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


METHODS
A 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.


RESULTS
Sofosbuvir/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.


CONCLUSIONS
Sofosbuvir/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.
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Guo-Feng
GF
Chen
Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Peking University People's Hospital, Peking University Hepatology Institute, Beijing, China.
Lai
L
Wei
Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR, China.
Jing
J
Chen
The Translational Hepatology Institue, Beijing You'an Hospital, Capital University of Medicine, Beijing, China.
Zhong-Ping
ZP
Duan
Department of Infectious Diseases, Shengjing Hospital, China Medical University, Shenyang, China.
Xiao-Guang
XG
Dou
Department of Infectious diseases, Shanghai Ruijin Hospital, Jiaotong University, School of Medicine, Shanghai, China.
Qing
Q
Xie
Key Laboratory of Medical Molecular Virology, Huashan Hospital, Fudan University, Shanghai, China Institute of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai, China.
Wen-Hong
WH
Zhang
Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Lun-Gen
LG
Lu
Department of Gastroenterology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Jian-Gao
JG
Fan
Liver Disease Center, Beijing Ditan Hospital, Capital University of Medicine, Beijing, China.
Jun
J
Cheng
Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
Gui-Qiang
GQ
Wang
Institute for Viral Hepatitis, Second Affiliated Hospital, Chongqing University of Medical Sciences, Chongqing, China.
Hong
H
Ren
Department of Infectious Disease, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Jiu-Ping
JP
Wang
Department of Infection, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China.
Xing-Xiang
XX
Yang
Center of Diagnosis and Treatment for Infectious Diseases of Chinese PLA, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.
Zhan-Sheng
ZS
Jia
Shanghai Liver Diseases Research Center, Nanjing Military Command, Shanghai, China.
Qing-Chun
QC
Fu
People's Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai, China.
Xiao-Jin
XJ
Wang
Department of Infectious Diseases, Henan Provincal People's Hospital, Zhengzhou University, Zhengzhou, China.
Jia
J
Shang
Department of Infectious Disease, Xinjiang Medical University First Affiliated Hospital, Urumqi, China.
Yue-Xin
YX
Zhang
Department of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Ying
Y
Han
Liver Disease Center for Combined Traditional Chinese Medicine and Western Medicine, 302 Hospital, Beijing, China.
Ning
N
Du
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Qing
Q
Shao
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Dong
D
Ji
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Fan
F
Li
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Bing
B
Li
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Jia-Liang
JL
Liu
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.
Xiao-Xia
XX
Niu
Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR, China.|State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Cheng
C
Wang
Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR, China.
Vanessa
V
Wu
Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR, China.
April
A
Wong
Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR, China.
Yu-Dong
YD
Wang
State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jin-Lin
JL
Hou
Liver Disease Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Ji-Dong
JD
Jia
Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
Hui
H
Zhuang
Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China.|Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR, China.
George
G
Lau
D044466:Asian People; D001562:Benzimidazoles / Q000008:administration & dosage / Q000191:economics*; D002681:China / Q000453:epidemiology; D003365:Costs and Cost Analysis; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000191:economics*; D016174:Hepacivirus; D006526:Hepatitis C / Q000188:drug therapy / Q000191:economics* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008390:Markov Chains; D018803:Models, Economic; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000191:economics*
D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir