A new agreement among drugmaker Viatris, MedAccess, and TB Alliance looks to reduce the price of pretomanid, a drug used to treat multidrug-resistant tuberculosis, by 34 per cent.
The agreement will help expand access to this critical new treatment in more than 140 countries, including those with the highest TB burden, said a joint note from the organisations.
Pretomanid (Pa) is used in combination with bedaquiline (B), linezolid (L), and sometimes moxifloxacin (M) to form BPaL and BPaLM – a six-month, all-oral treatment regimen, found to be effective at curing about 90 per cent of multidrug-resistant TB (MDR-TB) patients.
Treatment previously recommended has been limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. However, with the new WHO guidance on TB treatment, almost all drug-resistant TB patients will now be eligible for the shorter BPaL/BPaLM regimens, the note said.
In July 2020, the Drugs 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, the note said. 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 per cent 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, it added.
Volume guarantee
.A volume guarantee from MedAccess to Viatris will see the ceiling price of pretomanid reduced to $240 ex-works (excluding transportation and import costs) per six-month treatment course. It will help to bring both BPaL and BPaLM substantially closer to $500 per patient course, the note said.
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.
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, the note added.
The six-month drug-resistant TB treatment regimen was first developed by TB Alliance, a not-for-profit product development partnership committed to developing and delivering 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, 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,” he said.