TGA working with wholesalers to restrict available Actemra stock to community pharmacies and hospitals as stocks dwindle
Australia faces a shortage of arthritis drug Actemra (tocilizumab) following recommendation by the World Health Organisation as treatment for patients seriously ill COVID-19.
Shortages of some iterations of the interleukin-6 (IL6) receptor blocker class drug may, in some cases, last until early next year.
A TGA spokesperson said it was “working with pharmaceutical wholesalers to constrain supply of all Actemra products to hospitals and community pharmacies to facilitate equitable supply of available stock”.
A Medicine Shortages Action Group had been set-up with Actemra sponsor Roche, the Australian Rheumatology Association and Arthritis Australia “to discuss potential clinical management options during the shortage,” it said.
It is understood this is, at least in part, to discourage arthritis patients dependent on the medication from stockpiling.
It said Roche had advised of;
- a current shortage of Actemra 200mg/10mL vial until 31 August 2021
- an anticipated shortage of Actemra 400mg/20mL vial from 1 August 2021 until 31 January 2022
- an additional anticipated shortage of Actemra 162 mg/0.9mL pre-filled syringe from 1 August to 31 August 2021
However Roche had said to the TGA it also expected there were enough overall supplies of Actemra in other “various presentations” that patients were not expected to be impacted, it said.
The shortage is a product of the growing international usage of tocilizumab to reduce inflammation in patients suffering severe COVID-19 symptoms.
Though the repurposing of this drug class to help COVID patients suffering an immune system overreaction has been happening since shortly after the pandemnic hit it has been picking up pace as more evidence and has been presented and earlier this month the World Health Organisation released a statement actively recommending such usage.
It said that IL6 receptor blockers administered to severely or critically ill COVID-19 patients, especially when administered alongside corticosteroids, reduced “the odds of death by 13%, compared to standard care.”
At the same time it called on drug manufacturers to reduce prices “and make supplies available to low- and middle-income countries, especially where COVID-19 is surging”.
Roche took heed of that plea announcing that intertnationally it had “temporarily suspended its patent rights for Actemra in low and middle-income countries”.
A spokesperson for Roche Australia confirmed there was a shortage of some formulations of Actemra “due to a global demand for Actemra that has increased significantly in response to the COVID-19 pandemic”.
“We are working with the Therapeutic Goods Administration (TGA) and pharmaceutical wholesalers to manage supply of tocilizumab products,” the spokespeson said. “Roche is increasing production capacity as much as possible and is working with high priority and urgency to cover the Actemra demand globally”.
Clinical immunology/allergy specialists peak body the Australasian Society of Clinical Immunology and Allergy (ASCIA) flagged the potential of the drug as a potential COVID-19 treatment in May last year in a letter to Health Minister Greg Hunt while also flagging potential “ increased demand and reduced drug access worldwide”.
The letter said “we believe that securing supply for future use, should be a strategic goal of the Australian Government”.
Similarly the Society Of Hospital Pharmacies (SHPA), in a novel therapies overview last year, tipped its members that “a challenge for pharmacists is to juggle demand” as “the use of tocilizumab in COVID-19 could not have been predicted, highlighting the changeability of future demand”.
Actemra is currently approved to treat moderate to severe rheumatoid arthritis, systemic juvenile idiopathic arthritis and CAR-T treatment induced cytokine release syndrome.