Seven major changes in medical insurance access!

The barriers to entry for medical insurance have changed
.
The author's analysis found that the entry threshold for medical insurance has been adjusted to innovative drugs and improved drugs approved in the past five years (new indications); products that were on the market five years ago want to enter medical insurance, and only improved drugs (new indications) are left.
And the National Essential Medicine List
.
New drug companies who want to enter medical insurance should actively grasp the five-year golden period
.
According to the "Announcement on Publicizing Drugs and Information for the 2021 National Medical Insurance Drug List Adjustments Passed the Preliminary Formal Examination" published on the official website of the National Medical Insurance Administration, a total of 271 medicines passed the preliminary formal examination
.
Among the non-listed drugs that passed the preliminary formal review, the newly marketed drugs after 2016 accounted for 93.
02%
.
This is not because drugs that were on the market before 2016 do not want to declare to enter the medical insurance, but the entry threshold of medical insurance is increasingly inclined to new products approved in the past five years
.

01.
The entry barrier for new products has been reduced to three categories
of innovative drugs and improved drugs approved in the past five years (new indications), and the latest basic drugs in the 2021 "National Medical Insurance Drug Catalog Adjustment Work Plan" will include those outside the medical insurance catalog.
The conditions for products to enter the medical insurance catalog are divided into 4 categories, far fewer than the 7 categories in 2020
.
The 4 types of conditions for the 2021 medical insurance catalog adjustment plan include: from January 1, 2016 to June 30, 2021, new generic drugs approved for marketing by the State Drug Administration and drugs with major changes in indications or functions and indications ; Drugs for the treatment of respiratory diseases related to new coronary pneumonia; drugs included in the "National Essential Drug List (2018 Edition)"
.
But in fact, none of the products used for the treatment of respiratory diseases related to new coronary pneumonia have passed the formal review
.
This means that the entry barrier for new products has been compressed into three categories: innovative drugs and improved drugs approved in the past five years (new indications), and the latest basic drugs
.

　　02, Encouragement list to enter the medical insurance access shortcut is blocked.
The
first generic drug is blocked by the encouragement list to enter the medical insurance with the original research indications that have been marketed in China.
The encouragement list of the 2020 National Medical Insurance Drug List Adjustment Work Plan (included in the encourage a number of generic drug list, "" encourage the development of the first to declare the child a list of drugs "," the third installment to encourage research and development of medicines for children to declare the list of "national organizations centralized drug procurement of selected medicines, etc.
) conditions are deleted in 2021, which means that , The generic name products of the original research drug that have been marketed in China but have not entered the medical insurance.
The first generic drug wants to rely on the encouragement catalog to enter the medical insurance catalog with the indications of the original research drug that has been listed.
The access path has been blocked
.
The first generic drugs of the original research drugs that have not been listed are expected to be included in the medical insurance review catalogue in the future on the grounds of "new generic drugs approved for marketing by the State Drug Administration"
.

　　03.
New overseas drugs that are clinically necessary are no longer encouraged
.
Expensive orphan drugs usually involved in the list of urgently needed overseas new drugs for clinical use.
Other relief methods need to be considered.
It is worth noting that the list of urgently needed overseas new drugs in the 2020 encouragement list will no longer be used as medical insurance for 2021.
Conditions for catalog adjustment
.
This may be because the products included in the list of urgently needed overseas new drugs are usually very expensive orphan drugs, and the "basic" medical insurance fund cannot afford to pay
.
For these drugs, how to reduce the economic pressure of patients requires other relief methods to solve them
.
Moreover, these drugs are usually "new generic drugs approved for marketing by the State Drug Administration," and there is no need to list conditions separately
.

　　04.
There is a slim chance of transferring products from the provincial supplementary catalog to medical insurance
The only opportunity to enter medical insurance is "significant changes in indications or functional indications" and inclusion in the list of basic drugs.
According to the "National Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog" (2019) No.
46), all localities should strictly implement the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog", and they must not formulate the catalog or use alternative methods to add drugs in the catalog, or adjust the drugs in the catalog by themselves.
The limited scope of payment
.
For Class B drugs that were added as required in the original provincial drug catalog, they should be gradually digested within 3 years
.
During the digestion process, each province should give priority to adjusting the drugs included in the national key monitoring scope out of the payment scope
.
The 2020 national medical insurance drug catalog adjustment once gave the province an opportunity to add catalog products.
"Before December 31, 2019, drugs that have entered the latest provincial basic medical insurance drug catalog at 5 or more levels" have the opportunity to enter the national medical insurance catalog
.
This is the classification of the largest number of products into the list of declared drugs that have passed the formal review in 2020.
There are 493 products in total, but the success rate of entering the medical insurance catalog is very low.
Only 22 (8%) products will eventually become medical insurance catalog products
.
In 2021, there will be no opportunity for these provinces to add medical insurance catalog products to the national medical insurance
.
2022 is the last year for the retirement, and it is even more unlikely to give the province the opportunity to add products from the medical insurance catalog to the national medical insurance
.
The 471 provinces that have not entered the medical insurance list have supplemented medical insurance products.
The only opportunities to enter the medical insurance in the future are "drugs with major changes in indications or functions and indications" and "included in the National Essential Drug List"
.
The only one of the 471 supplementary medical insurance products in the provinces to enter the 2021 National Medical Insurance Drug List for adjustment of pidotimod oral solution is to pass the review on the grounds of "drugs with major changes in indications or functions and indications"
.

　　05.
Entering the list of essential medicines may not be eligible for medical insurance "admission tickets"
Enter the basic drug list or get the preparatory threshold of the medical insurance list, but it is not necessary to enter the threshold.
In 2021, the 6 products that entered the review list (citicoline sodium and sodium chloride injection, citicoline Choline Sodium Glucose Injection, Compound Potassium Hydrogen Phosphate Injection, Isosorbide Nitrate Sodium Chloride Injection, Isosorbide Nitrate Glucose Injection and Tang Herbal Tablets) have all entered the 2020 medical insurance review catalogue, but failed in 2020.
Enter the official medical insurance catalog
.
As it is a basic drug catalog product, it will continue to enter the medical insurance review catalog in 2021
.
It can be seen that entering the basic drug list may be able to get the preparatory threshold of the medical insurance list, but it is not a necessary threshold
.
Given that there are fewer and fewer ways to enter the medical insurance catalog in the future, it is expected that many non-medical insurance products that have been on the market for many years will expect to gain access to the medical insurance catalog by entering the basic drug catalog
.

　　06.
Exclusive Chinese patent medicines may consider adding new indications for medical insurance.
In the
future, more pharmaceutical companies will adopt real-world data to register new indications of Chinese patent medicines after fully assessing the feasibility of translational medicine.
During the period of June 30, 2021, approved by the State Drug Administration, the indications or functions and indications of the drugs have undergone major changes"
.
Usually new indications are initiated by the original research drug
.
After new indications are added to generic drugs that do not have the original drug on the market, the centralized procurement group is still grouped with those that have not increased, such as ibuprofen injection
.
Therefore, companies investing in new indications may not be able to benefit from centralized procurement, and it is expected that generic drug companies may not be willing to invest in new indications in the future
.
If the original research drug does not want to introduce foreign indications, then the corresponding indications are likely to be used clinically beyond the indications at most, but the indications are not reimbursed by medical insurance
.
As for the exclusive Chinese patent medicines that have not entered the medical insurance for many years, they may consider adding new indication paths if they want to enter the medical insurance in the future.

.
This will encourage more pharmaceutical companies to use real-world data to register new indications for proprietary Chinese medicines after fully assessing the feasibility of translational medicine
.

　　07.
Pharmacoeconomics is not a "stepping stone" for entering medical insurance.

For many years, drugs have only been used as a path for pharmacoeconomics to enter medical insurance.
It will become more complicated in the future.
In the past, pharmacoeconomics was a "stepping stone" for domestic enterprises to apply for entering medical insurance
.
From the 2021 "National Medical Insurance Drug Catalog Adjustment Work Plan", pharmacoeconomics can no longer be a condition for entering the medical insurance catalog, but it will become a key basis in the links of enterprise application and expert review
.
This means that when companies develop indications, they must also thoroughly research the supporting pharmacoeconomics.
This is actually the basis for establishing the clinical needs of improved drugs (adding new indications)
.
If a company wants to enter the medical insurance catalog without developing new indications, it can only hope that the data from its pharmacoeconomics research can be recognized by the basic medicine catalog
.
The drug enters the basic drug list and then applies for entry into the medical insurance list
.

　　Outlook >>> The
2021 National Medical Insurance Drug Catalogue Adjustment Work Plan adjusts the access standards of the medical insurance catalogue
.
From a result-oriented perspective, the medical insurance department is encouraging innovation
.
New drug companies should cherish the 5-year window period
.
Companies that want to acquire approvals for non-medical insurance products must carefully consider the feasibility of product transformation into new clinical indications
.