n the latest dust-up over access to needed medicines, Doctors Without Borders is criticizing Otsuka Pharmaceutical for the “ridiculously high” price the drug maker is charging for a tuberculosis treatment.
The criticism came in response to a deal that Otsuka reached this week to provide delamanid — which is one of two relatively new medicines to treat multidrug-resistant tuberculosis — to more than 100 low and middle-income countries. Otsuka is charging $1,700 for a six-month course of treatment, and financing will come from the Global Fund to Fight AIDS, Tuberculosis, and Malaria, a public-private partnership. The program will be administered by the STOP TB Partnership, which operates under United Nations auspices.
But the relief organization noted that delamanid, which is known commercially as Deltyba, must be taken with other medicines, which cost developing countries anywhere from $1,000 to $4,500 for a complete regimen. As a result, the price tag for the Otsuka drug may place the total cost of treatment out of reach for some governments, according to Sharonann Lynch, the HIV and TB policy advisor at Doctors Without Borders.
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“It’s an awful precedent for one of the first new TB drugs in decades to be priced ridiculously high,” she told us. “It’s unnecessary.”
The clash is yet another example of an ongoing struggle between the pharmaceutical industry and advocacy groups over the cost of life-saving medicines. Doctors Without Borders, in particular, regularly criticizes drug makers for their pricing in different countries. The relief organization is currently waging a campaign against Pfizer and GlaxoSmithKline over the prices of their pneumonia vaccines.
Tuberculosis threatens to become the latest flashpoint.
In 2014, 9.6 million contracted the disease, which led to 1.5 million deaths, including 140,000 children, according to data from the World Health Organization. More than 95 percent of the deaths occurred in low- and middle-income countries. Tuberculosis is also the leading killer of people with HIV, causing one in every three deaths among HIV patients last year.
“The problem is that most of the burden for TB falls in middle-income countries,” said Erica Lessem, the TB and HIV project director at Treatment Action Group, a research and policy advocacy group. “At face value, they have larger economics, but their health budgets are not always sufficiently funded or supported. So patients can fall through the cracks.” This is an issue for low-income countries, too.
Although she praised Otsuka for reaching the deal, Lessem agreed “the price is high and we hope it will come down.” And like Lynch, she criticized Otsuka for failing to make the drug more widely available since its launch two years ago. The drug maker has so far registered delamanid in the European Union, Japan, and South Korea, although relatively few people with multidrug-resistant tuberculosis live in those countries.
The advocacy groups, which estimate less than 200 people have been treated with delamanid to date, also criticized Otsuka for failing to register its drug in low- and middle-income countries where it ran clinical trials. And they noted delamanid will only be accessible through the funding program in countries where it’s registered for use or import waivers are put in place. In a statement, Treatment Action Group called these “provisional mechanisms.”
An Otsuka spokesman countered that the drug maker is trying to find the right balance between supporting research and providing access.
“The ideal would be universal access for all countries all at once for free, but that’s not the way drug development works, unfortunately,” he told us. “We’re trying to do something no other pharmaceutical company has done, which is to show we can make a sustainable business model in a neglected disease area … This approach allows us to reinvest in new products in the future.”
He also pointed out that Otsuka donated 400 treatments of delamanid last week. Meanwhile, the drug maker has filed registrations or is in the process of doing so in China, Hong Kong, Indonesia, Turkey and the Philippines. Filings are being eyed in South Africa, Russia and India, as well, the spokesman told us.
One thing Otsuka did get right, the advocacy groups said, was to establish one flat price for all countries. Initially, Johnson & Johnson, which markets the other multidrug resistant treatment, set different prices for high-, middle-, and low-income countries. But Lynch said this tiered pricing was, effectively, suspended for countries that receive financing after the company responded to criticism with a donation program.