The new tuberculosis drug is effective, but unaffordable

The drug "delamanid" is not registered in countries with high tuberculosis rates, limiting its access

 
By Kundan Pandey
Last Updated: Monday 29 February 2016 | 07:24:48 AM

A new drug to cure tuberculosis (TB) has been announced by Japanese pharmaceutical company Otsuka, making it one of the only two new drugs against the disease in fifty years. “Delamanid” will however be unaffordable for most, costing around US $1,700 per treatment course.

The drug is effective against the deadliest strains of the disease, including multidrug-resistant TB (MRD-TB) and extensively drug-resistant TB (XDR-TB). Many other drugs have failed to cure these forms of tuberculosis.

Delamanid needs to be taken with several other drugs to effectively treat drug-resistant TB (DR-TB). The regimens for DR-TB, excluding delamanid, cost between $1,000 – $4,500 per treatment course at the least, which is expensive for developing countries. The prices will only increase after delamanid is included in the regimen.

International medical humanitarian organisation Médecins Sans Frontières (MSF) had expressed great concern at the high pricing of delamanid.

It is estimated that up to two-thirds of the nearly half a million people who acquire drug-resistant TB each year could benefit from delamanid. However, in the two years since the drug has been approved, only 180 people have received this new treatment. This shows that the benefit of delamanid is not reaching those who need it.

The company marketing delamanid, Otsuka, has registered it in only four countries (Germany, Japan, South Korea and United Kingdom), none of which has a high burden of DR-TB. The drug should be registered in countries with high DR-TB burden and where clinical trials for the drug took place

Can delamanid benefit India?

India has the highest burden of drug-resistant TB in the world. MDR-TB and XDR-TB are on the rise, and access to new antibiotics will play a key role in developing new TB regimens to address growing treatment needs and improve cure rates in the country.

Otsuka has not applied to conduct phase three trials in India, a step necessary for obtaining approval from the Central Drugs Standard Control Organization.

The national TB programme needs access to the drug to obtain evidence on its effectiveness. However, without local clinical trials and marketing approval, delamanid cannot be procured by the national TB programme or other treatment providers like MSF to treat people infected with the most drug-resistant forms of the disease.

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IEP Resources:

Global tuberculosis report 2015

The potential impact of up-front drug sensitivity testing on India’s epidemic of multi-drug resistant tuberculosis

Evolution of extensively drug-resistant tuberculosis over four decades: Whole genome sequencing and dating analysis of mycobacterium tuberculosis Isolates from KwaZulu-Natal

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