Unitaid welcomes J&J’s announcement not to enforce patents for vital TB drug
Unitaid applauds Johnson & Johnson’s decision, announced Friday 29 September, not to enforce its secondary patents for bedaquiline, a critical medicine for treating drug-resistant tuberculosis (DR-TB). The decision will affect people in 134 low- and middle-income countries, many of which have the highest burden of disease and have struggled to supply the critical medicine due to high costs.
This news comes after months of campaigning by the TB community, including an open letter from Unitaid’s Executive Director to J&J dated 22 September urging immediate action.
“Bedaquiline underpins all the shorter regimens for treating DR-TB, effectively holding the key to tackling drug resistance and turning the tide on this dangerous and debilitating form of the disease,” said Dr Philippe Duneton, Executive Director of Unitaid.
“Unitaid welcomes the significant step to improve access to this vital TB medicine and is pleased to see that the scope of countries covered includes upper-middle income countries that are often left out of access agreements.”
“Unaffordable medicines, diagnostic challenges and insufficient access to services have created a situation in which most people suffering from DR-TB never get treated. J&J’s decision will help progress efforts to address the high cost of treatment. Unitaid has invested close to US$300 million over the past decade to improve DR-TB testing and treatment and will continue to support efforts to improve DR-TB care. We are pleased to see J&J playing its part to enable critical medicines to reach communities that need them,” said Dr Duneton.
To increase legal certainty for generic manufacturers, Unitaid urges J&J to withdraw their secondary patents in low- and middle-income countries, including any pending applications pertaining to bedaquiline. In the interim, the announcement from J&J is a significant move in the right direction.
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M: +33 6 22 59 73 54
Johnson & Johnson pricing agreement for critical TB drug still unfairly restricts access in countries where the need is greatest
- Open letter from Unitaid’s Executive Director calls on the drug company to drop secondary patents for the drug-resistant TB (DR-TB) medicine bedaquiline, and to make negotiated rates available to all countries, regardless of how they purchase drugs.
- The letter follows advocates’ unanswered calls for broad access to bedaquiline, which is critical to achieving the reduction in TB agreed at the United Nations High-Level Meeting on 22 September.
- Bedaquiline is a vital component of all shorter treatment regimens for DR-TB, the most deadly and difficult to treat form of TB that affects millions of people worldwide.
- A recent agreement between Johnson & Johnson and the Global Drug Facility lowers the price of a six-month supply of bedaquiline to US$130, but the deal is an incomplete solution that will restrict access to lower cost medicines in the near future.
- Upcoming competition from multiple generic manufacturers is expected to lead to lower prices, but these products will remain unavailable in the countries with the greatest MDR-TB burden.
Geneva – In an open letter to the Chief Executive Officer of Johnson & Johnson (J&J), Unitaid, while acknowledging the investments J&J has made to develop and market innovative medicines to treat tuberculosis (TB), expressed its concern that the recent agreement between J&J and the Global Drug Facility (GDF) to lower the price of bedaquiline is an incomplete solution that will hinder access long-term.
Drug-resistant TB (DR-TB), the most dangerous and deadly form of TB, affects nearly half a million people every year. Because so few currently access appropriate treatment, millions of people worldwide are in critical need of bedaquiline.
The J&J/GDF agreement saw a historic 55% price reduction of the drug, which is a welcome step in increasing access to this critical medicine that underpins all shorter regimens for treating DR-TB. However, the agreed price of US$130 for a six-month supply of J&J’s SIRTURO® (bedaquiline) is only available to countries when purchasing through GDF, which effectively excludes several countries where the rates of MDR-TB are highest.
Additionally, following the Indian Patent Office’s rejection of J&J’s secondary patent application for bedaquiline in the country in April, several generic manufacturers are expected to enter the Indian market, home to the highest number of people with MDR-TB in the world. This is likely to further reduce the cost of generic bedaquiline but secondary patents in place in low- and middle-income countries will restrict availability to these vital medicines in a subset of countries with the highest burden of disease.
Unitaid is calling on J&J to remove secondary patents or provide a comprehensive license to generics and allow all countries to purchase bedaquiline at the negotiated rates, including those excluded from the agreement or not procuring through GDF.
This follows numerous advocates’ unanswered calls for equitable access to bedaquiline in recent months, including action from nations not able to benefit from access prices such as South Africa, Belarus, and Ukraine, among others.
Meeting these demands is essential to fulfilling the commitment made by heads of state at the United Nations High-Level Meeting on TB on 22 September to reach 1.5 million people with DR-TB treatment by 2027.
Unitaid’s open letter to J&J is reproduced in full here.
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M: +33 6 22 59 73 54
Bill & Melinda Gates Foundation doubles its contribution to Unitaid to US$100 million over 5 years
The Bill & Melinda Gates Foundation announced a long-term commitment of $100 million to Unitaid to bring faster access to health products in low- and middle-income countries. This funding doubles the foundation’s previous commitment and will support Unitaid’s work to accelerate the introduction and delivery of new lifesaving solutions at equitable scale, including those for maternal and newborn health.
The foundation highlighted that Unitaid’s unique approach helps reach the health-related targets of the Sustainable Development Goals more quickly.
“It takes far too long for lifesaving products to get from approval to widespread adoption. For over 15 years, Unitaid has played a pivotal role in speeding up that process – developing new health innovations, then working with organizations like the Global Fund to get them to people faster,” said Bill Gates, co-Chair of the Bill & Melinda Gates Foundation. “We’re on the cusp of exciting new innovations that will help accelerate progress on HIV, TB, and malaria, as well as maternal and child health. By doubling our foundation’s commitment to Unitaid, we hope to get these tools in the hands of health workers in time to save millions of lives.”
The Bill & Melinda Gates Foundation has been a supporter of Unitaid since its inception and serves as a member of Unitaid’s Executive Board. Since our creation, they have contributed a total of US$150 million to Unitaid’s work to fast-track the development of lifesaving tests, treatments and tools and speed up access for the people who need them most. With support from donors like the Gates Foundation, Unitaid has unlocked access to more than 100 groundbreaking products that are now considered the gold standard for fighting HIV, tuberculosis and malaria, improving women’s and children’s health, and strengthening pandemic preparedness and response.
Unitaid thanks the Gates Foundation for its ongoing support and the new funding, which will help us find new solutions to the most pressing global health challenges.
Read the full press release here.
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Hervé Verhoosel
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M: +33 6 22 59 73 54
Unitaid to partner with communities and civil society to drive access to new drug-resistant TB treatment regimens with new call for proposals
Geneva – As the United Nations General Assembly convenes world leaders at the High-Level Meeting on Tuberculosis (TB) this week, discussions will focus on the urgent need for access and innovation to put an end to a disease that we have known how to cure for decades. Despite this, TB continues to kill more people each year than any other infectious disease.
Advocates and global health leaders have called out the persistent crisis of drug-resistant and multidrug-resistant TB, which continues to claim the lives of 2 in every 5 people affected. The challenge of treating drug-resistant TB is also a major driver of antimicrobial resistance and poses a serious threat to supplies of antibiotics critical to treating a range of infections.
But advances in drug-resistant TB treatment regimens bring hope. Dramatic improvements have cut treatment time in half and promise to radically alter outcomes for millions of people. However, new medicines and other tools are often slow to arrive in the countries that need them most, and even when they do, most people with drug-resistant TB never get diagnosed because access to testing that can accurately identify resistance is limited.
Unitaid’s latest call for proposals is aimed at driving demand for new medicines and accelerating the introduction of improved drug-resistant treatment regimens alongside complementary interventions such as improved diagnostics and adherence support. This package of care is intended to ensure people living with TB can get the medicines they need as quickly as possible while safeguarding against further resistance.
Civil society and community-based leadership will be critical to understanding the needs of affected communities as well as the barriers they face in accessing treatment. These advocates will play a key role in reaching policymakers and at-risk populations alike, raising awareness and understanding of drug-resistant TB treatment, driving demand for new regimens and diagnostics, and strengthening links between health services to reduce the gaps in the TB response.
These efforts should underpin targeted strategies to accelerate implementation, expand access to new regimens and improve case finding and resistance monitoring while protecting the long-term efficacy of key medicines for future generations.
Find out more about this latest funding opportunity here.
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Hervé Verhoosel
Team Lead, Communications
M: +33 6 22 59 73 54
Unitaid and tuberculosis
Failure to implement contact tracing and tuberculosis prevention would result in close to 1 million deaths by 2035, according to new study
Combination intervention found to be cost-effective in averting illness and deaths in high-risk groups
- People living in close contact with a person with TB disease are at highest risk of infection, and account for a significant percentage of the 10.6 million new TB infections each year.
- Analysis shows that implementing a combined strategy of identifying household contacts and providing TB preventive treatment is cost-effective and would cut deaths by 35% among household contacts of all ages and people living with HIV by 2035.
- Additionally, because TB diagnosis is so low among children under five – just over 3 in 10 children with TB are identified – contact tracing and prevention would have an outsized impact on reducing child death from TB.
- TB prevention and contact tracing can be delivered cost effectively thanks, in part, to the significant price reductions in short-course therapy achieved in recent years. With further decreases in price and by improving the efficiency and integration of contact tracing into disease responses, the intervention could benefit from greater cost savings and public health benefit.
- As world leaders prepare for the second United Nations High-Level Meeting on TB this September, up-front multi-stakeholder commitment and financial backing is urgently needed to reap the massive rewards of preventing TB illness and death.
Johannesburg/Geneva – A new study published today in The Lancet Global Health found that the lives of 850,000 people could be saved by 2035 if short-course tuberculosis (TB) preventive treatment is provided to people living with HIV and contacts of individuals newly diagnosed with TB. 700,000 of those lives saved would be among children aged 15 years and younger.
The study, co-authored by researchers from Johns Hopkins University, the Aurum Institute and global health agency Unitaid, also found the combined intervention of contact tracing and TB prevention to be broadly cost-effective for household contacts of all ages. The impact was particularly high among children under the age of five who face higher risks of death.
“Tuberculosis remains the world’s deadliest infectious disease, despite being preventable and curable,” said Professor Gavin Churchyard, Group Chief Executive Officer of the Aurum Institute. “Although progress has been made in preventing TB among people living with HIV, we’ve lagged behind in keeping family members—especially children—free of the disease when a parent becomes sick. This new study, we hope, provides the evidence needed to massively scale up the use of TB preventive treatment among those individuals at risk of developing TB.”
TB preventive therapy has made enormous strides in recent years: new shorter treatment regimens can clear TB infection before it develops into active disease with a once-weekly treatment over twelve weeks, called 3HP, or a daily treatment over one month, called 1HP. And a series of negotiations led by Unitaid, the Aurum Institute, and partners have reduced the price of treatment by more than 70% since 2017.
About one-quarter of the world’s population is infected with TB and at risk of developing active disease, which causes severe illness. The World Health Organization recommends TB preventive treatment for those at highest risk of infection, including people living with HIV and household contacts of people with TB. The first United Nations High-Level Meeting in 2018 set targets to accelerate efforts to end TB as a global health threat, including a goal to reach at least 30 million people with TB preventive treatment.
Only the target to reach people living with HIV was attained, and a corresponding decrease in the number of TB cases and deaths occurred within this population during the COVID-19 pandemic. In contrast, TB cases and deaths increased in all other populations over the same period.
“The imperative for TB prevention is clear,” said Vincent Bretin, Director of Results at Unitaid. “This cost-effectiveness analysis proves that preemptively reaching all at-risk individuals – even when it requires the logistical hurdles of going into communities to find those who may not be actively seeking care – is not just ethically sound. It is a smart investment capable of making an enormous impact on the fight to end TB worldwide.”
The study found that providing 3HP through contact tracing, in which the household members of a person diagnosed with TB are identified, assessed, and treated, could yield an estimated 13% cumulative reduction in the number of contacts developing TB through 2035 and an estimated 35% cumulative reduction in deaths.
Among children under five, the combination of 3HP with contact tracing showed to have a profound impact on the child TB burden overall, helping to drive up the identification of active disease in addition to preventing new infections. The impact on missing cases among this population was so substantial that the intervention would save more lives by treating TB disease and infection than the number of new infections prevented.
The study is the first to provide comparable evidence on the cost-effectiveness of short-course TB preventive treatment for people living with HIV and household contacts in three age groups (< 5, 5-14, and ≥ 15 years old), using consistent methods for all four populations. This provides a clear justification to support policy change and implementation of the life-saving approach where coverage is lagging.
“At the moment, too many family members of people diagnosed with TB are slipping through the cracks and too many lives are being lost,” said Tess Ryckman, faculty member at Johns Hopkins University and lead author of the study. “To finally make a significant dent in the TB epidemic, we need stronger recommendations in favor of TB prevention for household contacts along with a significant boost in resources. The stakes are too high not to act now.”
Despite the cost-effectiveness of TB preventive treatment, the researchers note that the absolute cost of scale up will be substantial. External funding—with an explicit plan to bridge to domestic support as TB burden declines—will be needed, as well as a further decrease in the price of the drug rifapentine, the key cost driver in short TB prevention regimens.
NOTES FOR EDITORS:
The analysis is based on modelling of 29 countries representing a range of income levels, geographic regions, and HIV and TB incidence expected to be applicable to other countries with high burdens of TB.
Burundi, Bangladesh, Brazil, Congo DRC, Ethiopia, Ghana, Haiti, Indonesia, India, Kenya, Cambodia, Liberia, Lesotho, Mongolia, Mozambique, Malawi, Namibia, Pakistan, Rwanda, Somalia, Eswatini, Thailand, Tajikistan, Timor-Leste, Tanzania, Uganda, South Africa, Zambia, Zimbabwe.
Information on the Unitaid-funded IMPAACT4TB Project
The IMPAACT4TB project has been working towards delivering transformational change in the accessibility and use of TB preventive treatment since 2018. Funded by Unitaid and led by the Aurum Institute with a consortium of partners, the project seeks to establish 3HP and 1HP as affordable, quality-assured, less toxic therapies suitable for wide introduction in countries most affected by TB.
Since its inception, IMPAACT4TB has:
- Reduced the price of 3HP from US$72 in 2017 to US$14.25 today
- Increased procurement of 3HP from 35,000 patient courses in 2017 to more than 4 million in 2022
- Improved supply security by bringing two new generic manufacturers into the market
- Helped surpass UN HLM prevention targets for people living with HIV
- Generated the missing evidence to enable people with HIV on first-line treatments to safely take short-course TB preventive treatment
By June 2022, 78 countries were using new short-course TB preventive treatments.
Figures on TB preventive treatment
According to the World Health Organization’s 2022 Global TB Report, the total number of people living with HIV and household contacts of people diagnosed with TB who were provided with TB preventive treatment increased from 1 million in 2015 to 3.6 million in 2019. There was a significant decrease in 2020 to 3.2 million, probably reflecting disruptions to health services caused by the COVID-19 pandemic.
The majority of all groups receiving TB preventive treatment are people living with HIV. TB preventive treatment among household contacts continues to represent a significant gap.
Contacts for the media
Kanya Ndaki, KNdaki@auruminstitute.org, +27 83 298 6100
Hervé Verhoosel, verhooselh@unitaid.who.int, +33 6 22 59 73 54
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 hosted by the World Health Organization.
About the 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