GENEVA/NEW YORK, October 9, 2019—The new price offered to South Africa for the the anti-tuberculosis (TB) drug delamanid remains too high and should be lowered and offered to all countries, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) today.
Delamanid is one of the most expensive drugs used to treat drug-resistant tuberculosis (DR-TB). As of June 1, 2020, Mylan—which licenses the drug from the patent-holder Otsuka—will charge the government of South Africa $940 US for a six-month treatment course that is currently priced at $1,700 through the Global Drug Facility (GDF), a TB drug and diagnostic procurement mechanism.
But this price is still too high, and it is unclear if Mylan plans to offer this price to all countries. Countries like India that are facing high rates of resistance to other TB drugs, such as fluoroquinolones, should take effective measures—including overriding patents through compulsory licenses—to enable generic manufacturers to enter the supply chain and bring the price down further. Researchers from the University of Liverpool have calculated that delamanid could be produced and sold at a profit for as little as $5 to $16 per month if the drug is widely used by national TB programs.
In response to the new price, Dr. Stobdan Kalon, MSF medical adviser in India, gave the following statement:
Even at $940, delamanid remains one of the most expensive DR-TB drugs, and its high price will continue to have a chilling effect on the scale-up of this drug in national TB programs. As long as these new drugs are priced out of reach for TB programs, an all-oral treatment regimen for people with pre-XDR-TB and XDR-TB [extensively drug-resistant-TB] and children with MDR-TB [multiple drug-resistant TB] will remain a distant reality. People will continue to suffer the devastating side effects of older drugs that have to be injected, including permanent deafness. Otsuka and Mylan must further drop the price of delamanid to ensure that TB programs are able to afford and scale up the use of all-oral treatment regimens.
We constantly struggle to successfully treat people with XDR-TB that has fluoroquinolone resistance and children with MDR-TB at our Mumbai clinic. [This] is a grave concern given the unacceptably high rates of treatment failure and death. In order to improve the chance for a cure, these patients need effective treatment regimens and immediate access to the newer drugs, bedaquiline and delamanid.”
Delamanid is just one of multiple drugs needed to treat people who have DR-TB. Its high price is a key driver of the high overall cost of treating people with MDR-TB and XDR-TB. A full 20-month treatment course for one person through GDF can cost between $8,000 and $12,000, depending on the length of treatment and the other drugs in the treatment regimen.
The high price keeps treatment from being scaled up as needed. Although delamanid was conditionally approved by the European Medicines Agency in April 2014, at the end of August 2019, only 2,902 people had been treated with delamanid, according to the DR-TB Scale-Up Treatment Action Team of global TB experts, which receives updates from National TB Programs and large treatment providers, including MSF.
The World Health Organization’s (WHO) treatment guidelines prioritize the use of newer drugs as part of all-oral regimens for the treatment of MDR-TB and XDR-TB. MSF urges more countries to make the switch from older, more toxic treatments that need to be injected to all-oral regimens that contain the newer drugs, including delamanid. These newer drugs are critical to improving the otherwise abysmal cure rates of 55 percent for MDR-TB and 34 percent for XDR-TB. Use of the newer TB drugs is also urgently needed for children with MDR-TB to improve treatment outcomes and reduce the risks of side effects.