Despite Johnson & Johnson (J&J) recently announcing it would lift patents on the lifesaving drug bedaquiline, a key component in the cocktail used to treat multidrug-resistant tuberculosis (MDR-TB), it could take years before South Africa benefits, says the Health Department.
J&J is currently the sole manufacturer of bedaquiline, but the announcement paves the way for the manufacturing of cheaper, generic versions of the drug to be sold in 134 low-and middle income countries.
However, writes Ndivhuwo Mukwevho in Health-e News, it’s unclear how soon the changes will filter down to national programmes in high burden countries like South Africa, with Dr Norbet Ndjeka, chief director of TB control and management at the National Department of Health, saying it could take years before the country benefits from the lifting of the patents.
“It’s a long process to have any drug, including a generic version, registered here. It can even take years. We just hope it will not take too long, as an Indian-based pharmaceutical company has already started manufacturing a generic version of bedaquiline,” he said.
High cost of care
With around TB 300 000 cases reported in South Africa each year, Ndjeka said the department spends around R300 per patient for a six-month TB treatment regimen.
The cost of treating MDR-TB is exponentially higher.
“Bedaquiline, alone, for six months costs R5 400. When we combine that with the cost of all the other drugs used with it, we spend around R20 000 per person for a six-month treatment period.”
South Africa treats between 7 000 and 8 000 MDR-TB patients annually, spending an estimated R160m a year on the drugs.
However, even if a generic version of bedaquiline were to be made available in the next few months, the country would not rush into procurement, Ndjeka said.
“We have stock of bedaquiline on our shelves that will last us for the next two years,” he said.
For now, South Africa’s contract with J&J is likely to be extended by a further two years from October 2023. Under the new arrangement the country will buy the drug for an increased price of R5 500.
Recently the Competition Commission launched an investigation into J&J’s pricing of the drug – with Siyabulela Makunga, Competition Commission spokesperson, confirming to Health-E News that it would continue with its probe, despite the company’s turnaround.
See more from MedicalBrief archives:
WHO may promote bedaquiline after SA brokers deal with J&J
J&J probed for high TB drug prices and patent law ‘abuse’
SA’s patent system denies vital drug access
TB drug costs to drop after J&J loses patent extension bid