Unitaid and the World Health Organization (WHO) have issued a joint statement regarding the shortage of tocilizumab. This was after Roche issued a statement warning of a global shortage of tocilizumab, an IL6 inhibitor WHO recommended in June for use as a treatment for severe COVID-19 cases.

Tocilizumab can play a key role in decreasing mortality and reducing need for invasive mechanical ventilation among severely ill patients. This is more so, when delivered alongside oxygen and corticosteroids.

WHO and Unitaid noted in the joint statement issued today that they welcome and acknowledge that Roche has announced measures to address the shortage.

Call for equitable supply of available stock

However, “we call on the company to ensure equitable allocation of current stocks of this medicine for all countries”. The statement stresses the availability of stocks particularly to low- and middle-income countries.

“We also strongly encourage Roche to facilitate technology transfer and knowledge and data sharing to broaden access to this important treatment”.
WHO and Unitaid

The statement notes that the ACT-A partnership Access to COVID-19 Tools (ACT) Accelerator partners are working with Roche. This collaboration is to set up channels for distribution of tocilizumab in places where it is not yet in use. It also forms part of their effort to support roll-out of effective new therapeutic products for COVID-19.

In addition, WHO has issued a call for Expression of Interest to its Prequalification programme. This is to expand the number of quality-assured manufacturers of the drug and thus to increase global supplies.

Commitment to ensure vaccine equality

Meanwhile, WHO and Unitaid reiterated their commitment to ensure equitable access to medicines for treating patients with severe COVID-19. According to them, this is a vital element of the effort to fight the pandemic everywhere and save lives.

Roche noted in the statement that tocilizumab has been widely used to treat hospitalised patients with severe or critical COVID-19 around the world. As a result, demand for the medicine has increased to unprecedented levels globally though it has not received the approval for the treatment of COVID-19 in any country.

It is however, accepted for Emergency Use Authorization for hospitalized adults and pediatric patients in the US. These are people who are receiving systemic corticosteroids and require supplemental oxygen.

Additionally, tocilizumab has also now been included in the WHO Therapeutics and COVID-19 living guideline. This is based on the body of evidence that has been generated throughout the last 18 months.

Rise in global demand

The company noted that in 2021 it has supplied Actemra/RoActemra at levels that have increased by more than 100% compared to before the pandemic. Roche revealed in the statement that so far, approximately 60% of its estimated COVID-19 supply has gone to developing countries. This is as a result of the urgent need and represents 300% growth compared to the pre-pandemic supply to these countries.

“We will experience shortages of Actemra/RoActemra globally over the weeks and months ahead”.
Roche

According to Roche, the shortage is due to global manufacturing capacity limits, raw material supply constraints, and the complex, labour-intensive process of manufacturing biologics. It also cited the dynamically evolving nature of the pandemic as one of the reasons.