NEW YORK/GENEVA, NOVEMBER 8, 2022—As two newer tuberculosis (TB) drugs, bedaquiline and delamanid, are set to go off patent in 2023, the pharmaceutical corporations that produce these medicines must remove additional barriers so more manufacturers can enter the market and bring prices down, said Doctors Without Borders/Médecins Sans Frontières (MSF) as the Union World Conference on Lung Health 2022 starts today. This would expand access to shorter, safer, and better treatment options for people with drug-resistant forms of the disease (DR-TB) at a time when cases have been increasing for the first time in years.
“I was diagnosed with DR-TB in 2013 and was treated with older medicines with terrible side effects that left me in significant pain, did not cure me, and ultimately resulted in the loss of one of my lungs,” said Meera Yadav, XDR-TB survivor in Mumbai, India and co-petitioner in a TB survivors’ court case for the Indian government to override patents on bedaquiline and delamanid. “When I was finally able to access the newer, lifesaving TB drugs, I realized that no one should have to go through such a harrowing experience. It is outrageous that patents and other barriers are stopping anyone who needs these TB drugs from accessing them.”
MSF’s new DR-TB Drugs Under the Microscope report examines the pricing and patent landscape of DR-TB medicines for adults and children and finds that extremely high prices are still being charged for newer TB drugs. This is a key factor hampering treatment scale-up. Currently, bedaquiline and delamanid are still patented medicines for which the originator pharmaceutical corporations, Johnson & Johnson (J&J) and Otsuka, respectively, have a global monopoly blocking price-lowering competition among generic manufacturers. However, with patents on bedaquiline and delamanid expiring in 2023, generic manufacturers could enter the market and help lower prices.
According to research that estimates the cost of production plus a reasonable profit for the company, delamanid is a shocking 13-18 times more expensive than it could be—ranging from $1,250 to $1,700 for a six-month treatment course when it could be priced at $96. Bedaquiline is almost three times more expensive than it could be, at $270 for a six-month treatment course when it could be $102.
The expiration of patents isn’t enough to lower prices alone. Additional barriers may prevent this, including secondary patents that extend the term of the monopoly for J&J and Otsuka in several countries, as well as opaque and restrictive licenses that undermine competition, such as the restrictive voluntary license between J&J and the not-for-profit organization TB Alliance. In addition, generic manufacturers require samples of the originator product like delamanid or bedaquiline to conduct the studies necessary to bring quality-assured generic medicines to market. However, pharmaceutical corporations generally do not make their products available for such studies. The World Health Organization (WHO) should address this additional barrier to entry by establishing a process for obtaining the necessary samples so other companies can make more affordable versions.
"In our Mumbai clinic, we are receiving increasing numbers of patients with TB with complex resistance who are in need of bedaquiline and delamanid to form an effective treatment regimen,” said Dr. Mabel Morales, medical coordinator for MSF in India. “There is an urgent need for delamanid to be more widely available for patients for whom an effective regimen cannot otherwise be formulated. The high price of delamanid is not only limiting our capacity to treat more patients but is also limiting the efforts of national TB programs to scale up the treatment.”
In addition to bedaquiline and delamanid, the TB drug pretomanid remains an important component of DR-TB treatment regimens, including in the new BPaLM regimen evaluated in MSF’s TB PRACTECAL clinical trial and recommended by WHO in May 2022. However, the current lowest global price for this regimen is out of reach at around $700 for a six-month course, with pretomanid alone accounting for nearly half the cost at $336. Given the significant public funding that the TB Alliance received for the development of pretomanid, this is unacceptable, especially considering that research estimates it could be produced and sold at profit for $210, much less than its current price. MSF has contended that, in total, the price of a complete DR-TB treatment course should be no more than $500 per person.
“Bedaquiline, delamanid, and pretomanid are game-changing TB drugs that could help save many more lives, so everyone with DR-TB should be able to access them,” said Christophe Perrin, TB advocacy pharmacist with MSF’s Access Campaign. “Drug corporations should not put their profits over people’s lives. It’s time for all three newer TB drugs to be affordable.”
MSF is one of the largest non-governmental providers of TB treatment in the world. In 2021, 17,221 people in MSF’s care were started on TB treatment, including 2,309 with DR-TB.