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Stop TB Partnership and Johnson & Johnson, with support from USAID and The Global Fund, Announce Price Reduction for SIRTURO® (bedaquiline) for Treatment of Drug-Resistant Tuberculosis in Low- and Middle-Income Countries

Originally published on jnj.com.

Joint efforts aim to accelerate scale-up of WHO-recommended all-oral treatment regimens – a transition urgently needed to help protect the health of people with drug resistant-tuberculosis who are particularly vulnerable during COVID-19 pandemic

In 2020, the initiative aims to reach at least 125,000 patients and could save National TB Programs in low- and middle-income countries up to USD$16 million

The Stop TB Partnership and Johnson & Johnson – with support from the Global Fund to Fight AIDS, TB and Malaria, and the U.S. Agency for International Development (USAID) – today announced joint efforts to help enable low- and middle-income countries to rapidly scale up use of SIRTURO® (bedaquiline) 100mg tablets in support of new, recently-released World Health Organization (WHO) treatment guidelines.

Effective immediately, Johnson & Johnson will make bedaquiline available to Stop TB Partnership’s Global Drug Facility (GDF) at a price of USD$340 per six-month treatment course for more than 135 eligible countries. To help support and accelerate further scale-up of all-oral treatment regimens, the company will also provide an escalating percentage of free goods when certain volume thresholds are reached on an annual basis: 10% above 55,000, 20% above 125,000 and 30% above 200,000 treatment courses.

With support from the Global Fund and USAID, as well as governments and other partners, the Stop TB Partnership expects to receive confirmed orders for at least 125,000 people with DR-TB in 2020 and will, therefore, receive two treatments for free out of every 10 ordered. This would reduce the effective net price of bedaquiline by 32%, compared to the original USD$400 price. In the first year alone, this could lead to an estimated savings of up to USD$16 million for national TB programs – equivalent to the amount needed to treat an additional 30,000 people with short-course DR-TB regimens.

“In a world filled with worrying news, this new agreement is a welcome development and one that will help us move closer to the United Nations High-Level meeting target of treating 1.5 million people with DR-TB by 2022,” said Dr. Lucica Ditiu, M.D., Executive Director of the Stop TB Partnership. “Even though these days we fight against the new COVID-19 pandemic, we cannot let this new virus stop our progress against TB, and it’s critical that diagnosis and treatment for all forms of TB continue to be prioritized.”

As the leading funder of TB programs in low- and middle-income countries, the Global Fund is working with partners to support countries in reaching the 125,000 MDR-TB treatment target for 2020.

“As the world responds to COVID-19, it is critical that we don’t just fight the new pandemic but act decisively to mitigate the knock-on impact on other diseases, protecting lifesaving programs and shoring up overstretched health systems,” said Peter Sands, Executive Director of the Global Fund to Fight AIDS, TB and Malaria. “This new agreement offers an opportunity to save more lives through scaling-up more effective treatment of a difficult-to-treat and deadly disease.”

For its part, USAID, the largest bilateral funder of TB efforts globally, has been a leader in partnering with high-burden TB countries in the successful implementation of their national TB strategies for over 20 years. USAID’s Global Accelerator to End TB is building countries’ commitment and capacity to reach the United Nations High-Level Meeting TB targets by 2022. This significant increase in the availability of bedaquiline will enable USAID to support high-TB burden countries to expand access to and improve the quality of MDR-TB diagnosis, care, and treatment services to save lives.

The new WHO guidance has become even more critical during the COVID-19 pandemic, with WHO advising TB-affected countries to urgently shift to all-oral treatment to enable home-based care and help protect the safety of people receiving DR-TB treatment. Historically, people with DR-TB had to take lengthy treatment regimens, some of which had suboptimal cure rates and included injectable medicines with significant side effects. In the current crisis, oral treatment regimens eliminate the need for frequent clinic visits to receive injectable medicines, enabling affected people to avoid unnecessary exposure to COVID-19.

“Enabling access to affordable, effective all-oral treatments for people with MDR-TB is an urgent and important step towards ending TB,” said Dr. Tereza Kasaeva, Director of WHO’s Global TB Program. “WHO welcomes this new agreement and calls all countries and partners to come together and implement ambitious programs to test and treat all people with TB for drug resistance, in line with the new WHO guidelines.”

People affected by TB are among the most vulnerable populations to the COVID-19 pandemic mitigation measures. Lockdowns can result in the interruption or absence of access to treatment, and the pandemic has also brought about new forms of economic hardship, isolation, stigma and discrimination. As such, the COVID-19 pandemic has proven to be a major setback in achieving the UN TB targets, as TB case detection has dramatically fallen, treatment initiation is being delayed, and the risk of treatment interruption and potential increase of people with drug-resistant TB has increased.

“Even as the world wages an unprecedented battle against a new enemy – COVID-19 – we must continue to protect vulnerable people around the world who are suffering from other health challenges, such as DR-TB,” said Dr. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “As we strive for people with TB to be safely treated at home where possible, during this challenging time of a global lockdown and social distancing, our joint efforts will help enable countries to transition to simpler, all-oral regimens and achieve that goal as quickly as possible.”

A recent modeling study released by the Stop TB Partnership in collaboration with the Imperial College, Avenir Health, and Johns Hopkins University shows a range of adverse impacts on TB diagnosis, treatment and mortality rates due to the national lockdowns and gradual restoration measures required to contain the COVID-19 pandemic. The study reported the potential for an additional 6.3 million TB cases between 2020 and 2025, and an additional 1.4 million TB deaths in this same period.

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