ROACTEMRA (tocilizumab) (Covid-19)

Key points

Favourable opinion for reimbursement only in the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, excluding patients requiring invasive mechanical ventilation.

Unfavourable opinion for reimbursement in patients requiring supplemental oxygen by invasive mechanical ventilation.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

The management of COVID-19 patient is detailed in the French High Council for Public Health (HCSP) report of 28 January 2021 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.

According to its report of 17 June 2021 concerning the use of IL1 and IL6 receptor antagonists, the HCSP recommends the use of tocilizumab (anti-IL6), in medical units in patient requiring high-flow supplemental oxygen and with a marked inflammatory status (CRP ≥ 75 mg/L) and in the absence of improvement after 48 hours of standard of care therapy including dexamethasone (or an equivalent corticosteroid). However, in critical care units, the HCSP does not recommend the use of tocilizumab in patients requiring invasive mechanical ventilation.

As regards sarilumab (anti-IL6) and anakinra (anti-IL1), the HCSP does not recommend their use irrespective of the situation.

Role of the medicinal product in the care pathway

ROACTEMRA (tocilizumab) was granted a specific MA for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

On the basis of the available data from the English RECOVERY study conducted in hospitals and the WHO meta-analysis having demonstrated:

• a beneficial effect on the reduction of mortality at 28 days, only in hospitalised patients receiving concomitant corticosteroid therapy and requiring supplemental oxygen, excluding patients requiring invasive mechanical ventilation,
• an absence of clinical benefit in patients not receiving concomitant corticosteroid therapy or requiring invasive mechanical ventilation.

the Committee considers that ROACTEMRA (tocilizumab) could constitute, in combination with the standard of care including corticosteroid therapy, a therapeutic option in the treatment of adult patients hospitalised for COVID-19 who are receiving concomitant corticosteroid therapy and require supplemental oxygen, excluding patients requiring invasive mechanical ventilation. Early administration following hospitalisation appears to be an important factor.

The Committee does not recommend its use in patients not receiving concomitant corticosteroid therapy (population excluded from the MA) or requiring invasive mechanical ventilation.

The Committee highlights the absence of data in immunocompromised patients (a population at high risk of severe COVID-19) for whom the risk of infection not related to COVID-19 could be increased by the use of this immunosuppressive treatment.

Special recommendations

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