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The National Medical Insurance Administration recently issued the "Announcement on the Phased Results of Expert Review of Declared Drugs Adjusted by the National Medical Insurance Drug Catalogue in 2022 and Passed the Formal Review", announcing the results of the expert review of the adjustment of
the National Medical Insurance Catalogue in 2022.
According to preliminary statistics, 344 drugs passed the preliminary examination
this time.
Compared with previous rounds of catalog adjustments, this adjustment is appropriately tilted
towards special populations such as rare diseases and children.
Industry insiders said that China's pharmaceutical development and medical insurance access mode has shifted from the past marketing advantage orientation to product and price advantage orientation, and in the future, drugs with product advantages, clinical advantages and price advantages will be more competitive
.
With the normalization of centralized procurement and medical insurance negotiations, the decline in new exclusive varieties tends to be stable, and the vast majority of innovative drugs will be exchanged for price
after entering medical insurance.
Medical insurance negotiations have entered the normalization stage According to the announcement, 344 of the 490 declared drugs in the national talks in 2022 will pass the preliminary review, with a passing ratio of 70%.
Including 199 outside the catalog, including 184 Western medicines (144 exclusive varieties), 15 proprietary Chinese medicines (14 exclusive varieties), and 153 newly listed drugs; There are 145 in the catalog, including 110 Western medicines (88 exclusive varieties), 35 proprietary Chinese medicines (all exclusive varieties), and 87 newly listed drugs
.
Compared with 2021 (474 drugs and 271 passed), the number of drugs declared and passed the preliminary formal examination has increased to a certain extent, and compared with previous rounds of catalog adjustments, this adjustment is appropriately tilted
towards special populations such as rare diseases and children.
The announcement makes it clear that the evaluation results announced this time are "new drugs to be added for negotiation", "new to be added to bid", "proposed to negotiate renewal"
, and "proposed simple renewal".
At the same time, several time nodes have also been announced: one is that the enterprise will upload the relevant confirmation letter and mail the original before October 20; Another time point is to confirm the participation in the negotiations and confirm the corresponding companies of the drugs participating in the bidding, and send the documents before November 3
.
Industry insiders expect that the specific date of negotiations in 2022 will not be too late
.
It is worth mentioning that the adjustment of the national medical insurance catalogue in 2020 renegotiated for the first time the 14 exclusive drugs in the catalogue, all of which were unnegotiated during the early access to the catalogue and whose assessed prices or costs were significantly high
.
All 14 drugs were successfully negotiated and retained in the catalogue, with an average price reduction of 43.
46%.
Adjust the scope of payment for the price or treatment cost in the same treatment field that is obviously high, the actual sales price of the drug at home and abroad or the converted price of the drug is significantly lower than the current payment standard, and the current round of
adjustment has similar competitors who have passed the evaluation and may have a greater impact on the price.
In addition, renegotiation of exclusive drugs in the catalogue that had increased too much in the Fund's expenditure budget for the next two years
.
Du Xiangyang, an analyst at the Southwest Securities Research and Development Center, said that the essence of the rules is to encourage innovation
.
He said that from the rules of the adjustment of the declaration list, drugs with major changes in indications or functional indications can also be declared, encouraging enterprises to increase innovation to increase patient drug benefits, rather than blindly imitating
.
Even if exclusive and non-exclusive products are under pressure in terms of price, the price of exclusive products is based on itself, and the pressure to reduce prices is relatively eased, which is beneficial to innovative pharmaceutical companies, and improving innovation capabilities may be the best choice
for pharmaceutical companies.
Shortening the adjustment cycle to ensure more demand Medical insurance negotiations are normalized, and the decline in new exclusive varieties tends to be stable
.
In 2016, the first medical insurance negotiation successfully negotiated a total of 3 varieties, with an average decrease of 59%; In 2017, a total of 36 varieties were included in the negotiations, with an average decrease of 44%; In 2018, 18 varieties were included in the negotiation, and 17 anti-cancer drugs were successfully negotiated, with an average decrease of 57.
06%; In 2019, the variety of medical insurance negotiations expanded to 97 varieties, with an average decrease of 60.
7% for 70 new varieties and 26.
4% for 27 renewed varieties.
In 2020, the average reduction rate of 119 new varieties in medical insurance negotiations was 50.
6%, and the average reduction rate for the first negotiation of 14 exclusive drugs in the catalogue was 43.
46%.
In 2021, a total of 94 varieties were successfully negotiated in medical insurance negotiations, and the average price reduction of 67 new varieties was 61.
7%.
Du Xiangyang said that the adjustment cycle of the national medical insurance catalogue has also been greatly reduced from the longest 8 years in the past to 1 year, and in the past four years, a total of 507 new drugs and good drugs have been included, 391 drugs with uncertain efficacy have been transferred, and the shortcomings of oncology drugs, rare diseases and children's drugs have been gradually filled
.
The number of drugs in the medical catalogue has also increased year by year, from 2,096 drugs in 2009 to 2,860 drugs
in 2021.
Compared with previous rounds of catalog adjustments, this adjustment is appropriately tilted
towards special groups such as patients with rare diseases and children.
There is no time limit for "approval for marketing after January 1, 2017" for the declaration conditions for rare disease drugs, and drugs included in the national list of encouraged generic drugs and encouraged research and development to apply for children's drugs can be declared in this year's medical insurance catalogue
.
Among the drugs that passed the preliminary review this time, 19 rare disease drugs were encouraged (3 of which were also encouraged children's drugs/generic drugs), and 5 encouraged children's drugs/generic drugs
.
Xiong Xianjun, former director of the Medical Service Management Department of the National Medical Insurance Bureau, said that not all drugs can enter the medical insurance catalog
.
According to the application materials of enterprises, all drugs included in the negotiation list will be evaluated by an expert group of pharmacoeconomics and a fund calculation expert group
.
The evaluation of pharmacoeconomics is measured by considering the degree of benefit of patients, adverse reactions, international prices, and the competitiveness of the drug itself
.
Xiong Xianjun explained that for example, to measure the value of a drug, it will consider how much more benefit A drug can benefit patients than B drugs, such as how long the tumor can prolong the survival, how much the efficiency is improved, and the improved part is the more money
A drug has than B drugs.
At the same time, it will measure the extent to which these drugs will have an impact on the fund if they are included in the catalogue, and will also consider the competitiveness of the drugs and the international lowest price
.
For the inclusion of rare diseases, Xiong Xianjun said that China is a developing country, to set a level suitable for China, according to the calculation of the National Medical Insurance Bureau, according to the European and American countries and other international peer pricing standards, with reference to 4 times the per capita GDP, most rare diseases a year drug cost can not exceed 300,000 yuan
.
This means that through basic medical insurance, serious illness medical insurance, etc.
, the patient also has to bear 50,000 to 80,000 yuan
a year.
For most patients and families in our country, the pressure is still high
.
"Therefore, in addition to reducing prices, it is a long-term strategy
to protect this part through the rare disease protection mechanism.
" Xiong Xianjun said
.
Through the adjustment and optimization of the drug catalog structure, the rationality of clinical medication can be promoted, and some products with better efficacy and excellent price can be widely used in clinical practice, which also improves the level of
clinical medication.
Resolving the "difficulty of entering the hospital" and increasing the volume is obvious In response to some patients' feedback on why the drugs that enter the medical insurance directory cannot be purchased in local hospitals, Xiong Xianjun said that the medical insurance catalog contains all kinds of drugs, and the same hospital cannot contain all the drugs
in the medical insurance catalog.
Each hospital has restrictions on the varieties and regulations related to drug admission, and it is necessary to hold a pharmaceutical meeting and other links to agree
on the entry of new drugs into the hospital and the elimination of old drugs.
Some drugs also take time to enter the hospital, and it is not possible to land at the moment of entering medical insurance, which is a normal phenomenon
.
In May 2021, the National Medical Insurance Administration and the National Health Commission jointly issued the Guiding Opinions on Establishing and Improving the "Dual Channel" Management Mechanism for National Medical Insurance Negotiated Drugs
.
The so-called "dual channel" refers to the mechanism of negotiating drug supply security and clinical use through the two channels of designated medical institutions and designated retail pharmacies, and simultaneously incorporating the mechanism of medical insurance payment - mainly to solve the problem
of entering the hospital for negotiated drugs.
According to CMH data, as of July 19, 2021, the total number of 92 medical insurance negotiated drugs included in the "dual channel" has exceeded 15,000 designated medical institutions and more than 31,000
designated retail pharmacies.
In the context of accelerated landing, the vast majority of innovative drugs have achieved price for volume after entering medical insurance, and sales have increased
significantly.
According to the Southwest Securities report, under the influence of policies, in terms of medical insurance negotiation varieties in 2018, the 17 varieties that were successfully negotiated in the final negotiation had an average decrease of 57%, all of which achieved positive growth, and the average increase in sales in the first year was as high as 1024%.
After the products entered the medical insurance in 2019, sales increased significantly in Q2 2021, an increase of 124%
year-on-year.
However, the 2020 negotiation drug was just implemented in March 2021, and the volume effect is not obvious
.
Du Xiangyang said that medical insurance is conducive to rapid expansion and sales have increased
significantly.
Taking ametinib, dapagliflozin, sindilimab and anlotinib included in medical insurance in the past two years, after being included in medical insurance, the products have basically achieved rapid increase and sales have also increased significantly
.
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