In what will come as good news for tuberculosis (TB) patients, life-saving drug bedaquiline by US pharma company Johnson & Johnson (J&J) is now being offered at $400 per patient — over 50% cheaper than the earlier price of $900 negotiated with the government two years ago.
The reduction has been made possible on account of a change in World Health Organization (WHO) treatment guidelines, which included newer drugs including bedaquiline for drug-resistant TB on August 17, and another TB hotspot South Africa negotiating a lower price with J&J earlier in July. The price reduction has a major significance for India — a country saddled with high healthcare costs, poor infrastructure and a high TB burden.
At present, India is one of the few countries where J&J offers the drug free of cost under a conditional access programme, which will end in March 2019. India has the highest burden of TB in the world, accounting for more than a quarter of all cases worldwide, with nearly 1.5 lakh new cases of multi drug-resistant TB (MDR-TB) a year. In 2016, there were an estimated 27.9 lakh TB cases in the country.
The regimen for drug-resistant TB by WHO recommends use of bedaquiline to be prioritised along with levofloxacin/moxifloxacin and linezolid, replacing painful and toxic injections with severe side-effects like hearing loss in patients. Bedaquiline (trade name Sirturo) is perhaps the first drug in decades to have a potential to dramatically improve MDR-TB outcomes and reduce the number of people who die.
Last month, South Africa became the first country in the world to recommend an injection-free treatment regimen for MDR-TB based on new data published in medical journal, The Lancet. The data showed bedaquiline-containing regimens were associated with a 41% increase in treatment success, and a three-fold reduction in mortality compared to regimens without the new drug.
When contacted, a top company official said the special price has been communicated to the Indian government recently, adding that if accepted, it will kick in once its conditional access programme under which the drug is offered free ends next year. The company offers this special price to eligible national TB programmes procuring bedaquiline through the Stop TB Partnership’s Global Drug Facility, including India, with the objective to make treatment accessible and affordable for a greater number of patients, he added.
Till now, 10,000 courses of bedaquiline have been committed to India for free, through the US Agency for International Development, of which 6,750 doses have been donated. These drugs are distributed through nodal DR-TB centres across the country.
However, activists have asked J&J to lower bedaquiline price to $32 per month, saying transparent volume-based reductions must be negotiated with global partners, including civil society. Research conducted at the University of Liverpool has estimated that bedaquiline could be produced and sold at a profitable mark-up for between $8 and $16 per month (between $48 and $96 for six months) — roughly a tenth of the price charged to the South African government and about one/300th of the price charged in some wealthy countries.
