WHO Recommends Two New COVID-19 Treatments – Cost and Availability Likely Barriers Medicines & Vaccines 14/01/2022 • Maayan Hoffman 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 email this to a friend (Opens in new window)Click to print (Opens in new window) COVID patient in hospital Two new treatments for COVID-19 were recommended on Thursday by the World Health Organization’s Guideline Development Group of international experts – one for severely ill patients and the other for those patients who are not severely ill but most likely to develop severe disease. The recommendations were announced Friday morning in the BMJ. Both drugs, however, are patented and could be expensive and lack accessibility for some low- and middle-income countries, some advocates warned. The first drug, baricitinib – a type of drug known as a Janus kinase (JAK) inhibitor – was “strongly recommended” for patients in severe or even critical condition from COVID-19. The drug has been used to treat rheumatoid arthritis and it is recommended that four milligrams be given once daily for 14 days in addition to previously-recommended corticosteroids. “The strong recommendation is based on evidence that it reduces mortality, shortens hospital stays and reduces the risk of requiring mechanical ventilation, with no observed increase in adverse effects,” explained François Lamontagne, Professor of Medicine at the Université de Sherbrooke, who sits on the panel, in an interview with Health Policy Watch. He explained that JAK inhibitors modulate the body’s response to an infection. The WHO experts noted that two other JAK inhibitors – ruxolitinib and tofacitinib – should not be used to treat patients with severe disease because “low certainty evidence from small trials failed to show benefit and suggests a possible increase in serious side effects with tofacitinib.” COVID-19 treatments and vaccines ‘Uncertain’ effectiveness against Omicron The second treatment that the panel recommended is a monoclonal antibody called sotrovimab, which is meant for patients with non-severe COVID-19 but who are at risk for developing severe disease. Sotrovimab, Lamontagne said, consists of antibodies directed against a specific part of the virus that prevents entry of the virus into cells. This drug is given intravenously, requiring one infusion. Lamontagne noted, however, that the panel only provided a “weak” recommendation of the treatment because the effectiveness of sotrovimab against Omicron is still uncertain. The recommendations are based on evidence from four trials (three for baricitinib and one for sotrovimab) involving several thousand people, Lamontagne said. WHO noted that “the panel considered a combination of evidence assessing relative benefits and harms, values and preferences and feasibility issues.” Baricitinib and sotrovimab join a concise list of drugs recommended by WHO experts, including the use of interleukin-6 receptor blockers and systemic corticosteroids for patients with severe or critical COVID-19, and conditional recommendations for the use of casirivimab-imdevimab in selected patients. WHO has recommended against the use of convalescent plasma, ivermectin and hydroxychloroquine. No formal recommendation yet from WHO on new oral drugs – Paxlovid and monulpiravir Significantly, WHO has not yet made a formal recommendation on the two new oral drug treatments that have now come on the market – Pfizer’s Paxlovid or Merck’s Molnupiravir. This is despite the fact that both drugs have been approved by the US Food and Drug Administration, and the Medicines Patent Pool has also contracted with Pfizer and Merck to produce generic versions of each drug for low-income countries. Countries around the world are rushing to secure doses of Paxlovid, in particular, due to its high efficacy and safety profile in the FDA reviews – where it has been reported to be 90% effective in preventing severe disease when administered early in the course of infection. Asked why the Organization had not yet made a recommendation on either drug, a WHO spokesperson pointed to a WHO Guidelines Development Group meeting that is scheduled to review Paxlovid [nirmatrelvir] on 9 February. “Based on an assessment of the totality of the evidence, WHO will make a recommendation,” the spokesperson said, saying that safety monitoring, affordability and access all need to be considered in any WHO recommendation on either drug. The WHO spokesperson, also stressed that “even if proven safe and effective, these drugs will not be an alternatives to vaccines.” The spokeperson also stressed that any new oral drugs also “should be made available and affordable in all countries”. Access advocates have complained that the current generic production arrangements for Paxlovid, aimed at 95 low-income countries, still leaves many gaps in affordability and access among lower-middle and middle-income countries which cannot afford the high prices of patented versions. ‘Baricitinib example of why TRIPS Waiver urgently needed’ Similarly, the cost and availability of both of the newly WHO-recommeded drugs could still also be barriers to their use in low- and middle-income countries, Lamontagne said. “These additional therapies are newer, not produced on the same scale [and some other drugs], not as available and are more costly,” Lamontagne said. “The panel that makes those favorable recommendations is aware of this and is aware there is a risk that these interventions won’t be available similarly everywhere and that this could worsen the differences in access to healthcare. “But at same time, in making those recommendations and stating that those are potentially life-saving and important therapies, the panel hopes to stress how important it is to strive to improve the accessibility of these emerging therapies across the board – in lower income areas just like in higher income areas,” he continued. Médecins Sans Frontières/Doctors Without Borders (MSF) reacted to the recommendations by calling on governments to “take immediate steps to ensure that patent monopolies do not stand in the way of access to this treatment.” The organization said that in many countries, generic baricitinib will not be available as the drug is under patent monopoly, including in some countries hit hard by the pandemic, such as Brazil, Russia, South Africa and Indonesia. In most cases, the patents do not expire until 2029. “Baricitinib is another example of why the TRIPS Waiver is urgently needed,” MSF said in a statement. “As new treatments emerge, it will be simply inhumane if they remain unavailable in resource-limited settings, just because they are patented and too expensive,” stressed Dr. Márcio da Fonseca, an infectious disease medical advisor who spoke on behalf of MSF. “With these proven therapeutics recommended by the WHO, it’s time now for low- and middle-income countries to finally access these therapies that are already in routine use in many high-income countries.” Image Credits: Wikimedia Commons, Bicanski on Pixnio. 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