New Delhi , 19 December 2022: Viatris, a global healthcare company, MedAccess, and TB Alliance have announced a new agreement to reduce the price of pretomanid, a drug used to treat multidrug-resistant tuberculosis, by 34%. Pretomanid is part of two new treatment regimens with high efficacy and shorter treatment durations recently recommended by the World Health Organization (WHO) as the preferred regimens for most drug-resistant tuberculosis patients.
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% of multidrug-resistant TB (MDR-TB) patients treated.
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.
In July 2020, the Drug Controller General of India (DCGI) had approved the TB drug pretomanid (developed specifically for certain drug-resistant forms of the disease) for conditional access under the National Tuberculosis Elimination Program (NTEP), making India the second country in the world to provide regulatory approval for this product.
TB is on track to regain its dubious distinction as the world’s deadliest infectious disease, killing more than three times as many people as COVID-19 every day. In 2021, an estimated 1.6 million people lost their lives to TB, including 187,000 people living with HIV. The WHO estimates that 10.6 million people fell ill with TB in 2021, an increase of 4.5% from 2020. Of the new cases, an estimated 450,000 were drug resistant. The COVID-19 pandemic also hampered access to MDR-TB treatment. In 2021, 162,000 MDR-TB patients were on treatment, compared to 182,000 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. Today’s announcement will help to expand access to a critical new treatment in more than 140 countries, including those with the highest TB burden.
A volume guarantee to be provided by MedAccess to Viatris will see the ceiling price of pretomanid reduced to $240 Ex Works per six-month treatment course. It will help to bring both BPaL and BPaLM substantially closer to $500 per patient course.
MedAccess projects that its guarantee will enable an additional 36,000 patients to be treated successfully and help avert 31,000 adverse events that require hospitalisation or cause disability as patients switch from the current standard-of-care.
“We welcome this news and commend Viatris, MedAccess, and TB Alliance for the announcement of a new agreement to reduce the price of pretomanid, a drug used to treat multidrug-resistant tuberculosis, by 34%,” said Blessi Kumar, CEO, Global Coalition of TB Activists. “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.”
Governments and global procurers are expected to make direct savings of $15.6 million thanks to the guarantee, with additional savings for national healthcare budgets as they care for fewer patients with long-term MDR-TB.
“Drug-resistant TB is a global health threat impacting the lives of hundreds of thousands of people every year,” said Michael Anderson, CEO of MedAccess. “Working in partnership, we can accelerate access to shorter-course DR-TB treatment to protect lives, help end TB, and curb antimicrobial resistance. A volume guarantee will provide Viatris with confidence to significantly reduce the price of pretomanid, making this highly-effective drug more widely accessible for people who need it.”
Viatris President Rajiv Malik said: “ We are proud of our innovative partnership with MedAccess and TB Alliance in setting new standards for accelerating the pace of access and delivering breakthrough treatments to patients in the greatest need. At Viatris, a key way we deliver on our mission to empower people worldwide to live healthier at every stage of life, regardless of geography or circumstance, is to provide access to medicines. The partnership is a step forward in the global fight against TB to enable greater access and affordability for those affected by multidrug-resistant TB.”
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, 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’s 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.”
Pretomanid, used within the BPaL and BPaLM regimens, is already being piloted and implemented in operational research programs 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 programs 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.
“This price reduction agreement is great news,” said Lucica Ditiu, Executive Director of the Stop TB Partnership. “We have the tools to end TB by 2030 but annual budgets for the response are currently half of what is needed. So paying a lower price for a shorter and much more effective DR-TB regimen will be a big step forward. Working through the Global Drug Facility and with TB REACH grants, we are determined to accelerate countries’ access to pretomanid and we hope that 2023 will see a substantial increase in the number of people treated with the BPaLM regimen.”
The new ceiling price will be available to more than 140 governments, and NGOs and public sector procurers purchasing pretomanid in those countries.