What factors depend on the entry of innovative drugs into medical insurance?

In recent years, the National Medical Insurance Catalog has continued to expand
.
Although each new edition of the catalog has varieties transferred in and out, the total volume continues to grow
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And from 8 years without adjustment to 1.
5 years, you can enter the medical insurance.
The dynamic adjustment satisfies the desire of innovative pharmaceutical companies! Undoubtedly, the speed of innovative drugs entering the medical insurance catalog has been significantly improved
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So, specific to individual cases, what factors will the speed of innovative drugs entering medical insurance in the future depend on? Background Review<<< The dynamic adjustment of the medical insurance catalog was once an extravagant dream of innovative pharmaceutical companies.
Looking back at the ever-changing national medical insurance catalog in recent years, it seems unimaginable that before 2017, the national medical insurance catalog had not been adjusted for 8 years
.
At that time, innovative drug companies were looking forward to the news of the adjustment of the National Medical Insurance Catalogue, because sales could grow rapidly only if they entered medical insurance and the innovative drug was recognized by the payer
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For innovative pharmaceutical companies, the ideal state is of course the dynamic adjustment of the medical insurance catalogue, because this is expected to allow innovative drugs that have experienced untold hardships in the research and development stage to enter medical insurance soon after they are launched, thereby obtaining more lucrative returns during the patent protection period.

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However, the national medical insurance catalogue has not been adjusted for a long time, and innovative pharmaceutical companies can only search for provincial medical insurance catalogues and strive to enter the provincial supplement
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The transformation began in 2017 In February 2017, after 8 years, a new version of the National Medical Insurance Directory was released
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Subsequently, the then competent department, the Ministry of Human Resources and Social Security, proposed to explore the establishment of a negotiated access mechanism on the basis of this version of the medical insurance catalog
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That year, 44 varieties were included in the scope of negotiation, and 36 were successfully entered into medical insurance
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In the summer of 2018, a "I am not a medicine god" hit the Chinese film/movie market severely, and the aftermath spread to the pharmaceutical market, so there was a special negotiation on anticancer drugs, and 17 varieties entered the medical insurance through negotiation that year.

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"Routine access" and "negotiated access" By 2019, when the medical insurance list was adjusted again, the adjustment plan clearly stated that the transfer was divided into two methods: "regular access" and "negotiated access".
Under the premise of safety, if the price (cost) is equal to or lower than the existing varieties in the drug catalog, it can be included in the catalog by conventional means; patented and exclusive drugs with higher price or greater impact on the medical insurance fund should be admitted through negotiation "
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However, the varieties that were successfully negotiated that year were released a few months later than the regular catalog
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"One adjustment every two years" to "one adjustment every year" Before the "Interim Measures for Medication Administration of Basic Medical Insurance" was issued, the industry generally believed that the dynamic adjustment of the medical insurance catalogue was in principle "one adjustment every two years", and the negotiation catalogue (ie " Negotiated drugs during the agreement period”) has officially become one of the five components of the medical insurance catalog
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Therefore, when the 2020 medical insurance catalog adjustment plan was released, many people were surprised
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But soon, the "Interim Measures for Medication Management of Basic Medical Insurance" was officially issued, which clearly pointed out that "a dynamic adjustment mechanism should be established and improved, and in principle, it should be adjusted once a year"
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Negotiated access mechanisms are also established in these management approaches
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At the end of 2020, a new version of the National Medical Insurance Catalogue will be released.
This time, the regular catalogue and the negotiation catalogue will be published at the same time
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So far, the dynamic adjustment mechanism of the medical insurance catalog that innovative pharmaceutical companies once dreamed of has basically been established, and innovative drugs have a channel to quickly enter the medical insurance catalog
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What are the main types of negotiation? As shown in Table 1, the number of medical insurance drug catalogues continues to grow, and more of them are negotiated
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The national talks actually date back to 2016
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That year, the former National Health and Family Planning Commission organized the first national drug negotiation, and the prices of tenofovir disoproxil for the treatment of chronic hepatitis B, icotinib and gefitinib for the treatment of non-small cell lung cancer were reduced respectively.
67%, 54%, 55%
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After the price reduction, 3 varieties can be directly linked to the Internet in provincial bidding and procurement
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Although it did not enter the medical insurance catalog immediately, it did not wait for a long time: in February of the following year, a new version of the medical insurance catalog was released, and all three varieties were included
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At that time, there was no regular catalogue and negotiation catalogue, and these three varieties actually entered the regular catalogue
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Until 2021, when the medical insurance catalogue is adjusted, icotinib will be transferred from the regular catalogue to the negotiation catalogue (the entry condition is "significant changes in indications or functions and major changes and the company voluntarily declares to adjust the limited payment scope")
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As shown in Table 2, each time the medical insurance catalog is adjusted, the number of negotiated varieties is increasing
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So, what is the future trend of negotiated varieties? The growth of the proportion of proprietary Chinese medicines is slowing down: the future trend? Among the varieties negotiated, western medicine varieties account for the majority
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Before 2019, there were only 5 types of Chinese patent medicines under negotiation, and the number of western medicines accounted for more than 90% of the number of types in the negotiation catalogue; later, the number of negotiated types of Chinese patent medicines increased, and by 2021, Chinese patent medicines accounted for about 22.
5%
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In the adjustment plans of the medical insurance catalogue in 2020 and 2021, clear adjustment conditions are given
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For example, due to the new crown epidemic in 2020, the first item to be included is "drugs included in the "New Coronary Virus Pneumonia Diagnosis and Treatment Program (Trial Version 7)" and "new generic drugs approved by the State Drug Administration".
Approved by the State Food and Drug Administration, the number of Chinese patent medicines that meet these conditions is far less than that of Western medicines
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However, another special condition in 2020 is: before December 31, 2019, enter 5 (inclusive) provincial-level supplemented varieties, and only 155 varieties of Chinese patent medicines meet this condition, and finally enter the medical insurance list ( Convention + negotiation) also mostly stem from this
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In the 2021 adjustment plan, this condition is no longer set, and the number of Chinese patent medicine varieties that have passed the preliminary formal examination has also dropped significantly to 31
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Therefore, in the future, the key to the new number of Chinese patent medicines entering the medical insurance list through negotiation will depend on the innovation process of Chinese patent medicines.

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The proportion of tumor drugs continues to increase: which mechanisms are more popular? In terms of categories, anti-tumor drugs and immunomodulators are the bulk of the Western medicines in the negotiated catalogue, and their growth rate is also fast.
By the 2021 edition, there are 71 varieties of the catalogue
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Among them, anti-tumor drugs and immunosuppressants are the main ones.
There are 51 and 15 in the 2021 negotiation catalogue respectively
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From the perspective of drug mechanism, there are many varieties of protein kinase inhibitors and monoclonal antibodies in anti-tumor drugs, with 30 and 10 in the 2021 version respectively
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The number of systemic anti-infectives has also grown rapidly
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Before 2019, there were only 2 such varieties in the negotiation, and by 2021, there were 32 varieties, and the growth rate was even much higher than that of anti-tumor and immunosuppressive agents
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Among them, anti-HCV and HIV drugs are the main ones
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Chinese and Western medicines are divided in different ways, and the Chinese patent medicines in the negotiation catalogue are mainly internal medicines
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Before 2019, the number of anti-tumor proprietary Chinese medicines, which accounted for a larger proportion, grew slowly, from the initial 3 to 6, of which adjuvant drugs for tumors had not increased
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How long does it take for innovative drugs to enter medical insurance? It is expected to enter the medical insurance within 1.
5 years after listing.
At present, the adjustment cycle of the national medical insurance catalogue is, in principle, a yearly adjustment
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However, the mechanism is still being improved, and the deadlines for listing in the negotiation are not the same in recent years
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The required listing time in 2019 is as of December 31, 2018, August 17 in 2020, and June 30 in 2021, the latter two being the release time of the adjustment plan
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However, the agreement period for the newly negotiated varieties in 2020 will start from March 2021, and the 2021 will start from January 2022
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That said, both the time-to-market deadline and the start of the agreement period were brought forward
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According to the current rules, innovative drugs will have the opportunity to enter medical insurance within about a year and a half after they are launched.

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In fact, judging from the changing trend of the time interval between the approval of the listing of the negotiated catalogue and the entry into medical insurance, it is getting closer and closer to this number
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Take the anti-tumor and immunomodulatory agents in the 2021 negotiating catalogue as an example
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There are 71 varieties in this category, and the average time interval from being approved for listing to entering medical insurance is about 2.
6 years
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Among them, since the medical insurance negotiation in 2017 is the real first medical insurance negotiation, there are many varieties that have been on the market for a long time, such as Novartis' everolimus and Simcere's recombinant human endostatin
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In this case, among the anti-tumor and immunomodulatory agents in the 2021 edition of the negotiated catalogue, the average time interval between the approval of the market and the entry into the medical insurance of the varieties that entered the medical insurance through negotiation in 2017 was 6.
5 years
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After that, the average time interval for entering medical insurance for the varieties that have been successfully negotiated every year has been shortened
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The average time interval for antitumor and immunomodulatory agents to be negotiated into Medicare for the first time in 2021 has been shortened to 1.
3 years
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In recent years, most of the newly marketed anti-tumor and immunomodulatory agents can enter medical insurance faster
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More domestic innovative drugs are included in medical insurance From 2019 to June 30, 2021, a total of 42 innovative anti-tumor and immunomodulatory drugs have been approved for marketing (calculated by generic name, refers to the first listing, excluding new indications, etc.
), Among them, 29 have entered the medical insurance catalog (16 domestic drugs and 13 imported drugs); among the 13 varieties that have not entered the medical insurance catalog, 3 domestic drugs and 10 imported drugs
.
From this perspective, more domestic innovative drugs have entered the medical insurance, and the main factors driving this are the price advantage of domestic innovative drugs and the state's support for domestic innovative drugs
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The average time interval for these 29 varieties to enter medical insurance is 1.
25 years
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Among them, darotamide, donafenib, almetinib, zanubrutinib, fumetinib, pamiparib, siponimod, tetahcept, vedicetumab, inito 10 varieties of monoclonal antibodies entered medical insurance in the year they were launched
.
There are 4 varieties of Dacomitinib, Apalutamide, Daratumumab, and Eribulin with an average time interval of more than 2 years.
These 4 varieties are all entered into medical insurance through negotiation in 2021
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Among them, the first 3 varieties passed the formal examination in 2020, but the negotiations were not successful
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Negotiated price threshold: is it within the expected range? Important hurdles to pass, from passing the formalities review to successful negotiation, also include annual treatment costs
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At present, this threshold is about 300,000 yuan, which is also the maximum annual cumulative payment of critical illness insurance for urban and rural residents in China
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For example, the high-priced CAR-T product, akirenzae injection, is too expensive, and it is not easy to enter the negotiation stage even if it passes the formal examination
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Those who enter the negotiation stage and fail in the end are generally because the company's quotation fails to fall within the expected price of the medical insurance department
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The expected price of the medical insurance sector is related to the results of pharmacoeconomics calculations.
In 2021, one drug is assigned to two pharmacoeconomics experts to independently calculate
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If the company's quotation falls below the expected range, it is basically difficult to succeed
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From this point of view, if an innovative drug is to be successfully negotiated, the pricing before the negotiation to the quotation during the negotiation is very important
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