Bedaquiline, which replaces older, more toxic TB treatments, was developed with considerable taxpayer, non-profit and philanthropic support. Operational research carried out by MSF and others was key in generating evidence of bedaquiline’s effectiveness against drug-resistant forms of TB. Additional clinical trials, by MSF and others, are underway that could further inform treatment options containing the drug. Despite these joint efforts, J&J sets the price for bedaquiline at its own discretion, effectively deciding who can have access.
People who can’t access the drug are forced to endure older, toxic treatments, including painful daily injections, that can cause devastating side effects such as permanent deafness and psychosis.
“J&J did not develop this important drug alone, and those who contributed to its development should have a say in how bedaquiline is made accessible at an affordable price for people who need it to stay alive and healthy,” said Dr Els Torreele, Executive Director of MSF’s Access Campaign. “We welcome J&J’s contributions in developing this new and more effective drug, but we can’t rely on company charity programmes to deliver the drugs we need to address global pandemics. For the development of bedaquiline, much of the critical work to demonstrate its therapeutic value was done by the TB community of researchers, ministries of health, and treatment providers, and financed by the public. These contributions must be recognised.”
“Given the joint effort and public investment that went into developing this drug, they should not decide on its price and availability alone," said Sharonann Lynch, HIV & TB Policy Advisor for MSF’s Access Campaign. "Bedaquiline is a gamechanger in fighting TB, the world’s deadliest infectious disease. But what good is a lifesaving drug if the people who need it most can’t get it?”
J&J currently sells bedaquiline for $400 per six-month treatment course to countries eligible to buy the drug through the Global Drug Facility, a TB drug and diagnostic procurement mechanism that is part of Stop TB Partnership, operating out of a UN agency. J&J has not disclosed prices for the drug in other countries. Researchers from the University of Liverpool have calculated that bedaquiline could be produced and sold at a profit for much less – as little as 25 cents per day if at least 108,000 treatment courses are sold per year.
After repeated public calls to J&J to recognise this joint effort and price this medicine more affordably, MSF sent a letter to the corporation in September 2018 to argue the case, but has yet to receive a response.
“J&J needs to agree to sell it for no more than $1 per day. The public has already paid for this drug; it’s time the public has affordable access to it,” said Lynch.
NOTES TO EDITOR
J&J currently sells bedaquiline for $400 per six-month treatment course to countries eligible to buy the drug through the Global Drug Facility, a TB drug and diagnostic procurement mechanism that is part of Stop TB Partnership, operating out of a UN agency. J&J has not disclosed prices for the drug in other countries. Bedaquiline is just one of four or more medicines needed to compose a treatment regimen for drug-resistant TB (DR-TB), and most people require the drug for longer than the marketed duration of six months. As of November 2018, only 28,700 people had received bedaquiline worldwide since it was approved for use in 2012, which is less than 20% of those who could have benefitted from it.
In 2019, the World Health Organization (WHO) issued guidelines recommending bedaquiline as a core drug in the treatment of multidrug-resistant TB, thereby more than tripling the number of people who need it each year.
MSF TB care
MSF is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps, and rural areas. As of September 2018, across MSF projects in 14 countries, more than 2,000 people have been treated with the newer drugs, including 633 with delamanid—the only other new TB drug developed in more than 40 years—1,530 with bedaquiline, and 227 with a combination of both medicines. Safety and efficacy data on the use of bedaquiline in MSF programs continues to contribute to the evidence base informing the use of bedaquiline in the treatment of drug resistant TB. Additionally, MSF is conducting two phase II/III clinical trials involving the use of bedaquiline: endTB and TB PRACTECAL.