Tocilizumab shortage in Australia as WHO approves use for COVID-19

Australia is facing a shortage of tocilizumab (Actemra) until at least September due to a surge in global demand for its use in treating COVID-19 patients.

Roche Australia has written to rheumatologists to advise that as of July 5 there was “an immediate shortage” of Actemra IV 200mg in Australia, and the company anticipated a shortage of Actemra IV 400mg and Actemra pre-filled syringe in August 2021. Tocilizumab is used for patients with rheumatoid arthritis, juvenile idiopathic arthritis and Giant Cell Arteritis.

Roche said it would do its best to provide up-to-date information on supply of the drug in Australia and would “work with healthcare professionals  to ensure the supply of Actemra to patients who need it most”.

The shortage coincides with the World Health Organisation recommending the use of interleukin-6 (IL-6) receptor blockers for severe and critical patients hospitalised with COVID after reviewing results from clinical trials.

Announcing the recommendation on July 6, the WHO said its decision was based on data from more than 10,000 patients enrolled in 27 clinical trials showing that the drugs reduced the odds of death by 13%, compared to standard care.

The WHO also called on the producers of IL-6 receptor blockers to rapidly increase access, particularly to low income countries where COVID-19 is surging.

“These drugs offer hope for patients and families who are suffering from the devastating impact of severe and critical COVID-19. But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

WHO also encouraged companies to agree to transparent, non-exclusive voluntary licensing agreements or to waive exclusivity rights.

Roche – the sole producer of tocilizumab – temporarily suspended its patent rights for the drug in low- and middle-income countries last week following the WHO recommendation.

Roche Australia said the shortfall in tocilizumab here had come about despite the Swiss company’s efforts to increase production amid soaring global demand in response to COVID-19.

“The supply situation has been evolving with the pandemic, resulting in different formulations of Actemra being affected,” the company said.

“Roche has increased production capacity during the constraints of the pandemic as much as possible and is working with high priority and urgency to cover the Actemra demand globally for patients on therapy for rheumatoid arthritis, polyarticular/systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.”

“We have increased our own production capacity significantly and have been working with external manufacturers on transferring our technologies to further increase global supply,” the company said in a statement after the WHO announcement.

“Despite all these efforts, it may still not be enough to meet the unprecedented demand for Actemra/RoActemra,” it said.

The TGA said it has “been closely working with Roche Australia regarding the supply of Actemra (tocilizumab) in Australia. The TGA is also working with the relevant peak body groups to assess how doctors can best assist their patients who use Actemra, and with pharmaceutical wholesalers to constrain supply of Actemra to facilitate equitable supply.”

“Roche has advised the TGA there is a current shortage of Actemra 200mg/10mL vial until 31 August 2021. Roche currently anticipates there will be a shortage of Actemra 400mg/20mL vial from 1 August 2021 until 31 January 2022 and Actemra 162 mg/0.9mL pre-filled syringe from 1 August to 31 August 2021,” it said in a statement to the limbic.

In May 2020, specialist groups wrote to health minister Greg Hunt warning of an impending spike in demand for IL-6 inhibitors and urging him to secure supplies for Australia.

“We believe that there is a rapidly closing window to secure supply of IL-6 blockers, before a large trial is reported out of Italy, which is likely to lead to increased demand and reduced drug access worldwide,” he was told by the COVID-19 Working Party of the Australasian Society of Clinical Immunology and Allergy (ASCIA).

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