'New TB drug too expensive for low and middle income countries'

bedaquiline Bedaquiline | TBfacts.org

High prices of drugs have put patients of drug-resistant tuberculosis (DR-TB) at a huge disadvantage, according to new report by MSF (Médecins Sans Frontières). In the report, titled DR-TB Drugs Under the Microscope, MSF has called out US pharmaceutical giant Johnson & Johnson (J&J) to cut the price of the newer TB drug bedaquiline in half, to ensure that more lives could be saved. MSF has been consistently making the demand for a reduction in prices of the new TB drug.

In August, the World Health Organization (WHO) recommended expanding the use of bedaquiline (produced by J&J) by making it a 'core drug' for treating DR-TB. The announcement came as game-changer in the treatment for TB. The use of bedaquiline, experts say, reduces the need for injectable drugs (administered daily) — side effects include deafness, renal failure, among others — as a 'last-resort' option only. “This change dramatically increases the number of people who should receive bedaquiline, and requires national TB treatment programmes to scale it up as part of the DR-TB treatment they provide. Despite the expected benefits, high prices remain a significant barrier,” activists from the MSF said in a press statement.

The organisation's research shows that DR-TB treatment regimens containing the two newer drugs bedaquiline and delamanid represent a significant price increase over older, no-longer-recommended treatment regimens.

People with DR-TB must receive individually tailored treatment consisting of at least five drugs for different durations, according to the type of drug-resistant TB that affects them. The estimated price of longer individualized treatment regimens could now reach more than US$2,000 for people who need at least 18 months of bedaquiline, which would represent a 50 per cent price increase over previous standard treatment. People who might need both bedaquiline and delamanid for as long as 20 months, the price increase could reach 500 per cent, with a treatment regimen priced at around $9,000.

“Our analysis clearly shows that the high price of the two newer TB drugs makes today’s best-possible treatment much more expensive than previous treatment regimens,” said Sharonann Lynch, HIV & TB advisor for MSF’s Access Campaign. “These newer TB drugs will save more lives, benefit programmes and make this arduous treatment more tolerable for people, but if they remain priced out of reach, they will not serve their purpose and the expected gains will not be achieved. Unless pharmaceutical corporations lower their prices substantially, people will continue to suffer without access to safer and more effective treatment.”

J&J recently announced a price reduction for bedaquiline for some countries, but this falls short of making the drug affordable in countries hardest hit by the DR-TB epidemic, according to MSF. The reduced price of $400 for six months of treatment is still too high, as many people need the drug for significantly longer than six months, driving the price even higher, said MSF.

To ensure the drug is accessible to all, the organisation has asked J&J to issue a non-exclusive license to the Medicines Patent Pool to allow for price-lowering competition among generic producers.

“The new treatment recommendations from WHO represent the best chance for a cure with fewer debilitating side effects for people with drug-resistant TB,” said Dr. Naira Khachatryan, Medical Coordinator of MSF’s project in Armenia. “If bedaquiline continues to be too expensive, countries will have limited opportunity to scale up treatment, and we’ll be stuck with the deadly status quo where the majority of affected people will not have a chance to benefit from more effective treatment.”

An estimated 558,000 people developed DR-TB in 2017, but only 25 per cent of those estimated cases were treated. Standard DR-TB treatment used by most countries up to now has required people to take up to 14,000 pills for nearly two years, including up to eight months of painful daily injections, causing severe side effects. The cure rate is only 55 per cent.

“To save as many lives as possible and really scale up treatment, the price of a full DR-TB treatment regimen should be no higher than 500 dollars per person in all low- and middle-income countries, plus high-burden TB countries,” said Lynch. India has the highest burden of tuberculosis in the world — each year, 29 lakh new cases of TB are reported; 4.20 lakh people, mostly poor, are known to die of the disease. Economic loss due to TB has been calculated to be 20,000 crore per annum.