Hepatitis C elimination and the role of innovative health financing
With the recent advance of new finite therapies that can cure Hepatitis C, what innovative financing mechanisms can the global development community employ to ensure access of these essential medicines to millions of patients in the developing world? Hepatitis C (HCV), a viral infection of the liver, is one of the largest neglected epidemics in global health. An estimated 170 million people—over 2 percent of the global population—live with the virus. Untreated, HCV can cause serious liver disease including cirrhosis, cancer, and liver failure that result in an estimated 500,000 deaths each year worldwide. Nearly 80 percent of the HCV dise?ase burden is in low- and middle-income countries.
The high morbidity and mortality of HCV is also associated with significant economic burden in resource-limited settings. One pharmacoeconomic study from Egypt, the country with the largest HCV burden, estimated the total direct health care sector costs, value of lost productivity (indirect costs) and the burden of disability associated with HCV infection to be at US$89 billion.
Until recently, HCV treatment required often-debilitating interferon injections taken for up to 48 weeks, with relatively poor cure rates. Since late 2013, a new generation of HCV therapies has begun to offer the possibility of shorter, simpler, and more effective therapeutic responses. One such medicine developed by Gilead Sciences is a combination of two compounds co-formulated into a single pill, taken once a day for up to 12 weeks, yielding cure rates of greater than 90 percent, while avoiding the negative side effects of older generation interferon-based therapies. Access in developing countries At Gilead, access to medicines in the developing world is central to our mission. We have a dedicated team, Access Operations & Emerging Markets, which overseas our company’s efforts to expand treatment access in resource-limited settings. We are building on the lessons learnt from our HIV treatment access programme to support efforts to deliver HCV medicines to as many people as possible, as quickly as possible. That means registering our medicines in each country (starting with the highest burden countries), providing significant discounts on our branded drugs, and licensing our patented technology directly to Indian manufacturers to make and distribute generic versions of our medicines.
In nearly all low- and lower-middle income countries, we offer Gilead’s branded HCV medicines at their lowest prices, US$400 per bottle or less—about 98 percent lower than the price in the United States. Additionally, in 101 countries, home to more than 103 million people living with HCV, we have licensed our drugs to 11 Indian generic companies, who are free to set whatever price they wish. Competition among generic manufacturers, along with the effective price ceiling established by our branded pricing, exerts significant downward pressure on the price of medicines. In fact, we have already seen these generic companies providing significant price reductions.
In upper-middle income countries, such as Brazil, Gilead adopts a tiered pricing approach, starting with a discounted price that reflects the country’s economic status, but offer additional discounts based on patient volume (aiming to encourage governments to commit to broad HCV treatment access for their citizens).
However, improving access is not just about increasing availability of drugs. To underpin the delivery of these medicines, we are helping countries adopt a public health approach to HCV by creating a comprehensive prevention, screening and treatment strategy. Although anchored to HCV, these initiatives aim to strengthen the entire health care system synergistically. For example, some of our sponsored activities focus on increasing laboratory capacity and health workforce task shifting. Both activities strengthen weak health care systems beyond just HCV—extending potential benefits to maternal and child health and improving the overall primary health care system. Early success Gilead began developing its HCV access programme in 2013, prior to the U.S. approval of its first HCV medicine. We announced generic licensing agreements in September 2014, and treatment with branded medicines began that same month in Egypt. As of July 2015, over 110,000 patients are completing or have completed treatment in Egypt, Pakistan, India and Brazil. HCV treatment with Gilead medicines is expanding to new countries monthly - most recently Mongolia, Thailand and Rwanda.
Despite the serious challenges that often face patients in developing countries, real-world cure rates mirror those seen in clinical studies. In Egypt, for example, the national HCV treatment programme has achieved a 93 percent HCV cure rate. This success is a testament to not only the simplicity and efficacy of today’s treatments, but also to the extraordinary commitment of governments, health care workers, advocates, industry and civil society working together to tackle the HCV pandemic. In early September 2015, recognition of global HCV elimination has prompted the World Health Organization to issue new global targets for the diagnosis, treatment and cure of HCV by 2030.
To encourage public health approaches for HCV elimination, we have sponsored a number of demonstration projects around the world. These projects employ the “Test and Treat” approach that has proven effective in HIV: provide widespread screening for people at risk of infection, and offer treatment to those who test positive. Most notably, in collaboration with the Georgian Ministry of Health and the U.S. Centers for Disease Control, Gilead is donating medicine to kick-start an ambitious programme to eliminate HCV in Georgia. If successful, this initiative will not only save the lives of many Georgians, but will demonstrate to the world through documented experience that eliminating HCV on a national scale is achievable.
Global scale-up Efforts to reduce the toll of other diseases such as HIV, tuberculosis and malaria have benefitted from extensive attention and support from bilateral and multilateral donors. However, there is no Global Fund or PEPFAR to treat, much less eliminate, HCV. In the absence of donor funding, especially in an age of donor austerity, the burden of financing HCV treatment in resource limited settings will likely rest with a country or the patient through out-of-pocket costs. Summary
Expanding access to HCV treatment presents a complex set of challenges. Nevertheless, there is an opportunity to strengthen health care systems in resource-limited settings by anchoring these interventions to HCV scale-up. Implementation will require the support and engagement of a broad and diverse range of stakeholders, including the global financing community. We hope that the vignettes presented in this article encourage creative and innovative discussions amongst development banks and other members of the development finance community to explore financial vehicles that can enable governments and/or patients to access HCV treatment, and in doing so save many lives.
A case study for health loans
Mongolia has among the highest HCV disease prevalence in the world, concentrated in those people in their most productive years, between the ages of 15-60. We estimate HCV morbidity and mortality in this age group to constitute at least US$1.4 billion in lost economic productivity. We estimate the total screening and treatment costs of a countrywide HCV disease elimination programme, by adopting a modified Test and Treat strategy that screens a third of the country and treats those infected with generic HCV drugs, is approximately US$140-150 million. The expected economic benefit of countrywide elimination would far outweigh the cost of the intervention, suggesting a cost beneficial public health strategy Would a development bank consider a health loan to support laboratory, infrastructure, health workforce education and treatment scale-up in Mongolia? What would the transaction design look like?
A case study for microfinance
Pakistan has the second-largest burden of HCV in the world, with over 11.5 million infected. The majority of health expenditure in Pakistan is out-of-pocket incurred by the patient. The availability of generic medicines could bring per patient costs of the entire continuum of HCV care, including treatment, to less than US$600 in the coming years. Concurrently, Pakistan also has some of the largest microfinance networks in the world. These networks could enable HCV patients to access treatment via a microfinance loan and provide a linked “test-treat-cure” health ecosystem for the provision of treatment. Microfinance networks also have the ability to support testing and treatment linkages via community health workers. Thus, a connection between the treatment and the delivery mechanism can potentially yield greater scope of HCV delivery as well as stimulate individual and local economies. Could microfinance warrant consideration as a health-financing tool in countries with high out-of-pocket spending? Would a development bank assist in the transaction design of a microfinance product for health? Could a development bank or foundation help underwrite the risk associated with a microfinance health loan in collaboration with a microfinance network?
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by Clifford Samuel
Senior Vice President, Access Operations & Emerging Markets
Photo: Gilead Sciences