How does Chinese patent medicine enter the DRG/DIP payment plan of western medical institutions

For Chinese patent medicines, which are unique products in China, on the one hand, the qualifications of Western medicine to prescribe Chinese patent medicines are restricted; on the other hand, the use of Chinese patent medicines in medical institutions is restricted
.
In some western medicine hospitals, Chinese patent medicines encounter the dilemma of "limiting, controlling and stopping", and even "one size fits all" discontinuation
.
The author believes that this is a difficult problem involving how Chinese patent medicines enter the DRG/DIP payment scheme of Western medical institutions
.
In fact, how to enter the DRG/DIP payment scheme of western medicine medical institutions is the biggest challenge for Chinese patent medicine companies in 2022
.
Chinese patent medicine enterprises face three major challenges 01.
Raising the threshold for physicians' prescriptions The state is increasingly demanding standardization of traditional Chinese medicine prescriptions
.
For the prescription of Chinese patent medicines by Western medicine, according to the "Notice on Printing and Distributing the First Batch of National Key Monitoring Rational Drugs List (Chemical Drugs and Biological Products)" issued by the National Health Commission and the State Administration of Traditional Chinese Medicine on July 1, 2019, except for Physicians of other categories other than those in the category of traditional Chinese medicine, "after systematically studying professional knowledge of traditional Chinese medicine for not less than one year and passing the examination, they can issue prescriptions for proprietary Chinese medicines in accordance with the basic principles of syndrome differentiation and treatment in traditional Chinese medicine
.
" That is to say, only Western doctors with knowledge system of traditional Chinese medicine are required to prescribe Chinese patent medicines
.
For Chinese herbal decoction pieces, it is even more required that only those who have obtained a professional academic degree or degree in traditional Chinese medicine, integrated traditional Chinese and Western medicine, or ethnic medicine recognized by the educational administrative department at or above the provincial level, or have participated in the training of Western medicine for more than 2 years recognized by the provincial traditional Chinese medicine department.
Classes (the total number of hours is not less than 850 hours) and obtained the corresponding certificate, or in accordance with the relevant provisions of the "Traditional Medicine Teachers and Professionals Physician Qualification Examination Method" to study Chinese medicine with a teacher for 3 years and obtain the "Traditional Medicine Teacher Inheritance" Certificate" can only be prescribed
.
02.
Encountering the “restriction, control and suspension” of medical institutions On the one hand, compliance can reduce the abuse of Chinese patent medicines; but on the other hand, in reality, some medical institutions (especially some western medicine hospitals) adopt a “one size fits all” approach to the management of Chinese patent medicines The use of proprietary Chinese medicines at the terminals of medical institutions encounters the dilemma of “restriction, control, and suspension”.
For example, the hospital pharmacy committee that decides to enter the hospital directly eliminates proprietary Chinese medicines and directly abandons proprietary Chinese medicines in terms of access
.
As a result, some Chinese patent medicine + western medicine schemes that have actual clinical medication experience and were approved by patients in the past have been "discontinued" in western medicine hospitals before they have been summarized and promoted
.
03.
DRG/DIP payment for all diseases is a general trend.
According to the Notice of the National Medical Security Administration on the issuance of the "Three-Year Action Plan for the Reform of DRG/DIP Payment Methods" in November 2021, on the basis of the 2019-2021 pilot, according to 2022 Three-year schedule for 2023, 2024 and 2024
.
Taking provinces (autonomous regions and municipalities directly under the Central Government) as the unit, start not less than 40%, 30%, and 30% of the overall planning areas to carry out the reform of DRG/DIP payment methods and actually pay
.
After the overall planning area starts the DRG/DIP payment reform, the three-year arrangement will achieve full coverage of eligible medical institutions that provide inpatient services, and the annual progress should be no less than 40%, 30%, and 30% respectively
.
After the overall planning area starts the DRG/DIP payment reform work, the comprehensive coverage of DRG/DIP payment medical institutions will be achieved according to a three-year arrangement, and the annual progress should not be lower than 70%, 80%, and 90% respectively
.
This means that it is the general trend for all diseases to adopt DRG/DIP payment
.
According to the "Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine" issued by the National Medical Security Administration and the State Administration of Traditional Chinese Medicine in December 2021, "TCM medical institutions may temporarily Do not implement payment by disease diagnosis-related group (DRG), and appropriately increase the coefficient and score of TCM medical institutions and TCM disease types in areas that have implemented DRG and payment by disease type, fully reflecting the characteristics and advantages of traditional Chinese medicine services
.
Rehabilitation, palliative care and other predominant TCM diseases requiring long-term hospitalization can be paid on a bed-day basis
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Explore the TCM diseases with long treatment cycle, controllable risks, and continuous treatment, provide daytime TCM medical services, implement payment by disease, reasonably determine the payment standard, and uniformly formulate the disease category catalog for day wards
.
” It can be seen that the use of proprietary Chinese medicines in TCM medical institutions will not be affected in the short term
.
However, how proprietary Chinese medicines can enter the DRG/DIP payment scheme of Western medical institutions is a must for Chinese patent medicine companies in 2022.
01.

Striving for a consensus on the guideline for entering Western medicine, but requires Chinese patent medicines that have already entered the medical insurance catalogue on clinical basis, if they are newly added to the medical insurance catalogue through the medical insurance negotiation catalogue after 2020, they can make full use of the "dual-channel" drug management mechanism Entering medical institutions; Chinese patent medicines entered into the essential drug list can enter medical institutions through the requirements of the use ratio of essential medicines in medical institutions and the "1+X" medication mode; Chinese patent medicine medical insurance products that are not in the above categories can basically only rely on themselves Develop hospitals with channel expansion capabilities
.
Non-medical insured Chinese patent medicines can usually only be sold in out-of-hospital pharmacies, and drug costs are usually paid by patients themselves, and are less affected by DRG/DIP
.
The basis for western medicine to enter DRG/DIP is usually the consensus of guidelines and the fact that each hospital has many years of experience.
The individualized clinical path of each hospital based on the practical experience of drug use
.
For Chinese patent medicine, it is necessary to have clinical basis to enter the guideline consensus of Western medicine
.
02.
Newly marketed Chinese patent medicines have been compared with first-line western medicines.
Newly marketed Chinese patent medicines There are often clinical trial data, and some are comparative studies with first-line western medicines
.
On January 10, 2022, the 1.
2 innovative drug icariin soft capsules (declared as acridine) were approved for marketing with conditions.
) as an example
.
The drug is used for unresectable hepatocellular carcinoma that is not suitable for or the patient refuses to receive standard treatment and has not received systemic systemic therapy before, and the patient's peripheral blood composite markers meet at least two of the following detection indicators: AFP≥400ng/ mL; TNF-α<2.
5pg/mL; IFN-γ≥7.
0pg/mL
.
Acoladine has compared the first-line traditional Chinese medicine and the first-line western medicine: First, in view of the heterogeneity of Chinese patients with advanced hepatocellular carcinoma, most of them are related to hepatitis B virus, the underlying disease is complex and serious, and the physical characteristics are poor, etc.
On the basis of Phase I, IIa/IIb clinical trials, in September 2017, the research and development party carried out a Phase III clinical trial of acridine compared with the traditional Chinese medicine cinobufacin (registration number CTR20170667), using the composite biomarker adaptability With enrichment design, 312 patients were planned to be enrolled, and a total of 283 patients with advanced hepatocellular carcinoma have been enrolled
.
After statistical analysis, at the time of analysis on December 30, 2020, the independent data monitoring committee (IDMC) determined that the enriched population of advanced patients met the prespecified primary study endpoint, the primary efficacy endpoint of the enriched population of the study, overall survival period (OS) reached the preset superiority threshold
.
Second, in September 2017, the developer also launched a multi-center randomized open-label phase III clinical trial on the efficacy and safety of acridine versus sorafenib in the first-line treatment of PD-L1-positive advanced hepatocellular carcinoma subjects.
In the experiment, 200 patients were planned to be enrolled, and 89 patients were actually enrolled
.
At present, there are not many proprietary Chinese medicines that dare to be compared with first-line western medicines, and not many are compared with first-line Chinese medicines.
Most of the phase III trials are still placebo-controlled according to the registration requirements
.
03.
What kind of clinical evidence is needed for the combination of Chinese and Western medicines? When Western medicine is used for treatment, many indications are combined with medication.
If the combination of Chinese and Western medicines is to enter DRG/DIP, clinical evidence must first be obtained
.
The establishment of clinical evidence is based on the existing clinical programs to investigate the current unmet clinical needs, and to set up clinical studies that the combination of Chinese patent medicine and western medicine can solve the unmet clinical needs
.
This requires a full investigation of the indications.
The role of Chinese patent medicines in the entire combined drug regimen may be "filling" and preventing
.
What needs to be considered is the recognition of such clinical research by the medical insurance department, because the enrollment setting and number of clinical research required for registration and listing may not be completely equivalent to the real-world data of clinical application
.
In addition, the combination of traditional Chinese and Western medicines for cardiovascular, children's colds, rehabilitation and other related indications that have extensive clinical drug experience can be directly entered into the DRG/DIP directory of each hospital? Or must the CDE approve the relevant combination regimen to enter the DRG/DIP? Will the clinical research, real-world data or pharmacoeconomics research initiated by corporate entities be recognized by the medical insurance department? Analyzing the data of Xianda Pharmaceutical Sea, it is found that there are not many domestic Chinese patent medicine manufacturers currently launching Phase III and Phase IV clinical trials in combination with Western medicines
.
For the combination of Chinese patent medicine and western medicine, only the compound Huangdai tablet of Anhui Tiankang Pharmaceutical Co.
, Ltd.
clearly mentioned the generic name of the specific chemical drug in the relevant test plan.
Phase III clinical trial of adjuvant therapy for cellular leukemia; in 2018, Phase IV clinical trial of combined treatment of acute promyelocytic leukemia with retinoic acid was initiated
.
04.
Can those who are listed with conditions and entered into the medical insurance negotiation catalogue enter the DRG/DIP? It is also worth noting that for the conditional listing of Chinese patent medicines and natural medicines, it is still necessary to continue to complete relevant post-marketing research work
.
For this type of Chinese patent medicine, if it has entered the medical insurance negotiation catalog, can it enter the DRG/DIP?