Civil society groups remain unhappy with the price South Africa is paying for the GeneXpert MTB/RIF – a rapid diagnostic for tuberculosis (TB), multidrug-resistant TB (MDR-TB) and TB in HIV-infected individuals developed by molecular diagnostics company Cepheid. Representatives from the Treatment Action Campaign (TAC), The Treatment Action Group, The AIDS Rights Alliance of South Africa and Partners in Health called on Cepheid CEO John Bishop and Dr. Giorgio Roscigno of the Foundation for Innovative New Diagnostics (FIND) – the company that co-developed Xpert with Cepheid – in a letter to do more to make the test affordable in South Africa and to shed some light on the pricing and price negotiation process.
“These machines are being purchased for public sector, non-commercial use in a country facing a massive TB public health crisis,” according to the letter. South Africa is home to the second largest number of MDR-TB cases in the world, 20 percent of the world’s HIV-associated TB cases, and 70 to 80 percent of the country’s TB suspects are HIV infected. “TAC and partners remain concerned that there is little transparency around pricing, particularly as Cepheid is currently in negotiations with South Africa’s Department of Health regarding the procurement of these machines.”
The letter cites a policy brief from the Health Economics and Epidemiology Research Office that estimates the number of TB cases detected will increase by 30 percent and the number of MDR-TB cases will increase by 76 percent if GeneXpert is rolled out to all National Health Laboratory Service (NHLS) facilities in South Africa by 2014.
The World Health Organization announced its support of the GeneXpert test in December of last year. FIND has worked with Cepheid to negotiate lower prices for the machine and machine cartridges in low-income and some middle-income countries facing large epidemics. Cartridge prices specifically are sent to decrease as demand for them increases, to an eventual $10.72 per test cartridge by 2014. But the FIND-negotiated cost for the machine is still $17,000, and annual machine maintenance fees can range from $500 to $1800.
“TAC and partners call on Cepheid to provide greater transparency on the overall cost structure, including manufacturing, setup and operational costs, calibration and training requirements, royalty fees and IP holders. The agreement between FIND and Cepheid should be made public,” the civil society letter states.
The groups hope to speak with the head of Cepheid sometime this month, “due to the urgency of South Africa’s rollout plans for the GeneXpert,” according to a follow up email a sent to Bishop and Roscigno from TAC Senior Researcher Catherine Tomlinson. The civil society letter notes that the Department of Health has announced plans to place Xpert machines in all 50 health districts by yearend, and in all remaining NHLS facilities by the end of 2012.