Pharma giant Roche has repeated assurances that it is going all out to ramp up global production of tocilizumab (Actemra) to cover arthritis patients in therapy as well as supply growing numbers of severely ill COVID-19 patients around the world.
Roche Australia earlier this month notified the TGA and rheumatologists that three formulations of tocilizumab would be affected for varying lengths of time.
It said the Actemra 200mg/10mL vial was already in shortage and expected to remain scarce until 31 August 2021.
It also anticipated 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.
While the uncertain outlook around tocilizumab supply will likely deter doctors from initiating patients on the anti-inflammatory drug, existing patients should not be badly affected if the shortage remains within the indicated timeframe, according to Sydney rheumatologist Dr Sean O’Neill.
In the vast majority of cases, tocilizumab is given by sub-cutaneous injection and alternative medications are available if the supply shortage becomes critical, he told the limbic.
“Medication supply problems are always concerning, but it would not be a big clinical problem for the majority of existing patients,” Dr O’Neill said.
“I understand there are about 5,500 patients in Australia on tocilizumab. The majority – 85% – are on it for rheumatoid arthritis, for which there are a lot of alternatives such as conventional DMARDS, prednisone and other biologic agents you might use if you were initiating a patient.
“Whereas, for other indications there are fewer options. For Giant Cell Arteritis, there’s about 600 patients in Australia and there’s no alternative biologic. It’s pretty much just prednisone in high doses. For juvenile idiopathic arthritis, they have fewer biologics as well.”
Asked by the limbic to put hard numbers on the extent of the expected shortfall, Roche Australia responded:
“During the pandemic, the demand for Actemra (tocilizumab) has increased significantly at a global level.”
“Roche has been working urgently to increase manufacturing capacity and supply by ramping up our global production network and collaborating with external partners and is working with high priority and urgency to cover the Actemra demand globally for patients currently on therapy.
“Roche continues to work closely with TGA and other stakeholders with the goal of minimising the impact on patients in Australia.”
The company is also working with pharmaceutical wholesalers to ensure “equitable access”, including steps to avoid possible stockpiling of Actemra.
The July 5 announcement of the shortage coincided with the World Health Organisation’s recommendation of tocilizumab for use in severe COVID-19 cases.
And on 24 June the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for tocilizumab in the treatment of hospitalized COVID-19 patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).