Will Sofosbuvir/Ledipasvir (Harvoni) Be Cost-Effective and Affordable for Chinese Patients Infected with Hepatitis C Virus? An Economic Analysis Using Real-World Data

Abstract

BackgroundLittle is known on the cost-effectiveness of novel regimens for hepatitis C virus (HCV) compared with standard-of-care with pegylated interferon (pegIFN) and ribavirin (RBV) therapy in developing countries. We evaluated cost-effectiveness of sofosbuvir/ledipasvir for 12 weeks compared with a 48-week pegIFN-RBV regimen in Chinese patients with genotype 1b HCV infection by economic regions.MethodsA decision analytic Markov model was developed to estimate quality-adjusted-life-years, lifetime cost of HCV infection and incremental cost-effectiveness ratios (ICERs). SVR rates and direct medical costs were obtained from real-world data. Parameter uncertainty was assessed by one-way and probabilistic sensitivity analyses. Threshold analysis was conducted to estimate the price which can make the regimen cost-effective and affordable.ResultsSofosbuvir/ledipasvir was cost-effective in treatment-experienced patients with an ICER of US$21,612. It varied by economic regions. The probability of cost-effectiveness was 18% and 47% for treatment-naive and experienced patients, and it ranged from 15% in treatment-naïve patients in Central-China to 64% in treatment-experienced patients in Eastern-China. The price of 12-week sofosbuvir/ledipasvir treatment needs to be reduced by at least 81% to US$18,185 to make the regimen cost-effective in all patients at WTP of one time GDP per capita. The price has to be US$105 to make the regimen affordable in average patients in China.ConclusionSofosbuvir/ledipasvir regimen is not cost-effective in most Chinese patients with genotype 1b HCV infection. The results vary by economic regions. Drug price of sofosbuvir/ledipasvir needs to be substantially reduced when entering the market in China to ensure the widest accessibility.

Economic Evaluation of Hepatitis C Treatment Extension to Acute Infection and Early-Stage Fibrosis Among Patients Who Inject Drugs in Developing Countries: A Case of China

“…All costs were expressed as US dollars using official exchange rates as of 2018 (US$1 = 6.62 CNY) [43]. Regimen costs of pegIFN-based and DCV+ASV regimens were derived from previous economic evaluations in a Chinese setting [42,44]. The annual direct medical costs of managing patients at stages F0-F4, DC, and HCC were obtained from a real-world study in China [44], which included the costs of outpatient visits and post-treatment monitoring.…”

“…Regimen costs of pegIFN-based and DCV+ASV regimens were derived from previous economic evaluations in a Chinese setting [42,44]. The annual direct medical costs of managing patients at stages F0-F4, DC, and HCC were obtained from a real-world study in China [44], which included the costs of outpatient visits and post-treatment monitoring. The annual costs of liver transplantation and post-liver transplantation were gained from literature focused on health costs among chronic hepatitis B infection in China [45].…”

Economic Burden of Hepatitis C Infection

“…42 In contrast, initial reports from less developed countries were, generally, less favorable toward the immediate use of the second-generation DAAs at their current price levels. [43][44][45][46][47] Nevertheless, national strategies in some countries have led to price negotiations for the new anti-HCV regimens, and this will likely allow making these regimens affordable and cost-effective in the future. 46,48 This example also highlights the importance of having a national strategy to deal with HCV on a country-bycountry basis, because solutions suitable for developed countries may be not directly applicable to countries with fewer resources.…”

Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis

“…All‐oral pangenotypic regimens are simplified treatment options that were recommended by the World Health Organization (WHO) HCV guidelines (2018 version). A simple, affordable, universal, pangenotypic treatment regimen is preferred for anti‐HCV treatment in clinical practice and public health efforts in China . However, pangenotypic regimens, such as sofosbuvir, daclatasvir and sofosbuvir/velpatasvir, have not been covered by health insurance in China, and the price is high, so many patients cannot afford these treatments.…”

“…A simple, affordable, universal, pangenotypic treatment regimen is preferred for anti-HCV treatment in clinical practice and public health efforts in China. 8 However, pangenotypic regimens, such as sofosbuvir, daclatasvir and sofosbuvir/velpatasvir, have not been covered by health insurance in China, and the price is high, so many patients cannot afford these treatments. Therefore, a simple, pangenotypic, effective and affordable treatment regimen for patients with a broad range of chronic HCV infections remains an unmet medical need in China.…”