Dataset Information

A Model-Based Cost-Effectiveness Analysis of Long-Acting Monoclonal Antibody (Tixagevimab and Cilgavimab: Evusheld) Preventive Treatment for High-Risk Populations Against SARS-CoV-2 in Korea.

ABSTRACT:

Background

Tixagevimab and cilgavimab (Evusheld) administration is a recommended strategy for unvaccinated patients with immunocompromised conditions and severe allergic reaction conditions to protect high-risk individuals and control the coronavirus disease 2019 (COVID-19) epidemic. We estimated the cost-effectiveness of Evusheld in key risk populations: 1) immunocompromised (vaccinated/unvaccinated), 2) severe allergic reaction, and 3) unvaccinated elderly high-risk groups.

Methods

Based on the estimated target risk group population, we used a model of COVID-19 transmission to estimate the size of the risk group population for whom Evusheld treatment may help prevent symptomatic COVID-19 (and deaths) in 2022. We projected Evusheld intervention costs, quality-adjusted life year (QALY) lost, cost averted and QALY gained by reduced COVID-19 incidence, and incremental cost-effectiveness (cost per QALY gained) in each modeled population from the healthcare system perspective.

Results

Our study demonstrated that Evusheld treatment for COVID-19 infection in South Korea is highly cost-effective for unvaccinated risk groups ($18,959 per QALY gained for immunocompromised and $23,978 per QALY gained for high-risk elderly groups) and moderately cost-effective among individuals who are vaccinated immunocompromised ($46,494 per QALY gained), or have severe allergic reactions ($45,996 per QALY gained). Evusheld's cost-effectiveness may be subject to risk-group-specific COVID-19 disease progression and Evusheld efficacy and cost, which may change in future epidemic scenarios.

Conclusion

As the COVID-19 variants and risk group-specific durable efficacy, toxicity (and/or resistance) and optimal dosing of Evusheld remain uncertain, better empirical estimates to inform these values in different epidemiological contexts are needed. These results may help decision-makers prioritize resources toward more equitable and effective COVID-19 control efforts.

SUBMITTER: Jo Y

PROVIDER: S-EPMC10427216 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

A Model-Based Cost-Effectiveness Analysis of Long-Acting Monoclonal Antibody (Tixagevimab and Cilgavimab: Evusheld) Preventive Treatment for High-Risk Populations Against SARS-CoV-2 in Korea.

Jo Youngji Y Kim Sun Bean SB Jung Jaehun J

Journal of Korean medical science 20230814 32

<h4>Background</h4>Tixagevimab and cilgavimab (Evusheld) administration is a recommended strategy for unvaccinated patients with immunocompromised conditions and severe allergic reaction conditions to protect high-risk individuals and control the coronavirus disease 2019 (COVID-19) epidemic. We estimated the cost-effectiveness of Evusheld in key risk populations: 1) immunocompromised (vaccinated/unvaccinated), 2) severe allergic reaction, and 3) unvaccinated elderly high-risk groups.<h4>Methods< ...[more]

PMID: 37582500

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Project description:Background Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based on results of a clinical trial conducted prior to the emergence of the Omicron variant. The clinical effectiveness of T/C has not been well described in the Omicron era. We examined the incidence of symptomatic illness and hospitalizations among T/C recipients when Omicron accounted for virtually all local cases. Methods Through retrospective electronic medical record chart review, we identified patients who received T/C between January 1 –July 31, 2022 within our quaternary referral health system. We determined the incidence of symptomatic COVID-19 infections and hospitalizations due to or presumed to be caused by early Omicron variants before and after receiving T/C (pre-T/C and post-T/C). Chi square and Mann-Whitney Wilcoxon two-sample tests were used to examine differences between the characteristics of those who got COVID-19 before or after T/C prophylaxis, and rate ratios (RR) and 95% confidence intervals (CI) were calculated to assess differences in hospitalization rates for the two groups. Results Of 1295 T/C recipients, 105 (8.1%) developed symptomatic COVID-19 infection before receiving T/C, and 102 (7.9%) developed symptomatic disease after receiving it. Of the 105 patients who developed symptomatic infection pre-T/C, 26 (24.8%) were hospitalized, compared with six of the 102 patients (5.9%) who were diagnosed with COVID-19 post-T/C (RR = 0.24; 95% CI = 0.10–0.55; p = 0.0002). Seven of the 105 (6.7%) patients infected pre-T/C, but none of the 102 infected post-T/C required ICU care. No COVID-related deaths occurred in either group. The majority of COVID-19 cases among those infected pre-T/C treatment occurred during the Omicron BA.1 surge, while the majority of post-T/C cases occurred when Omicron BA.5 was predominant. In both groups, having at least one dose of vaccine strongly protected against hospitalization (pre-T/C group RR = 0.31, 95% CI = 0.17–0.57, p = 0.02; post-T/C group RR = 0.15; 95% CI = 0.03–0.94; p = 0.04). Conclusion We identified COVID-19 infections after T/C prophylaxis. Among patients who received T/C at our institution, COVID-19 Omicron cases occurring after T/C were one-fourth as likely to require hospitalization compared to those with Omicron prior to T/C. However, due to the presence of changing vaccine coverage, multiple therapies, and changing variants, the effectiveness of T/C in the Omicron era remains difficult to assess.

Project description:BackgroundDuring the COVID-19 pandemic, some populations, including immunocompromised patients, could not tolerate COVID-19 vaccination or had low responses. Evusheld is a combined neutralizing monoclonal antibody containing tixagevimab and cilgavimab. The World Health Organization (WHO) has approved this combination as pre-exposure prophylaxis (PrEP) and treatment for immunocompromised patients. With the new variant, the (WHO) recommended an increase in dose from 300 to 600 mg with a booster dose after 6 months. The target of this review was to compare the efficacy of the two doses, 300 mg and 600 mg of tixagevimab/cilgavimab (Evusheld) as prophylaxis for higher-risk individuals to reveal if there is a significant difference in efficacy between those two doses of the drug.MethodsIn this study, electronic databases (PubMed, Web of Science core collection, Scopus, and Cochran) were investigated for articles up to 31/12/2022 in English using a well-established search strategy. We included studies conducted in immunocompromised patients (aged ≥ 12 years) (WHO) received Evusheld as prophylaxis or treatment for COVID-19. After excluding studies inconsistent with the selection criteria, 24 were involved, 22 of which were included in the meta-analysis. We analyzed the data by using RevMan 5.4 program software.ResultsIn the double-arm subgroup analysis, Evusheld 600 mg, administered as prophylaxis, showed no significant difference in the COVID-19 infection rate, mortality rate, or needed hospitalization rate compared with the dose of 300 mg (p = 0.13, p = 0.29, and p = 0.25, respectively). In the single-arm subgroup analysis, Evusheld 600 mg, administered as prophylaxis, showed a significant decrease in the COVID-19 infection rate and the hospitalization rate compared with the dose of 300 mg (p = 0.0001, p = 0.007, respectively). As a treatment, Evusheld showed a significant decrease in the mortality rate over the placebo group (p = 0.01) in COVID-19 patients.ConclusionThis result indicated that Evusheld was an effective prophylactic and therapeutic drug for COVID-19 infection, especially for immunocompromised patients, but there was no considerable variation between the high and low doses. Further prospective and randomized controlled trials (RCTs) with increased population sizes are necessary to show the valuable benefit of the high dose of Evusheld in COVID-19 prevention and treatment and to compare the difference between the two doses within adverse events.

Project description:BackgroundThe monoclonal-antibody combination AZD7442 is composed of tixagevimab and cilgavimab, two neutralizing antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that have an extended half-life and have been shown to have prophylactic and therapeutic effects in animal models. Pharmacokinetic data in humans indicate that AZD7442 has an extended half-life of approximately 90 days.MethodsIn an ongoing phase 3 trial, we enrolled adults (≥18 years of age) who had an increased risk of an inadequate response to vaccination against coronavirus disease 2019 (Covid-19), an increased risk of exposure to SARS-CoV-2, or both. Participants were randomly assigned in a 2:1 ratio to receive a single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of either 300 mg of AZD7442 or saline placebo, and they were followed for up to 183 days in the primary analysis. The primary safety end point was the incidence of adverse events after a single dose of AZD7442. The primary efficacy end point was symptomatic Covid-19 (SARS-CoV-2 infection confirmed by means of reverse-transcriptase-polymerase-chain-reaction assay) occurring after administration of AZD7442 or placebo and on or before day 183.ResultsA total of 5197 participants underwent randomization and received one dose of AZD7442 or placebo (3460 in the AZD7442 group and 1737 in the placebo group). The primary analysis was conducted after 30% of the participants had become aware of their randomized assignment. In total, 1221 of 3461 participants (35.3%) in the AZD7442 group and 593 of 1736 participants (34.2%) in the placebo group reported having at least one adverse event, most of which were mild or moderate in severity. Symptomatic Covid-19 occurred in 8 of 3441 participants (0.2%) in the AZD7442 group and in 17 of 1731 participants (1.0%) in the placebo group (relative risk reduction, 76.7%; 95% confidence interval [CI], 46.0 to 90.0; P<0.001); extended follow-up at a median of 6 months showed a relative risk reduction of 82.8% (95% CI, 65.8 to 91.4). Five cases of severe or critical Covid-19 and two Covid-19-related deaths occurred, all in the placebo group.ConclusionsA single dose of AZD7442 had efficacy for the prevention of Covid-19, without evident safety concerns. (Funded by AstraZeneca and the U.S. government; PROVENT ClinicalTrials.gov number, NCT04625725.).

Dataset Information

A Model-Based Cost-Effectiveness Analysis of Long-Acting Monoclonal Antibody (Tixagevimab and Cilgavimab: Evusheld) Preventive Treatment for High-Risk Populations Against SARS-CoV-2 in Korea.

Background

Methods

Results

Conclusion

Publications

A Model-Based Cost-Effectiveness Analysis of Long-Acting Monoclonal Antibody (Tixagevimab and Cilgavimab: Evusheld) Preventive Treatment for High-Risk Populations Against SARS-CoV-2 in Korea.

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