Lead Story. Charting the right course on Bedaquiline for India

What more does a company need to do, asks Sanjiv Navangul, India-head of Janssen, the pharmaceutical division of Johnson & Johnson, laying out the Bedaquiline story and fielding queries that continue to be asked of this drug and its distribution programme.

Bedaquiline is the first new drug to treat tuberculosis in 40 years. So despite side effects and limited data available, regulators gave Janssen’s Bedaquiline an accelerated approval with guidelines and warnings. And the World Health Organisation (WHO) recommended it to treat multi drug resistant (MDR) TB for those with no other option.

In drug resistant (DR) TB, bacteria is resistant to standard drugs used to treat it — a major worry for governments working to eliminate TB. But there’s an irony of sorts when it comes to Bedaquiline in India. Countries like South Africa and Russia have marched ahead in distribution and readying self-sustaining models for the future. This, despite India being a base for many things around Bedaquiline — from developing the formulation, to producing the API (active pharmaceutical ingredient), to exporting to other countries.

In March 2016, Janssen and India’s Revised National Tuberculosis Control Programme announced an access programme to provide Bedaquiline free to 600 patients. As the programme stands poised for a scale-up to get the drug to more patients, advocacy groups have raised concerns on having a sole supplier for the drug, even as other voices call for transparency on the deal between the Government and the company.

Navangul points out that the United States Food and Drug Administration approved the product in 2012 on data that outlined patient benefits, even as Phase III trials were to be completed. The WHO also came out with interim treatment guidelines. India is following a globally established pattern, he says, and possibly 1,000 patients are presently treated. “Everybody started around the same time, but Russia has treated more than 10,000 patients, South Africa has treated more than 16,000 patients,” says Navangul, and these countries have created a sustainable model to purchase Bedaquiline. Janssen’s tier-pricing for the drug is pegged at $30,000 for a six-month course in high-income countries, $3,000 for middle-income and $900 for low-income regions.

Data vs debate

South Africa has even replaced toxic injectibles with Bedaquiline in its national programme, a move applauded by patient groups. Their Government must have taken that decision seeing their data from patients, says Navangul, asking detractors of the drug roll-out programme, “is that data more important or is that debate more important?”

Of the 30,000 courses given to USAID, India secured about 11,000, free, he says. “India has 27 per cent of the disease burden. India has got more than 35 per cent free. So India has got disproportionate help. Though India is not a low-income country (it is in that bracket),” he says. Between South Africa, Russia and India, data is available for over 25,000 patients, “No clinical trial Phase III can have 25,000 patients’ data,” he says, adding that it would be reviewed by the WHO.

“For India we did quite a few things ...We have done transfer of technology to make API here. ...we make the formulation (finished medicine) here,“ he says. Last August, J&J said it would partner with the Institute of Microbial Technology (part of the Council of Scientific and Industrial Research - CSIR) to develop new oral treatments for TB. “So manufacturing, access, the right pricing, R&D (research & development), everything that an organisation can do, we have done. Today I ask this question’s reverse to everyone, tell me what more a company could have done,” says Navangul.

Countering the call for voluntary or compulsory licensing so more companies can make the drug at a lower price, he says, “if there is one supplier who can supply everybody, at an economical price, there is no capacity constraint, there is no pricing constraint, there is no access constraint. So if there is no constraint, then this debate is of no value.”

Donation caution

But Leena Menghaney with humanitarian organisation MSF’s Access Campaign cautions that “donations” are anti-competitive as it means dependence on one pharma company and patients could be impacted if the company faces a sudden production issue or it decides to change its policy on donations. “TB manufacturers need to use available flexibilities to develop and register the generic product and keep it ready for use when licences become available or the patent expires in 2023 on this drug,” she adds.

As many such concerns continue to be discussed, India’s course on getting Bedaquiline to more patients will be critical. Specially as heads of State meet at the UN General Assembly in New York this September for the first-ever high-level meeting towards eliminating TB.

COMMENT NOW