New National Essential Drugs List Includes Hepatitis C Drug Epclusa; Experts Urge Swift Inclusion in National Reimbursement Drug List
The newly released 2018 edition of the National Essential Medicines List has included Epclusa, a new hepatitis C drug developed by Gilead Sciences. It is the first globally and the only domestically available all-oral, pangenotypic, single-tablet regimen for hepatitis C treatment to be included.
Benefiting from the accelerated drug review and approval reforms in China, Epclusa (sofosbuvir/velpatasvir) was officially approved for marketing in China this May. Within just a few months, it was included in the National Essential Medicines List. Consequently, when it will be covered by the national medical insurance has become a topic of concern for both the medical community and patients. In this regard, the author recently interviewed Wang Jun, Deputy Director of the Hepatology Department at Guiyang Public Health Clinical Center, to gain insights into hepatitis C prevention and control efforts in China.
Wang Jun, Deputy Director of the Department of Hepatology, Guiyang Public Health Clinical Center
Viral hepatitis is a global public health issue, with hepatitis B and hepatitis C being the two most predominant types, accounting for over 90% of total hepatitis-related mortality. Hepatitis B and hepatitis C are also major causes of liver cirrhosis and hepatocellular carcinoma in China. In his report titled "Epidemiology and Disease Burden of Liver Disease in China," presented at the 2018 China-Pakistan Joint Academic Conference on Liver Diseases on October 12, Academician Zhuang Hui from Peking University Health Science Center pointed out that the number of reported hepatitis C cases in China increased annually from 2007 to 2017. The number rose from 92,376 cases in 2007 to 242,897 cases in 2017, representing a 2.6-fold increase. According to reports, the prevalence of hepatitis C virus ribonucleic acid (HCV RNA) in the general population of China is 0.7%, with an estimated 10 million patients suffering from hepatitis C. The prevalence of anti-HCV antibodies is even higher among high-risk populations; for instance, it reaches 60%–90% among people living with HIV/AIDS and 48.67% among people who inject drugs. In recent years, public health emergencies caused by iatrogenic transmission of hepatitis C have occurred occasionally. However, unlike hepatitis B, which is widely recognized by the public, hepatitis C suffers from low public awareness, low diagnosis rates, and low treatment rates—a fact widely acknowledged within the medical community.
According to Wang Jun, there are six main genotypes of hepatitis C virus (HCV). Genotype 1b is predominant in China, whereas genotype 3 is more common in Guizhou Province, where people who inject drugs constitute the majority of his patients. Because HCV causes less severe liver damage than hepatitis B virus (HBV) and is asymptomatic in its early stages, making it difficult to detect, patients rarely seek testing proactively. “Among the HCV patients I see in my outpatient clinic, most are diagnosed incidentally during preoperative screening for other conditions.” Many others may not seek medical attention until after 10–20 years of disease progression, when complications such as cirrhosis or even hepatocellular carcinoma develop.
To make matters worse, unlike hepatitis B, for which an effective vaccine is available to provide robust prevention, no effective vaccine has yet been developed for hepatitis C. Because the hepatitis C virus (HCV) is an RNA virus with a high mutation rate, and because non-human animals other than chimpanzees are not susceptible to HCV infection, making it difficult to identify suitable animal models, vaccine development faces substantial challenges.
This means that hepatitis C lacks an effective vaccine for prevention and exhibits high stealthiness after infection, becoming an undetected "silent killer" that poses a serious threat to public health.
On July 25, Gilead Sciences announced the official launch of Epclusa® (sofosbuvir/velpatasvir), a new medication for chronic hepatitis C that was approved on May 30 this year. Within just a few months, it was included in the National Essential Medicines List.At the State Council’s regular policy briefing held on September 5, Zeng Yixin, Deputy Director of the National Health Commission, stated, “The newly launched Epclusa can cure hepatitis C, representing a major breakthrough in medicine. We will ensure that such drugs, which deliver definitive therapeutic effects for patients’ conditions, are included in the National Essential Medicines List.”
According to Wang Jun, “Epclusa is currently the first globally and the only domestically available all-oral, pangenotypic, single-tablet novel therapy for hepatitis C. As a pangenotypic agent, it demonstrates excellent efficacy across all HCV genotypes and can also be used in patients with advanced complications such as cirrhosis. The cure rate per treatment course can reach 98%–99%. Prior to the development of direct-acting antiviral (DAA) drugs, we could only adopt interferon-based regimens, which were associated with significant toxicity and side effects and had limited therapeutic efficacy.”
As the saying goes, “you get what you pay for.” Epclusa delivers strong therapeutic efficacy, and its price is naturally high. The cost of one treatment course approaches RMB 70,000. Wang Jun admitted, “Many patients are people who use drugs, which has already imposed a severe economic burden on their families. Moreover, many of them are recipients of subsistence allowances, so this price is indeed difficult for them to afford.”
Given that the majority of hepatitis C patients reside in remote rural areas and many are impoverished, social forces are also taking action to provide assistance.
It is reported that, to support impoverished patients, the China Primary Health Care Foundation partnered with Gilead Sciences to launch the “Seeking Answers, Curing Hepatitis C” assistance program earlier this year. The program will cover more than 200 hospitals across 51 cities, initially benefiting over 4,000 hepatitis C patients from low-income households and those receiving subsistence allowances. Patients receiving subsistence allowances may apply for free medication, while low-income patients (with an annual household income below RMB 150,000) may apply for a “buy three, get three free” assistance offer.
However, assistance from non-governmental sources is inherently limited. “Some patients are purchasing affordable generic drugs from abroad,” expressed Director Wang Jun with concern. “I do not recommend generics to my patients, as their quality and efficacy cannot be guaranteed; it is essential to use formally approved medications that have undergone inspection by the National Medical Products Administration. Nevertheless, some patients truly cannot afford them due to financial burdens.”
Therefore, the swift inclusion of Epclusa (sofosbuvir/velpatasvir) in the National Reimbursement Drug List has become a shared expectation among both the industry and patients. However, some stakeholders have expressed concerns about the financial sustainability of the medical insurance fund. Based on the current cost of RMB 69,600 per treatment course, the total medication expense for approximately 7.6 million patients would amount to RMB 530 billion. Given the national reimbursement rate of 70%, the medical insurance fund would need to cover RMB 370 billion.
In October 2015, with the approval of the State Council, 16 ministries and bureaus, including the National Health and Family Planning Commission, established an inter-ministerial joint conference system for drug price negotiations. The prices of the first batch of drugs under negotiation—tenofovir disoproxil fumarate, a first-line treatment for chronic hepatitis B; and icotinib and gefitinib, targeted therapies for non-small cell lung cancer—were all cut by half or even more.
The summer blockbuster “Dying to Survive” also exerted a certain pressure, prompting a number of well-known pharmaceutical companies to voluntarily reduce prices.
At the 69th World Health Assembly in 2016, the WHO proposed targets for hepatitis C control by 2030: a 65% reduction in annual deaths and an increase in treatment coverage to 80%. China also released its guidelines for the prevention and control of hepatitis C in 2015.
To achieve this goal, Wang Jun stated, “First and foremost, we must intensify screening efforts. However, hepatitis C screening requires blood draws at hospitals, unlike HIV screening, which has the convenience of rapid test strips. Since most people are reluctant to proactively visit hospitals for testing, if the government could organize relevant personnel to go to grassroots communities and rural areas to provide free screening for high-risk groups, we believe many more people would be willing to participate.”
Meanwhile, Wang Jun specifically highlighted the critical role of new technologies in the prevention and control of hepatitis C. In the “Relentless Pursuit, Hepatitis C Cure” assistance program, Gilead’s strategic partner, Medlinker—a leading domestic provider of healthcare solutions—leveraged its one-stop patient management services to establish a closed-loop service model encompassing remote follow-up consultations, e-prescriptions, and home delivery of medications, thereby addressing multiple pain points in the medical care process.
Wang Jun has established medical records for over a hundred of his patients through the Yilian Internet Healthcare Platform, significantly facilitating patient management and enabling the easy provision of services such as disease guidance and follow-up consultations. He stated, “As Epclusa (sofosbuvir/velpatasvir) is not yet covered by national medical insurance and it will take some time before it is fully available in hospitals, our patients currently purchase their medications through the Yilian platform. On this platform, patients can choose either home delivery or pickup at designated pharmacies.”
It is understood that many remote areas in Guizhou suffer from inconvenient transportation, requiring patients to spend several days traveling to major hospitals for medical consultations, with significant expenses incurred for transportation, accommodation, and meals. Now, through the Medical Union Platform, doctors can issue prescriptions online, allowing patients to purchase reliable medications on the platform and have them delivered directly to their homes. This not only saves travel time but also substantially reduces costs.
Precisely because hepatitis C predominantly affects rural and remote areas, where patients are largely from impoverished and vulnerable populations, all aspects—including screening methods, public education and guidance, the use of technological platforms, and the operation of charitable projects—must be tailored to the specific needs of this group. The next step of incorporating Epclusa (sofosbuvir/velpatasvir) into the national medical insurance scheme tests not only a country’s financial capacity but also reflects the broader society’s commitment to hepatitis C prevention and control, as well as its care and support for vulnerable groups.