Price of new lifesaving TB drug, Pretomanid, too high, says MSF

M Somasekhar Hyderabad | Updated on October 30, 2019

The drug was developed by the TB Alliance, funded by various governments and philanthropic sources

The slew of newer TB drugs that have hit the market recently promise to tackle the disease better, but the high price can prove a dampener to realise the goal of taming the deadly disease on a war footing, feel experts, advocacy groups and medical organisations who are meeting this week in Hyderabad for a global event on TB and Lung disease.

On Monday, a newly approved three-drug treatment for TB was priced at $1,040 for a complete regimen, which was twice the cost proposed in the past by advocacy groups for other treatments. The drug cocktail will be available in 150 countries including India and South Africa, according to media reports.

“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, therefore, this drug should be affordable and accessible to anyone who needs it. What good is a life-saving drug if people who need it can’t afford it?”, said Sharonann Lynch, HIV & TB Advisor, Medicins Sans Frontieres (MSF) Access Campaign.

The Global Drug Facility (GDF) has just announced a price of $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.

The Stop TB partnership’s GDF lists the first ever, all oral regimen for highly resistant forms of drug resistant TB at $1,040 for the full treatment course.

Médecins Sans Frontières (MSF) has urged the TB Alliance (TBA), a non-profit TB drug development organisation, and its commercial partner, pharmaceutical corporation Mylan, to lower the price of Pretomanid, as it is just one part of multiple medications 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, funded by various governments (eg 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 non-responsive multidrug-resistant pulmonary TB.

This new regimen has the potential to dramatically shorten treatment length to six months, significantly reduce the number of pills required, and helps increase XDR-TB cure rates from the abysmal 39 per cent, experts say.

According to the Monday’s price announcement, the lowest global price for a six-month course of BPaL regimen is $1,040, which is double of 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.

Bedaquiline, another new drug has similarly been priced quite high at $400 for a six-month treatment course, which could also impede the uptake of the BPaL regimen in high TB burden countries. MSF has launched a global campaign calling on Johnson & Johnson (J&J) to lower the price of bedaquiline to no more than $1 per day ($200 for six months, or half of what J&J currently charges).

Johnson & Johnson in response to the high pricing of TB drugs states that  “We share MSF’s goal of ensuring that bedaquiline reaches all patients who need it. Bedaquiline is available in more than 130 countries at a not-for-profit price of $400 – which is on par with or even cheaper than some generic medicines used to treat TB. Over the past four years, we have partnered with the U.S. Agency for International Development and JSC Pharmstandard to provide 105,000 courses of treatment, free of charge, to 80 countries in greatest need of the medicine".

 The company said Bedaquiline was the first novel medicine approved for MDR-TB in nearly 50 years. The company fully funded all 14 studies that were included in the initial submission that supported the regulatory approval of bedaquiline by the U.S. Food and Drug Administration.

  "All the revenues are reinvested to support critical activities, including global manufacturing and distribution of the medicine and, importantly, surveillance programs to safeguard the antibiotic’s effectiveness. We are also investing significantly in R&D to develop new medicines that will be needed to achieve the goal of ending TB,” said Seema Kumar, Vice President, Innovation, Global Health and Policy communication.

Published on October 30, 2019

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