August 1, 2022: Unitaid, The Aurum Institute, the Clinton Health Access Initiative (CHAI), and MedAccess today announced two new agreements to lower the price of rifapentine (RPT)-based treatments to prevent tuberculosis in low- and middle-income countries.
The agreements, negotiated with manufacturers Macleods Pharmaceutical Ltd. and Lupin Limited, mean that:
- 3HP, a three-month, once-weekly oral treatment, will now be available at a ceiling price of US$14.25 from both Macleods and Lupin.
- Rifapentine 300 mg single tablets, used in 3HP and 1HP (a one-month, once-daily oral treatment) will be available from Lupin for US$33.90 per 100 tablets.
The new prices will be available in 138 low- and middle-income countries, including those with the highest burden of tuberculosis (TB) globally. TB claimed an estimated 1.5 million lives in 2020, making it the second-leading infectious disease killer globally after COVID-19. Latent TB is often cited as the reservoir of the TB epidemic. Worldwide, an estimated 1.7 billion people are living with latent TB, usually without symptoms. Without treatment, five to 10 percent of people with latent TB will develop active TB in their lifetimes.
1HP and 3HP both contain rifapentine and isoniazid and are two of several regimens recommended for the treatment of latent TB infections. For 1HP, patients take tablets every day for one month. For 3HP, patients take a fixed-dose combination tablet once a week for three months.
These regimens significantly reduce the duration of treatment. In the past, TB preventive treatments (TPTs) have required patients to take multiple pills daily for six months or more. By reducing the pill burden and treatment duration, patients are more likely to take and complete the full treatment cycle. A 2021 study showed that 90 percent of patients prescribed 3HP completed treatment compared to 50 percent of patients prescribed isoniazid alone[1].
Access to TPT is especially important for people living with HIV. The probability of latent TB infection activating to TB is much higher in people living with HIV and their household contacts. People living with HIV are also particularly vulnerable to the effects of TB, which contributed to 214,000 AIDS-related deaths in 2020.
The new price agreements are part of a determined effort by partners to increase access to and improve supply security of short-course TPTs. Since 2018, Unitaid has supported the introduction and scale-up of affordable, shorter rifapentine regimens for preventive treatment through the ‘Increasing Market and Public health outcomes through scaling up Affordable Access models of short-course preventive Therapy for TB’ (IMPAACT4TB) program, led by the Aurum Institute.
“Unitaid’s sharp focus on TB through comprehensive interventions such as our IMPAACT4TB project on TB prevention has improved access to key products for those at risk while realizing significant savings for the health systems. Five years in, this innovation has been scaled up in over 50 countries – surpassing global targets to reach people living with HIV. We hope this price reduction and market expansion will help us reach more young children and household contacts, where prevention of TB remains unaddressed,” said Dr. Philippe Duneton, Executive Director of Unitaid.
Unitaid, Global Fund, and the Stop TB Partnership, though the Global Drug Facility (GDF), first established an access price for rifapentine 150 mg in 2019 with originator company, Sanofi. In February 2021, Unitaid and IMPAACT4TB partner CHAI announced a package of support for the commercialization of the first fixed-dosed combination of 3HP from Macleods Pharmaceutical Limited. In August 2021, MedAccess, in partnership with CHAI and Unitaid executed a volume guarantee agreement with Macleods to extend the access pricing and support expansion of Macleods’ 3HP production capacity to meet growing demand.
In July 2022, MedAccess and Macleods updated their 3HP volume guarantee agreement, while Unitaid, GDF, and CHAI negotiated a new agreement with Lupin to secure affordable prices for 1HP and 3HP.
“Every year, TB claims more than 1.5 million lives and disproportionately affects people in the most vulnerable communities,” said Hema Srinivasan, Chief Access Officer at MedAccess. “The price reductions announced today will help to make highly effective, short-course preventive therapies more affordable for procurers and national programs. Working with our partners, we are committed to expanding access to these therapies.”
“We have been working with partners since 2018 to introduce and expand choices for shorter, more patient-friendly treatments to prevent tuberculosis,” said Dr. Neil Buddy Shah, CHAI CEO. “We are thrilled that countries now have two cost-effective options – 3HP at US$14.25 and 1HP at below US$20 per course – to save the lives of their populations and prevent this disease.”
Efforts to increase access to short-course preventive treatments are being bolstered by funding and technical assistance from The Global Fund and PEPFAR and procurement support from i+Solutions and GDF.
“StopTB/GDF has prioritized support for TPT, providing technical assistance on adoption of rifapentine-based TPT in more than 35 countries and procurement support to more than 50 countries. We hope lower medicine prices will translate into more people being treated for TPT towards meeting commitments made in the 2018 UNHLM Political Declaration on TB,” said Dr. Lucica Ditiu, Executive Director, Stop TB Partnership.
Vijay Agarwal, CEO, Macleods said: “Since our first TB product was prequalified by WHO in 2007, Macleods has secured prequalification for 35 products to tackle TB. Staying true to our mission, we have focused our research and development efforts on TPT, securing approval for 3HP and filing for prequalification for Rifapentine 300 mg tablets. In the coming, years we are aiming to file for approval of a further seven TB products currently in development.”
“Tuberculosis is one of humanity’s oldest, deadliest, and most persistent diseases. Lupin is the largest supplier of anti-TB drugs globally and we are excited to partner with Unitaid, The Aurum Institute, and CHAI to help TB preventive therapy reach individuals and countries where access to these medicines is so urgently needed. Being backwardly integrated with complex fermentation-based anti-TB drugs like rifapentine and rifampin, Lupin is uniquely placed to provide affordable access to the management of prevention and treatment of tuberculosis,” said Naresh Gupta, President API Plus, Lupin.
[1] Churchyard et al, 2021 https://www.acpjournals.org/doi/abs/10.7326/M20-7577?journalCode=aim
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For further information, please contact Hervé Verhoosel, Spokesperson and Head of Communications at Unitaid, on +44 7729 618634 or verhooselh@who.int, Rob Kelly, Head of External Relations at MedAccess, on +44 7867 132038 or rkelly@medaccess.org or Corina Milic, Acting Director of Communications at CHAI, cmilic@clintonhealthaccess.org
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization. For more information, please visit www.unitaid.org
About Aurum Institute
The Aurum Institute is a proudly African organisation working to advance health science and innovation to create a healthier world for future generations. We partner with governments, the private sector and civil society to design and deliver high-quality care and treatment to people in developing communities.
https://www.auruminstitute.org/
About MedAccess
MedAccess is a UK-based social finance company with a mission to make global healthcare markets work for everyone. Our core purpose is to make medical supplies more widely available at lower prices in under-served markets. By applying the rigour and skills of business finance, we’re providing a novel solution to the challenge. We offer volume guarantees that reduce commercial risk and allow medical manufacturers to accelerate supplies into new markets at affordable and sustainable prices. In this way, vaccines, medicines, diagnostic tests and medical devices can reach patients far sooner than existing market forces would allow.
For more information see www.medaccess.org and follow MedAccess on Twitter @MedAccessUK.
About CHAI
The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low- and middle-income countries. We work with our partners to strengthen the capabilities of governments and the private sector to create and sustain high-quality health systems that can succeed without our assistance. https://www.clintonhealthaccess.org/
About Macleods
Macleods Pharmaceuticals Limited is a 38-year-old Indian company specialising in the manufacture of generic products across several therapies and dosage forms. We have developed a range of essential medicines in our portfolio of products to tackle HIV, malaria, tuberculosis and neglected tropical diseases, 68 of these received WHO prequalification. Our work on tuberculosis has led to the development of products for adults and children to tackle both drug-susceptible and drug-resistant tuberculosis.
About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India with 15 manufacturing sites, 7 research centers and more than 20,000 professionals working globally. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the anti-TB, cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
