Xpert Mycobacterium Tuberculosis and Resistance to Rifampicin (MTB/RIF) Buy-Down

Partners: United States President’s Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID), UNITAID, and The Bill & Melinda Gates Foundation

On August 12, 2012, PEPFAR, USAID, UNITAID, and The Bill & Melinda Gates Foundation announced an agreement to expand access to Xpert MTB/RIF®, a new molecular diagnostic system for tuberculosis. Cepheid’s Xpert MTB/RIF® is a molecular diagnostic system that can detect TB disease and resistance to the antibiotic rifampicin – a widely accepted indicator of the presence of multi-drug resistant TB – in less than two hours. The system also can be used outside of conventional laboratories because it is self-contained and does not require specialized training.

Funds provided by the partners have reduced the cost of Xpert MTB/RIF cartridges, which are only available through Cepheid, from $16.86 to $9.98 in 145 high-burden and developing countries worldwide. In addition, the buy-down ensures that the price will not increase until 2022. Prior to the initiation of the partnership, the high unit cost of Xpert® MTB/RIF cartridges proved to be a barrier to their introduction and widespread use in low- and middle-income countries.

In December 2010, the World Health Organization (WHO) recommended use of the product for diagnosis of pulmonary TB. Until Cepheid developed the Xpert MTB/RIF assay, the only method used in most primary care settings in developing countries was smear microscopy. Smear microscopy is particularly insensitive for diagnosing TB in patients who are co-infected with HIV. It also does not help clinicians detect the presence of drug-resistant strains of TB. The limitations of traditional smear microscopy, along with the cost and long delays to receive culture results, had limited the ability to diagnose and treat HIV-related TB and drug-resistant forms of the disease.

Because TB is the leading cause of death among people living with HIV in Africa, greater access to this test offers a significant advance in the capacity of health care workers to diagnose TB quickly and help reduce TB transmission, the development of TB disease, and premature TB deaths.

As of September 2013, 1,843 XPert MTB/RIF® instruments (9,625 modules) and 4.2 million Xpert MTB/RIF cartridges had been procured in the public sector in 95 of the 145 countries eligible for concessional prices.