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VEKLURY

Opinions on drugs - Posted on Oct 23 2020

Reason for request

Inclusion in list

First assessment

Application for reimbursement withdrawn by the pharmaceutical company

Favourable opinion for reimbursement only in the treatment of COVID-19 in hospitalised patients aged 12 years and older with body weight at least 40 kg with pneumonia requiring low-flow supplemental oxygen and at the MA dosages.

Unfavourable opinion for reimbursement in the treatment of COVID-19 in hospitalised patients aged 12 years and older with body weight at least 40 kg with pneumonia requiring high-flow supplemental oxygen or supplemental oxygen during non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Maintenance of the conclusions of this opinion is subject to submission of data at D28, in particular mortality data from the American ACTT trial whenever these become available and, at the latest, in October 2020.

On 31 August 2020, the pharmaceutical company Gilead withdrew its application for reimbursement of the proprietary medicinal product VEKLURY (remdesivir).

No clinical added value on the basis of currently available data.


Clinical Benefit

Low

The Committee considers that the clinical benefit of VEKLURY (remdesivir) is:

  • LOW in the treatment of COVID-19 in hospitalised patients aged 12 years and older with body weight at least 40 kg with pneumonia requiring low-flow supplemental oxygen;

 

Insufficient
  • INSUFFICIENT to justify its funding by the French national health insurance system in the treatment of COVID-19 in hospitalised patients aged 12 years and older with body weight at least 40 kg with pneumonia requiring high-flow supplemental oxygen or supplemental oxygen during non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

The Committee indicates that maintenance of this assessment is conditional on reevaluation of VEKLURY (remdesivir), in particular based on D28 mortality data from the American ACTT trial, whenever these become available and, at the latest, by October 2020.

This assessment reflects the still high level of uncertainty with respect to the efficacy and safety of VEKLURY (remdesivir) in a context of very rapidly evolving treatment strategies and the public health need


Clinical Added Value

no clinical added value

Considering:

  • the available clinical data limited to the results of 3 comparative studies conducted in hospitalised patients (Chinese study NCT04257656 stopped early, preliminary results of the American ACTT study, SIMPLE study without a control group) presenting numerous methodological limitations and conflicting results,
  • preliminary results from the pivotal American ACTT study with the biggest population (n = 1,063 hospitalised patients with pneumonia, including 88.7% with a severe form requiring oxygen), which suggest an at best weak effect size of remdesivir versus placebo, in combination with the standard of care: 4-day reduction in the time to clinical recovery (11 days versus 15 days; HR=1.32 [1.12-1.55]), primary endpoint of debatable clinical relevance,
  • and the absence of any demonstrated impact in this study on the reduction in mortality at D14 (7.1% in the remdesivir group versus 11.9% in the placebo group (HR = 0.70; 95% CI [0.47 to 1.04], NS, secondary endpoint), although the subgroup analyses suggest a positive effect on this endpoint only in the subgroup of patients receiving low-flow supplemental oxygen,
  • the absence of mortality data at D28 in the ACTT study,
  • the absence of data enabling a robust conclusion to be reached with respect to efficacy depending on the stage of the disease and the optimal treatment duration;
  • the absence of a demonstrated impact of remdesivir in terms of the expected negative conversion of viral load;
  • and despite the medical need to have access to effective and well-tolerated curative treatments for COVID-19 due to its severity, its contagiousness and its impact on healthcare organisation, particularly in intensive care units, as well as the absence of an available curative treatment;

On the basis of currently available data, the Committee considers that VEKLURY (remdesivir) provides no clinical added value (CAV V) for the treatment of COVID-19 in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia and receiving low-flow supplemental oxygen


Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 16 juillet 2020.

 

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