Anti-tumor drug shuffle! New listing, high prices, high-risk varieties focus on monitoring!

Medical Network July 30, July 29, the National Health and Care Commission Medical and Health Administration and Hospital Authority issued the "Anti-Tumor Drug Clinical Application Management Measures (draft for comments)" (referred to as "draft for comments"), aimed at further strengthening the management of the clinical application of anti-tumor drugs in medical institutions, improve the level of clinical rational application of anti-tumor drugs, standardize the clinical application of anti-tumor drugs, to ensure medical quality and medical safety.
With the increase of cancer incidence in China, the reform of the drug regulatory review and approval system has further promoted the market of innovative drug research and development, and the cancer innovation drug has become a hot area of heavy investment of pharmaceutical companies.
around market segments and clinical needs, truly patient-centered, serious and rational use and benign market competition, has caused the regulatory authorities to attach great importance to.
"graded management" has been emphasized that the clinical application of anti-tumor drugs should follow the principles of safety, effectiveness and economy.
, medical institutions and medical personnel should, on the basis of evidence-based medical evidence, and on the basis of relevant diagnostic and treatment norms, clinical guidelines, clinical pathways and drug specifications, give full consideration to the value and accessibility of clinical treatment of drugs, and rationally apply anti-tumor drugs in order to treat tumors, improve patient survival rate, improve patient survival quality and prolong patients' lives.
is why the Draft for Comments clearly the clinical application of anti-tumor drugs to implement hierarchical management, the main considerations include safety, accessibility, economic and other factors, and specifically the anti-tumor drugs are divided into restricted use and general use level.
specific classification criteria are as follows: (1) restricted use of grade anti-tumor drugs refers to anti-tumor drugs with one of the following characteristics: 1. Drug toxic side effects, including toxic drugs management, strict adaptation certificate, taboo evidence, must be used by medical personnel with rich clinical experience, improper use may cause serious damage to the human body anti-tumor drugs;
(ii) General use of grade anti-tumor drugs refers to other anti-tumor drugs other than restricted use of anti-tumor drugs.
in fact, the idea of "graded management" of anti-tumor drugs has long been known.
as early as 2012, the former Ministry of Health Office issued the "Three-level Cancer Hospital Evaluation Standards (2011 edition) Implementation Rules", hospitals to implement the classification of cancer chemotherapy drugs (such as special management drugs, general management drugs and clinical trial drugs three).
further, since 2018, the National Health and Care Commission Medical and Hospital Authority has issued the 2018 edition and the 2019 edition of the "New Anti-Tumor Drug Clinical Application Guidelines", emphasizing that medical institutions must establish a clinical application management system of anti-tumor drugs, carry out clinical application monitoring of anti-tumor drugs, strict classification management system implementation, and anti-tumor drugs will be divided into general use level, restricted use level of two categories, for the use of dozens of tumor drugs clear requirements.
the Draft is based on the summary of past practical experience, the Guiding Principles are raised to the "Management Measures", and further clarify the "restricted use of grade" tumor drugs considerations, especially for the new listing, high prices, high-risk varieties of key monitoring, emphasizing that anti-tumor drug classification management directory by medical institutions, and dynamic adjustment.
industry analysis, before the management of tumor drugs graded management ideas refer to the management method of catalog access, the "National Basic Medicine Stakes Directory" "National Basic Medical Insurance Directory" and the national negotiated drug anti-tumor drug varieties as the focus of clinical management, the future with innovative drugs continue to market, clinical use of more dimensions to consider safety, accessibility and payment, really focus on clinical value.
"ultra-adaptive drug" strict supervision in the promotion of cost-plus, auxiliary drug crowded cancer drug market, the introduction of new management methods targeted, no doubt in the clinical application level to the rational use of anti-tumor drugs set a "tight spell."
industry generally believes that from the current drug marketing and marketing dimensions, tumor pharmaceutical companies not only need to try their best to or the small advantages of ORR, PFS, OS data as far as possible, but also need to match the ability to accompany diagnosis, patient management, in addition, the most important thing is still whether the indications can expand, "ultra-adaptive use" of much attention.
taking into account that the drugs currently listed in China (or approved indications) can not fully meet the drug needs of cancer patients, the industry is generally concerned about the problem of hyper-adaptive drug use, the "draft for comments" is also open a "mouth", and stressed in accordance with a certain level of evidence-based medical evidence for use and management: medical institutions should follow the guidelines for clinical application of drugs, diagnostic norms, clinical guidelines and drug specifications, such as rational use of anti-tumor drugs.
In the absence of better treatment and other special circumstances, the corresponding management system, technical norms should be formulated, the drug specifications are not clear, but there is evidence-based medical evidence of the use of drugs to strictly manage. The evidence-based medical evidence adopted in the use of anti-tumor drugs in
special circumstances is, in turn, the use indicated in the drug specifications of other countries or regions, the norms of diagnosis and treatment issued by the International Authoritative Association or Organization, the guidelines for clinical diagnosis and treatment, and the norms of diagnosis and treatment, clinical guidelines, clinical pathways, etc. approved by the National Health AndI, issued by the National Association of Science. At the same time,
the policy also emphasizes the important role of clinical pharmacists in the rational use of anti-tumor drugs, emphasizes that anti-tumor drug prescriptionshould be reviewed and formulated by pharmacists, fosters clinical pharmacists to participate in the formulation and adjustment of the patient's anti-tumor drug treatment program, carries out the examination and intervention of anti-tumor drug prescription (medication advice), provides indencyt monitoring and drug education, etc. In the area of
supervision, the Draft for Comments clearly requires the local health and health administrative departments at or above the county level to take serious treatment in accordance with relevant laws and regulations of the State for the collection and receipt of property from pharmaceutical production enterprises, pharmaceutical enterprises or their agents, or by issuing anti-tumor drugs.
the measures for the clinical application of anti-tumor drugs (draft for comments) Chapter 1
General
The first
to strengthen the management of the clinical application of anti-tumor drugs in medical institutions, improve the level of clinical application of anti-tumor drugs, and ensure medical quality and medical safety. Article 2
the term "anti-tumor drugs" as mentioned in these Measures
refers to drugs that act at the cellular and molecular levels through cellular killing, immunomodulation, endocrine regulation, etc., to inhibit tumor growth or eliminate tumors, and generally include chemical therapy drugs, molecular-targeted drugs, endocrine therapy drugs, immunotherapy drugs, etc. Article 3 of the

the National Health And Health Commission is responsible for the supervision and management of the clinical application of anti-tumor drugs nationwide. The administrative department of local health and health at or above the county level at the
level shall be responsible for the supervision and management of the clinical application of anti-tumor drugs in medical institutions in the administrative area. Article 4

These Measures shall apply to the clinical application management of anti-tumor drugs in all medical institutions at all levels for the development of tumor diagnosis and treatment and the application of anti-tumor drugs. Article 5
the clinical application of anti-tumor drugs
shall follow the principles of safety, effectiveness and economy.
medical institutions and medical personnel should, on the basis of evidence-based medical evidence, and on the basis of relevant diagnostic and treatment norms, clinical guidelines, clinical path and drug specifications, give full consideration to the value and accessibility of clinical treatment of drugs, and rationally apply anti-tumor drugs in order to treat tumors, improve patient survival rate, improve the quality of life of patients, and prolong patients' lives. article 6
the implementation of graded management
the clinical application of anti-tumor drugs.
according to safety, accessibility, economy and other factors, anti-tumor drugs are divided into restricted use and general use level.
specific classification criteria are as follows: (1) restricted use of grade anti-tumor drugs refers to anti-tumor drugs with one of the following characteristics: 1. Drug toxic side effects, including toxic drugs management, strict adaptation certificate, taboo evidence, must be used by medical personnel with rich clinical experience, improper use may cause serious damage to the human body anti-tumor drugs;
(ii) General use of grade anti-tumor drugs refers to other anti-tumor drugs other than restricted use of anti-tumor drugs.
the catalogue of graded management of anti-tumor drugs is formulated by medical institutions and dynamically adjusted.
guidance on the development and adjustment of the catalogue of graded management of anti-tumor drugs by local health and health administrative departments. article 7

health administrative departments at all levels and various medical institutions at all levels shall strengthen publicity and education for the public and tumor patients, promote health knowledge of tumor prevention and treatment, improve the scientific understanding of tumor diseases in the whole society, eliminate misunderstandings in the field of cancer treatment, and establish scientific treatment concepts. Chapter II of

Organization s agency and responsibilities Article 8
the principal person in charge of medical institutions is the first person responsible for the clinical application management of anti-tumor drugs in this institution. Article 9 of the

medical institutions shall establish and improve the system for the administration of anti-tumor drugs in this institution. Article 10 of the

medical institutions shall establish an anti-tumor drug management organization or a designated special (and) staff responsible for the administration of anti-tumor drugs in the institution.
medical institutions above the second level that carry out cancer diagnosis and treatment services shall set up a working group on anti-tumor drug management under the Committee on Drug Administration and Pharmacology. The working group on anti-tumor drug management in
is composed of the heads of medical, pharmaceutical, clinical departments, medical imaging, pathology, nursing, examination, information management, quality control and other departments or personnel qualified for senior technical posts in relevant professions, and jointly manages the clinical application of anti-tumor drugs, and the departments of medicine and pharmacy are jointly responsible for day-to-day management. Other medical institutions
to carry out cancer diagnosis and treatment services may appoint specialized (and) professional personnel to be responsible for specific management if they do not have the conditions for the establishment of a working group on anti-tumor drug management. article 11
The main duties of the organization of anti-tumor drug management in
medical institutions are: (1) implement the laws, regulations and regulations related to the management of anti-tumor drugs, formulate the anti-tumor drug management system of this institution and organize the implementation; And organize the implementation; (3) to monitor the clinical application of anti-tumor drugs in this institution, regularly analyze, evaluate, report monitoring data and publish relevant information, propose intervention and improvement measures; (4) to conduct training for medical personnel on anti-tumor drug management laws, regulations, rules and regulations, and organize publicity and education on the rational use of anti-tumor drugs by patients.
Article 12 Where a
medical institutions to carry out multidisciplinary diagnosis and treatment of tumors, they shall include the relevant professionals in oncology, pharmacy, pathology, imaging, testing and other relevant professionals in the multidisciplinary medical and therapeutic teams, implement the requirements of anti-tumor drug management, guarantee rational drug use, and improve the level of comprehensive cancer management. article 13

medical institutions shall strengthen the staffing of pharmacy, train clinical pharmacists, participate in the formulation and adjustment of the patient's anti-tumor drug treatment program, carry out the examination and intervention of anti-tumor drug prescriptions (drug prescriptions), and provide pharmacy monitoring and drug education. Article 14

health administrative departments and medical institutions at all levels to strengthen the construction of relevant disciplines related to the management of clinical application of anti-tumor drugs, establish a system of professional personnel training and appraisal, and give full play to the role of relevant professional and technical personnel in the management of the clinical application of anti-tumor drugs. Chapter III of the

Article 15 of the Clinical Application Management of Anti-Tumor Drugs
Medical institutions shall strictly implement the relevant provisions and technical specifications such as the Drug Administration Law and its implementing regulations, the Prescription Management Measures, the Regulations on the Administration of PharmaceuticalS in Medical Institutions, and the Code of Prescription Audit of Medical Institutions, and strengthen the whole process management of the selection, procurement, storage, prescription, deployment, clinical application and drug evaluation of anti-tumor drugs. Article 16

medical institutions shall establish a system for the selection and evaluation of anti-tumor drugs, formulate a catalogue of anti-tumor drugs in accordance with the needs of the institution for the diagnosis and treatment of cancer diseases, and adjust them regularly. The selection of anti-tumor drug varieties in
medical institutions should be based on clinical needs, giving priority to the selection of the national list of essential drugs, the national basic medical insurance drug catalogue, the centralized negotiation or tender procurement, and the national health and wellness announced by the norms of diagnosis and treatment, clinical diagnosis and treatment guidelines, clinical path recommended varieties. article 17
Article 17 Anti-tumor drugs in
medical institutions shall be purchased and supplied by the pharmacy department in a unified manner, and no other department or department shall engage in the procurement or dispensing activities of anti-tumor drugs.
due to special treatment needs, medical institutions need to use anti-tumor drugs outside the institution's anti-tumor drug supply catalogue, may start the temporary procurement procedures, by the clinical department to apply, after the agency's anti-tumor drug management working group review and approval, by the pharmaceutical department of the temporary one-time purchase of use. article 18
the selection of
medical institutions and the introduction of new anti-tumor drug varieties shall be submitted by the clinical department of the application report, by the anti-tumor drug management working group issued preliminary opinions, after discussion and approval by the pharmaceutical management and drug treatment committee.
for innovative drugs with obvious clinical advantages, high safety or clinical urgent need, and irreplaceable alternatives, medical institutions should simplify the introduction process and timely be included in the list of anti-tumor drug supply on the basis of full evaluation.
for anti-tumor drugs with major safety hazards, uncertain efficacy, poor cost-effect ratio or serious illegal use, the clinical department, the pharmacy department, the anti-tumor drug management working group shall put forward the withdrawal or replacement opinion, which shall be implemented after discussion and adoption by the Pharmaceutical Management and Pharmacology Committee.
the varieties or regulations of anti-tumor drugs that have been cleared or replaced shall not re-enter the list of anti-tumor drug supply sates within 12 months. Article 19 of the
,
medical institutions that carry out tumor diagnosis and treatment in the medical association shall strengthen the convergence of anti-tumor drug supply catalogues, establish a joint management mechanism, do a good job in ensuring the supply of anti-tumor drugs, gradually realize the sharing of drug resources in the region, and guarantee the demand for two-way referral drugs. article 20
Medical institutions at or above the level of
shall regularly train and examine the knowledge of the clinical application of anti-tumor drugs among the physicians, pharmacists and nurses concerned with anti-tumor drugs in their institutions.
physicians and pharmacists in other medical institutions.