NEW YORK/THE HAGUE, OCTOBER 23, 2018—As US pharmaceutical corporation Johnson & Johnson (J&J) continues to charge high prices for its newer tuberculosis (TB) drug bedaquiline, people with drug-resistant tuberculosis (DR-TB) are forced to go without the best possible treatments, according to a new report—DR-TB Drugs Under the Microscope—released today by Doctors Without Borders/Médecins Sans Frontières (MSF) at the 49th Union World Conference on Lung Health in The Hague. J&J should cut the price of bedaquiline in half so more lives can be saved, said the international medical humanitarian organization MSF.
According to the report, J&J’s high prices remain a significant barrier to accessing bedaquiline even though the World Health Organization (WHO) recommended in August expanding the use of this drug by making it a core drug for treatment of DR-TB. This recommendation increases the number of people who should receive bedaquiline and requires national TB treatment programs to scale it up as part of the DR-TB treatment they provide. The WHO’s recommendations also relegate drugs that need to be injected daily—ones that can cause deafness, renal failures, and other severe side effects—to last resort options only.
“These newer TB drugs will save more lives, benefit programs, and make this arduous treatment more tolerable for people,” said Sharonann Lynch, HIV & TB advisor for MSF’s Access Campaign. “But if they remain priced out of reach, they will not serve their purpose and the expected gains will not be achieved. Unless pharmaceutical corporations lower their prices substantially, people will continue to suffer without access to safer and more effective treatment.”
MSF’s research shows that the high price of the two newest and more effective TB drugs bedaquiline and delamanid—produced by Japanese pharmaceutical company Otsuka—makes DR-TB treatment regimens more expensive than previous treatment regimens. People with DR-TB must receive individually tailored treatment consisting of at least five drugs for different durations. The estimated price of longer individualized treatment regimens could now reach more than $2,000 for people who need at least 18 months of bedaquiline, which would represent a 50 percent price increase over previous standard treatment. For people who might need both bedaquiline and delamanid for as long as 20 months, the price increase could reach 500 percent, with a treatment regimen priced at around $9,000.
J&J recently announced a price reduction for bedaquiline for some countries, but this falls short of making the drug affordable in countries hardest hit by the DR-TB epidemic. Its price of $400 for six months of treatment is still too high, as many people need the drug for significantly longer than six months, driving the price of a cure even higher.
“To save as many lives as possible and really scale up treatment, the price of a full DR-TB treatment regimen should be no higher than $500 per person in all low- and middle-income countries, plus high-burden TB countries,” Lynch said.
An estimated 558,000 people developed DR-TB in 2017, but only 25 percent of those estimated cases were treated. Standard DR-TB treatment used by most countries up to now has required people to take up to 14,000 pills for nearly two years, including up to eight months of painful daily injections, causing severe side effects. The cure rate with these medicines is only 55 percent.
“The new treatment recommendations from WHO represent the best chance for a cure with fewer debilitating side effects for people with drug-resistant TB,” said Dr. Naira Khachatryan, medical coordinator of MSF’s project in Armenia. “If bedaquiline continues to be too expensive, countries will have limited opportunity to scale up treatment, and we’ll be stuck with the deadly status quo where the majority of affected people will not have a chance to benefit from more effective treatment.”
J&J, which received substantial taxpayer money from the US and other governments for the development of bedaquiline, has failed to register bedaquiline in many countries that need it, including many high-burden TB countries.
MSF 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. In 2017, MSF supported more than 22,000 people with TB on treatment, including 3,600 people with drug-resistant forms of TB. Across MSF projects in 14 countries, more than 2,000 people have been treated with the newer drugs—633 with delamanid, 1,530 with bedaquiline, and 227 with a combination of both medicines—as of September 2018. Additionally, MSF is participating in two of several clinical trials underway, endTB and PRACTECAL, that are evaluating the optimal use of bedaquiline, delamanid, and other new medicines in shorter DR-TB regimens.