Reason for request
Application for reimbursement withdrawn by the pharmaceutical company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.
The Committee considers that the clinical benefit of VEKLURY (remdesivir) is:
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||
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