Public hospitals will now be allocated only a quarter of their usual supplies of intravenous tocilizumab (Actemra) while private hospitals will be limited to 10% of usual supply, the TGA has announced.
The regulator said it had been notified by manufacturer Roche that there was now a critical shortage of the immunosuppressive drug and immediate curbs on supply were necessary to avoid stocks running out completely.
The IL-6 inhibitor is in great demand globally because of its effectiveness against severe COVID-19 disease, and the TGA has previously advised on how tocilizumab should be used sparingly and only for rheumatic disease patients for whom there is no alternative.
In a statement issued on 9 September the TGA said that due to extremely limited stock of intravenous (IV) tocilizumab until early 2022, supply of IV tocilizumab from wholesalers will be reduced to 25% of usual supply for public hospitals and 10% of usual supply for private hospitals and community pharmacy, effective immediately.
Wholesalers will allocate stock to individual hospitals and pharmacies based on an average of 12 months of sales prior to when the shortage began.
“Customers will be limited to purchasing a proportion of their average monthly purchases. Roche will no longer supply Actemra IV directly to hospitals and pharmacies,” the TGA advised.
“These allocations have been developed to support access to patients in greatest need of tocilizumab. We will continue to monitor stock and will review constraints monthly. Hospitals and pharmacies must urgently implement conservation methods to manage stock they have available.”
In a statement co-developed with the Australian Rheumatology Association, pharmacy and industry stakeholders, the TGA said it had been agreed that the priority indications for tocilizumab are Cytokine Release Syndrome (CRS), systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA).
“All patients who are able to, should be moved from intravenous tocilizumab to another treatment during the shortage. Clinicians should prioritise use of their existing and new stock for the priority conditions,” the statement advised.
The other priority group for IV tocilizumab is COVID 19 patients in ICU who are mechanically ventilated or unable to take alternative treatments (such as baricitinib)
“Patients with the above indications have no or very few alternative treatments. Therefore, hospitals and clinics should ensure stock of IV tocilizumab is reserved for these patients,.
“Patients who are prescribed IV tocilizumab for rheumatoid arthritis should be switched to alternate treatments immediately wherever possible,” it added..
The TGA said limited stocks of subcutaneous tocilizumab are available and the priority indications for the SC formulation are systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA).
“New patients should not be started on subcutaneous tocilizumab unless there are no suitable alternative treatments. Wholesalers have been advised to constrain supply of subcutaneous tocilizumab to usual purchasing history,” it said.