Cost estimate and budget impact analysis of implementing the new guidelines for management of hepatitis C virus in China: a micro-costing study

Abstract Background New international guidelines, local experts, and the WHO China Office recommend a standardised package of treatment for hepatitis C virus, using sofosbuvir as the direct-acting antiviral drug due to its high efficacy and ease of use. Unlike currently available injection-based treatments (interferon or peginterferon-based therapy), sofosbuvir is taken orally, with improved treatment adherence expected. However, sofosbuvir is currently not in the market in China, and would be unaffordable to many patients. We aimed to assess the average cost of care for chronic hepatitis C virus in China with current injection-based therapies compared with the cost of sofosbuvir-based treatment, and the budget impact of introducing new guidelines for treatment of chronic hepatitis C virus with sofosbuvir. Methods A micro-costing multilevel and multicentric study collecting data on all care activities for chronic hepatitis C virus was designed and sent to a random sample of tertiary provincial hospitals in the east, central, west, and northwest regions of China. Snowball sampling was utilised to contact tertiary city hospitals, secondary city hospitals, and secondary county hospitals. 16 hospitals filled out the survey of 16 invited to take part. Average cost per patient per year was assessed; because large standard deviation in costs indicated large variations in the sample, we weighted costs by the number of patients with chronic hepatitis C virus (as a proportion of all patients in the country). Because there is no current price for sofosbuvir, we used a cost-effective price compared with the current regimen of peginterferon in China, the price of sofosbuvir in India, and the price of sofosbuvir in Brazil. We conducted a one-way sensitivity analysis on weights and treatment drug cost, and a computer-based budget impact analysis. Findings The average yearly cost for each patient (weighted by patient load per hospital) was ¥45 700. The cost of the standard package regimen (using the cost-effective sofosbuvir price) was ¥31 700 per patient, although this fell to ¥11 400 using the current price of sofosbuvir in India and rose to ¥75 000 using the price of sofosbuvir in Brazil. Pre-assessment and monitoring costs were much higher than the standard package (more than four times). Patients paying all costs of care paid ¥45 700 per year under the current practice, ¥31 748 under the standardised care using the cost-effective sofosbuvir price, and ¥11 360 using the Indian sofosbuvir price. These costs compared with the threshold for catastrophic health expenditure of ¥20 167 for average households, ¥28 844 for urban households, and ¥9892 for rural households, suggesting that rural patients cannot afford full chronic hepatitis C care. If a public payer were to cover all care costs for patients with hepatitis C virus in China (100 000 individuals), it would cost ¥4·6 billion for current care practices (including ¥4·1 billion for currently used antiviral treatments only) and ¥1·1 billion for standardised care (¥1·0 billion for standard-package antiviral treatments only), equivalent to 0·48% of the Ministry of Finance health expenditure for 2013 for the current package and 0·12% for the standard package. The total cost after 5 years would be ¥22·9 billion for the current package (including ¥20·4 billion for antiviral drugs) and ¥5·7 billion for the standard package (including ¥5·1 billion standard package for antiviral drugs). Based on the one-way sensitivity analysis, the sofosbuvir regimen price was the biggest cost-driver, followed by the target population. Interpretation At present, care for chronic hepatitis C virus is unaffordable for Chinese patients. Considering that current treatment costs are unaffordable for patients, and that better and curative therapies are available that could save lives and resources in the long run, it is reasonable for China to consider funding or reimbursing standardised care for hepatitis C virus with evidence-based therapies. Funding World Health Organization China.