July
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Breakthrough agreement will reduce costs and increase access to diagnostic technology for millions in low- and middle-income countries

Published July 25th, 2018

Amsterdam – A breakthrough pricing agreement will significantly reduce the cost of diagnostic testing for HIV/AIDS, hepatitis and cervical cancer for millions of people in low- and middle-income countries. Diagnostic testing improves patient care, helps prevent the spread of disease, and reduces healthcare spending.

The new agreement, announced today at the 2018 International AIDS Conference, will enable public sector programs in low- and middle-income countries to access the Hologic Panther® system, an integrated molecular diagnostic instrument, at a price of US$12 per patient sample with no upfront costs or capital expenditure. The new testing platform will generate faster results to patients and increase adherence to treatment. The agreement covers tests for HIV, hepatitis B and C (HBV and HCV), as well as tests for human papilloma virus (HPV), the leading cause of cervical cancer. The World Health Organization (WHO) has recommended molecular diagnostic viral load testing as the gold standard for monitoring the effectiveness of treatment for HIV. Today only 56 percent of people living with HIV have routine access to viral load testing. The savings generated from the agreement will allow governments to accelerate scale-up to improve treatment monitoring for hundreds of thousands of patients.

The new agreement, announced by the United Kingdom’s Department for International Development (DFID), Unitaid, MedAccess (backed by the UK government), the Clinton Health Access Initiative (CHAI), the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the African Society for Laboratory Medicine (ASLM), and the government of Zambia, takes an important step toward ensuring the sustainability and affordability of HIV viral load testing services for people living with HIV in low- and middle-income countries.

“I am proud that UK aid is playing a role in driving down HIV treatment and testing prices, to ensure these lifesaving technologies reach the countries and people who cannot afford them at current rates. The Hologic Global Access Initiative is a great step forward in expanding access to HIV testing across the developing world – cutting edge initiatives like this are vital if we are to meet our commitment to end AIDS by 2030.” said Rt Hon Alastair Burt, Minister of State at DFID.

At least five countries in sub-Saharan Africa are expected to introduce this technology as part of their viral load scale-up programs in 2018. With funding and support from PEPFAR and DFID, Zambia is the first country to implement the Hologic Panther platform for routine viral load testing under an all-inclusive pricing contract. Unitaid, through a competitive process carried out by UNICEF, has just selected Hologic to pilot the all-inclusive pricing approach across different tests in Malawi, Tanzania, Uganda and Zimbabwe. This approach, which will generate faster results, strengthen health systems, and lower costs, is key to scaling up viral load testing coverage in the next three years.

“Given the many benefits of viral load testing for the men, women, and children that PEPFAR supports with lifesaving antiretroviral treatment, we are encouraged that across much of the marketplace, the costs of its use continues to decline,” said Ambassador Deborah L. Birx, U.S. Global AIDS Coordinator and Special Representative for Global Health Diplomacy.

Unitaid has played an important complementary role in this initiative through its multiple investments to improve testing options and coverage in less-affluent countries, including its recent focus on affordable and sustainable pricing of tests for multiple diseases.

“This deal is a real breakthrough in the diagnostics space as it will allow governments to increase the number of people tested for various life-threatening diseases at no added cost,” said Unitaid Executive Director Lelio Marmora. “We are committed to pursuing innovations that will increase the value for money of current investments, as global health funding stagnates. We want to raise the bar so that integration and transparency in pricing become the gold standard for the diagnostics market.”

Since officially adopting the instrument in April 2018, the Zambian Ministry of Health has embarked upon an ambitious plan to deploy Panther instruments at large regional hospitals in order to augment the existing testing network. This approach, which will add much-needed capacity, lower costs, and help reduce turnaround time, is a key part of the government’s strategy for scaling up viral load testing coverage so as to achieve epidemic control of HIV in the next three years.

“The introduction of the Panther system has come at an opportune time,” stated Dr. Aaron Shibemba, National Coordinator of Pathology and Laboratory Services at the Zambia Ministry of Health. “The fully automated platform enabled the Center for Infectious Disease Research Zambia (CIDRZ) to perform over 20,000 tests in just two months, thus assisting in the elimination of Zambia’s national testing backlog. As a Ministry, and with support from PEPFAR, we will be rolling out an additional six instruments in high priority testing sites as we work towards meeting our 90-90-90 targets.”

“ASLM’s vision is to see a heathier Africa through access to quality laboratory services for all,” stated Prof. Alash’le Abimiku, Board Chair of ASLM. “Affordability of good diagnostics remains key to increasing healthcare access for the most vulnerable and needy populations on the continent. We believe that this initiative paves the way towards more efforts to reduce pricing for other essential diagnostics and drugs for diseases that still disproportionally burden the African continent.”

MedAccess, with the support of CHAI, has completed a ceiling price agreement with Hologic that will allow national testing programs to enjoy the advantages of the Panther system at a significantly reduced rate. The US$12 price includes the full set of supplies and services needed to generate a patient result, including reagents, instrument placement, service and maintenance, consumables and controls, as well as full freight and logistics delivered to the laboratory (DAP Incoterm). The price applies equally to Hologic’s HIV, HBV, HCV, and HPV Aptima® Assays regardless of sample type and is expected to promote integration of testing and disease control programs. The ceiling price agreement applies to all qualified purchases made for public sector use beginning in August 2018 and is anticipated to save public sector purchasers at least US$50 million over the next four years and beyond. Further details are available on request to Hologic and can be found at www.hologic.com/GlobalAccessInitiative.

“This initiative is truly unprecedented since a single price covers all service, maintenance, and the regular delivery of goods to the place of use. It will increase predictability, reduce costs, and save lives,” said Michael Anderson CB, CEO of MedAccess.

Over the past decade, CHAI has partnered with DFID to improve access to high-quality, low-cost commodities for HIV, tuberculosis, hepatitis and other diseases in low- and middle-income countries; their work together has thus far achieved an estimated US$2 billion in cost savings to date, improving access to quality healthcare for patients in 19 countries across Africa, India, and Southeast Asia.

“This agreement provides significant savings to our partners that are scaling up HIV viral load testing. It will also enable countries to increase routine screening for hepatitis C and HPV. Since effective treatments are available for these diseases, early detection will save lives,” stated CHAI Vice President of Global Markets, Alan Staple.

“As a global leader in diagnostics, we understand the challenges faced by our partners in resource-limited settings. And we are committed to offering life-changing and life-saving solutions that help providers improve patient care where it’s needed most. It is a privilege for Hologic to be a part of this initiative to help mitigate the burden of infectious diseases, especially HIV, with increased testing supply and superior technology. We are proud to be doing our part,” said Tom West, president, Diagnostic Solutions Division at Hologic.

 
About

The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low- and middle-income countries, while strengthening the capabilities of governments and the private sector in those countries to create and sustain high-quality health systems that can succeed without our assistance.

MedAccess (Private) Ltd is a UK social finance company with government backing that works to make medical supplies more widely available at affordable prices, particularly in Africa and South Asia. With a mandate covering medicines and vaccines as well as diagnostic tests, MedAccess provides financial products that can help reduce uncertainty for both suppliers and purchasers, allowing new products to come into use more quickly and at lower cost. MedAccess is a subsidiary of CDC, the UK Development Finance Institution.

The African Society for Laboratory Medicine (ASLM) is a pan-African professional body that coordinate, galvanizes and mobilizes relevant stakeholders – local, national and international – to improve access to world-class laboratory services and ensure healthy communities now and for the long term.