Future medical insurance catalog adjustments will rely more on real-world research data
The adjustment of the medical insurance catalogue in 2021 will continue to reduce the price of medicines through national negotiations, but it has also triggered some topics of social concern.
Why can the Ganlut Sodium Capsules that have been approved for marketing conditionally enter the medical insurance?
Why can individual OTC drugs be covered by medical insurance?
Why doesn't the negotiation site directly show the reserve price for the company to choose whether to accept it?
The National Medical Insurance Administration answered questions from reporters on the release of the 2021 medical insurance catalogue on the 7th, responded to the hot spots of social concern in this year’s medical insurance negotiations, and explained Ganlut Sodium Capsules (code GV-971, trade name "Nine Phase One"), The causes and consequences of the inclusion of clotrimazole vaginal swelling suppositories and other varieties with high social concern into medical insurance, and further explained the direction of the adjustment of the national medical insurance catalogue.
The National Medical Insurance Bureau stated in an answer to reporters that since most of the drugs currently included in the scope of adjustment are newly approved drugs, many of which were even marketed that year, the expert review mostly relies on data collected during clinical trials of drugs.
In future work, companies will be encouraged to carry out real-world research on drugs, and will rely more on real-world research data in catalog adjustments.
China Business News learned from those involved in medical insurance negotiations and calculations that "encouraging innovation" is an important principle for the adjustment of the medical insurance catalog, and major innovative drugs are included in the medical insurance fund calculations.
In the past four rounds of national medical insurance negotiations, a number of innovative drugs have been marketed that year and entered medical insurance that year.
It can be seen from the above statement of the National Medical Insurance Administration that with the increase of newly approved drugs for marketing, the adjustment of the medical insurance catalogue will rely more on real-world research data.
"Nine Phase One" gets 70.47 points and enters medical insurance negotiation
The National Medical Insurance Administration responded to the question "How to grasp the effectiveness of the drugs to be included in the catalog during the adjustment process? What are the next steps?"
According to the current rules, the National Medical Insurance Bureau mainly starts from three aspects to ensure the effectiveness of medicines:
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, the National Medical Insurance Administration has researched and formulated a review index system. Experts have conducted separate assessments of Western medicines and Chinese patent medicines in terms of safety, effectiveness, economy, innovation (inheritance and innovation), and fairness. Review.
According to the National Medical Insurance Administration, taking Ganlute Sodium Capsules as an example, the drug is included in the scope of support for "Major New Drug Development and National Science and Technology Special Projects."
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.
Why is the OTC drug "clotrimazole vaginal swelling suppository" included in medical insurance
Article 36 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" stipulates that in principle, OTC drugs will no longer be added to the "Drug List".
However, in the adjustment of the national medical insurance drug list, OTC drugs that belong to the national essential drug list can still be included in the national medical insurance drug list according to the procedures.
Therefore, in the 2020 national medical insurance drug catalog adjustment, OTC essential drugs such as "Niuhuang Qinggan Capsules" and "racemic anisodamine tablets" will be included in the scope of medical insurance payment; in the 2021 national medical insurance drug list adjustment, OTC essential drugs "Clontrimazole vaginal expansion suppository" is included in the scope of medical insurance payment.
The National Medical Insurance Bureau stated that the inclusion of essential medicines (including OTC essential medicines) into the scope of medical insurance payment has two main considerations: 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 will meet 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 insured.
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.
Innovative drugs in medical insurance will rely more on real-world data
This year's "Nine Phase One" has been included in medical insurance, which has triggered a controversy in the society about whether drugs that are conditionally marketed are in compliance with medical insurance. Should medical insurance "pay the bill" for drugs whose safety and efficacy require time and clinical testing?
The establishment of the dynamic adjustment mechanism of the National Medical Insurance Bureau's catalog has opened the door for innovative drugs to "running" into medical insurance.
Relevant data shows that it will take 4 to 9 years for new drugs to enter medical insurance in 2017, shortened to 1 to 8 years in 2019, and further compressed to 0.5 to 5 years in 2020.
In this regard, there are suggestions in the industry that in view of the increasing number of drugs that are conditionally approved for marketing and limited controlled data, they should be given a real-world study period of at least one year to observe their safety and efficacy before deciding whether to qualify for negotiation.
The National Medical Insurance Administration said: “It needs to be pointed out that since most of the drugs currently included in the adjustment scope are newly approved drugs, many of which were 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."
In addition, in response to the concern of the society, "The negotiation site does not allow companies to quote, and experts directly show the reserve price. Wouldn't it be more straightforward to see if the company can accept it?" Whether there is an intersection with the bottom line of the business side.
From a practical point of view, the responsibility of the medical insurance negotiator is to use the negotiation mechanism to guide the enterprise to quote the lowest price it can accept.
In other words, negotiating experts strive to strive for more favorable prices for the common people within the range that the fund can bear and the enterprise can accept. This is the charm and value of "soul bargaining".
Author: Guo Jinhui