Evidence map›Paper›PMID 35490085›Full record

ArticleValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2022

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

Abstract read
In one paragraph

Article in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information.Medical decision making : an international journal of the Society for Medical Decision Making · 2024
    Article
  8. Evidence of quality of life for hospitalised patients with COVID-19: a scoping review.Health technology assessment (Winchester, England) · 2024
    Article
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Stijntje W DijkDepartments of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Eline M KrijkampDepartments of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Natalia KunstDepartment 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.
Cary P GrossCancer Outcomes, Public Policy, and Effectiveness Research Center, Yale University School of Medicine, New Haven, CT, USA.
John B WongDivision of Clinical Decision Making, Tufts Medical Center, Boston, MA, USA.
M G Myriam HuninkDepartments 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.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

objectivesThe 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.

methodsUsing 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.

resultsAssuming 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).

conclusionsEstimating 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.

Indexed as

COVID-19 Drug TreatmentAntibodies, Monoclonal, HumanizedCost-Benefit AnalysisDexamethasoneHumansHydroxychloroquineInterferon beta-1aLopinavirQuality-Adjusted Life YearsRandomized Controlled Trials as TopicRitonavirAntibodies, Monoclonal, HumanizedcasirivimabDexamethasoneHydroxychloroquineimdevimabInterferon beta-1aLopinavirRitonavircost-benefit analysisCOVID-19decision support techniquesdrug approval

Identifiers

PMID35490085
PMCPMC9045876

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.