveness Analysis of Antiviral Therapy for Untreated Minimally Active Chronic Hepatitis B to Prevent Liver Disease Progression.

INTRODUCTION: Antiviral therapy (AVT) for chronic hepatitis B (CHB) can prevent liver disease progression. Because of its stringent reimbursement criteria, significant numbers of patients with untreated minimally active (UMA)-CHB exist, although they are still subject to disease progression. We thus performed a cost-effectiveness analysis to assess the rationale for AVT for UMA-CHB. METHODS: We compared cost and effectiveness (quality-adjusted life years, QALYs) in virtual UMA-CHB cohorts of 10,000 50-year-olds receiving AVT (scenario 1) vs no treatment (scenario 2) for 10 years. A Markov model, including 7 health states of CHB-related disease progression, was used. Values for transition probabilities and costs were mostly obtained from recent South Korean data. RESULTS: The simulation of AVT vs no treatment predicted $2,201 incremental costs and 0.175 incremental QALYs per patient for 10 years, with an incremental cost-effectiveness ratio (ICER) of $12,607/QALY, suggesting cost-effectiveness of AVT. In sum, if 10,000 patients received AVT, 720 incident hepatocellular carcinoma and 465 CHB-related more deaths could be averted in 10 years relative to no treatment. When the simulated analysis period was extended to 20 years, AVT was also highly cost-effective with an ICER of $2,036/QALY. Although hepatocellular carcinoma-related mortality was a major factor influencing ICER, its fluctuation can be accepted within willingness to pay of $33,000 in South Korea. According to probabilistic sensitivity analysis with the threshold of willingness to pay, the probability of AVT cost-effectiveness was 83.3%. DISCUSSION: Long-term AVT for patients with UMA-CHB may contribute positively toward individual clinical benefit and national health care budget.

Direct-Acting Antiviral Treatment Use Remains Low Among Florida Medicaid Beneficiaries With Chronic Hepatitis C.

Medicaid prior authorization (PA) policies for treatment of hepatitis C virus (HCV) with direct-acting antiviral (DAA) therapy are changing. We aimed to evaluate effects of changes in PA requirements on treatment uptake and to determine the factors associated with DAA treatment among Florida Medicaid beneficiaries with HCV. This is a retrospective cohort analysis of Florida's Medicaid administrative claims and electronic medical records (2013-2018). A total of 14,063 newly diagnosed patients with HCV were grouped based on human immunodeficiency virus (HIV) co-infection and/or a substance use disorder (SUD) (7,735 HCV mono-infected with a SUD, 5,180 HCV mono-infected without a SUD, 564 HCV/HIV co-infected with a SUD, and 584 HCV/HIV co-infected without a SUD). Although the treatment rate increased three-fold after June 1, 2016, when a fibrosis-stage restriction was eliminated, only 8% received DAAs. Compared to HCV mono-infected without a SUD, HCV mono-infected with a SUD and HCV/HIV co-infected with a SUD were 47% (adjusted hazard ratio, 0.53; 95% confidence interval, 0.47-0.60) and 59% (adjusted hazard ratio, 0.41; 95% confidence interval, 0.28-0.61) less likely to initiate DAAs. Those with HCV/HIV/SUD did not experience a DAA initiation increase after a fibrosis-stage restriction was eliminated. Compared with Whites, Blacks were less likely to receive DAAs but were more likely to complete treatment. Use of medication-assisted therapy was low, despite those on medication-assisted therapy being 60% more likely to initiate DAA therapy and no more likely to discontinue therapy. Conclusion: Despite changes in Florida's Medicaid PA requirements for DAA treatment, only 8% received treatment. Disparities in treatment access were found among patients with HIV and a SUD, and who were Black.