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On September 17, after a week-long publicity, the Medical Insurance Bureau completed the review and result revision based on the feedback, and officially released the "List of Declared Drugs Approved by the Form Review of the Adjustment of the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue in 2022"
General availability
The official draft contains 183 Western medicines outside the catalogue and 15 proprietary Chinese medicines; There are 111 Western medicines and 34 proprietary Chinese medicines in the
Included in the official draft
This indicates that a new round of state talks is about to enter the next stage
Time rhythm 9 - October to submit materials and conduct on-site negotiations, November results are produced, and the new version of the catalog will be implemented on January 1 next year
According to statistics, a total of 34 new domestic drugs (approved between July 1, 2021 and June 30, 2022) that are eligible for medical insurance negotiations are 34 (excluding traditional Chinese medicines and vaccines
WuXi Giant CAR-T Cell Therapy Ricky Orense, Corning Jerry and Henlius Henlius' PD-(L)1 monoclonal antibody, BeiGene stoximab, Hansen Pharmaceuticals' first new biological drug, Inelizumab, and Kangfang Bio's PD-1/CTLA-4 dual antibody carmonilizumab
Ricky Orensey PD-(L)1 monoclonal antibody stoximab inelizumab carmonilizumab
Policies are repeatedly sending positive signals
The PD-(L)1 scuffle intensified
The PD-(L)1 scuffle intensifiedPD-(L)1 drug, as the drug with the widest sales amount and coverage indications in the field of oncology, is one of the key products in this round of
In this round of national talks, imported varieties such as Merck's Pablizumab, Bristol-Myers Squibb's navurizumab, AstraZeneca's dulvalizumab and Roche's attilizumab still did not appear in the preliminary list in order to maintain the price system of
Pabolizumab, navurizumab, dullizumab attilizumab
In stark contrast to imported PD-(L)1, in addition to Kangfang Bio's paimalizumab and Yuheng Pharmaceutical's sepalizumab, the rest of the domestic products that have qualified for the national negotiation have all entered the game, and the annual scuffle is about to start
According to Insight statistics, among the four PD-1 monoclonal antibodies in the new and continued negotiations of the current round of national medical insurance negotiations, Hengrui's carilimizumab will have 8 indications, including 4 indications including new advanced lung squamous cell carcinoma and first-line esophageal squamous cell carcinoma; Cinda's Cindilizumab will have 6 indications, including new indications for advanced esophageal cancer and first-line advanced gastric cancer; BeiGene's tirelizumab will have 9 indications involved, including 4 indications for the addition of the only domestically approved second-line post-treatment of advanced NSCLC; Junshi Bio's terreprimumab will have 4 indications involved, including 2 new indications
According to Insight statistics, in the four catalogues of new and continued negotiations in this round of national medical insurance negotiations, PD-1 monoclonal antibody
Details of the four major domestic PD-1 monoclonal antibody medical insurance negotiations
Target* New indications for late 2021 negotiations
Image source: Insight collation
The competition of domestic PD-(L)1 has been fully rolled
The competition of domestic PD-(L)1 has been fully rolled
Paimalizumab and Sepalizumab who did not participate in the national talks
For example, Paiaprimumab, with the strong sales ability of Chia Tai Tianqing, has achieved quite good sales performance in the market, and the indications for first-line squamous non-small cell lung cancer and nasopharyngeal cancer are also expected to be approved
What is the pressure of China's first double-antibody price reduction?
What is the pressure of China's first double-antibody price reduction?Kangfang Bio's carmonil monomab is the world's first approved tumor double immunosuppressive point double antibody, and also the first approved double immunosuppressive point double antibody in China, and the approved indication is recurring/metastatic cervical cancer
From: Official information on health insurance filing
For recurrent or metastatic cervical cancer that has failed first-line platinum-containing chemotherapy, Pabolizumab (only for patients with positive PD-L1 expression) and carmonilisomab (including patients with positive or negative PD-L1 expression) have been approved by the FDA and NMPA for the treatment of cervical cancer worldwide, although the indications for the treatment of cervical cancer with K drugs are not approved
In terms of efficacy, although the reference significance of non-head-to-head data is limited, cardonizumab has shown superior results
From: Official information on health insurance filing
It is reported that Kangfang Bio is also actively preparing for this medical insurance negotiation
.
With the exclusivity of the product, excellent efficacy and good safety, and the uniqueness of clinical value, Cardonili's medical insurance negotiation price reduction may be relatively limited
.
Even if the negotiations with the expert group are not agreed, with the above characteristics, it is not expected to have too much negative impact on
the sales of cardonizumab.
Domestic CAR-T is still facing commercialization pressure
Domestic CAR-T is still facing commercialization pressure CAR-T cell therapy is expensive due to technical characteristics, although the price of CAR-T therapy in China has been reduced compared with similar products listed overseas, and the price of more than 1.
2 million yuan will still bring greater pressure
to domestic patients.
At present, there are 2 domestic CAR-T new drugs on the market, namely WuXi Junuo's Regie Oren Race and Fosun Kate's Achillen Race
.
The last round of national talks entered the preliminary examination of the catalogue of the Achillencia this time, and the September 2021 approval of the Ricky Oren race became the only new CAR-T drug
to enter the preliminary list this year.
From: Official information on health insurance filing
According to public information and semi-annual reports, each sales volume of Ricky Olens Race reached 1.
29 million yuan, and 77 prescriptions were issued in the first half of 2022, completing the return of 64 patients and achieving sales of 66 million yuan
.
In the Chinese market, where the patient's out-of-pocket and commercial insurance payment capacity is insufficient, the high sales price has affected the development
of the Chinese market of Reggio Olensei.
In contrast, in February 2022, the US FDA approved the legendary creature's CAR-T therapy Cidaki Olense, overseas sales, but higher pricing, in the first half of the year, global sales reached 48 million US dollars, about 330 million yuan
.
From the perspective of drug use pattern, most of the drugs for hematological tumors have more choices, and the efficacy has been relatively significant, and patients can achieve a long time to survive
with the disease.
Therefore, obtaining medical insurance reimbursement qualifications through national medical insurance negotiations, significantly reducing the patient's out-of-pocket payment ratio, and forming a payment combination with commercial insurance may become the key
to opening up the situation in the domestic market.
Directly proportional to the strong expectation of manufacturers entering medical insurance, perhaps the bargaining range
of medical insurance negotiation experts.
At the end of the article, a link to the official information can be copied to the address bar for viewing:
At the end of the article, a link to the official information can be copied to the address bar for viewing: 1.
Official drug list announcement and PDF
Official drug list announcement and PDF
Announcement of the National Medical Security Bureau on the announcement of the list of drugs reviewed by the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue in 2022
2.
Declaration information of each drug (PDF and PPT)
Declaration information of each drug (PDF and PPT)
In 2022, the national basic medical insurance, work injury insurance and maternity insurance drug catalogue adjustment passed the preliminary form of review of the declared drug information
3.
Policy interpretation
Policy interpretation
In 2022, the national basic medical insurance, work injury insurance and maternity insurance drug catalogue adjustment passed the preliminary form of review of the drug list publicity interpretation