Public investments in the clinical development of bedaquiline

Introduction: In 2012, bedaquiline became the first new treatment from a novel class to be approved for tuberculosis in nearly five decades and is now a core component of the standard of care for multidrug-resistant tuberculosis. In addition to the originator pharmaceutical company, Janssen, a range of governmental and non-profit entities have contributed to the development of bedaquiline. Materials and methods: We identified various avenues of public investments in the development of bedaquiline: direct funding of clinical trials and a donation programme, tax credits and deductions, and revenues resulting from the priority review voucher (PRV) awarded to the originator. Data on investments were gathered through contact with study leads and/or funders; for non-responses, published average costs were substituted. The originator company’s expenses were estimated by similar methods. Tax credits and deductions were calculated based on estimated originator trial costs and donation expenses. The value of the PRV was estimated by application of a published model. Results: Public contributions through clinical trials funding were estimated at US$109–252 million, tax credits at US$22–36 million, tax deductions at US$8–27 million, administration of a donation programme at US$5 million, PRV revenues at US$300–400 million. Total public investments were US$455–747 million and originator investments were US$90–240 million (if capitalized and risk-adjusted, US$647–1,201 million and US$292–772 million, respectively). Conclusions: Estimating the investments in the development of a medicine can inform discussions regarding fair pricing and future drug development. We estimated that total public investments exceeded the originator’s by a factor of 1.6–5.1.