For years the Global Fund has invested in co-infections and co- morbidities (COIMs) that undermine the impact of efforts to fight the three diseases, but without any overall framework for doing so. When new, powerful oral direct acting antivirals (DAAs) for hepatitis C treatment came to market, it pushed the Global Fund to reflect on how or whether to fund requests for highly effective HCV treatment—as well as other priority co infections and co morbidities, such as cervical cancer.
In the case of hepatitis C, DAA represent a truly revolutionary public health opportunity: preventing millions of people with hepatitis C virus (HCV) from dying of liver disease, and setting the world on a course toward HCV eradication. These medicines make hepatitis C remarkably easy to cure, regardless of HIV status. Combinations of these drugs can cure HCV in 12 weeks—or fewer.[i] DAAs represent a major advance over the previous standard of care, in terms of toxicity, cure rate, and diagnostics and monitoring requirements. Drug costs are astronomically high—for now. But DAAs could be mass-produced at a profit for a fraction of the prices paid in high-income countries.
Experts estimate that a 12-week treatment course of sofosbuvir + daclatasvir, a highly-effective (cure rate: 84-100%), safe and tolerable regimen that can be co-administered with WHO-recommended antiretroviral agents could be produced for less than US $125.00.[ii],[iii]
At the Global Fund’s 33rd Board Meeting on April 1, Global Fund Head of Strategy and Policy Harley Feldbaum and Senior Advisor, HIV and AIDS Ade Fakoya presented on COIMs, noting that the Board at its previous meeting in November 2014 had approved an interim measure for the financing of Hepatitis C treatment until the approval of a broader policy on COIMs (Decision Point GF/B32/DP07).
Ade presented the COIM universe below:
Ade presented the disease burden, cost estimates, and donor landscape of five particular COIMs:
- Hepatitis C
- HPV/cervical cancer
- Nutritional support
Harley noted that the Strategic, Investment, and Impact Committee (SIIC) had considered three options moving forward:
- Maintain the current process for financing COIMs
- Enhanced guidance on financing COIMs
- COIMs are not covered – no further support to conditions that indirectly affect AIDS, tuberculosis, and malaria
The SIIC recommended Option 2 and the Board approved a framework for financing COIMs.
The purpose of the framework is to provide guidelines to countries, where appropriate, on developing an investment case for COIM funding within their relevant country allocations and provide guidance to the Technical Review Panel (TRP) on assessing COIM funding requests.
The Secretariat and TRP will review and potentially recommend funding requests that contain COIM interventions to the Board in accordance with the framework and standard access-to-funding processes.
The Global Fund will consider financing a COIM intervention when there is sufficient evidence that the intervention:
- Is based on a strong investment case considering impact and cost within the context of existing programs within that country and;
- Extends the life expectancy, prevents, and/or reduces mortality and morbidity of people living with HIV, TB, and malaria by acting directly on HIV, TB, or malaria or;
- Is an effective health intervention that prevents or treats a COIM that has a disproportionate impact on people living with HIV, TB, or malaria
- Financing would not detract from or displace financing for cost-effective HIV, TB, or malaria interventions and;
- Global Fund financing would not displace resources from other funding sources and;
- There is alignment with national policy guidelines and;
- Interventions are synergistic and can be integrated with other HIV, TB, or malaria delivery platforms
“This framework is an important step forward for communities and countries struggling to respond to severe epidemics of untreated co infections and co morbidities, particularly for conditions such as hepatitis C and HIV co infection, where new medicines present a gamechanging opportunity to transform the course of the epidemics.
Now we must ensure rapid implementation, to increase demand for generic competition that will drive down the cost of these medicines, and to deliver the provision of technical support from experts so countries can develop and implement funding requests, and scale up evidence based interventions to save lives.”
- Asia Russell (SIIC member, Developed Country NGO Delegation; Executive Director, Health GAP)
[ii] Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. New England Journal of Medicine. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.
[iii] Hill A, Van de Ven N, Simmons B, et al. Minimum target prices for production of direct-acting antivirals and associated diagnostics for developing countries (Poster LBPE12). 20th International AIDS Conference; 2014 July 20-25. Melbourne, Australia. http://pag.aids2014.org/abstracts.aspx?aid=11076