ABSTRACT
About 10 million people in China are infected with hepatitis C virus (HCV), with the seroprevalence of anti-HCV in the general population estimated at 0.6%. Delaying effective treatment of chronic hepatitis C (CHC) is associated with liver disease progression, cirrhosis, hepatocellular carcinoma, and liver-related mortality. The extrahepatic manifestations of CHC further add to the disease burden of patients. Managing CHC-related advanced liver diseases and systemic manifestations are costly for both the healthcare system and society. Loss of work productivity due to reduced well-being and quality of life in CHC patients further compounds the economic burden of the disease. Traditionally, pegylated-interferon plus ribavirin (PR) was the standard of care. However, a substantial number of patients are ineligible for PR treatment, and only 40%-75% achieved sustained virologic response. Furthermore, PR is associated with impairment of patient-reported outcomes (PROs), high rates of adverse events, and poor adherence. With the advent of direct acting antivirals (DAAs), the treatment of CHC patients has been revolutionized. DAAs have broader eligible patient populations, higher efficacy, better PRO profiles, fewer adverse events, and better adherence rates, thereby making it possible to cure a large proportion of all CHC patients. This article aims to provide a comprehensive evaluation on the value of effective, curative hepatitis C treatment from the clinical, economic, societal, and patient experience perspectives, with a focus on recent data from China, supplemented with other Asian and international experiences where China data are not available.
ABSTRACT
The China National Formulary (CNF) for reimbursable drug use, also known as the National Reimbursement Drug List (NRDL), was formally established in 2000, revised in 2004 and 2009, and covers 52% of China's population under the government urban health insurance programs. A third major and long-awaited update to the formulary was completed in February 2017 based on intensive reviews by a group of experts in medicine, pharmacology, health economics, and health policy. Shortly after this major update, a pilot project at the central government level was implemented for negotiations mainly on innovative but expensive medicines that were still outside the National Formulary. The pilot, conducted between March and July 2017, eventually reached an overall agreement rate of 81.8% regarding approved indications and drug prices between China's government and the pharmaceutical companies. This pilot showcased numerous leading edge features including a working definition of innovative medicines and opportunities to submit dossiers on drug clinical and economic information. This pilot covered 44 medications for negotiations in a breakthrough attempt to increase the appropriate access to innovative but expensive medicines. The implications to the future of the CNF go beyond the drugs included in the pilot. This paper describes the background of the CNF and the negotiation pilot. In addition, authors of this paper make six recommendations critical to CNF future developments, including enhancing criteria and process for evaluations, standardizing the dossier format, specifying data requirements, refining pricing calculation, and cultivating evaluation professional development.
Subject(s)
Costs and Cost Analysis , Drug Approval/economics , Health Policy , Insurance, Health, Reimbursement/economics , Negotiating , China , Government Regulation , Health Expenditures , Humans , Pilot ProjectsABSTRACT
OBJECTIVE: To evaluate the efficacy and safety of oseltamivir in the treatment of influenza in a high risk population. METHODS: A randomized, open, control trial was conducted from Nov. 2002 to Feb. 2003. Patients with chronic respiratory disease, such as chronic bronchitis, obstructive emphysema, bronchial asthma, bronchiectasis or chronic cardiac disease, and with symptoms of influenza were enrolled. They should satisfy the following criteria: Fever > or = 37.8 degrees C plus at least two of the following influenza symptoms: coryza/nasal congestion, sore throat, cough, myalgia/muscle aches and pain, fatigue, headache and chills/sweats. Within 48 h after the onset of the symptoms, the patients were randomly assigned to oseltamivir group (oseltamivir 75 mg, twice daily for 5 days) or control group (symptom relief medicine only). RESULTS: Fifty-six of the 108 recruited patients were identified as influenza-infected through laboratory test. They were defined as intent-to-treat infected population (ITTI) (27 oseltamivir, 29 control). The duration of influenza symptom was 64 h shorter (36.7%) and AUC score of the influenza symptom was decreased by 618 (43.1%) in the oseltamivir group as compared with those in the control group. The fever duration was 46.8 h (45.0%) less in the oseltamivir group than that in the control group. It took 6 d for the oseltamivir group and 11 days for the control group to recover to the basic health status. Secondary complications such as bronchitis, sinusitis and pneumonia occurred 11% (3/27) in the oseltamivir group and 45% (13/29) in the control group. The treatment expense for influenza and its complication was 587.4 RMB in the oseltamivir group and 786.5 RMB in the control group, which showed no significant difference (P = 0.246). CONCLUSIONS: It is suggested that oseltamivir is effective and well tolerated in patients with chronic respiratory or cardiac diseases. It can reduce the fever duration and severity of influenza symptom, and decrease the incidence of secondary complications and antibiotic use, while does not increase the total medical cost.
