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On October 16, 2022, the National Medical Insurance Administration issued the "Announcement on the Phased Results of the Expert Review of Declared Drugs Adjusted by the National Medical Insurance Drug List in 2022 and Passed the Formal Review", which means that the expert review of the national medical insurance negotiation in 2022 has been completed
.
Earlier, on June 29, the National Medical Insurance Bureau issued the "2022 National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug Catalogue Adjustment Work Plan" and related documents, marking the official launch
of the fifth round of national medical insurance drug catalogue adjustment.
Among them, compared with 2021, the main contents of the expert review stage are changed as follows:
343 drugs passed the formalities examination and negotiations are imminent
343 drugs passed the formalities examination and negotiations are imminent On September 17, the National Medical Insurance Bureau announced the "2022 National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug Catalogue Adjustment of the List of Drugs Passed the Formal Review", which was slightly adjusted compared with the preliminary review list announced on September 6, and the non-listed drug Metronitrix Vigginthus vaginal expansion suppository was removed, and a total of 343 drugs passed the formal review (see the appendix at the end of the article for details).
According to the document, this year's medical insurance catalogue adjustment process is still divided into five stages
: preparation, declaration, expert review, negotiation and announcement of results.
It is worth noting that the Medical Insurance Bureau has further optimized the content of enterprise declarations, enriched the requirements for drug submission information in the declaration materials, including effectiveness, safety, economy, innovation and fairness, etc.
, and invited enterprises to submit drug information summary slides to give enterprises more opportunities to introduce their varieties
to experts.
The expert review has now been completed, which means that the high-profile negotiation phase is coming, and according to the announcement of the deadline for enterprises to submit materials on November 3, the negotiations may take place
in November.
The list of drugs is full of highlights
The list of drugs is full of highlights 343 drugs that passed the formal examination this time, including 183 new varieties of Western medicines and 15 proprietary Chinese medicines added to the catalog; There are 111 renewals of Western medicines and 34 proprietary Chinese medicines in the catalog
.
Through combing, it is found that this round of medical insurance negotiations is still full
of highlights.
Tilted towards rare diseases and children's drugs
Tilted towards rare diseases and children's drugs Compared with the previous adjustment of the medical insurance catalog, this round of adjustment is tilted
towards rare diseases and children's medication.
This is reflected in the fact that there is no restriction
on "approval for marketing after January 1, 2017" for the declaration of rare disease drugs.
In terms of children's medication, compared with 2021, "drugs included in the list of encouraged generic drugs or encouraged R&D and application of children's drugs, and approved for marketing by the national drug regulatory department before June 30, 2022" have been added to the medical insurance list
.
According to statistics, there are 19 rare disease drugs
in the list that passed the formality review this year.
According to a special report previously released by GBI (click to read), a total of 7 new rare disease drugs were successfully negotiated in 2021, and the indications involved Fabry disease, hemophilia B, hereditary angioedema (HAE), homozygous familial hypercholesterolemia (HoFH), spinal muscular atrophy (SMA), protein amyloid cardiomyopathy and multiple sclerosis
.
Among them, Biogen's SMA treatment drug noxinaxen sodium entered medical insurance coverage at a price of about 33,000 yuan per needle, with a unit price of 550,000 yuan as the benchmark reduction of 93.
97%.
It is worth looking forward to what new breakthroughs will be made
in the negotiations on rare disease drugs this year.
The "sky-high" CAR-T has attracted attention again
The "sky-high" CAR-T has attracted attention again Also on the list is Trima-Cel Injection (Carteyda), an autologous CAR-T cell immunotherapy drug targeting CD19 independently developed by JW Therapeutics, which was approved for marketing in China on September 1, 2021, and is the second CAR-T therapy
approved in China after Fosun Kate Aquilencel Injection (trade name: Yikaida).
。 Last year, Yikaida was also on the list of 273 drugs that passed the formal examination, but because its high price (1.
2 million yuan / needle) did not meet the principle of "basic insurance" in medical insurance negotiations and was not economical, it was ultimately unable to qualify for
the arrangement.
What will be the fate of the 1.
29 million/needle Carteyna this year? Can it create a precedent for "sky-high" drugs to enter the medical insurance catalog? See you in November
.
The largest number of oncology drugs, domestic PD-1 indications war
The largest number of oncology drugs, domestic PD-1 indications war The PD-(L)1 drug owned by the multinational pharmaceutical company did not appear in the list, and the relevant "fight" will be launched
in domestic pharmaceutical companies.
Among them, Hengrui Pharmaceutical carrelizumab added 4 indications; Junshi Biologics added 2 indications for trepilimab; Innovent Biologics added 2 new indications for Cintilimab; BeiGene tislelizumab adds a new combination regimen
for 4 new indications and 1 catalogue indication.
In addition, Henlius PD-1 strulilimab, Corning Jereh/Sidi/Simcere PD-L1 envolimab, and Akeso PD-1/CTLA-4 bispecific antibody cardonilimab are also on the
list.
What will be the competitive landscape for PD-(L)1 when new entrants join? Let's look forward to
it together.
Will the new crown oral drug officially enter the medical insurance?
Will the new crown oral drug officially enter the medical insurance? It is also worth noting that the domestic new crown oral drugs Azvudine tablets and Pfizer Paxlovid (nematervir tablets / ritonavir tablets) also appear in the
list that passed the formality review.
Among them, the drug information of azvudine shows that the declared indication is HIV-1 infection
with high viral load.
Azvudine tablets are oral small molecule drugs independently developed in China, which were approved for HIV and COVID-19 indications in July 2021 and July 2022 respectively, and Fosun Pharma has exclusive commercial rights and interests
in some regions of the drug.
In August 2022, Azvudine was included in the ninth edition of the new crown diagnosis and treatment plan
.
Paxlovid is an oral small molecule new coronavirus treatment drug, which was conditionally approved for import registration by the State Food and Drug Administration in February 2022, and the first batch of 21,200 boxes of Paxlovid entered China in March of the same year, with a purchase price of 2,300 yuan / box, and included in temporary medical insurance
.
Can Paxlovid enter into this negotiation? Worth paying attention
to.
The "annual drama" is about to be staged, and GBI will continue to pay attention to
how it progresses in the future.
