Pact signed to reduce price of multidrug-resistant tuberculosis treatment by 34%

Pretomanid (Pa) is used in combination with bedaquiline (B), linezolid (L) and sometimes moxifloxacin (M) to form BPaL and BPaLM – six-month, all-oral treatment regimens, found to be effective at curing 89-91 per cent of multidrug-resistant TB (MDR-TB) patients treated.

Blessi Kumar, CEO, Global Coalition of TB Activists, said, “We welcome this announcement of a new agreement to reduce the price of pretomanid.” He added, “Coming on the heels of the WHO consolidated guidelines for DR-TB treatment, we hope this will be the game changer in ensuring access for people with DR-TB and reaching better treatment outcomes. The challenge, however, continues to be the uptake at country level and we urge National Treatment Programmes to make this shorter regimen available for people with DR-TB at the earliest. Ensuring early and easy access is key to a people-centred, rights-based TB response.”

Globally, less than two-thirds of drug-resistant TB patients are successfully treated. Previously recommended treatment options have been limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. With the new WHO guidance on TB treatment, almost all drug-resistant TB patients will now be eligible for the shorter BPaL/BPaLM regimens.

TB is on track to regain its dubious distinction as the world’s deadliest infectious disease, killing more than three times than Covid-19 every day. In 2021, an estimated 1.6 million people lost their lives to TB, including 1,87,000 people living with HIV. The WHO estimates that 10.6 million people fell ill with TB in 2021, an increase of 4.5 per cent from 2020. Of the new cases, an estimated 4,50,000 were drug resistant. The Covid-19 pandemic also hampered access to the MDR-TB treatment. In 2021, 1,62,000 MDR-TB patients were on treatment, compared to 1,82,000 in 2019.

Bold investments are required to reverse recent increases and get on track to meet global goals to end TB. Better treatments, vaccines and diagnostics are required alongside more trained healthcare workers and stronger health systems. Civil society organisations have long called for greater access to short-course treatment regimens like BPaL and BPaLM.

Thursday’s announcement will help to expand access to a critical new treatment in more than 140 countries, including those with the highest TB burden.

Six-month drug-resistant TB treatment regimens were first developed by TB Alliance, a not-for-profit product development partnership committed to developing and delivering ground-breaking TB therapies. Its drug pretomanid received its first regulatory approval from the US Food and Drug Administration in 2019 as part of a six-month, all-oral regimen. For high-burden countries, TB Alliance has granted non-exclusive licenses for pretomanid to multiple high-quality drug manufacturers, including Viatris.

“Whether it’s the United States at the height of the Covid-19 emergency, or Ukraine in a time of war, the six-month DR-TB therapy has already proven itself to be an invaluable tool in the fight against TB,” said Mel Spigelman, MD, President and CEO, TB Alliance. “No medical innovation is complete until it is able to reach every patient who needs it. This new access partnership will accelerate the pace of progress and move us closer to a world in which no one dies of TB,” Spigelman added.

Pretomanid, used within the BPaL and BPaLM regimens, is already being piloted and implemented in operational research programmes run by government agencies and civil society organisations and supported by USAID, KOICA and the STOP TB Partnership. The lessons and foundations built by these programmes are facilitating increased access and accelerating introduction of these important new regimens. To date, more than 40 countries have procured over 5,000 treatment courses of pretomanid since it was first approved.