Another New Deal, three grades of Chinese patent medicine sales or drop 80%!

China's clinical path management work was officially launched in 2009. In December 2009, the National Health and Family Planning Commission promulgated the Notice on Launching the Pilot Work of Clinical Pathway Management. According to the "Guiding Opinions of the Ministry of Health on Promoting Clinical Pathway Management during the Twelfth Five-Year Plan Period", by the end of 2015, all tertiary hospitals and 80% of secondary hospitals in all provinces (autonomous regions and municipalities) should carry out clinical pathway management, and Gradually increase the number of clinical path management specialists and diseases.

By the end of 2015, there were 1,599 tertiary hospitals and 4,563 secondary hospitals across the country to carry out clinical pathway management. However, relevant data on the effects of drug structure after the implementation of the clinical pathway were not reported. On May 9, 2016, the Health and Family Planning Commission proposed that all three hospitals will carry out clinical pathway management. With the continuous enrichment of the types of clinical pathways, the impact on the use of drugs in Chinese hospitals will increase.

First, want to enter the clinical path, first into the guide

The author selected the clinical path of the treatment options or diagnosis based on the discovery that the clinical path will often refer to the three major sources of clinical treatment evidence.

The first is the Chinese Medical Association’s guidelines for clinical and technical practices and guidelines for diagnosis and treatment, and the relevant series of journals of the Chinese Medical Association, such as “Clinical Technology Practices - Cardiovascular Surgery” (edited by the Chinese Medical Association, People’s Military Medical Press, 2009). Clinical Practice Guide - Psychiatry Volume (edited by the Chinese Medical Association, People's Medical Publishing House), Guidelines for the Diagnosis and Treatment of Bipolar Disorders (edited by the Chinese Medical Association), Guidelines for the diagnosis and treatment of pulmonary thromboembolism (Draft) ( Chinese Medical Association, Respiratory Disease Branch, 2001), Chinese Medicine Association, “Guidelines for Diagnosis and Treatment of Common Internal Diseases in Traditional Chinese Medicine”, Endocrinology and Metabolomics Group of Pediatrics of Chinese Medical Association, and Newborn Screen of Birth Defects Prevention and Control Professional Committee of Chinese Preventive Medicine Association The inspection group “Consensus for the diagnosis and treatment of hyperphenylalaninemia” (Chinese Journal of Pediatrics, 2014, 52(6): 420-425).

The second is the standards for diagnosis and treatment, standards for diagnosis and treatment, and diagnosis and treatment protocols promulgated by the Health and Family Planning Commission or the State Administration of Traditional Chinese Medicine, as well as application guidelines and management methods, such as "Guidelines for the diagnosis and treatment of gastric cancer (2011)" and "The diagnosis of pulmonary tuberculosis in the health industry in the People's Republic of China." Standards (WS288-2008), "Specifications for Diagnosis and Treatment of Primary Lung Cancer (2011 Edition)", "Diagnostic Criteria for Primary Lung Cancer (2010 Edition)", State Administration of Traditional Chinese Medicine's "Eleventh Five-Year" Key Specialist Collaborative Group on Stroke (Cerebral Infarction) Diagnosis and Treatment Plan for Acute Period, "Administrative Measures for Clinical Application of Antibacterial Drugs" (Ministry of Health Decree No. [2012] No. 84) and "Guiding Principles for Clinical Application of Antibacterial Drugs (2015 Edition)" (Guowei Health Care [2015] 43 No.) etc.

Third, guidelines for Europe and the United States, WHO's expert consensus, are the basis for clinical pathway reference, such as NCCN Clinical Practice Guide for Colon Cancer (China Version) (2012), NCCN Clinical Practice Guide for Rectal Cancer (China) (2011) 》, “Clinical Practice Guide for Antithrombotic Therapy and Thromboprophylaxis Based on Evidence-Based Medicine” (American College of Chest Physicians, 2012), Guidelines for Diagnosis and Management of Acute Pulmonary Embolism (European Cardiology Society, 2014), Pulmonary Artery Guidelines for the diagnosis and treatment of hypertension (European Respiratory Society, 2009). Expert consensus on diagnosis and treatment of pulmonary hypertension (World Health Organization Working Group, 2013).

This shows that preclinical access to the clinical pathway and access to the above clinical and publications are the first steps. This means that drugs that can enter the clinical pathway usually have certain scientific evidence, and the benefits of the drug exceed its potential risks. . Scientific evidence often needs well-designed evidence from clinical trials. For drugs that are only marketed in China, this clinical data needs to be supplemented according to actual conditions.

Second, after the use of traditional Chinese medicine and chemical drugs

Judging from the current clinical pathways promulgated by the Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine, the clinical route promulgated by the Ministry of Health and Family Planning basically focuses on chemical drugs. There are basically no traditional Chinese medicines and only a few, such as the clinical treatment of severe rheumatoid arthritis. Pathway's treatment plan and drug selection mentioned "plant drugs include tripterygium wilfordii, total glucosides of peony, etc.

Biological agents can be considered according to their condition, including tumor necrosis factor inhibitors, IL-6 antagonists, etc., in the refractory patients with poor efficacy of the above-mentioned drugs. Both chemical and biological agents are recommended.

The clinical path promulgated by the State Administration of Traditional Chinese Medicine is based on Chinese medicine therapy.

The actual treatment plan for existing clinicians is often combined with Chinese and Western medicines. The implementation of the clinical pathway to each hospital can be fine-tuned. Once the clinical pathway is opened, if Western medicine departments strictly follow the clinical path of the Health and Family Planning Commission, traditional Chinese medicine may lose the current market.

According to Table 1, in the Guangzhou region, sales of traditional Chinese medicines are distributed approximately 82% at Western Hospital. From Table 2, it can be seen that the sales contribution of some proprietary Chinese medicines for chronic diseases is more obviously concentrated in Western hospitals. Therefore, for Chinese medicine, if you want to continue to gain market share, you will need to provide clinical evidence with greater benefits from combined use.

Third, good test reagents?

Regardless of the clinical path promulgated by the Ministry of Health and Family Planning and the State Administration of Traditional Chinese Medicine, the inspection items and methods are basically the same, that is, the requirements for the related equipment and test reagents are also similar. Together with the target of long-term fee control, where 30% of drugs account for the long-term, the prescribing doctor will strictly abide by the inspection items required on the clinical path. The temporary doctor's orders that may or may not be done on the project list may all be selected.

Overuse of drugs by doctors may lead to over-examination. Paying by type of disease will be a more effective management method. Clinical channels such as "Postoperative Radiotherapy for Breast Cancer (Clinical Pathway for 2012)" and other clinical pathways once indicated reference cost criteria, such as "breast mammary irradiation of 2.5-3 million yuan, combined regional lymph node irradiation (no matter breast conservation or radical mastectomy/improvement) After radical surgery) 3.5-4 million yuan, but the newly published clinical path basically did not mention reference standards.