Hyderabad, 29 October 2019 – The Global Drug Facility has just announced a price of US$364 for a six-month treatment course of pretomanid, only the third new drug developed for TB in half a century. Pretomanid was approved for use by the US Food and Drug Administration in August 2019. Médecins Sans Frontières (MSF) is calling on the TB Alliance (TBA), a non-profit TB drug development organisation, and its commercial partner pharmaceutical corporation Mylan, to further lower the price of this drug, as it is just one part of a regimen of multiple drugs that people need. MSF has been calling for the price of a complete DR-TB treatment course to be no higher than $500 per person.
Pretomanid was developed by the TB Alliance, a not-for-profit organisation, funded by governments (e.g. Australia, Germany, the UK and the US) and philanthropic sources. It is the first TB drug to be developed and approved as part of a ready-to-use treatment regimen (BPaL: bedaquiline + pretomanid + high-dose linezolid) for people with extensively drug resistant (XDR)-TB, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary TB. This new regimen has the potential to dramatically shorten treatment length to six months, greatly reduce the number of pills required, and helps increase XDR-TB cure rates from the abysmal 39%.
In light of yesterday’s price announcement, the lowest global price for a 6-month course of BPaL regimen is US$1,040, which is double what MSF is calling for.
Researchers from the University of Liverpool have estimated that generic versions of pretomanid could be produced and sold at a profit for less than $1.35 a day, or less than $35 a month.
The high price of one of the other newer TB drugs, bedaquiline, at $400 for a six-month treatment course will also impede the uptake of the BPaL regimen in high TB burden countries. MSF has launched a global campaign calling on pharmaceutical corporation Johnson & Johnson (J&J) to lower the price of bedaquiline to no more than US$1 per day ($200 for six months, or half of what J&J currently charges).
Furthermore, the TB Alliance must also support or carry out research to address outstanding medical questions concerning the safety and efficacy of its drug independent of the BPaL regimen and in comparison to another drug in the same class, as well its suitability for different populations including children, pregnant women, and people living with HIV receiving the antiretroviral dolutegravir.
Response from Sharonann Lynch, HIV & TB Policy Advisor, MSF Access Campaign
“Newer TB drugs, including pretomanid, may have tremendous potential for tackling difficult-to-treat drug-resistant forms of TB, but only if they are affordable. The high price of this drug could have a chilling effect on its uptake in high TB burden countries.
We are calling on Mylan and the TB Alliance to bring the price of pretomanid down much further, so that the TB Alliance can hold true to its stated mission of developing and making improved TB medicines accessible to people who need them.
After half a century, we finally have new TB drugs that can offer a better chance of survival for people who otherwise continue to die from the world's leading infectious disease killer. The public helped pay for the development of this drug, and therefore, this drug should be affordable and accessible to anyone who needs it. What good is a lifesaving drug if the people who need it can’t afford it?”