In this study, we look at how the expansion of the 4 + 7 pilot program affects the utilization, costs, and affordability of the included chemical drugs (atorvastatin and rosuvastatin) and their corresponding Chinese patent medicine alternatives (Xuezhikang and Zhibitai) in terms of DDDs, expenditures, and affordability.
Research has found that after the implementation of the policy, the proportion of chemical drugs included in the clinical use of lipid-lowering agents increased. The total amount of the two kinds of chemical drugs increased by 203.263 million DDDs (an increase of 126.5%). This phenomenon is closely related to the significant reduction in the prices of the bid-winning lipid-lowering drugs, indicating that the accessibility of the bid-winning lipid-lowering drugs has been enhanced. In addition, it may also be related to the need for hospitals to prioritize the use of selected products and fulfill their agreed procurement volumes under the purchase contract.
After the implementation of the policy, the unit comparable prices of the two kinds of chemical drugs decreased significantly (by 363.7 million CNY), indicating that the policy has an initial cost-saving effect on lipid-lowering chemical drugs. Price is the primary determinant of drug affordability [12], and the unreasonable prices and high costs of lipid-lowering drugs have been important factors restricting effective control of the drug burden for patients with hyperlipidemia in China. [13] In recent decades, the increase in ASCVD among the Chinese population has been significant, and only 14.5% of patients with ASCVD have received lipid-lowering treatment. Lower prices can effectively increase the treatment rate, thus generating long-term benefits.
Researchers have found that after the implementation of the policy, the DDDs of lipid-lowering Chinese patent medicines did not significantly decrease but increased by 28.77 million DDDs. These findings indicate that after policy intervention, the use of these two types of lipid-lowering Chinese patent medicines was not significantly impacted, and there was no significant demand transfer between drugs. The reasons behind the increase in the use of Chinese patent medicines may involve multiple levels, such as product characteristics, patient choice, doctor prescribing habits, and policy guidance.
Regarding product characteristics, in the field of lipid-lowering agents, some Chinese patent medicinal products have irreplaceable and differentiated competitive advantages, with a high demand for rigidity and product viscosity. For example, [14] systematic evaluations have shown that, compared with statin controls, Xuezhikang capsules can reduce TC and LDL-C levels while increasing HDL-C levels. These agents have good lipid-lowering effects, low rates of adverse reactions, and better tolerability among the population, making them popular among doctors and patients. Numerous clinical studies have also been conducted in China on the treatment of chronic diseases such as atherosclerosis, coronary heart disease, kidney disease, and hypertension with lipid-lowering Chinese patent medicine agents, including Xuezhikang and Zhibitai. [15] These studies have pointed out other benefits beyond cholesterol reduction for patients, which has also promoted the clinical application of these agents to a certain extent. In addition, different target values are adopted for lipid-lowering treatment in different atherosclerotic-related diseases. The personalized lipid-lowering treatment brings different needs for different lipid-lowering agents with different efficacy, providing space for clinical applications of lipid-lowering Chinese patent medicine agents.
In terms of patient choice, which is influenced by traditional Chinese medicine theories, personal physical conditions, medication history, and emotional preferences, local older people have a high level of acceptance and recognition of Chinese medicines. Patients who previously used Chinese patent medicines may tend to maintain this medication choice and not leave the system. [16] In addition, factors such as an aging population, an increase in chronic disease morbidity rates, and an increase in public awareness of medical security also drive demand for Chinese patent medicines. Conducting relevant surveys at the patient level may further help us understand factors such as treatment effectiveness, reasons for selection, and patient satisfaction with lipid-lowering Chinese patent medicine agents.
In terms of doctor prescribing habits, the policy has not affected the structure of medication usage of Chinese patent medicines, so we guess that in clinical use, there is no unreasonable medication behavior of doctors increasing the use of Chinese patent medicines to increase medical income due to the reduction of total costs of chemical drugs. Under the national policy of giving equal development priority to traditional Chinese and Western medicine, Chinese patent medicines are widely used in China. With advanced research, it is beoming more widely recognized in clinical practice, and its benefits are gradually highlighted. It can be accepted by the majority of doctors and promoted for clinical use, primarily for the diagnosis and treatment of some common chronic diseases.
In terms of policy guidance, China has recently issued a series of encouraging policies to support the development of the traditional Chinese medicine industries. The implementation of long-term comprehensive plans such as the "Outline Development Plan for the Development of Traditional Chinese Medicine (2016–2030)" and the "Healthy China 2030" Plan provides a long-term driving force for the development of the traditional Chinese medicine industry, promoting the joint efforts of pharmaceutical companies and medical institutions, which is beneficial to the market of Chinese patent medicines.
At the same time, ITS results show that there is no significant upward trend in DDDs and expenditure for Chinese patent medicines after the implementation of the policy. By analyzing the changes in DDDs and expenditure in specific areas, it was found that there were significant differences in DDDs and expenditure of lipid-lowering drugs between primary, secondary, and tertiary hospitals before the implementation of the policy. The DDDs and expenditures in secondary and tertiary hospitals are much higher than those in primary hospitals. We guess that this phenomenon may be related to the replacement effect of Xuezhikang. The recognition, drug availability, and affordability of Xuezhikang are better than those of Zhibitai capsules in grass-roots areas. No significant changes were observed in lipid-lowering drugs such as Zhibitai and Xuezhikang at both levels and trends following the policy's implementation (p > 0.05), indicating that the substitution effect of bid-winning chemical drugs has no impact on Chinese patent medicines at all levels of medical institutions.
In summary, NVBP has achieved an initial cost-saving effect in the short term through the inclusion of high-quality and widely used varieties of lipid-lowering drugs, reflecting China's efforts in the fairness and accessibility of pharmaceutical services. In the future, further expanding the scope of procurement to include chronic diseases and drugs with high demand in the procurement catalog is expected to effectively reduce the drug burden of Chinese patients.