Emerging Therapies for COVID-19: The Value of Information From More Clinical Trials

Stijntje W Dijk; Eline M Krijkamp; Natalia Kunst; Cary P Gross; John B Wong; M G Myriam Hunink

doi:10.1016/j.jval.2022.03.016

Emerging Therapies for COVID-19: The Value of Information From More Clinical Trials

Value Health. 2022 Aug;25(8):1268-1280. doi: 10.1016/j.jval.2022.03.016. Epub 2022 Apr 28.

Authors

Stijntje W Dijk¹, Eline M Krijkamp¹, Natalia Kunst², Cary P Gross³, John B Wong⁴, M G Myriam Hunink⁵

Affiliations

¹ Departments of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
² Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA; Cancer Outcomes, Public Policy, and Effectiveness Research Center, Yale University School of Medicine, New Haven, CT, USA.
³ Cancer Outcomes, Public Policy, and Effectiveness Research Center, Yale University School of Medicine, New Haven, CT, USA.
⁴ Division of Clinical Decision Making, Tufts Medical Center, Boston, MA, USA.
⁵ Departments of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands; Netherlands Institute for Health Sciences, Erasmus University Medical Center, Rotterdam, The Netherlands; Center for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: m.hunink@erasmusmc.nl.

Abstract

Objectives: The COVID-19 pandemic necessitates time-sensitive policy and implementation decisions regarding new therapies in the face of uncertainty. This study aimed to quantify consequences of approving therapies or pursuing further research: immediate approval, use only in research, approval with research (eg, emergency use authorization), or reject.

Methods: Using a cohort state-transition model for hospitalized patients with COVID-19, we estimated quality-adjusted life-years (QALYs) and costs associated with the following interventions: hydroxychloroquine, remdesivir, casirivimab-imdevimab, dexamethasone, baricitinib-remdesivir, tocilizumab, lopinavir-ritonavir, interferon beta-1a, and usual care. We used the model outcomes to conduct cost-effectiveness and value of information analyses from a US healthcare perspective and a lifetime horizon.

Results: Assuming a $100 000-per-QALY willingness-to-pay threshold, only remdesivir, casirivimab-imdevimab, dexamethasone, baricitinib-remdesivir, and tocilizumab were (cost-) effective (incremental net health benefit 0.252, 0.164, 0.545, 0.668, and 0.524 QALYs and incremental net monetary benefit $25 249, $16 375, $54 526, $66 826, and $52 378). Our value of information analyses suggest that most value can be obtained if these 5 therapies are approved for immediate use rather than requiring additional randomized controlled trials (RCTs) (net value $20.6 billion, $13.4 billion, $7.4 billion, $54.6 billion, and $7.1 billion), hydroxychloroquine (net value $198 million) is only used in further RCTs if seeking to demonstrate decremental cost-effectiveness and otherwise rejected, and interferon beta-1a and lopinavir-ritonavir are rejected (ie, neither approved nor additional RCTs).

Conclusions: Estimating the real-time value of collecting additional evidence during the pandemic can inform policy makers and clinicians about the optimal moment to implement therapies and whether to perform further research.

Keywords: COVID-19; cost-benefit analysis; decision support techniques; drug approval.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Monoclonal, Humanized
COVID-19 Drug Treatment*
Cost-Benefit Analysis
Dexamethasone
Humans
Hydroxychloroquine / therapeutic use
Interferon beta-1a
Lopinavir / therapeutic use
Quality-Adjusted Life Years
Randomized Controlled Trials as Topic
Ritonavir / therapeutic use

Substances

Antibodies, Monoclonal, Humanized
Lopinavir
imdevimab
Hydroxychloroquine
Dexamethasone
casirivimab
Ritonavir
Interferon beta-1a

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States