Médecins Sans Frontières (MSF)/Doctors Without Borders has called on the Swiss pharmaceutical corporation, Roche, the sole producer of the drug Tocilizumab, to lower the price of their drug and make it affordable and accessible for other countries battling COVID-19.
Tocilizumab is the second drug recommended by WHO for COVID-19 treatment after recommending dexamethasone in Sept. 2020.
It belongs to the class of drugs called monoclonal antibodies (mAbs), used in the treatment of various diseases including cancers.
However, most of the existing mAbs have been priced extremely high, and are virtually impossible to access in low- and middle-income countries.
“Medical practitioners in Africa and Latin America, who are struggling with transmissible variants of coronavirus, are now struggling to keep their patients alive. This drug could become essential for treating people with severe cases of COVID-19 and reduce the need for ventilators which are scarce resources in many places,” said Julien Potet, Neglected Tropical Diseases Policy Advisor at MSF’s Access Campaign.
“Roche must stop following a business-as-usual approach and take urgent steps to make this drug accessible and affordable for everyone who needs it by reducing the price and transferring the technology, know-how and cell lines to other manufacturers. Too many lives are at stake.”
Even though Tocilizumab has been in the market since 2009 for treatment of rheumatologic diseases, access has remained a challenge.
Roche kept the price of this drug very high in most countries, with price tags ranging from$410 in Australia, $646 in India to $3,625 in the USA per dose of 600mg for COVID-19.
The cost to manufacture Tocilizumab is estimated to be as low as $40 per dose of 400mg, given that the manufacturing costs of monoclonal antibodies are below $100 per gram when produced on a large-scale.
In this raging pandemic, people in low and middle-income countries continue to fall sick and demand for this drug is expected to increase.
Shortages of Tocilizumab have been observed in many countries that have started using it for COVID-19 treatment. In India, during the second wave in May, Roche’s distributor ran out of the drug and not a single vial was available in the country for critical patients.
“Over the last few months, we have witnessed people in South Asia struggle to get tocilizumab for patients with severe COVID-19, manufacturers based in low- and middle-income countries urgently need to register and scale up production to increase the global supply,” said Leena Menghaney, Global IP advisor for MSF Access Campaign.
“With more than 3.9 million lives already lost to COVID-19, the world cannot wait to access treatments that can help in increasing the chances of survival.”
While there are few mAbs that have been approved by the US Food and Drug Administration for treatment of COVID-19, there are many newer mAbs that are currently being investigated as potential treatments. However, high prices and limited volumes of mAbs is expected to remain a barrier for accessing these drugs in low- and middle-income countries.
Two new antiviral mAbs, casivirimab and imdevimab, produced as a cocktail by the US pharmaceutical corporation Regeneron, have recently showed in a clinical trial to decrease the risk of death among hospitalised seronegative COVID-19 patients who were in critical condition.
While these mAbs are not yet recommended by the WHO, Regeneron has valued this cocktail at a price of $820 in India, $2,000 in Germany and $2,100 in the USA.
Another mAb recommended by WHO today, sarilumab is under wide patent protection globally.
Regeneron has applied for and been granted patents on sarilumab and its formulation in at least 50 low and middle-income countries, raising immediate challenges of ensuring uninterrupted production and supply by diverse producers in these countries.
“With several monoclonal antibodies in the pipeline that could be useful in treating COVID-19, but also others are available or in development for treating other diseases including various cancers, governments need to step up to ensure wider accessibility and affordability for this critical class of drug,” said Potet.
“MSF is also calling on all governments to overcome the intellectual property barriers on these crucial drugs by supporting the “TRIPS waiver” at the World Trade Organisation.”
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