Breakthrough Global Agreement Sharply Lowers Price of Early Infant Diagnosis of HIV

Monday, July 20, 2015

Global partners in the Diagnostics Access Initiative have joined with Roche Diagnostics to announce a 35% reduction in the price for HIV early infant diagnostic technologies. The new access price is US$ 9.40 per test, including proprietary reagents and consumables associated with diagnosing HIV in very young children. Partners involved in the negotiation of this reduced access price include UNAIDS, the Clinton Health Access Initiative Inc., the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis and Malaria and UNITAID.

With peak mortality among children living with HIV occurring at 6-8 weeks, the World Health Organization recommends that all children exposed to HIV receive early infant diagnostic screening within the first two months of life. However, only around half of children exposed to HIV receive early infant diagnostic screening, in part because costs have limited the number of testing platforms currently used in low- and middle-income countries. This has contributed to a major gap in HIV treatment access, as in 2014 only 32% of children living with HIV received antiretroviral therapy compared with 41% of adults living with HIV. Without knowing the HIV status of a child it is impossible to access life-saving treatment. Without treatment, half of all children born with HIV will die by the age of two and the majority will die by the age of five.

“This agreement with Roche Diagnostics is a powerful step towards ending the unconscionable failure of the world to meet the treatment needs of children living with HIV,” said UNAIDS Executive Director Michel Sidibé. “We now need to use this agreement to rapidly scale up diagnostic and treatment services for all children living with HIV, in line with the 90-90-90 target.”

The 90-90-90 target provides that by 2020, 90% of all people living with HIV will know their HIV status; 90% of all people with an HIV diagnosis will receive sustained antiretroviral therapy; and 90% of all people receiving antiretroviral therapy will achieve viral suppression.

“As the leader in HIV diagnostics, Roche is proud to support the UNAIDS 90-90-90 goal by expanding access to quality HIV testing for early infant diagnosis in resource limited settings,” stated Roland Diggelmann, Chief Operating Officer of Roche Diagnostics. “Increased access to early infant diagnosis can provide an impactful contribution for mother and child and contribute to achieving UNAIDS’ goals for controlling and eradicating the HIV/AIDS epidemic.”

This is the second major pricing agreement that partners in the Diagnostics Access Initiative have forged with Roche Diagnostics. In 2014, these partners, joined by the Government of South Africa, announced a 40% reduction in the global price of the leading platform for HIV viral load testing. The new cost for early infant diagnosis is the same as the one negotiated for viral load testing for adults.

The UNAIDS-sponsored Diagnostics Access Initiative, launched at the International AIDS Conference in Australia in July 2014, issued a call to the global community to achieve more affordable pricing for viral load testing. Through the leadership of South Africa and in partnership with CHAI, UNAIDS, UNITAID, The Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR), suppliers were challenged to lower viral load prices, and Roche is the first company to step forward and offer the HIV community an access policy that will accomplish these goals. Other partners in the DAI include the World Health Organization, US Centers for Disease Control and Prevention, African Society for Laboratory Medicine and UNICEF.

“This new agreement reduces prices by 35% for HIV tests for infants,” said CHAI Chief Executive Officer Ira C. Magaziner. “This will allow more infants to be tested which will in turn save the lives of many children who will now be able to enter treatment sooner. I congratulate Roche. This represents the latest in a series of agreements where Roche has been a pioneer in bringing state of the art testing to resource poor settings at affordable prices.”

Leading AIDS financing organizations also welcomed the new agreement.

“No child should die because early infant diagnostic screening isn’t available. This price reduction will be a positive step forward to make diagnosis of HIV more widely available and to ensure children exposed to HIV are diagnosed early and receive the life-saving treatment they need,” said Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and U.S. Representative for Global Health Diplomacy.

“This agreement builds on and supports other efforts of a strong partnership to make the market for viral load testing more competitive and transparent, and that better serves children affected by HIV,” said Mark Dybul, Executive Director of the Global Fund.

“Our collective efforts, including this further reduction in the price of infant testing, will help make it possible to find every newly infected child with HIV and immediately link them to care” said UNITAID’s Executive Director, Lelio Marmora. “This encouraging development is aligned with UNITAID’s investments to improve access to better, more affordable HIV testing and treatment for children, which are accelerating innovation of paediatric HIV diagnosis through the optimization of existing laboratory-based systems as well as the introduction of novel technologies at and near the point-of-care.”

Source: Press Release (link opens in a new window)

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