South Africa has signed a deal with bedaquiline manufacturer Janssen to drop the price of the drug from $750 for a full course to $400, Health Minister Aaron Motsoaledi is quoted in a Science Speaks blog as saying. The news follows the announcement last month that South Africa will expand access to bedaquiline – one of the two new tuberculosis drugs to come out in over half a century – and stop the use of toxic and painful second-line injectable tuberculosis drugs in multi-drug resistant TB treatment.
“It is our hope that this will be the new price ceiling globally, not only in South Africa,” he said.
News of the price reduction and expanded access was met with applause at the AIDS 2018 pre-conference meeting focused on addressing the joined epidemics of HIV and TB.
South Africa is the first country to roll out an injection-free MDR-TB treatment regimen and make bedaquiline available to all eligible patients infected with TB bacteria resistant to rifampicin – not only patients infected with bacteria resistant to two or more first-line TB drugs.
Trials have shown that the new regimen reduces treatment time and presents an alternative to a drug causing permanent hearing loss – one of the side effects of the only choice before bedaquiline’s development and release.
It is the first new TB drug in more than 40 years and is safer and more tolerable than the injectable drugs it replaces, reports Business Day. The injectable aminoglycosides, such as kanamycin, frequently cause permanent hearing loss and kidney damage.
The price applies to South Africa 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 South Africa will plunge from R10,000 per patient to about R5,400 a patient, Janssen’s technical and medical affairs director, Abeda Williams, said.
“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 in the report that 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 Section27 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 South Africa’s TB burden. However, Section27 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 Section27 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 South Africa annually. “All eligible patients will receive it,” she said.
The report says bedaquiline has been used in South Africa since 2013 and about 15,000 patients have been treated so far. 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.
The report says take-up of the drug has been relatively slow, due to previous safety concerns.