REGEN-COV Joins COVID-19 Treatment List; WHO and MSF Call for Lower Prices and Increased Access
Riviera Beach Fire Rescue starts REGEN-COV Infusion treatments within the city of Riviera Beach, Florida.

REGEN-COV, the antibody cocktail made famous by Donald Trump when he became ill with COVID in 2020,  was added Friday to WHO’s list of recommended drug treatments in updated COVID-19 clinical management guidelines, published Friday. 

At the same time, WHO and Médecins Sans Frontières/Doctors Without Borders (MSF) called on the US pharma firm Regeneron, which developed the cutting-edge drug treatment, to reduce the high prices for the drug and expand now-limited production of the medicine. 

“WHO calls on Regeneron to lower prices and distribute it equitably across all regions, especially in LMICs,” the WHO statement said, adding that Regeneron should also “transfer the technology” so that similar versions of the treatment may be created and easily accessed in lower-income settings. 

“It is simply not fair that people living in low- and middle-income countries cannot access new COVID-19 treatments that can decrease the risk of death because of pharmaceutical companies’ monopolies and wishes for high returns,” said Dr Elin Hoffmann Dahl, Infectious Disease Advisor for the MSF Access Campaign, in another statement from MSF.

He also noted that the pharma company had benefited from significant public funding to develop the cocktail in the first place, with the US signing a US $450 million contract with Regeneron last year.  

Regeneron has ignored pressures by access groups to lower prices and widen access to cocktail

Regeneron has so far ignored pressures by access groups for such concessions. 

It has priced the antiviral cocktail at US $820 in India, US $2,000 in Germany and US $2,100 in the US.  The company also has filed patent applications in at least 11 more low- and middle-income countries (LMICs) – clearly demonstrating its intent to protect markets there against less expensive, biosimilar alternatives.  

The drug is the first to be recommended by WHO for use in patients with non-severe COVID-19, but  at high risk of more severe disease progression.  It’s also being recommended for people with severe infection, but lacking sufficient antibodies of their own. 

The antibody cocktail includes two monoclonal antibodies (mAbs), casirivimad/imdevimab, shown to have decreased the risks of hospitalization for non-severe COVID-19 patients with high risk of developing severe disease.  The drug has also been shown to  decrease the risk of death for COVID-19 patients already in severe condition, with their own antibody deficiencies.  

It was authorized for emergency use by the US  Food and Drug Administration in November, and is now part of the “handful of authorised COVID-19 treatments [that] are becoming standard of care for COVID-19 patients,” according to International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General Thomas Cueni, in a media briefing early September.

“Monoclonal antibody treatments are beginning to offer promise as are novel antivirals,” said Cueni.

MSF: ‘Price Should Reflect Cost of Production’

REGEN-COV is part of a drug class of monoclonal antibodies, or mAbs.

The US has recently purchased an additional 1.4 million doses of REGEN-COV, to be provided at no cost to patients.

Large scale production of monoclonal antibodies (the drug class casirivimab and imdevimab belong to) is estimated to be below $100/per gram, says the MSF statement. 

One dose of REGEN-COV is 1,200 mg, purchased from the US government at US $2,100 per dose. This price is 17 times the value of large-scale production of mAbs. 

Accordingly,  Regeneron should “drop the price to reflect the cost of production”,  MSF said. 

“Regeneron should instead set an example for all manufacturers of monoclonal antibodies by putting people’s lives before profits, immediately lower the price, stop pursuing monopolies and share the know-how and technology to produce casirivimab and imdevimab with manufacturers in low- and middle-income countries.” 

Scarcity of COVID-19 treatment ‘Unacceptable’

Monoclonal antibodies have long been used to treat other diseases, including cancers. There have been long standing problems with high prices and supply shortages for older mAbs used in other treatments as well, said former MSF Emergency Field Coordinator Joan Tubau, who described the situation as “unacceptable.” 

In light of that history, MSF’s concerns about REGEN-COV are particularly acute, he emphasized. 

“Access to new COVID-19 treatments must be ensured, especially in places where vaccine coverage is low and recurrent waves are inevitable, to prevent even more inequity in this deadly pandemic,” said Tubau.

That’s particularly true in light of the history of high-income countries monopolizing COVID-19 vaccines, he said.  

“And yet, we’re seeing the same governments that bought up and stockpiled COVID-19 vaccines make similar advance purchases of COVID-19 treatments, leaving little supply for the rest of the world unless Regeneron allows other companies to help boost the global supply.”

Additionally, REGEN-COV could play a particularly lifesaving role in countries with low vaccination rates.  And yet, paradoxically, those same countries may be the last to be able to access the lifesaving antibody cocktails, she warned, thanks to the market dynamics of pharma sales.  

“In many countries where MSF works in Latin America and Africa, scarce access to hospital beds, insufficient numbers of health care workers to deal with the surge of patients, and lack of medical oxygen makes prevention of hospitalisation vital – an antiviral cocktail like casirivimab/imdevimab could be essential.” 

Image Credits: Riviera Beach Fire Rescue/Twitter, NHS Research Scotland/Twitter.

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