In 3Q15, Gilead Sciences (GILD) has been actively involved in increasing access to hepatitis C (or HCV) drugs Sovaldi and Harvoni both in developed as well as developing markets. According to the World Health Organization’s guidelines for the screening, care, and treatment of persons with Hepatitis C Infection from April 2014, there are about 185 million patients infected with HCV in the world.
In the US, 79% of HCV patients have genotype one HCV, 13% have genotype two HCV, 7% have genotype three HCV, and the remaining 1% have other genotypes of HCV. Gilead Sciences’ Harvoni is approved for genotype one HCV while Sovaldi is approved for genotype one to four in the US. In the European Union, Harvoni is approved for genotype one and certain subgroups of genotype three while Sovaldi is approved for genotype one to six. In Japan, Harvoni is approved for genotype one while Sovaldi is approved for genotype two HCV patients. To learn more about Gilead Sciences’ HCV drugs, please refer to Gilead’s Hepatitis C Portfolio: 2 Key Drugs.
The widespread prevalence of the disease coupled with broad approvals received by Gilead Sciences’ HCV drugs underlines the scale of HCV opportunity available to the company. Currently, HCV is treated by Gilead’s Sovaldi and Harvoni and AbbVie’s (ABBV) VIEKIRA PAK as well as interferon therapy injected subcutaneously, or under the skin, mainly provided by Roche (RHHBY) and Merck (MRK).
Gilead Sciences negotiates with payers and enters into licensing arrangements to reach the majority of HCV patients.
Health insurance access
The majority of health insurance companies currently limit Harvoni and Sovaldi coverage to HCV patients with fibrosis scores of three and four. According to BioPredictive, “Hepatic fibrosis is a process of scarring through fibrous tissue deposit which results in the destruction of the parenchyma, with the ultimate progressive stage being cirrhosis. The METAVIR score assesses fibrosis in chronic hepatitis C according to a 5-stage classification.” The score starts at “F0,” which implies no cirrhosis. Scores go up to “F4″ for patients suffering from the most severe liver cirrhosis.
According to Gilead market research from July 1, 2015, to September 13, 2015, about 51% of the total US HCV patients that are intended to be treated by Sofosbuvir-based regimens, Sovaldi and Harvoni, have a fibrosis score of F0 to F2. This implies that these patients have limited probability of reimbursement for HCV drugs. To expand into this patient population, Gilead Sciences relies on real world data for its HCV drug Harvoni, also substantiated by health insurance company Cigna. Also, the average treatment duration for 40% of Harvoni patients in 3Q15 was eight weeks, indicating that the drug is needed for a shorter duration for less severe cases. As health insurers become more aware of the cost benefits involved in treating patients with less severe cases, Gilead Sciences expects a gradual rise in access to the HCV drugs.
Through the years 2014 and 2015, Gilead Sciences entered into licensing arrangements with 11 India-based generic companies to manufacture HCV drugs, including Sovaldi and Harvoni. These drugs will be distributed in 101 developing countries that have more than 100 million people suffering from HCV.
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