The availability of RoActemra (tocilizumab), a drug used for certain rheumatological and hematological disorders, can still not be fully guaranteed. Currently, there is a stock for both the intravenous and subcutaneous form of administration, taking into account the previously approved indications, i.e. exclusive use in COVID-19 patients. Based on the information currently available to the FAMHP, Roche will also not be able to confirm deliveries long in advance in the coming months.
On 6 December 2021, the European Medicines Agency (EMA) published recommendations to add treatment of severe COVID-19 in adults to the approved indications for the intravenous administration form of RoActemra. This recommendation was forwarded to the European Commission, which approved it.
Effective use for COVID-19 could mean faster depletion of the stockpile. The FAMHP therefore continues to emphasise the importance of the rational use of stocks. The attending physician's decision should be based on the assessed risk to the individual patient and the expected efficacy and side effects of the treatment.
The experts from the Unavailability Task Force have drawn up new recommendations for (hospital) pharmacists, general practitioners and specialist doctors:
There is prioritisation according to the indication for which the drug can be used. In order of priority, this is:
1. Cytokine Release Syndrome (CRS) after CAR T-cell therapy
At the request of the Unavailability Task Force and in collaboration with the centres involved, Roche has reserved the stock necessary for this indication.
2. Giant Cell Arteritis (GCA)
Where availability permits, RoActemra can be used subcutaneously (S.C.). Consider extending interval between two doses where the patient's situation permits.
Restart or increase the dose of another treatment, such as corticosteroids.
3. Active systemic juvenile idiopathic arthritis (sJIA) and Juvenile idiopathic polyarthritis (pJIA)
Where availability permits, RoActemra can be used subcutaneously (S.C.) or intravenously (I.V.). Consider dose reduction (for I.V.) or extending interval (for S.C.) where the patient's situation permits.
Addition or increase in dose of a conventional/biological/targeted oral Disease Modifying AntiRheumatic Drug (DMARD) and/or glucocorticoids.
4. Rheumatoid arthritis (RA)
- In patients already being treated with RoActemra
- As availability permits, if the use of RoActemra is really necessary and where the patient's situation permits: switch from I.V. to S.C. or vice versa. Consider dose reduction (for I.V.) or extending interval (for S.C.).
- Switching to an alternative drug (e.g. Sarilumab) where RoActemra is not available.
- In patients with a new indication for starting an interleukin-6 antagonist
- Start-up with an alternative interleukin-6 blocking drug (e.g. Sarilumab).
- Where Sarilumab is not available, add or increase the dose of the ongoing conventional/biological/targeted oral DMARD and/or glucocorticoids.
A single administration of RoActemra I.V. 8mg/kg must be limited to a subset of patients within the approved indication. Specifically, patients under therapy with corticosteroids, who progress from severe to critical COVID-19 with exponentially increasing oxygen deprivation and high inflammation rate. For these patients, treatment must be started early (within two to three days of hospital admission and within 24 hours of starting oxygen organ support in the intensive care unit).
The FAMHP will continue to monitor the situation closely at a Belgian and European level.