Bedaquiline, a drug in demand for treating Tuberculosis (TB)has been placed in the list of ‘priority’ drugs by the World Health Organisation (WHO). This was stated in a rapid communication issued by the WHO to all the countries, and seen by BusinessLine .
Bedaquiline was previously placed in ‘Group C’, which indicated drugs that can be used ‘when agents in Group A and B cannot be used.’ The communication states that Bedaquiline is placed in ‘Group A’ — medicines to be prioritised, along with Levofloxacin/Moxifloxacin.
The WHO however warned that it does not have an evidence on safety and effectiveness of Bedaquiline if used beyond six months.
In what will be a substantial revision of guidelines since 2016 the WHO no longer recommends use of Kanamycin and Capreomycin in TB patients. This is due to the increased risk of treatment failure and relapse associated with their use.
Currently, US-based Johnson and Johnson’s (J&J) Janssen holds patents for producing Bedaquiline, until 2023. Under the conditional access programme by the the Indian government, Bedaquiline imported from Janssen is being administered on 1,000 patients. By the Government’s own admission, over 2,000 patients require the drug, though experts say that the number may be closer to 20,000 patients. There has been no official survey of how many patients need the drug. While there are 1.3 lakh estimated drug-resistant patients, Bedaquiline is not to be given to children, pregnant or lactating mothers.
J&J recently announced a price reduction for Bedaquiline in some countries, including India. India has received the current stock through donation.
“J&J falls short in terms of making the drug affordable in countries that are hardest hit by DR-TB. The reduced price of $400 for six months of treatment that certain countries are promised, remains excessive. In countries excluded from J&J’s price reduction, the corporation currently charges between $3,000 and $30,000 for six months of treatment,” said a statement released by Doctors Without Borders (MSF).
On the patent battle, the statement saidy, “to ensure the long term affordability and sustainable supply of bedaquiline — which is patented quite widely until 2023 — MSF called on J&J to also issue a licence to the Medicines Patent Pool, which would enable access to affordable generic versions of the drug.”