High prices and corporations’ unwillingness to license their drugs so generics can be produced are standing in the way of improved DR-TB treatment outcomes with these new drugs. Currently, the price of DR-TB regimens ranges from US$1,040 to $11,680, depending on the treatment length and combination of drugs needed. In order for more lives to be saved, MSF demands the following:

• Bedaquiline:

Since it was approved for use in 2012, just over 37,000 people have ever received bedaquiline. Johnson & Johnson (J&J) must lower the price of bedaquiline to no more than $1 per day ($30 per month/$180 for a six-month treatment course) for everyone who needs it. MSF demands this price cut considering that bedaquiline is the result of a joint research and development effort by public and private entities, and the larger TB community—not by J&J alone. Substantial public investments and contributions to provide evidence on the drug’s therapeutic value have come from the US government; UNITAID; health ministries in countries with high rates of TB; the South African Medical Research Council; academic institutions; non-governmental organisations (including MSF); and a host of philanthropic donors. J&J should therefore not be the sole decisionmaker regarding who has access to the drug. Currently, the corporation charges at least double the $1 per day price MSF is demanding: the lowest price for bedaquiline is $400 for a six-month treatment course ($67 per month) for countries eligible to purchase the drug through the Global Drug Facility (GDF), an organisation run by the Stop TB Partnership that supplies TB drugs to low- and middle-income countries. And J&J charges far more in other countries. Additionally, many people require up to 20 months of the drug, raising the price of bedaquiline alone to $1,200 – and multiple additional drugs are needed to treat DR-TB. Researchers have calculated that the drug could be produced and sold at a profit for much less – as little as $0.25 per day* (less than $8 per month) if the drug is scaled-up by TB programmes.

Having multiple producers of critical drugs is important to secure a stable supply, and competition among producers is a proven way to reduce the price of medicines. MSF therefore also urges J&J to issue a non-exclusive license to the Medicines Patent Pool (MPP), which would enable multiple drug manufacturers to produce more affordable generic versions of bedaquiline. J&J has so far refused to license bedaquiline to the MPP.

• Delamanid:
  Since it was approved for use in 2014 and until two months ago, fewer than 3,000 people have ever been treated with delamanid. It is one of the most expensive DR-TB drugs, which its producer, Otsuka, prices at $1,700 for a six-month treatment course ($283 per month) through the GDF. Its high price contributes significantly to the cost of treating people with MDR-TB and XDR-TB, and has had a chilling effect on treatment scale-up. Mylan, which licenses the drug from patent-holder Otsuka, recently announced that it will charge $940** for a six-month treatment course ($157 per month) as of June 2020 in South Africa. At this price, the drug remains unaffordable. Estimates suggest that delamanid could be produced and sold for a profit for as little as $0.16 per day* (less than $5 per month). MSF urges Mylan and Otsuka to lower the price of the drug much further for all countries, and calls on Otsuka to issue a non-exclusive license to the MPP to encourage multiple generic manufacturers to produce more affordable versions of the drug.
• Pretomanid:
  In August 2019, the US Food and Drug Administration (FDA) approved the use of a three-drug regimen (BPaL: bedaquiline + pretomanid + high-dose linezolid) containing a new drug, pretomanid, for people with XDR-TB and those who cannot tolerate or haven’t responded to standard MDR-TB treatment. Pretomanid was developed by the not-for-profit organisation TB Alliance, and in April 2019, was licensed to pharmaceutical corporation Mylan to manufacture, register and supply the drug. This week, TB Alliance announced an agreement for Indian drug corporation Macleods Pharmaceuticals to manufacture the drug. GDF recently announced that Mylan will charge $364 for a six-month treatment course of pretomanid ($61 per month). This price is still too high, especially considering that DR-TB treatment requires multiple drugs and people who do not respond to treatment may require treatment for longer than six months. With this price, a six-month treatment course of the BPaL regimen will be priced at $1,040. It has been estimated that generic versions of pretomanid could be produced and sold at a profit for as little as $0.36 per day* (less than $11 per month). MSF calls on TB Alliance to make the drug affordable for everyone who needs it, especially considering that TB Alliance is a not-for-profit organisation, funded by governments (including Australia, Germany, the UK and the US) and philanthropic sources, that has a specific mandate to deliver new TB treatments to those in need. TB Alliance therefore does not need to recoup any investments through high pricing. Instead, they must ensure affordable access to all. MSF also joins the TB community in urging TB Alliance to promptly address the unanswered research questions around pretomanid, and publish and make available its pretomanid clinical trial data.