Partners announce reduced price for patient-friendly tuberculosis preventive treatments
Geneva, 1 August 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 $14.25 from both Macleods and Lupin.
- Rifapentine 300mg single tablets, used in 3HP and 1HP (a one-month, once-daily oral treatment) will be available from Lupin for $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) programme, 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 commercialisation 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 programmes. 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 $14.25 and 1HP at below $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 into TPT, securing approval for 3HP and filing for prequalification for Rifapentine 300mg 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
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, 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.
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.
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.
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 which have 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.
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CHAI
Corina Milic
Acting Director of Communications
cmilic@clintonhealthaccess.org
Unitaid and the Government of Kenya strengthen collaborative partnership to advance global health goals
Nairobi/Geneva – Global health agency Unitaid and the Government of Kenya are launching a newly reinforced cooperation, with a memorandum of understanding between the two parties signed in Nairobi.
Over its decade and a half history, Unitaid has worked closely with Kenyan partners to enable affordable, equitable, and rapid access to game-changing health innovations for those who need them. These include early infant HIV diagnostics, best-in-class antiretroviral drugs for adults and children with HIV, child-friendly tuberculosis (TB) medicines, cutting-edge screen-and-treat solutions for cervical cancer, indoor sprays to curb malaria, and access to COVID-19 tests and medical oxygen, among many others.
The agreement will further improve alignment between Unitaid investments and Kenyan health priorities, enable early access to innovations, and strengthen capacity of Kenyan health services, systems, research institutions and manufacturers.
“Unitaid’s collaboration with Kenya dates from its very beginnings 15 years ago. Nearly 80% of Unitaid’s US$1.5 billion currently invested supports work on the African continent. Kenya is a close partner in these efforts – both as one of the countries where the greatest number of Unitaid projects are running, and as one of the quickest countries to adopt and scale up critical health innovations,” said Dr Philippe Duneton, Executive Director of Unitaid. “This partnership will further advance our shared goals to improve health in Kenya and beyond.”
“Advances in health innovations hold game-changing potential when implemented widely and equitably, but ensuring products reach the last mile is far from guaranteed. This is why our partnership with Unitaid is so valuable: together we will design the most impactful solutions so no one is left behind,” “said Sen. Mutahi Kagwe, Cabinet Secretary for Health of the Republic of Kenya.
Joint efforts will focus on advancing sustainable approaches to reduce the burdens of HIV, TB, malaria, cervical cancer, hepatitis and COVID-19, improve the health of women and children, increase regional and domestic manufacturing of essential health products and strengthen pandemic preparedness and response efforts.
The Ministry of Health and Global health agency Unitaid have signed a memorandum of understanding that seeks to strengthen collaborative partnership to advance global health goals. 1/5 pic.twitter.com/f4lId488m4
— Ministry of Health (@MOH_Kenya) June 30, 2022
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Unitaid Strategy 2023-2027
Unitaid calls for renewed efforts to end tuberculosis and reinforce global health responses in advance of World TB Day
Geneva – In advance of World TB Day, 24 March, Unitaid reaffirms its commitment to bring innovative approaches to the fight against TB.
The COVID-19 pandemic has had a devastating effect on health programmes worldwide, but tuberculosis (TB) efforts have been disproportionately affected. Disruptions and delays to crucial services caused deaths from TB to increase for the first time in over a decade.
“In a rapidly changing world, the need to confront new challenges with updated tools and strategies is more salient than ever,” said Dr Philippe Duneton, Executive Director of Unitaid. “The tuberculosis bacteria was identified 140 years ago. Yet it continues to cause 1.5 million deaths each year, and millions of people around the world still lack access to the best tools, treatments, and prevention.
“The COVID-19 pandemic puts this in a particularly stark light. Since it began just over two years ago, we have developed and deployed rapid at-home tests, several powerful vaccines, multiple treatments that avert severe disease and mobilized billions in financing. And though there remains much to do, we are hopeful that we’re starting to turn a corner.
“Breakthroughs in TB in the past 10 years have pushed forward significant progress. Three new drugs – the first in half a century – and the first-ever child-friendly formulations for TB made treatment shorter, more effective, and less toxic. And with quicker and more accurate diagnostic tools and improved preventive therapies, more people can access care that, previously, was often too complicated, long, or expensive.
“But TB programmes worldwide are now facing severe setbacks. Even before COVID-19 shuttered services, 30% of all people with TB were not diagnosed, and therefore did not access treatment. And others at high risk of infection, including young children, pregnant women, and household contacts, were not reached with critical preventive treatment.
“Our past investments in TB prepared us to respond to COVID-19. When the first cases emerged, our TB experts were called in as the first line of defense, leveraging their expertise in controlling airborne infectious diseases to develop effective containment strategies.
“Now, our future investments must shore up efforts to end TB. These commitments today will not only galvanize the fight to beat a curable and preventable disease, but they will form the backbone of vital global health responses to protect people everywhere from whatever comes next.”
- Find out more about Unitaid and tuberculosis
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Innovations in paediatric medicines delivery awarded UnitaidExplore funding
- Two new awards announced under Unitaid’s agility mechanism, UnitaidExplore; DelSiTech and FluidPharma will each receive investment for innovations to make medicines easier to give to children
- Latest call comes in context of Unitaid’s ground-breaking work on paediatric formulations to treat HIV, TB and malaria
- Children in low- and middle-income countries have lower treatment coverage and worse health outcomes than adults – a lack of paediatric formulations is a major contributing factor.
Geneva, 4 October 2021 – Two companies developing potentially game-changing medicine delivery mechanisms for children are the latest recipients of UnitaidExplore funding.
Finnish company DelSiTech and British enterprise FluidPharma have each been awarded funding following the latest call for applications under Unitaid’s pioneering agility mechanism.
Children in low- and middle-income countries have lower treatment coverage and worse health outcomes than adults. A major barrier is a lack of medication that is specifically formulated for their needs. Often medicine is too bitter, difficult to swallow or not correctly dosed, making it hard for children to stay on treatment for diseases such as HIV, malaria and TB.
The latest UnitaidExplore call specifically targeted this issue, inviting applicants to apply for funding to push forward innovation in this field. It builds on Unitaid’s significant work in the field of paediatric formulations for HIV, TB and malaria treatments, and its key role in WHO’s GAP-f network.
FluidPharma will use UnitaidExplore funding to take forward development of their MicroCoat™ technology, which utilises tiny cellulose spheres with taste-masking properties to deliver medication in a formulation that is more palatable to children. It is hoped that this technology could be used across a range of disease areas, with initial development of an artesunate/amodiaquine malaria combination therapy.
DelSiTech’s work focuses on the development of long-acting injectables to deliver medicines to children, reducing the burden of tablets and the associated stigma with taking such medication. The technology involves the use of thin, minimally invasive needles to deliver a unique silica-based formulation via sub-cutaneous injection. The technology can be used to administer drugs that treat or prevent a wide range of conditions, while significantly extending the effective duration of the treatment from a single dose.
Unitaid Director of Strategy Janet Ginnard said: “Innovations in medicine delivery that are specifically aimed at children are of utmost importance and we are pleased to announce this funding to DelSiTech and FluidPharma. These investments fit firmly with Unitaid’s track record in facilitating access to the best medicines for the most vulnerable people. These innovations will help ensure that children can benefit from lifesaving treatment and have the best possible health outcomes.”
The investments from Unitaid will accelerate both companies’ paediatric delivery mechanisms, covering pre-clinical work for several different potential applications.
Professor John Reeder from WHO’s GAP-f network said: “Unitaid’s new investments in innovative delivery approaches for children are extremely welcome, as they spark new energy and collaborations to ensure that science and innovation are at the service of those who have been too often left behind, our children.”
Dr. Lasse Leino, Chief Executive Officer from DelSiTech said: “Alliances, such as with Unitaid, are essential to us and to healthcare organisations around the world for the realisation of our common goal, securing real advancements in global health. DelSiTech is committed to pursuing long lasting strategic partnerships, enabling us to play a role in improving treatment outcomes, now for clearly underserved children. We are thrilled to collaborate with Unitaid and are prepared to leverage the full extent of our technologies and expertise for paediatric solutions for patients, wherever they may be”.
Dr Fang Liu from Fluid Pharma said: “We are really excited for this opportunity to join Unitaid’s excellent work in making medicines suitable for children. Applying the MicroCoatTM technology, we will develop paediatric anti-malarial treatments that are palatable, easy to swallow and stable, to improve compliance and treatment outcomes for children.”
This announcement complements two awards given last year to the first UnitaidExplore recipients, Vayu Global Health and EPFL EssentialTech, to take forward innovations in paediatric oxygen delivery.
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as 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. Unitaid is hosted by the World Health Organization.
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Hervé Verhoosel
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Unitaid, Geneva
tel. +44 77 29 618 634
Maggie Zander
Communication Officer
Unitaid, Geneva
tel. +41 79 593 17 74
Digital technologies support patients with treatment from a distance, allowing more flexibility in care
Research begins into new digital tools to support patients and healthcare workers through tuberculosis treatment
The Hague / Geneva, 4 August 2021 – A large global study which aims to determine if digital adherence technologies (DATs) can provide more patient-friendly approaches to improve tuberculosis (TB) treatment outcomes launches in Ethiopia, Tanzania, South Africa, the Philippines and Ukraine, as part of the ASCENT project.
The digital adherence technologies studied include medication labels and sleeves, smart pill boxes and video supported treatment that allow for remote communication between patients and healthcare centers.
These technologies respond to a key challenge in TB treatment: treatment is long and difficult to complete, lasting anywhere from six months to two years. Because of this, public health strategies have historically relied on Directly Observed Therapy (DOT), in which a clinician observes a patient taking their medicine each day to ensure adherence. These technologies aim to reduce or remove regular in-person visits required under the DOT model and enable healthcare workers to intervene only when necessary.
After COVID-19, TB is the deadliest infectious disease in the world, leading to 1.5 million deaths every year, despite being a curable disease.
The technologies are expected to improve experiences for TB patients and increase treatment completion rates by removing the heavy logistical, financial and time burdens that DOT places on both patients and health systems. Additionally, removing the need for DOT would make TB care significantly more efficient and represent huge savings to public health programmes.
The main research phase, now launched in all countries, evaluates three digital adherence technologies:
- Smart pillboxes that send a message to the clinic every time the patient opens it up to take their medicine.
- Medication labels or sleeves that help patients to send a code via SMS to the clinic every time they take their dose.
- A video application that helps patients film themselves taking their medicine, and then securely sends the video to the clinic.
Wide reaching applications
ASCENT aims to enroll thousands of TB patients by the end of 2022. If proven effective, these tools could have wide-reaching applications to support patients undergoing treatment for any disease which requires them to take medication over an extended period.
“Practical, patient-centered solutions are essential in developing public health strategies that work. Digital adherence technologies are designed to support people in taking their medication while providing information that helps healthcare workers give more tailored care. These innovations, when coupled with advances in treatment and prevention, could modernize and accelerate global efforts against TB,” said Janet Ginnard, Director of Strategy at Unitaid, global health agency and funder of the ASCENT project.
Research phase
ASCENT facilitates adoption and uptake of DATs in the five project countries in partnership with the national TB programs. The research component generates evidence for the proper use and scale-up of these innovations. The results are expected to offer guidance to the World Health Organization (WHO) and national TB programs.
“We are trying to effectively evaluate whether health facilities that utilize DATs do better in terms of treatment outcomes than facilities that do not and why. We are also focused on understanding the acceptability of DAT and the social and financial benefits to both the patients and the health facilities,” said Jens Levy, chief researcher of the ASCENT project at the KNCV Tuberculosis Foundation.
In the Philippines, Ukraine, Tanzania and South Africa treatment outcomes will be reviewed during the six months of treatment. In Ethiopia the study includes a six-month follow-up beyond treatment to see if there is recurrence of TB. Study protocols are nearly identical in each country, allowing researchers to evaluate the effectiveness of DATs in a variety of healthcare settings and circumstances.
TB policy
“For everyone working with these interventions and for those who want to in the future, scientific evidence is crucial. We are honored to lead this research. Contributing to the fight against TB in a patient friendly way”, said Mustapha Gidado, executive director of the KNCV Tuberculosis Foundation.
“If it’s shown to be a successful intervention, this could be very beneficial for worldwide TB programmes. It could also change TB treatment policy around the world,” said Katherine Fielding of the London School of Hygiene and Tropical Medicine, who is the co-investigator of the overall project and chief investigator for the Ethiopian study.
The Unitaid-funded and supported ASCENT project is led by the KNCV Tuberculosis Foundation (KNCV) in partnership with the Aurum Institute, the London School of Hygiene & Tropical Medicine (LSHTM), and PATH.
About the ASCENT project
The Unitaid-funded ASCENT project aims to help patients succeed in TB treatment using digital adherence technology, towards reducing TB incidence, mortality and financial consequences.
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as 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. Unitaid is hosted by the World Health Organization.
Media contacts
For more information and media requests
KNCV Tuberculosis Foundation
Laura Goense, Campaign and Media Manager
+31 (0)613 913 577
Unitaid
Hervé Verhoosel, Director, External Relations and Communication a.i.
+44 77 29 618 634