Patients group voice concern over high price of new drug-resistant TB drug

Patient groups and medical humanitarian organisations have voiced concern over the availability and prices of a new tuberculosis (TB) drug, even as they stressed that treatments needed to be accessible for patients suffering from drug-resistant strains of the disease.

Though Japanese pharmaceutical company Otsuka announced on Wednesday that its TB drug delamanid, would be available in developing countries at $1,700 per treatment course, might not be available in India at an early date.

Though the Japanese company had reportedly obtained a patent more than three years ago, it had not applied for regulatory approval to market it.

It had also not applied to conduct phase III trials in India, a necessary requirement for obtaining approval from the drug regulator (CDSCO). India has the highest incidence of drug-resistant TB in the world.

The drug available for $1700 per treatment course is not affordable for the country's state-run tuberculosis-control initiative, and therefore beyond the reach of thousands of patients.

Delamanid works in combination with several other drugs to effectively treat drug-resistant TB (DR-TB); and the regimens, without delamanid, already cost between $1,000-4,500 per treatment course at the lowest prices available to developing countries, which was not affordable for governments, according to experts.

To help with wider use in drug-resistant -TB treatment, Médecins Sans Frontières (MSF) has suggested a price of $500 per treatment course for drug-resistant TB.

"Countries should start scaling up treatment for more people with drug-resistant TB using the most effective drugs available, but delamanid is neither affordable nor available in most countries today," said Grania Brigden, TB advisor for MSF's Access Campaign.

"The price for delamanid needs to come down to an affordable level, and Otsuka should also register delamanid quickly in all countries where the drug has been tested in clinical trials, as well as in countries with the highest burdens of drug-resistant TB."

According to MSF, patents were not granted to merely to enable patentees to enjoy a monopoly on a patented medicine. It added that the government must take steps to ensure that this life-saving medicine became available to the National TB programme so that MDR-TB and XDR-TB patients in India had access to the most effective treatments, the MSF further said.