Quantification of investments in the development of bedaquiline finds total public and philanthropic expenditures are three to five times those of Johnson & Johnson.
Hyderabad, India –– October 31, 2019 –– Presented at the 50th Union World Conference on Lung Health, an analysis by Treatment Action Group (TAG) finds that total public expenditures on the development of bedaquiline –– an important medicine for drug-resistant tuberculosis (DR-TB) –– far exceed those of the originator company, Johnson & Johnson. Public investment in bedaquiline was 3.1–5.0 times those of the originator (US$455-747 million versus $90-240 million), or 1.6–2.2 ($647-1,201 million versus $292-772 million) when the cost of failures and costs of forgoing other investment opportunities are counted.
Dzintars Gotham, the lead author of the study, remarks, “Measuring the value of the public’s investments in bedaquiline is important given ongoing debates about the pricing of bedaquiline and lagging access to the drug among people who need it.” Dr. Gotham, an independent academic consultant contracted by TAG for this analysis, continued, “More broadly, it illustrates the substantial role of the public sector in pharmaceutical research and development, especially for medicines of high value to global health.”
Earlier this year, the World Health Assembly passed a resolution on drug pricing transparency. “Governments must fully commit to holding pharmaceutical companies accountable for reporting the costs of research and development and of manufacturing,” commented Mike Frick, Co-Director of the TB Project at TAG. “In the meantime, academics and activists are busy building an evidence-base that strips bare the primary argument used by pharmaceutical companies to justify high prices. Pharma will tell you they need to recoup their investments in R&D, but the closer we look, the less this argument holds up.”
To quantify public and philanthropic investments in the development of bedaquiline, Gotham et al. identified various avenues of public investments in the development of bedaquiline, including direct funding of clinical trials, funding for administration of a donation program, tax credits and deductions, and expected revenues resulting from the priority review voucher (PRV) awarded to Johnson & Johnson for bedaquiline’s approval by the U.S. Food and Drug Administration in 2012. The full oral abstract and presentation which explain the methodology and findings in further detail are available here.
The World Health Organization considers bedaquiline an essential medicine and recommends it as a preferred option for treating DR-TB. The price of this life-saving but underused drug must come down in order for national TB programs to ensure access to bedaquiline for all people with DR-TB. “These findings confirm that bedaquiline is a public good and must be treated as such. Johnson & Johnson must lower the price of bedaquiline to $1 a day,” said Lindsay McKenna, Co-Director of TAG’s TB Project. “We know that the public has shouldered the majority of development costs, and that bedaquiline can be produced and sold at a profit for as little as $0.25 to $0.50 cents a day.1 Charging eight times this amount for a lifesaving drug is egregious and despicable mercenary behavior by Johnson & Johnson that can’t be allowed to continue.”
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About Treatment Action Group (TAG): TAG is an independent, activist, and community-based research and policy think tank fighting for better treatment and prevention, a vaccine, and a cure for HIV, TB, and hepatitis C virus (HCV). TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.
About bedaquiline: Bedaquiline is a core component of treatment regimens for drug-resistant tuberculosis (DR-TB), receiving a strong recommendation from the World Health Organization in 2018.2 In treatment regimens for DR-TB, bedaquiline enables the replacement of older, less effective and more toxic medications such as the second-line injectable agents, which can cause permanent hearing loss. Bedaquiline also dramatically improves rates of treatment success –– people with DR-TB treated with regimens that include bedaquiline are three times less likely to die than people treated with regimens without bedaquiline.3 Yet globally, only an estimated 37,000 people with drug-resistant TB have been treated with bedaquiline from 2016–20194 this is only 20% of the estimated number of people who need access to bedaquiline. Johnson & Johnson is now charging $400 for six months of bedaquiline; many patients will need more than six months.
1. Gotham D, Fortunak J, Pozniak A, et al. Estimated generic prices for novel treatments for drug-resistant tuberculosis. Journal of Antimicrobial Chemotherapy 2017; 72: 1243–1252.
2. World Health Organization. 2019 WHO Consolidated Guidelines on Drug-resistant Tuberculosis Treatment. Geneva: World Health Organization; 2019. https://www.who.int/tb/publications/2019/consolidated-guidelines-drug-resistant-TB-treatment/en/
3. Schnippel K, Ndjeka N, Maartens G, et al. Effect of bedaquiline on mortality in South African patients with drug-resistant tuberculosis: a retrospective cohort study. Lancet Respir Med 2018; 6: 699–706.