A newly approved three-drug treatment for tuberculosis, BPaL, is to be made available in 150 countries with high TB rates including India and South Africa. However, it may be priced at $1,040 for a complete regimen, more than twice the cost proposed in the past by advocacy groups for other treatments. This was announced in October 2019.
The United Nations-backed Stop TB Partnership said that BPaL would be obtainable in eligible countries through the Global Drug Facility (GDF), a global provider of TB medicines created in 2001 to negotiate lower prices for treatments.
BPaL is an oral treatment that is expected to provide a shorter, more convenient option to existing TB treatment options, which involve many antibiotic drugs to be taken for up to two years.
BPaL will be available in bottles of 26 tablets, with a six-month treatment requiring seven bottles. India-based Macleods Pharmaceuticals Ltd has also been granted a non-exclusive license to make pretomanid as part of the BPaL regimen.
The new mixture, which will treat extensively drug-resistant strains of the illness, includes pretomanid, a newly-approved medicine still to be tested brought out by drug developer TB Alliance. It also consists of linezolid and bedaquiline, prepared by Johnson & Johnson (J&J).
Pretomanid, to be made available at $364 per treatment course, is the third new medicine for drug-resistant tuberculosis to be approved in about 4 decades, J&J’s bedaquiline and Otsuka Pharmaceutical Co Ltd’s delamanid being the other 2. Bedaquiline and delamanid have remained very expensive. Medecins Sans Frontieres (MSF) has waged a running battle with J&J over its $400 price tag for a six-month course for bedaquiline. It has argued that bedaquiline could easily be produced and sold at a profit for 25 cents per day. Moreover, the price of treatments for drug-resistant TB should not exceed $500 for a complete course of treatment.
The fact, however, is that price of pretomanid is almost as much as the price of bedaquiline. Stop TB Partnership contends that costs of other regimens for extremely drug-resistant TB range from $2,000 to $8,000 for courses of at least 20 months.
Brewing Tensions
TB Alliance in April 2019 granted a license to U.S. drugmaker Mylan NV (MYL.O) to manufacture and sell pretomanid as part of certain regimens in high-income markets, as well as a non-exclusive license for low-income and middle-income countries, where most tuberculosis cases occur. Those at Stop TB Partnership are irked and have said that their company would start supplying BPaL following WHO’s guidance on using the drug. This is even as Mylan said it will also sell the drug directly to countries. Prices in low-income countries would be in-line with the price offered through GDF, but would be decided on a case-by-case basis where the drug is not supplied through GDF, it said.
Tuberculosis was responsible for 1.5 million deaths in 2018.