The global public-health agency updated its Covid-19 treatment guidelines on Tuesday to strongly recommend that people with severe or critical disease be given drugs tocilizumab and sarilumab to combat the haywire inflammatory immune reaction of some patients.
The drugs are designed to block a protein called interleukin-6, or IL-6, that is thought to play a role in the hyper-inflammation experienced by some Covid-19 patients.
The WHO said the drugs are the first found to be effective against Covid-19 since the agency recommended the use of steroids in September.
“Patients severely or critically ill with Covid-19 often suffer from an overreaction of the immune system, which can be very harmful to the patient’s health,” the WHO said in a statement. “Interleukin-6 blocking drugs-tocilizumab and sarilumab-act to suppress this overreaction.”
As the World Health Organization (WHO) recommended tocilizumab today for people with severe COVID-19, Médecins Sans Frontières/Doctors Without Borders (MSF) has called on the Swiss pharmaceutical corporation Roche, the world’s sole producer of the drug, to lower the price of the drug to make it affordable and accessible for everyone who needs it, everywhere. Roche must end its monopoly and urgently share the know-how, master cell lines and technology needed to produce this drug with other manufacturers across the world to ensure supply and improved access.
Tocilizumab is the second drug ever recommended by the WHO for COVID-19 treatment after recommending dexamethasone in September 2020. It belongs to the class of drugs called monoclonal antibodies (mAbs), that are used in the treatment of various diseases including cancers. However, most of the existing mAbs have been priced extremely high, and are hence virtually impossible to access in low- and middle-income countries.
“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 Julien Potet, Neglected Tropical Diseases Policy Advisor at MSF’s Access Campaign. “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. 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 on 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 US$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 often below $100 per gram when produced on a large-scale. Roche should agree to sell tocilizumab for COVID-19 at a much more affordable price than they currently do.
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. Several ‘biosimilar’ versions are under development, but none have been approved by a regulatory authority, meaning that despite being off-patent, Roche continues to have de facto market exclusivity that impacts the availability of the drug in the absence of sufficient supply. (WSJ, ReliefWeb)