Finally, Therapeutics for Severe COVID-19 – But They Come With Hefty Price Tags COVID-19 Science 06/07/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Tocilizumab, manufactured by Roche. After months with virtually no therapeutic options for people with severe COVID-19, the World Health Organization (WHO) recommended the use of a class of medicines called interleukin-6 antagonists on Tuesday. The medicines, tocilizumab and sarilumab, reduced the risk of death and ventilation when combined with corticosteroids, according to a study published the same day in the Journal of the American Medical Association (JAMA). Interleukin-6 is a protein or cytokine that can cause excessive inflammation, and it is a factor in rheumatoid arthritis and many cancers. “In severely ill COVID-19 patients, the immune system overreacts, generating cytokines such as interleukin-6. Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction,” according to the WHO> The use of these drugs reduced the odds of death by 13% in severely ill and critical patients, and the odds of them needing mechanical ventilation by 28%, compared with standard care. These are the first drugs found to be effective against COVID-19 since corticosteroids were recommended by WHO in September 2020 – but they are costly “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. Dr Tedros Adhanom Ghebreyesus, WHO Director General. “The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19. So, the greatest need for these drugs is in countries that currently have the least access. We must urgently change this,” said Tedros. MSF Calls on Roche to Reduce Prices Meanwhile, Médecins Sans Frontières (MSF) called on the Swiss pharmaceutical company, Roche, the world’s only producer of tocilizumab, to lower its price “to make it affordable and accessible for everyone who needs it”. “Even though tocilizumab has been on the market since 2009 for treatment of rheumatologic diseases, access has remained a challenge,” according to MSF. “Roche kept the price of this drug very high in most countries, with price tags ranging from US$410 in Australia, $646 in India to $3,625 in the USA per dose of 600mg for COVID-19.” Julien Potet, Policy Advisor at MSF’s Access Campaign, called on Roche to “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”. “Medical practitioners in many countries in Africa and Latin America, who are grappling with newer and more transmissible variants of coronavirus, are right now struggling to keep their patients alive,” said Potet. “This drug could become essential for treating people with critical and severe cases of COVID-19 and reduce the need for ventilators and medical oxygen which are scarce resources in many places.” Regeneron holds the patent for the second drug, sarilumab, in “at least 50 low- and middle-income countries, raising immediate challenges of ensuring uninterrupted production and supply by diverse producers in these countries”, according to MSF. Study involved almost 11,000 patients The study, a meta-analysis of 27 randomised trials involving nearly 11,000 patients, was coordinated by the WHO in partnership with King’s College London, the University of Bristol, University College London and Guy’s and St Thomas’ NHS Foundation Trust. Researchers examined the clinical benefit of treating hospitalised COVID-19 patients with interleukin-6 antagonists, compared with either a placebo or usual care. They combined data from 27 randomised trials in 28 countries, involving 10,930 patients, 6,449 of whom were randomly assigned to receive interleukin-6 antagonists and 4,481 to receive usual care or placebo. “While science has delivered, we must now turn our attention to access. Given the extent of global vaccine inequity, people in the lowest income countries will be the ones most at risk of severe and critical COVID-19. Those are the people these drugs need to reach,” said Dr Janet Diaz, Lead for Clinical management, WHO Health Emergencies. The WHO has called on companies making the medicines to issue “transparent, non-exclusive voluntary licensing agreements using the C-TAP platform and the Medicines Patent Pool, or to waive exclusivity rights”. It has also launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers. “The main patent on tocilizumab expired in 2017, yet several secondary patents remain on the medicine in a number of low- and middle-income countries that may cause uncertainties,” according to MSF. “Several ‘biosimilar’ versions are under development, but none have been approved by a regulatory authority, meaning that despite being off-patent, Roche continue to have de facto market exclusivity.” India has already started using tocilizumab to treat those with severe COVID-19, but supplies ran out during May, according to MSF. “Over the last few months, we have helplessly witnessed people in South Asia scrambling to get hold of tocilizumab for patients with severe forms of COVID-19,” said Leena Menghaney, Global IP advisor for MSF Access Campaign. “Manufacturers based in low- and middle-income countries urgently need to register and scale up production to increase the global supply. With more than 3.9 million lives already lost to COVID-19, the world cannot wait any longer for access to treatments that can help in increasing the chances of survival.” Image Credits: Roche, WHO. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.