Why doesn't the negotiation of medical insurance drugs directly show the low price?

Recently, "700,000-a-dose of sky-high price drugs into medical insurance" has been on the hot search and has become a hot spot of concern from all walks of life

1.

From the perspective of the process, it is mainly divided into five stages: preparation, declaration, expert review, negotiation, and announcement of results

Therefore, on-site negotiation is only one link in the catalog adjustment process

2.

The main purpose of the drug negotiation is to give full play to the role of the medical insurance department’s strategic purchase.

3.

It needs to be emphasized that in the calculation process, experts fully refer to the pharmacoeconomics guidelines and the latest international technology and methods, and fully consider factors such as China's medical insurance positioning and market environment

4.

The ultimate success of the negotiation depends on whether there is an intersection between the bottom line of the medical insurance party and the enterprise side

5.

There are two main considerations for including essential medicines (including OTC essential medicines) into the scope of medical insurance payment: one is to implement legal and policy requirements
.
Article 59 of the Basic Medical Hygiene and Health Promotion Law of the People's Republic of China stipulates that essential drugs shall be included in the list of basic medical insurance drugs with priority in accordance with regulations
.
The "Opinions on Improving the National Essential Drug System" (Guobanfa [2018] No.
88) issued by the General Office of the State Council requires that for the therapeutic drugs in the essential drug list, the medical insurance department shall comply with the conditions according to the procedures when adjusting the medical insurance list.
Prioritize inclusion in the scope of the catalog
.
The second is to help reduce the burden on the people participating in the insurance
.
The “Opinions of the General Office of the State Council on Further Doing a Good Job in Guaranteeing Supply and Stabilizing Prices of Drugs in Shortage” (Guobanfa [2019] No.
47) stipulates that the priority allocation and rational use of essential medicines should be promoted, and the proportion of essential medicines used should be increased
.
Strengthening coordination with the essential drug system and management measures will help reduce the burden on patients and increase the level of benefit for the masses
.

6.
How to grasp the effectiveness of drugs to be included in the catalog during the adjustment process? What are your plans for the next step?

According to the current rules, in order to ensure the effectiveness of medicines, we mainly start from the following aspects:

One is that the drug must pass the review by the drug regulatory authority and be approved for marketing
.
Article 7 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" stipulates that the drugs included in the national "Drug List" should be chemical drugs, biological products, and Chinese patent drugs (ethnic drugs) that have been approved by the national drug regulatory authority and obtained a drug registration certificate
.
In recent years, the national medical insurance drug catalogue has been adjusted, mainly for drugs newly approved for marketing in recent years
.

The second is that companies must submit materials that can prove the effectiveness of drugs
.
In the reporting, review, and negotiation stages, relevant companies are organized to submit data and corresponding evidence in terms of validity and other aspects as required
.
In order to ensure the authenticity of the materials, the materials submitted by the enterprises shall be publicized during the declaration process and shall be supervised by the whole society
.
The drug administration, health and health departments are requested to provide drug support materials to provide support for the review
.

The third is that the drug can pass expert review
.
According to the adjustment rules, the drugs that meet the application requirements and are successfully declared need to undergo multiple rounds of demonstrations by experts in pharmacy, clinical medicine, pharmacoeconomics, and medical insurance management
.
In the review in 2021, we researched and formulated a review index system.
Experts reviewed Western medicines and Chinese patent medicines in terms of safety, effectiveness, economy, innovation (inheritance and innovation), and fairness
.

Taking Ganlu Turner capsules as an example, the drug was included in the scope of support for the “Major New Drug Creation and National Science and Technology Special Project”
.
In 2020 and 2021, the application was successful, and both passed the expert review
.
The failure of negotiations in 2020 was not included in the catalog
.
In this year’s adjustments, after 32 experts’ review, an average score of 70.
47 was obtained, and the drug was qualified to negotiate according to the rules
.
Through negotiation, a 66.
92% price reduction was included in the catalog
.
Through negotiation of price cuts and medical insurance reimbursement, the burden of medication for patients will be significantly reduced
.

It should be pointed out that since most of the drugs currently included in the scope of adjustment are newly approved drugs, and many of them are even marketed that year, the expert review mostly relies on the data collected during the clinical trial of the drug
.
In future work, we will encourage companies to carry out real-world research on drugs, and we will rely more on real-world research data in catalog adjustments
.

7.
How is the management of medical insurance drug payment restrictions considered? What do you plan to do?

In 2004, the former Ministry of Labor issued the "National Basic Medical Insurance and Work Injury Insurance Drug Catalog", which began to limit the scope of medical insurance drug payment, and it has been used today
.
Objectively speaking, limiting the scope of payment for medical insurance drugs played a certain role in maintaining fund safety and preventing drug abuse under specific historical conditions
.
But at the same time, the fairness and rationality of the limited payment scope have also been repeatedly questioned
.

Since the establishment of the National Medical Insurance Administration, it has actively carried out national organization of centralized drug procurement and drug catalog access negotiations, fully promoted the reform of DRG, DIP and other payment methods, strengthened the supervision of medical insurance funds, and strived to improve the level of informatization and intelligent management of medical insurance.
The whole chain of the chain has exerted efforts, and the ability and level of drug use supervision and management have been significantly improved, and the need to limit the scope of drug payment outside the instructions has been greatly reduced
.
At the same time, more and more medical staff and patients report that the limitation of medical insurance drug payment has gradually become an important factor that affects clinical rational use of drugs and even triggers medical disputes
.
Therefore, from the perspective of maintaining fairness in patient medication, improving the relationship between doctors and patients, and facilitating reasonable clinical treatment, it is necessary to gradually restore the scope of drug payment in the catalog to the scope of the drug insert approved by the drug regulatory authority, and the right to choose medication and decision-making Return it to the clinician
.

For the 94 medicines successfully negotiated during the adjustment this year, the payment range has all been consistent with the instructions
.
For other medicines with original payment restrictions in the catalog, in view of the complexity and sensitivity of payment restrictions, involving fund safety, patient benefits, and corporate interests, in order to be stable, orderly, fair and just, after research, we decided to launch a pilot medical insurance payment standard
.
During the pilot process, according to the voluntary application of the enterprise, the payment scope of the drugs included in the pilot program will be restored to the drug insert simultaneously
.
In the early stage, we organized experts to repeatedly study and demonstrate the pilot work, solicited opinions and suggestions from finance, health, and drug supervision departments, as well as local medical insurance departments, and reached an agreement
.
At the same time, we also solicited opinions and suggestions from related companies
.
Some chemical drugs and proprietary Chinese medicines, such as Glycine Diazole Sodium for Injection, Irecoxib Tablets, Arbidol Hydrochloride Tablets, Danhong Injection, and other 30 drugs have been included in the pilot scope, and the medical insurance payment standards have been re-determined in accordance with the rules.
And restore the payment scope to the drug instructions
.
During the pilot period, we plan to include all pilot drugs in the key monitoring scope, strengthen supervision, ensure the rationality of drug use, and safeguard the interests of patients and the safety of funds
.

In the next step, we will gradually restore the scope of payment for more drugs in the catalog to the drug inserts based on the progress of the pilot, under the premise of ensuring the safety of the fund and the fairness of patients' medications, and in accordance with the principle of reducing increments and digesting stocks
.

Source: National Medical Insurance Administration