As Drug Resistant Tuberculosis Infections Increases, Price Of Treatments To Also Increase Drastically Worldwide
According to WHO, Tuberculosis
was responsible for 1.5 million deaths in 2018. Despite advances in medical sciences, Tuberculosis
infections are on the increase and spreading with drug resistant strains manifesting in numerous locations worldwide.
A newly developed and approved three-drug treatment for tuberculosis
will be available in 150 countries including South-East Asia, India and South Africa, priced at $1,040 for a complete regimen, more than twice the cost of existing treatments.
The UN-backed Stop TB Partnership said on Monday 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.
The new treatment protocol called BPaL
is an oral treatment which promises a shorter, more convenient option to existing TB treatment options, which use a cocktail of antibiotic drugs over a period of up to two years.
The new drug cocktail, which will treat extensively drug-resistant strains of the illness, consists of drug developer TB
Alliance’s newly-approved medicine pretomanid, in combination with linezolid and Johnson & Johnson’s bedaquiline.
Pretomanid, which will be available at $364 per treatment course, is only the third new medicine for drug-resistant tuberculosis
to be approved in about 40 years, after J&J’s bedaquiline and Otsuka Pharmaceutical Co Ltd’s delamanid.
NGOs have long criticized the cost for bedaquiline and delamanid. Not-for-profit Médecins Sans Frontières (MSF) has waged a running battle in public with J&J over its US$400 price tag for a six-month course for bedaquiline. MSF has argued that bedaquiline could be produced and sold at a profit for 25 cents per day, and that the price of treatments for drug-resistant TB
should be no higher than $500 for a complete treatment course.
Leena Menghaney, the South-Asia head for MSF’s Access Campaign told Thailand Medical
News, that it was a cause of concern that pretomanid was priced just below the price of bedaquiline.
But Stop TB Partnership says costs of other regimens for extremely drug-resistant TB range from $2,000 to $8,000 for courses of at least 20 months.
TB Alliance in April granted a license to U.S. drugmaker Mylan NV 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
Stop TB Partnership said it would start supplying the regimen following World Health Organization’s guidance on using the drug. Mylan, however, 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.
The drug will be available in bottles of 26 tablets, with a six-month treatment requiring seven bottles.
Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. Novel compounds are important in pursuing new TB treatments because resistance to drugs and drug classes currently used to treat TB is widespread
. During early development, pretomanid was referred to as PA-824. Pretomanid was developed by TB Alliance as an oral tablet formulation for the treatment of tuberculosis in combination with other anti-tuberculosis
One such combination is BpaL
which consists of bedaquiline, pretomanid and linezolid.
Pretomanid as part of the BPaL
regimen is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with pulmonary extensively drug-resistant tuberculosis
(XDR-TB) or multidrug-resistant TB (MDR-TB) that is treatment-intolerant or non-responsive.
was first studied in the Nix-TB trial, which enrolled people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. Nix-TB data have demonstrated a successful outcome in 95 of the first 107 patients after six months of treatment with BPaL
and six months of post-treatment follow-up. For two patients, treatment was extended to nine months.
Current therapy for drug-resistant TB
often requires people to take drugs for 6 months to 2 years or longer or risk developing more difficult to treat drug-resistant TB. The WHO reports historical treatment success for XDR-TB at about 34 percent. BPaL
has been tested in drug-resistant TB
patients co-infected with HIV, including those receiving antiretrovirals (ARVs).