What Non-Profit Development of Pretomanid Can Teach About Paths to Innovation and Global Access to Treatments for Diseases of Poverty?
Author(s)
Payal Arya, PhD, Fred Ledley, MD.
Center for Integration of Science and Industry, Bentley University, Waltham, MA, USA.
Center for Integration of Science and Industry, Bentley University, Waltham, MA, USA.
OBJECTIVES: Pretomanid, developed by the non-profit TB Alliance, is one of only three drugs (pretomanid, bedaquiline, delamanid) approved in the past 40 years to treat pulmonary multidrug-resistant tuberculosis (MDR-TB). BPaL (bedaquiline, pretomanid, linezolid) or BPaLM (with moxifloxacin) regimens offer a 90% cure with 6 months treatment. This study describes TB Alliance’s non-profit model for developing pretomanid and challenges in achieving global adoption.
METHODS: Literature review; interviews with TB Alliance staff and selected stakeholders in public health, government.
RESULTS: Pretomanid development cost $206M provided by philanthropies or government grants, is approved by the FDA (2019), EMA (2020), and 20 other countries (through 2023), and is licensed to multiple generic manufacturers for regional sales. WHO issued guidance for use in operational research (2020) and MDR-TB treatment (2022), prequalification (2020), and designation as an essential medicine (2023). TB Alliance received $105M from sale of a priority review voucher but receives no revenue from pretomanid sales outside of high-income countries (except China, Russia).
From 2019-2023, 40,000 people received pretomanid-containing regimens for MDR-TB, which WHO estimated incidence (pulmonary+non-pulmonary) of 410,000 with 190,000 deaths (2022). TB Alliance projects 2024 usage will be >100,000 individuals. Pretomanid uptake was more rapid than bedaquiline and delamanid.
CONCLUSIONS: Pretomanid’s development demonstrates the feasibility of drug development by an independent, non-profit firm. TB Alliance minimizes drug costs by eliminating cash distributions to shareholders (the distinguishing feature of non-profits) and eschewing returns from sales outside high-income countries. Without a cost-recovery mechanism, however, TB Alliance relies on philanthropy and grants to sustain operations and new development. The complex process of gaining product acceptance may provide an opportunity for non-profits like TB Alliance to have even greater impact by becoming trusted partners to the public health community in adopting innovative cures. The authors thank TB Alliance for their participation in this project.
METHODS: Literature review; interviews with TB Alliance staff and selected stakeholders in public health, government.
RESULTS: Pretomanid development cost $206M provided by philanthropies or government grants, is approved by the FDA (2019), EMA (2020), and 20 other countries (through 2023), and is licensed to multiple generic manufacturers for regional sales. WHO issued guidance for use in operational research (2020) and MDR-TB treatment (2022), prequalification (2020), and designation as an essential medicine (2023). TB Alliance received $105M from sale of a priority review voucher but receives no revenue from pretomanid sales outside of high-income countries (except China, Russia).
From 2019-2023, 40,000 people received pretomanid-containing regimens for MDR-TB, which WHO estimated incidence (pulmonary+non-pulmonary) of 410,000 with 190,000 deaths (2022). TB Alliance projects 2024 usage will be >100,000 individuals. Pretomanid uptake was more rapid than bedaquiline and delamanid.
CONCLUSIONS: Pretomanid’s development demonstrates the feasibility of drug development by an independent, non-profit firm. TB Alliance minimizes drug costs by eliminating cash distributions to shareholders (the distinguishing feature of non-profits) and eschewing returns from sales outside high-income countries. Without a cost-recovery mechanism, however, TB Alliance relies on philanthropy and grants to sustain operations and new development. The complex process of gaining product acceptance may provide an opportunity for non-profits like TB Alliance to have even greater impact by becoming trusted partners to the public health community in adopting innovative cures. The authors thank TB Alliance for their participation in this project.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR89
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity
Disease
SDC: Infectious Disease (non-vaccine)