New Delhi: As the conditional Access program with the Government of India for the provision of Bedaquiline is soon coming to an end, come 2019, Johnson and Johnson will offer its blockbuster tuberculosis (TB) drug, at $900 (Rs 62,000 approx) according to a recent report in ET.
Bedaquiline is the last line of treatment for patients with MDR – TB who are left with MDR TB. J&J said India is eligible for the lowest global price and that it is working on a sustainable access strategy.
Hindu reports that 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.
Sanjiv Navangul, managing director, J&J India told ET, “Recognising the ongoing and significant burden of TB, we are in conversations with the Indian government to ensure affordable and sustainable access to bedaquiline in the long term, once the Janssen-USAID donation programme comes to an end in early March 2019.”
The program will offer 10,000 courses of Bedaquiline and government has received 6,750 courses and the remaining courses will be delivered within the agreed timelines placed by the Central TB division. In conditional access programme the courses to be administered across six centers in India.
However, the drug share some controversy, the medical professionals, drug researchers and patient rights activists groups have raised different issues on the efficacy of the drug.
Bedaquiline has got conditional approval from USFDA on the basis of a phase 2 studies this means the drug has to be administered following certain protocols.
The company has also been accused that Indian patients who were administered the drugs were not told that they were part of a clinical trial through the conditional access programme (CAP).
The accusations were denied by the firm saying that it has partnered with the Indian government through the CAP is not a clinical trial but “will help generate real-world experience, for the national TB program to evaluate and explore opportunities for expanded access to bedaquiline for patients in India”.
Sanjiv Navangul told ET, “We have been working closely with the government of India on the appropriate rollout and use of the drug. We have communicated the safety aspects of bedaquiline to the Indian government and trained more than 12,000 physicians on the clinical management of the drug. The patient information booklet also covers safety information regarding the drug.”
In an interview with ET in June this year, Nobel laureate John Walker said Bedaquiline might not be without side effects, and there should be enough data before expanding the drug roll out. This is what has alarmed scientists like Walker.
“We should wait for more data to emerge. You have to approach in a step-wise manner and expand gradually once it becomes clear if there are not any contraindications,” Walker has told ET.