"No small group
should be given up"
National medical insurance personnel
These words at the negotiation table
have touched the hearts of many people
When rare disease patients
yearning for life is taken seriously
Our hearts Being warmed again
Whether it is the "Clobazam Plan"
or the adjustment of the medical insurance drug catalog
tilting towards rare disease patients and children
they are all running for the relay of life
igniting hope for life
is the deepest compassion for suffering
Clobazam, a rare life-saving epilepsy drug, can be imported!
html It is available in 150 hospitalsThere are two in Shaanxi
The "2022 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog Adjustment Work Plan" and related documents were officially announced a few days ago, marking the official announcement of a new round of national medical insurance drug catalog adjustment. start up.
According to the relevant person in charge of the National Medical Insurance Administration, this year’s adjustment work will firmly adhere to the system positioning of “guaranteeing basics”, focusing on including drugs with high clinical value, reasonable prices, and able to meet basic medical needs into the catalog.
Compared with the catalog adjustments in previous years, this round of adjustments to the medical insurance drug catalog optimizes the scope of application, appropriately tilting it towards special groups such as patients with rare diseases and children. Among them, there is no time limit for "approval for marketing after January 1, 2017" for the application conditions for rare disease drugs. Drugs included in the national encouraged generic drug catalog and the national encouraged research and development application list of children's drugs can apply for this year's medical insurance catalog.
This round of adjustments to the medical insurance drug catalog has improved the access method. The payment standards are determined simultaneously when non-exclusive drugs are admitted. This mainly solves the problem of non-exclusive drugs being unable to be included in the catalog due to the higher prices of individual companies. This access method draws on the principle of negotiation. Experts calculate and determine the willingness to pay for medical insurance, and then companies make independent quotes. As long as one company participates and the price is lower than the willingness to pay for medical insurance, the generic name can be included in the directory, and the lowest bid is used as the generic name. payment standards. The
work plan also adjusts the contract renewal rules to include non-exclusive drugs and exclusive drugs that have gone through two agreement periods but have no changes in payment standards and payment scope into regular catalog management; this year’s adjustment of the medical insurance payment scope will have no impact on the fund budget. Big medicines can also be easily renewed.
According to reports, according to the current arrangement, if progress goes well, the new round of national medical insurance drug catalog adjustments will officially start application on July 1, 2022, announce the results in November, and be implemented on January 1, 2023. According to Based on the functional positioning of basic medical insurance and work-related injury insurance, clinical needs for drugs, and fund affordability, the adjustment scope of the drug catalog in 2022 is as follows:
1. Western medicines and proprietary Chinese medicines outside the catalog
comply with Article 7 of the "Interim Measures for the Administration of Drug Use of Basic Medical Insurance " , Article 8 stipulates that drugs outside the catalog that meet one of the following circumstances can apply to participate in the 2022 drug catalog adjustment.
1. From January 1, 2017 to June 30, 2022 (inclusive, the same below), new generic drugs approved by the national food regulatory department are listed.
2. Between January 1, 2017 and June 30, 2022, drugs whose indications or functional indications have undergone significant changes have been approved by the national drug regulatory department.
3. Drugs included in the latest version of the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia".
4. Drugs included in the "National Essential Drugs List (2018 Edition)".
5. Drugs that are included in the list of encouraged generic drugs or the list of children’s drugs encouraged to apply for research and development, and have been approved for marketing by the national drug regulatory department before June 30, 2022.
6. Rare disease treatment drugs approved by the state drug regulatory department before June 30, 2022.
2. Western medicines and Chinese patent medicines in the catalog
1. Negotiated medicines whose agreement will expire on December 31, 2022.
2. The agreement expires on December 31, 2023, and between January 1, 2017 and June 30, 2022, with the approval of the national drug regulatory department, there are major changes in indications or functional indications, and the company voluntarily declares to adjust medical insurance payment Negotiation of range of medicines.
3. From January 1, 2017 to June 30, 2022, with the approval of the national drug regulatory department, there are major changes in indications or functional indications, and the company voluntarily applies for drugs in the regular catalog that adjust the scope of medical insurance payment.
4. Drugs that comply with the provisions of Article 9 and Article 10 of the "Interim Measures for the Administration of Drug Use under Basic Medical Insurance".
3. Others
1. According to regulations, qualified traditional Chinese medicine pieces will be included in the adjustment scope.
2. Improve the general rules of the drug catalog, standardize drug names and dosage forms, and appropriately adjust drug A and B categories, catalog classification structure, remarks, etc.
3. The identification of exclusive drugs will be based on June 30, 2022.
4. For non-exclusive drugs to be included in the drug catalog, the medical insurance payment standards will be determined simultaneously through bidding and other methods. According to CCTV website
two departments released a temporary import plan for clobazam
50 hospitals can use it
Two hospitals in Shaanxi can buy clobazam
In order to further improve the drug supply guarantee policy and satisfy the people's demand for clobazam and other foreign products that have been marketed , the demand for a small amount of specific urgently needed clinical drugs that are not available in the country, the National Health Commission and the State Food and Drug Administration recently jointly issued the "Work Plan for the Temporary Import of Clinically Urgent Drugs" and the "Work Plan for the Temporary Import of Clobazam" (hereinafter referred to as "Plan" and "Clobazam Plan"), released a list of 50 medical institutions that take the lead in importing and using clobazam. Among them, there are two hospitals in Shaanxi, namely the First Affiliated Hospital of Xi'an Jiaotong University and Xi'an Children's Hospital.
The relevant person in charge of the National Health Commission said that the formulation and announcement of the two plans will help to steadily solve the problem of a small number of specific medical needs of patients. It is of great significance for guiding medical institutions to standardize clinical use and ensuring the safety of patients' medication. In addition, many of the drugs that need to be temporarily imported have been registered and marketed abroad for many years. Therefore, capable domestic manufacturers are encouraged to speed up imitation. At the same time, overseas drug manufacturers with urgent clinical needs are also encouraged to actively apply for registration and listing in China.
The "Plan" is an overall guidance document and is applicable to small quantities of drugs that have been marketed overseas and are urgently needed for clinical use without domestic registration and production, or that cannot be resumed in a short period of time. Among them, drugs that are urgently needed for clinical use in small quantities are drugs that meet one of the following conditions: drugs used to treat rare diseases; drugs used to prevent and treat serious life-threatening diseases for which there is no effective treatment or prevention method; drugs used to prevent and treat serious life-threatening diseases, and drugs with obvious clinical advantages.
The "Clobazam Plan", in accordance with the relevant provisions of the "Plan", clarifies the application workflow for temporary import of clobazam, drug use management, and prescribing physicians' requirements on the basis of early understanding of clinical drug demand and medical institution qualifications. Qualification conditions, management requirements, rights and responsibilities of relevant parties, etc. serve as individual plans for the management of the use of temporarily imported drugs.
The relevant person in charge of the National Health Commission introduced that clobazam belongs to the second category of psychotropic drugs in the national catalog of narcotic drugs and psychotropic drugs. The "Clobazam Plan" regulates the conditions of medical institutions selected for use, the qualifications of prescribers and Management requirements were clarified and detailed. Based on the evaluation of diagnosis and treatment capabilities, in order to ensure the medication needs of patients in various regions, each province has selected at least one medical institution that can use clobazam.
At the same time, the "Clobazam Plan" clarified that each prescription should not exceed one month's dosage, and announced the list of medical institutions that take the lead in importing and using clobazam. Peking Union Medical College Hospital is the lead importing hospital. The conditions for medical institutions selected for use include: tertiary hospitals; doctors with epilepsy subspecialties or related majors who have been engaged in the diagnosis and treatment of epilepsy or childhood epilepsy for more than 10 years; clinical safety use specifications of clobazam and emergency response plans, and the establishment of clinical , pharmacy and medical multidisciplinary diagnosis and treatment team.Comprehensive Xinhua News Agency
Clobazam temporary import application process
(1) The National Health Commission organizes the clinical demand for clobazam, determines the list of medical institutions using it, selects the medical institution that will lead the import, and organizes the formulation of drug usage specifications and prescription qualifications Requirements to clarify patient informed consent and physician exemption requirements.
(2) The medical institution taking the lead in importing shall submit a temporary import application to the State Food and Drug Administration and provide relevant materials as required.
(3) After receiving relevant applications from medical institutions, the State Food and Drug Administration will issue a reply in the form of a comprehensive departmental letter from the bureau approving the import within 3 working days for those that meet the requirements. A copy of the reply will be sent to the National Health Commission and all relevant authorities. Provincial drug regulatory authorities and port drug regulatory authorities, and the National Health Commission shall send copies to all provincial health authorities. At the same time, an import permit is issued.
(4) The import unit shall go through customs clearance procedures directly with the customs with the import permit. Such imported drugs do not need to undergo port inspection. According to the National Medical Products Administration website
How important is clobazam to them?
â– Their "life-saving medicine"
In November last year, a news article about "Drug Dealer's Mother" reported the shortage of specific drugs for people with rare epilepsy diseases, which aroused great concern from all walks of life.
On December 2 last year, Health Times , sponsored by the People's Daily, published "More than 1,000 family members of children with rare diseases jointly asked for help: Our children need clobazam", further reporting on the difficulties faced by this group, topic "Our children need clobazam" became a trending topic on Weibo. It is reported that children with rare epilepsy diseases will have repeated epileptic seizures; some children have dozens or even hundreds of seizures a day, and some will have status epilepticus, with an attack lasting more than an hour or even longer; Some will die due to lack of timely rescue.
â– Facing the risk of "drug discontinuation"
reports pointed out that clobazam is a broad-spectrum anti-epileptic seizure drug for the treatment of rare epilepsy diseases. It is used as an anti-epileptic drug in more than 100 countries; however, clobazam is the first anti-epileptic drug in my country. Class II psychotropic drugs are not approved for sale in China, and the children’s families can only purchase clobazam, which is officially on the market, from abroad. At that time, as the customs intensified its investigation and handling of clobazam drugs, many children were already at risk of discontinuing the drug.
Relevant experts said that psychotropic drugs do have harmful effects such as addiction, but they are indeed needed by some children. It is recommended that relevant departments establish a green channel to ensure the medication of such children.
â– "Letter of help" from patients
In the previous letter of help made public to the whole society, the patients said, "We hope to get the attention of the government department and give us a legal channel for children who really need clobazam. Everyone, take medicine openly. We are willing to buy medicine legally and accept supervision. Every parent of a child is not willing to take the risk of "illegal crimes" to obtain these life-saving medicines. "
html On the afternoon of June 29, rare epilepsy. "Songsongba", a patient group leader, told reporters that it has been more than seven months since the media first reported the clobazam shortage last year, and patients are still unable to purchase clobazam through legal channels, despite the current import plan. It has been officially released, but the drug officially enters the Chinese market through import and needs to go through a series of applications and approval processes. "I hope it will be faster, and faster." According to Red Star News
