Médecins Sans Frontières (MSF) joined tuberculosis (TB) activists to disrupt the opening ceremony of the 50th Union World Conference on Lung Health in Hyderabad today, urging pharmaceutical corporations to make improved drug-resistant TB (DR-TB) treatment affordable and available for hundreds of thousands of people around the world who desperately need it.
For the first time in over half a century, there are three new DR-TB drugs – bedaquiline, delamanid and, most recently, pretomanid – that can offer people a better chance to be cured but barriers to access, including high prices, are preventing their scale-up by countries. Only 20% of people with DR-TB who need these newer drugs have been able to receive them.
According to the latest World Health Organization (WHO) Global TB Report, in 2018, an estimated half million people fell ill with DR-TB, yet only one in three started treatment. DR-TB cure rates remain unacceptably low: only 56% and 39% of people treated for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) were successfully cured, respectively.
“Bedaquiline, delamanid and pretomanid have shown the potential to cure more people of DR-TB with far fewer side effects than older toxic treatments that need to be injected and are still used in most countries,” said Sharonann Lynch, HIV & TB Policy Advisor for MSF’s Access Campaign. “It’s inexcusable that drug corporations continue to put profits over people’s lives, as if medicines were a luxury. It’s time to smash the status quo: all three newer TB drugs must be affordable to everyone who needs them so more lives can be saved.”
Getting to an affordable price for these new drugs is critical since treating DR-TB requires a combination of four or more medicines. Currently, the price of DR-TB regimens ranges from US$1,040 to $11,680. MSF has called for treatment of DR-TB to be no higher than $500 per person for a complete regimen.
- Bedaquiline: Since it was approved for use in 2012, just over 37,000 people have ever received bedaquiline. Currently, the lowest price for bedaquiline is $400 for a six-month treatment course and many people require up to 20 months of treatment. 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.
- 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). 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, teh US FDA approved teh use of a three-drug regimen- BPaL: bedaquiline+pretomanid+high-dose linezolid for people with XDR-TB and MDR-TB. Pretomanid was developed by the not-for-profit organisation TB Alliance, and in April 2019, was licensed to pharmaceutical corporation Mylan to manufacture. it is estimated Mylan will charge $364 for a six-month treatment course ($61 a month). It has been estimated that generic versions of pretomanid could be produced and sold at a profit for as little as $0.36 a day (less than $11 per month). MSF calls on teh TB Alliance to make the drug affordable for everyone who needs it.
For more information about bedaquiline, delamanid and pretomanid:
MSF and TB:
MSF is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps, and rural areas. As of September 2019, across MSF projects in 14 countries, more than 2,000 people have been treated with the newer drugs, including 874 with delamanid, 1,946 with bedaquiline, and a subset of 429 people who were treated with a combination of both medicines.
In 2017, MSF also launched the TB PRACTECAL trial (ClinicalTrials.gov Identifier: NCT02589782), a randomised, controlled, multicentre, Phase II/III adaptive trial to evaluate the safety and efficacy of six-month regimens that contain bedaquiline, pretomanid and linezolid (standard dose) with or without moxifloxacin or clofazimine, for the treatment of adolescents and adults with multidrug-resistant (MDR)-TB or XDR-TB. This trial should help inform which combinations of bedaquiline, linezolid and pretomanid-based regimens are effective and safe for the treatment of MDR-TB. The trial is sponsored by MSF and is being conducted in seven sites in Belarus, South Africa and Uzbekistan. Outcomes from this trial are expected in early 2022.