The Department of Health has negotiated an almost 50% cut in the ceiling price of Janssen Pharmaceutica’s tuberculosis (TB) drug bedaquiline, opening the way for increased access for patients around the globe.
The development comes just a month after SA became the world’s first country to make bedaquiline part of routine treatment for patients with multidrug-resistant TB (MDR-TB).
It is the first new TB drug in more than 40 years and is safer and more tolerable than the injectable drugs it replaces.
The injectable aminoglycosides, such as kanamycin, frequently cause permanent hearing loss and kidney damage.
The price applies to SA and to other countries that procure bedaquiline through the Global Drug Facility of the Stop TB Partnership. At current exchange rates, the price of treatment in SA will plunge from R10,000 per patient to about R5,400 a patient, Janssen’s technical and medical affairs director, Abeda Williams, said.
Janssen, a subsidiary of Johnson & Johnson, announced earlier this week it had cut the price of bedaquiline to $400 for a full, six-month course of treatment.
"Tackling the global burden of MDR-TB is a shared responsibility and one we take extremely seriously," said Johnson & Johnson’s chief scientific adviser, Paul Stoffels.
"We have offered a commitment to the Department of Health to provide bedaquiline at a ‘special effort’ price to enable rapid scale-up to a much larger population that will now benefit from more effective and less toxic treatment," Stoffels said.
The health department’s deputy director-general for HIV/TB, child and maternal health, Yogan Pillay, said the new price would apply to the current tender with Janssen. He anticipated a further reduction once other countries began providing the drug and the company’s sales volumes increased.
Health advocacy group Section 27 welcomed news of the price cut but said Janssen should drop the price further.
"The reduced price will no doubt enable the South African government to scale up treatment for MDR-TB, which is critical given SA’s TB burden.
"However, Section 27 and other organisations globally called for a much lower price of $200 for a six-month course of treatment and we encourage all governments to seek further reductions in the price over time," said Section 27 deputy director Umunyana Rugege.
Williams said bedaquiline would only be provided to patients in the public sector.
This is in line with the health department’s strategy for providing TB treatment, according to which all patients will receive their medicines via the government. While private sector patients may receive care from their own healthcare professional, their drugs are provided via government channels.
About 12,000 patients with MDR-TB were expected to be eligible for bedaquiline in SA annually. "All eligible patients will receive it," she said.
Bedaquiline has been used in SA since 2013 and about 15,000 patients have been treated so far. A South African study published in July in the Lancet Respiratory Diseases showed bedaquiline-based treatment regimens were associated with a large reduction in mortality in patients with drug-resistant TB, compared to the standard regimen.
Compared to standard regimens, bedaquiline cut the risk of all-cause mortality by 75% in people with extensively drug-resistant tuberculosis and by 65% in people with rifampicin-resistant or MDR-TB.
Janssen said that bedaquiline had been provided to about 63,000 patients in 100 countries since it was approved by the US Food and Drug Administration in 2012.
Take-up of the drug has been relatively slow, due to previous safety concerns.