Special assessment of outpatient treatments for COVID-19: final evidence report and meeting summary
- Collection:
- Health Policy and Services Research
- Author(s):
- Yeung, Kai, 1981- author Whittington, Melanie D., author Beinfeld, Molly, author Mohammed, Rasheed, author Wright, Abigail, (Of Institute for Clinical and Economic Review), author Nhan, Emily, author Fluetsch, Noemi, author Richardson, Marina, (Of Institute for Clinical and Economic Review), author Pearson, Steven D., author
- Contributor(s):
- Institute for Clinical and Economic Review, issuing body. Midwest Comparative Effectiveness Public Advisory Council, issuing body.
- Publication:
- [Boston, Massachusetts] : Institute for Clinical and Economic Review, May 10, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Ambulatory Care COVID-19 Drug Treatment Home Infusion Therapy United States
- Genre(s):
- Technical Report
- Abstract:
- COVID-19 is an infectious respiratory disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As of April 2022, there have been over 80 million confirmed COVID-19 cases and 980,000 COVID-19 deaths in the United States (US). The severity of the disease is classified into four levels. Most symptomatic COVID-19 patients have mild or moderate disease and do not require hospitalization. Patients who develop severe or critical disease require hospitalization with respiratory support. Many factors can increase the risk for developing severe or critical COVID-19. Some of the most common risk factors are older age, obesity, cardiovascular disease, and chronic obstructive pulmonary disease. This Evidence Report is considered an Institute for Clinical and Economic Review (ICER) Special Assessment because the epidemiological landscape and evidence base for potential treatments for COVID-19 are both rapidly evolving and will continue to change throughout and beyond the course of this review. This constantly shifting landscape is a dominant contextual reality. However, due to the unprecedented immediacy and scale of COVID-19, and the near-term policy decisions that will be made across multiple treatment options, ICER believes that an independent review of existing evidence on comparative clinical effectiveness and value of these treatment options will be helpful to all stakeholders. In this Evidence Report, ICER is presenting a full evaluation of clinical and economic outcomes of three treatments for mild-to-moderate COVID-19 among outpatients at high risk of progression to severe disease: molnupiravir, Paxlovid™, and fluvoxamine. The scope of the review had additionally included two monoclonal antibody treatments, REGEN-COV and sotrovimab. However, neither treatment currently has emergency use authorization (EUA) from the Food and Drug Administration (FDA) for use in any US region due to substantially reduced activity against the Omicron variant and Omicron BA.2 subvariant, respectively. Around the time of posting of the draft Evidence Report, the FDA granted EUAs for remdesivir and bebtelovimab for our population of interest. Further, peginterferon lambda is seeking EUA based upon recent positive trial results.4 While these treatments emerged too late for us to consider in the Evidence Report, we note that the interactive economic model will be available on ICER Analytics. Decisionmakers can input clinical and economic data on other emerging treatments to generate cost-effectiveness results and suggested health-benefit price benchmarks.
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (various pagings))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918506283506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918506283506676