The Bedaquiline Donation Program: progress and lessons learned after 4 years of implementation.

The Bedaquiline Donation Program was a global public-private partnership between the US Agency for International Development (USAID) and Janssen Therapeutics. The 4-year program was intended to accelerate access to bedaquiline (BDQ) by committing 30 000 treatment courses to more than eligible 100 countries. The program was designed to remove barriers by making the drug available through the Global Drug Facility (GDF); prepare TB programs to a changing drug-resistant TB (DR-TB) treatment landscape; improve quality of the entire DR-TB care paradigm; gather additional effectiveness and safety data in programmatic settings; and identify programmatic challenges associated with new TB drug introduction. By the end of the program (in April 2019), 80 countries had ordered 104 344 BDQ courses, of which 33 119 had been delivered (the rest were pending delivery). The introduction of new TB drugs offers hope to patients and an opportunity to transform DR-TB treatment with shorter, simpler and more tolerable regimens. The Bedaquiline Donation Program demonstrated that access to new drugs can be accelerated. Technical support to improve the overall quality of care is critical as are investments beyond the cost of the drug.