Cost of tuberculosis (TB) treatment will be halved by up to 55percent following a deal to permit generic versions for bedaquiline, a life-saving drug to treat drug-resistant TB.
According to announcement made by the -United Nations-backed- The Stop TB Partnership’s Global Drug Facility (GDF) price reductions up to 55 percent for Sirturo (bedaquiline), a critical drug used to treat drug-resistant TB (DR-TB).
Johnson & Johnson’s price for Sirturo (bedaquiline), considered the backbone of treatment for drug-resistant TB will drop from $289 (£227) to $130 for a six-month course until December 2024.
Johnson & Johnson had previously been the only supplier of bedaquiline but in July agreed to allow generic versions to be supplied to poorer countries.
The Indian drug manufacturer Lupin has also agreed to reduce the cost of its TB treatments by a third to $194 for a six-month course.
The price reductions come a month after the expiration of the primary patent for bedaquiline, which was developed by J&J and is the “backbone” of the two World Health Organization (WHO)-recommended treatment regimens for rifampicin-resistant and multidrug-resistant (MDR)-TB—BPaL (bedaquiline, pretomanid, and linezolid) and BPaLM (bedaquiline, pretomanid, linezolid, and moxiflacin).
The 6-month, all-oral regimens are significantly shorter, less toxic, and more effective than previous regimens. Before bedaquiline and later pretomanid came along, DR-TB regimens lasted up to 2 years, included painful injectable drugs with significant side effects, and had a treatment success rate of less than 50percent.
Around 450,000 people are estimated to have drug-resistant TB. The GDF estimates its lower bedaquiline prices will generate US$8 million in savings over the 16-month contract period, an amount sufficient to procure more than 51,000 additional bedaquiline treatments and potentially support thousands more people to access critical treatment for drug-resistant tuberculosis.
Bedaquiline is a core component of nearly every regimen recommended by the World Health Organization (WHO) for treatment of DR-TB. Bedaquiline, together with pretomanid, linezolid, and moxifloxacin comprise BPaLM, the preferred regimen recommended by the WHO for treatment of DR-TB. For people with resistance to moxifloxacin, WHO recommends the use of BPaL (bedaquiline, pretomanid, and linezolid) for DR-TB treatment. The reduction in the price of bedaquiline will result in an overall decrease in the cost of 6-month treatment regimens for DR-TB of between 27percent and 29percent.
“This price reduction is a momentous breakthrough in the fight to end TB and it is especially timely in the leadup to the UN High-Level Meeting on TB to be held in New York in September”, said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership. “The rise of drug-resistant TB is a huge threat to the fight against TB. Worryingly, every year around 300,000 people with drug-resistant TB remain missed by the health services, therefore potentially spreading the infection.”
“No one should have to suffer from drug-resistant tuberculosis simply because they cannot afford treatment,” said Dr. Atul Gawande, Assistant Administrator of USAID’s Global Health Bureau. USAID is the largest bilateral donor leading the international TB response. “This historic price reduction will broaden access to this life-saving drug and keep us on the path to end TB by 2030.”
“Today marks the culmination of several years of collaborative effort across numerous stakeholders, including the United States Agency for International Development, Stop TB, the World Health Organization, The Global Fund, pharmaceutical manufacturers, national TB programs and others to build a competitive bedaquiline market able to deliver quality-assured, affordable bedaquiline to low- and middle-income countries”, said Dr. Brenda Waning, GDF Chief.
“The World Health Organization (WHO) welcomes the significant reduction in the price of bedaquiline, one of the most important medicines for the treatment of drug-resistant tuberculosis,” said Dr Tereza Kasaeva, Director of WHO’s Global Tuberculosis Programme. “This drug price reduction will significantly increase access to treatment for those who are in need, especially in countries with a high burden of drug-resistant tuberculosis This will help save lives and help accelerate the progress towards achieving the End TB Strategy targets.”
“MDR-TB is a terrible disease, highly infectious and with a high fatality rate, but it can be cured with the right treatment,” said Peter Sands, Executive Director of the Global Fund. “Significantly reducing the price of Bedaquiline will enable more people with MDR-TB to be treated effectively, saving lives and reducing the probability of onward infection. This price reduction is a great example of how delivering affordable access to those most in need can be achieved – it takes leadership and partnership.”
Countries can access the new bedaquiline prices in the GDF Medicines Catalog and place new orders for bedaquiline and other medicines on the Stop TB website.
