HAS says Gilead's Veklury 'does not improve benefit' for COVID19 patients; EMA to review safety
HAS announced that Gilead has withdrawn the refund request of Veklury (remdesivir) for COVID19 patients.
HAS conducted the assessment and considered the drug to be fit for the reimbursement in patients aged 12 years or over and weighing at least 40 kg, hospitalized for COVID-19 with pneumonia requiring low-flow oxygen therapy. However, HAS was not in favor of the reimbursement in patients who require high-flow oxygen therapy or oxygen therapy during non-invasive assisted ventilation or invasive or extracorporeal membrane oxygen therapy (ECMO).
In France, currently, corticosteroids were considered as a recommended therapy for severe COVID19 patients.
HAS commented that there are uncertainties in the clinical trial data of Veklury; however, the drug is of use in certain patients.
During the assessment, the HTA body considered NIAID ACTT study; questioned the clinical recovery rate's appropriateness as the primary endpoint. The recovery time of Veklury + SoC was 11 days compared to the placebo arm. Subgroup analysis showed that significant improvement was demonstrated only in patients who require low oxygen flow and showed no improvement in the severe forms of COVID19 patients.
The HTA body has requested more data to determine the efficacy of the drug.
Veklury received SMR low in patients requiring low flow oxygen therapy and insufficient (no reimbursement) in patients requiring high flow oxygen therapy.
The product received ASMR V, making it challenging for the product to receive any premium price.
Meanwhile, EMA started reviewing the safety profile Veklury (remdesivir). There were reports that Veklury causes kidney injury. Veklury has received conditional marketing authorization from EMA, meaning the regulatory body requires more data post-authorization of the drug.
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