DEXAMETHASONE MYLAN (dexamethasone)

Key points

Favourable opinion for reimbursement in the treatment of SARS-CoV-2 19 coronavirus infection (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy.

What therapeutic improvement?

Therapeutic improvement in management.

Role in the care pathway?

The management of COVID-19 patient is detailed in the French High Council for Public Health (HCSP) report of 25 November 2020 and is based on supportive and preventive treatments:

• Appropriate oxygen therapy,
• Analgesics and antipyretics,
• Prevention of the thrombotic risk,
• Antibacterial antibiotics in the event of arguments in favour of co-infection.

Corticosteroid therapy is an integral component of the standard of care according to national (HCSP) and international (WHO) guidelines.

No other specific immunomodulatory or antiviral treatment is currently recommended outside of clinical trials.

Role of the medicinal product in the care pathway

DEXAMETHASONE MYLAN and KRKA for injection are the first dexamethasone-based medicinal products to have obtained a specific MA in the treatment of COVID-19 in adult and adolescent patients who require supplemental oxygen therapy. The recommended dosage regimen, in accordance with the RCP, is 6 mg per day intravenously for a maximum of 10 days, depending on the patient’s clinical condition.

Oral or IV dexamethasone is the first-line treatment for hospitalised patients with COVID-19 receiving oxygen therapy. At present, it is the only curative medicinal product having demonstrated a benefit in terms of reducing mortality in hospitalised patients with COVID-19 requiring supplemental oxygen.

The Committee points out that systemic corticosteroid therapy, including with dexamethasone, is not recommended in COVID-19 patients not requiring supplemental oxygen, since the available data has not demonstrated a benefit in this clinical situation. It should be noted that corticosteroid therapy may be detrimental at early stages of the disease not requiring supplemental oxygen.

In addition, the Committee highlights the fact that data in patients aged over 70 years is limited, as well as the lack of clinical data in special populations (pregnant women, children) and data relative to optimisation of the treatment regimen in terms of dose and duration based on patient characteristics (age, weight, etc.).

Special recommendations

The Committee would like new presentations better suited to the dosage regimens to be made available, particularly a 6 mg/ml strength and an oral form.

The Committee points out that demonstration of the value of dexamethasone in COVID-19 is the fruit of academic clinical research work.