The renewal of the Hunan antibiotics standard is good for the selected enterprises in the national procurement!

Medical Network News on August 12th.
The draft for the contract renewal of Hunan antibiotics has come out.
We believe that its characteristics are: divided into four categories for classified management (including nationally sourced varieties), four categories of different selection and price reduction methods, and medication phase Cost control measures
.
Comprehensive management is carried out from price formation to medication and cost control
.
The contract renewal plan incorporates other specifications of the selected companies in the national procurement, expanding the scope of drug use and sales of the selected companies, and is an extension of the implementation of the national procurement policy
.
And since there is no proportional restriction on the nationally sourced varieties in the agreed purchase amount, it is good for the nationally sourced and selected manufacturers
.
Correspondingly, it squeezed the market space of the original provincial-level antibiotics selected enterprises
.
In addition, through measures such as price continuation and gradient price reduction through classification, prices are further squeezed, and are restricted by various cost control measures in use, and the amount of antibiotics will further decline in the future
.
On August 10, Hunan Province issued a letter on soliciting opinions on the "Hunan Province 2021 Implementation Plan for Concentrated Procurement of Antibacterial Drugs in 2021 (Draft for Comment)", requesting feedback before August 13
.
Prior to this (August 31, 2019), the Hunan Provincial Medical Insurance Bureau issued the "Implementation Plan for Special Centralized Procurement of Antimicrobial Drugs (Draft for Comment)", which intends to start with the category of antibiotics and try to explore a feasible centralized procurement path for promotion To other categories
.
On November 12 of the same year, the Hunan Pharmaceutical Procurement Platform officially released the 2019 public medical institution special centralized procurement announcement of antibacterial drugs, and a total of 52 drugs were included in the centralized procurement list
.
On April 15, 2020, Hunan Province announced the winning bid for the special centralized procurement of antibacterial drugs.
Among 52 varieties, 47 varieties were successfully negotiated.
Amoxicillin, polymyxin B, amphotericin B, roxithromycin, and There were 5 varieties of Timicin passed the bid, and a total of 86 companies won the bid
.
Among the foreign companies, only Bayer's moxifloxacin won the bid, which is embarrassing
.
The winning bid was officially implemented on May 1
.

The following is the main content of the Hunan Antibiotic Renewal Program (Draft for Solicitation of Comments):
Renewal subject and cycle: all public medical institutions at all levels in the province and hospitals of the troops stationed in Hunan all participate, and other agreed medical institutions are encouraged to participate independently (hereinafter referred to as medical institutions)
.
This round of procurement cycle is 1 year, calculated from the date of execution
.
If you need to extend the procurement cycle, a separate announcement will be made
.

　　Procurement catalog and rules
(1) National centralized procurement of drugs: The antibacterial drugs (21) selected by the national procurement are implemented according to relevant national policies and included in the overall management of the special centralized procurement of antibacterial drugs in our province
.
For the other unselected specifications of the selected drugs in China, the corresponding over-evaluated (including deemed over-evaluated, the same below) drugs by the selected Hunan manufacturer will be included in the selected list after calculation according to the current price difference rules, and the purchase amount will be included after conversion.
Agreed purchase quantity
.
(2) Drugs for contract renewal: the generic formulations are not included in the National Procurement's 2019 Hunan Province Antibacterial Drug Special Collection List of the fourth quality level selected drugs (38).
If the selected companies wish to renew the contract, submit a drug supply guarantee commitment After the book, the contract will be renewed at the original selected price; if the selected company does not renew the contract, based on clinical drug needs, other unselected drugs with the same generic name and dosage form can be selected at the original selected price.
If no substitute is selected and the generic name formulation has no other specifications If the drug is selected, the generic name and dosage form of the drug shall be included in the monitoring catalog management
.
(3) Transitional drugs: The generic name formulations are not included in the national procurement of the second and third quality levels in the list of selected antibacterial drugs in the special centralized procurement of Hunan Province in 2019.
According to the previous procurement cycle (May 1, 2020 to (April 30, 2021) Renewal of purchase price reduction, where the purchase amount (based on the distribution amount, the same below) exceeds 200 million yuan with a drop of not less than 10%, and the purchase amount exceeds 100 million yuan and less than or equal to 200 million yuan The rate of decrease is not less than 8%, the purchase amount exceeding 50 million yuan and less than or equal to 100 million yuan, the rate of decrease is not less than 5%, and the purchase amount less than 50 million yuan can be independently reduced.

.
Those who agree to price reductions are included in the management of the antibacterial drug transitional period catalog, and those who do not accept price reductions are included in the monitoring catalog management
.
Original drugs with the same generic name, same dosage form and same specifications, reference preparations, and drugs that have passed consistency evaluation can be included in the transitional drug catalog management at no higher than the lowest price of transitional drugs with the same generic name, same dosage form and same specifications.

.

(4) Monitoring catalogue
1.
Antimicrobial drugs whose generic name or dosage form is not in the above procurement catalogue shall be included in the monitoring catalogue in accordance with the relevant regulations of Hunan Province on drug listing .
Among them, essential drugs that are included in the 2021 version of the Hunan Provincial Antibacterial Drugs Clinical Application Classification Management Catalogue for use by primary health care institutions can be listed on the Internet according to the requirements of three other provincial procurement platforms, and the drug can be applied for inclusion at the lowest price not higher than the provincial level.
Monitoring directory .
2.
Among the drugs of other companies under the generic name of the selected drugs in the national centralized procurement, which are generic drugs, apply for inclusion in the monitoring catalog in accordance with the relevant regulations of the province’s drug listing, and the price is not higher than the selected drugs; they are originally developed drugs, reference preparation drugs, Drugs that pass the consistency evaluation can be included in the monitoring catalogue according to the result of a gradient price reduction not higher than that of Shanghai or with reference to the Shanghai gradient price reduction rules .
Different specifications are converted according to the price difference rule .
3.
Renewal drugs with the same generic name, same dosage form and specifications, other unselected generic drugs can be included in the monitoring catalog at the lowest price not higher than the same review group A for the special collection of antibacterial drugs in 2019; drugs with the same generic name, same dosage form and other specifications , You can apply for inclusion in the monitoring catalog after calculating the selected price difference ratio and not exceeding 1.
8 times .
Drugs that belong to the original research and development drugs, reference preparation drugs, and drugs that have passed the consistency evaluation can be included in the monitoring catalogue in accordance with the relevant regulations of our province's drug listing .


According to the functional positioning of medical institutions, clinical drug demand, and the characteristics of the use of antibacterial drugs, the 　　agreed procurement volume shall be managed in proportion to the procurement volume of medical institutions with the same generic name and the same dosage form.
　　






.
In principle, the renewal drug purchase dose of the tertiary medical institution shall not be less than 50% of the total dose of the drug purchased in the generic dosage form of the medical institution, and the renewed drug purchase dose of the second-level medical institution shall not be less than the generic name of the medical institution selected.
60% of the total drug purchase dose, and the first-level and primary-level medical institutions renew the drug purchase dose not less than 70% of the total drug purchase dose of the generic dosage form selected by the medical institution
.
Drugs that belong to the state's centralized procurement are not subject to this ratio limit
.

　　Adhere to the "two-invoice system" and encourage the "one-vote system"
drug manufacturers to be the first person responsible for ensuring the quality and supply of drugs.
According to the principle of "relative concentration", they must independently select strong distribution capabilities and high recognition by medical institutions.
Reputable distribution company
.
In the case of non-contractual supply and inability to guarantee quality and supply, measures such as corresponding compensation, punishment, withdrawal and emergency guarantee shall be adopted
.
Adhere to the "two-invoice system" for drug procurement and encourage the "one-vote system"
.
It shall not be used for reasons such as cost control, product regulation requirements, and approval by the Pharmaceutical Affairs Committee.
No second bargaining shall be allowed.
Under the premise of complying with the basic drugs and antibacterial drug classification management policies, relevant medical institutions shall promptly adjust the procurement catalog and give priority to purchasing and The use of selected drugs shall not affect the procurement and rational use of selected drugs on the basis of cost control, medical institution drug product specifications and quantity requirements, and approval by the Pharmaceutical Affairs Committee, so as to ensure that the channels for clinical use of selected drugs are unblocked
.
All medical institutions must purchase drugs online through the provincial procurement platform, and must not purchase drugs offline or non-specified channels; they must not organize a second price negotiation for drugs selected in the volume procurement catalog or require companies to rebate or rebate under various names .

.
Implement the total cost control of antimicrobials, and the total purchase amount shall not exceed 90% of the previous year.
During the procurement cycle, implement the total cost control of antimicrobial drugs, and the total amount of antimicrobial drug purchases by medical institutions (the relevant data is subject to the data collected by the provincial procurement platform, the same below) It shall not exceed 90% of the total amount of antibacterial drugs purchased by this medical institution in the same period of the previous year
.
Among them, the purchase amount of antibacterial drugs in the monitoring catalogue, tertiary medical institutions shall not exceed 25% of the total amount of antibacterial drugs purchased by this medical institution in the same period of the previous year, and other medical institutions shall not exceed 20% of the total amount of antibacterial drugs purchased by this medical institution in the same period of last year
.
For special reasons such as the large number of critically ill patients and the significant increase in outpatient and inpatient visits, medical institutions really need to adjust control indicators.
Medical institutions should make relevant statistical accounts and report to the territorial medical security and health departments in writing.
Provincial medical insurance The bureau will work with the Provincial Health Commission to deal with it as appropriate after verifying the situation
.
Establish and improve the macro and micro monitoring system, and strengthen the tracking and monitoring of abnormal purchasing behaviors.
1.
The purchase amount of antimicrobial drugs has been higher than the amount of antimicrobial drugs purchased in the same period of the previous year for three consecutive months
.
2.
The purchase amount of antibacterial drugs in the monitoring catalogue was higher than the monthly average of 25% of the total purchase amount of antibacterial drugs in the previous year for three consecutive months, and a single drug entered the top 80% of the province's antibacterial drug platform purchase amounts for three consecutive months
.
3.
The distribution rate of selected drugs has been lower than 80% for 3 consecutive months, and the manufacturer can unilaterally cancel the distribution relationship
.
4.
The purchase amount of antibacterial drugs by medical institutions was higher than the average monthly amount of antibacterial drugs purchased by this medical institution for 3 consecutive months
.
5.
The procurement dosage of the transitional period medicines of the same generic name and dosage form of the medical institution exceeds the agreed control ratio for 3 consecutive months
.
The clinical efficacy evaluation, adverse reaction monitoring, and bacterial resistance monitoring of antimicrobials should be carried out in accordance with relevant requirements and procedures.
Antimicrobial drugs with a resistance rate of more than 50% of the main target bacteria should be monitored.
Antimicrobial drugs with a resistance rate of more than 75% should be monitored.
Stop using the drug in this medical institution
.
It is necessary to strengthen the monitoring and information feedback of the clinical supply of anti-infective drugs for patients with acute and critical illness, and formulate emergency response plans
.
For drugs that cannot be supplied in a timely manner or have serious adverse reactions, a withdrawal mechanism shall be established
.
In order to ensure clinically reasonable and safe medication, if clinically it is necessary to adjust the agreed purchase amount of antibacterial drugs, the medical institution may, after a written report to the local health and medical insurance department, be handled by the Provincial Health Commission and the Provincial Medical Insurance Bureau as appropriate
.
Encourage places where conditions permit to accelerate direct settlement with selected pharmaceutical production or distribution companies.
In order to promote timely payment and online payment and settlement, refer to the state’s organization of centralized drug procurement and use practices.
After signing the purchase and sales contract, medical insurance agencies at all levels The medical insurance fund shall be paid in advance to the special supervision account of public medical institutions in this coordinating area established by the Provincial Public Resources Trading Center according to 50% of the contract amount in a timely manner, as the working capital for the payment of drugs to pharmaceutical companies
.
Among them, Changsha urban area and provincial medical institutions are prepaid by the provincial medical insurance agencies
.
Medical institutions purchase selected drugs through the provincial procurement platform, and must strictly implement the payment collection requirements, and the settlement time shall not exceed the end of the next month after the delivery and acceptance is passed, so as to effectively reduce the transaction costs of selected drug companies
.
Encourage places where conditions permit to speed up the settlement of drug payments by medical insurance agencies directly with selected drug production or distribution companies
.
The prices of drugs with the same generic name and the same dosage form in the monitoring catalog are quite different, and price corrections are carried out.
Adhere to sunny procurement, unblock complaint channels, and create an open, fair and just procurement environment
.
Strengthen the supervision and management of the online prices of drugs in the monitoring catalog, and the prices of drugs with the same generic name and the same dosage form in the monitoring catalog may differ greatly.
In principle, price correction can be carried out
.
If a new price of online drugs (including selected drugs) appears on other provincial platforms across the country and is lower than the price of the online (selected) in our province, the manufacturer should apply to the provincial procurement platform for adjustment within 15 working days
.
If a pharmaceutical company fails to report and conceal price information, supply drugs that are of substandard quality, unauthorized provision of drugs outside the procurement catalog to replace selected drugs, or fail to deliver drugs in a timely manner, once verified, it will follow the "Hunan Medical The Security Bureau's Implementation Opinions on Establishing a Medical Price and Recruitment Credit Evaluation System (Xiang Medical Insurance Fa [2020] No.
54) and other documents deal with relevant provisions
.