Casirivimab and imdevimab: Cost-effectiveness analysis of the treatment based on monoclonal antibodies on outpatients with Covid-19

PLOS ONE RESEARCH ARTICLE Casirivimab and imdevimab: Costeffectiveness analysis of the treatment based on monoclonal antibodies on outpatients with Covid-19 Matteo Ruggeri ID1,2*, Alessandro Signorini3, Silvia Caravaggio2 a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 Istituto Superiore di Sanità (ISS), Rome, Italy, 2 St. Camillus International University of Health Sciences, Rome, Italy, 3 John Cabot University, Rome, Italy * Abstract Background and objectives OPEN ACCESS Citation: Ruggeri M, Signorini A, Caravaggio S (2023) Casirivimab and imdevimab: Costeffectiveness analysis of the treatment based on monoclonal antibodies on outpatients with Covid19. PLoS ONE 18(2): e0279022. https://doi.org/ 10.1371/journal.pone.0279022 Editor: Christoph Strumann, Universitatsklinikum Schleswig Holstein Campus Lubeck, GERMANY Received: June 27, 2022 Accepted: November 28, 2022 In 2020, the world was profoundly affected by the spread of SARS-CoV-2, a novel coronavirus first identified in December 2019, that was the causative agent of coronavirus disease 2019 (Covid-19), a severe respiratory disease classified as a pandemic by the World Health Organization (WHO) in March 2020. Covid-19 had a significant negative impact on the healthcare facilities and the economies of many countries. A need for pharmacological treatments for Covid-19 patients rapidly emerged to limit the damage caused by the disease and allow for more efficient management of hospital resources. A possible alternative treatment that has achieved encouraging results on Covid-19 is the use of monoclonal antibodies. This research aims to evaluate the cost-effectiveness of a type of monoclonal antibody, specifically the combination of casirivimab and imdevimab, and assess its impact on the Italian healthcare system. Published: February 10, 2023 Copyright: © 2023 Ruggeri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are located at Github (https://github.com/owid/covid19-data/tree/master/public/data) All other data are within the manuscript and supporting information. Funding: This study was funded by a grant from Roche Spa (Roche Italia) to UniCamillus Medical University of Rome (Grant No. 44000). The vision expressed in this paper is the one of the authors and does not represent any involvement of the bodies or authorities of affiliation. The funders had no role in study design, data collection and Methods The casirivimab and imdevimab treatment efficacy on outpatients with Covid-19 was tested using a predictive Markov model. Research endpoints include hospitalizations, Intensive Care Unit (ICU) admissions, and deaths. This was translated into terms of benefits (savings) and costs for the Italian National Health Service (NHS). The model operates on a predictive time frame of 20 weeks starting from September 2021 until January 2022. The data used to populate the model comes from international academic studies and open-access resources on online databases. Results The model estimates the effects that can be achieved by administering casirivimab and imdevimab treatment on outpatients with Covid-19. According to the estimates, the treatment can prevent approximately 4,000 hospitalizations, 3,589 ICU admissions, and 1,500 deaths in the considered 20-week period. The potential cost savings amount to EUR 78 million, mainly PLOS ONE | https://doi.org/10.1371/journal.pone.0279022 February 10, 2023 1 / 13 PLOS ONE analysis, decision to publish, or preparation of the manuscript. Matteo Ruggeri didn’t receive any remuneration for taking part to this study. Competing interests: The authors have declared that no competing interests exist. Cost-Effectiveness analysis of the treatment based on monoclonal antibodies on outpatients with Covid-19 attributable to the reduction in the number of hospitalizations and access to ICU. More specifically, a difference of EUR 15,4 million can be observed due to the reduction in the number of hospitalizations, a difference of EUR 59,3 million due to the reduction in the number in intensive care, and a difference of EUR 20,3 million due to the reduction in deaths as a consequence of the reduction of hospitalizations. These results are already very significant, considering that in Italy, only 4.76% of the population is eligible for monoclonal antibody treatment. Conclusion The administration of casirivimab and imdevimab in outpatients with Covid-19 can accelerate recovery from the disease for patients, make hospital resource management more efficient and significantly reduce costs for healthcare facilities. 1. Introduction On March 11th, 2020, the World Health Organization (WHO) officially declared a pandemic, caused by the new Coronavirus (SARS-CoV-2) [1], Covid-19 disease. Since then, structural investments in researching new pharmaceutical products for the care of Covid-19 patients have multiplied in quantity and purpose. In Italy, as of October 4th, 2021, a total of 4,743,720 cases have been registered [2]. Indirectly, COVID-19 has also caused important economic and health problems. According to a report by GIMBE Foundation [3], only in 2020 severe repercussions on patients and hospitals were experienced due to the missed hospitalizations and medical services in various areas, such as oncology, neurology, and cardiovascular sectors. GIMBE Foundation estimates losses worth more than EUR 5 billion [3]. This state of emergency led the Italian Medicines Agency (AIFA) to approve on February 6th, 2021, on a temporary basis, the administration of casirivimab and imdevimab (cas&im) on patients suffering from Covid-19 [4]. Cas&im is a cocktail made up of two noncompeting, neutralizing human IgG1 antibodies that target the receptor-binding domain of the SARS-CoV-2 spike protein and prevent viral entry into human cells through the angiotensin-converting enzyme 2 (ACE2) receptor [5]. In phase III of an outpatient study by Regeneron Pharmaceuticals [6], cas&im proved to significantly reduce the duration of symptoms, hospitalization, ICU, and death rates. By November 2021, cas&im are administered to a limited percentage of patients infected with Covid-19, equal to approximately 4.76% [7]. The drug was approved by the European Medicines Agency (EMA) [8] on November 12th, 2021. The recommended posology is a single 600 mg dose of casirivimab and a single 600 mg dose of imdevimab administered intravenously or subcutaneously. The posology differs from the recommendation in the Emergency Use Act where the dosage was a single 1200 mg infusion of casirivimab and a single 1200 mg infusion of imdevimab [9]. The most recent guidelines of Italian Medicines Agency (AIFA), published in the Official Gazette no. 282, November 26th, 2021, for the administr (...truncated)