The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is calling on governments and donors to speed up access to new, shorter, safer, and more effective treatments for drug-resistant tuberculosis (DR-TB), as well as the diagnostic tests needed to initiate treatment on these medicines. This is part of a “Call to Action” that MSF joined with the World Health Organization (WHO) and other actors ahead of World TB Day on March 24.
Following MSF’s TB PRACTECAL clinical trial, WHO issued new guidelines in December 2022 that recommend countries roll out a safer and shorter regimen called BPaLM to treat people with DR-TB—a six-month regimen comprised of bedaquiline, pretomanid, linezolid, and moxifloxacin. However, a lack of access to diagnostic testing for resistance is standing in the way of rolling out safer and shorter DR-TB treatment regimens.
“In a country like Afghanistan, where people are struggling to afford basic food items, travel expenses, and medical fees at hospitals, being able to treat people with DR-TB within six months instead of up to two years with the older treatment regimens would be a blessing,” said Dr. Geke Huisman, MSF medical coordinator in Afghanistan. “Access to affordable diagnostic tests remains a major challenge in Afghanistan and other countries in this region because of high prices. Governments, donors, and pharmaceutical corporations must act now to ensure an affordable supply of these critical tests and treatments for TB so that more lives can be saved.”
Cepheid’s GeneXpert MTB/RIF test is currently the most widely available rapid molecular diagnostic in high-TB- burden countries to detect resistance to the first-line TB drug rifampicin. Resistance to rifampicin means a patient would need a DR-TB regimen like BPaLM instead. Despite high sales volumes in high-TB-burden countries and MSF’s analysis showing that it costs Cepheid less than $5 to produce one test, the corporation has kept the price of the test at $9.98 for more than a decade.
“It is critical that we have better access to tests to diagnose TB and resistance to drugs that are used for treating TB so that we can identify more people who need treatment and roll out the shorter and safer all-oral treatment regimens,” said Stijn Deborggraeve, diagnostics advisor at MSF’s Access Campaign. “We, yet again, call on Cepheid to reduce the price of the TB tests to no more than $5 each so more people with DR-TB can be diagnosed more quickly and be offered improved lifesaving treatments.”
Drug prices are also a barrier to accessing better treatments for DR-TB. Currently, the lowest available price for BPaLM is $570. MSF has called for the price of a complete DR-TB course, including the BPaLM regimen, to be no more than $500.
Prices could be driven down if national TB treatment programs start rolling out new regimens more widely, which would increase demand and reduce the cost of production. Additionally, more manufacturers supplying affordable generic versions of bedaquiline and pretomanid—the two most expensive medicines in the BPaLM regimen—would help drive the prices down. Five countries where MSF works have started implementing the shorter regimens to date, including Belarus, Uzbekistan, Tajikistan, Sierra Leone, and Pakistan.