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Recently, the National Medical Insurance Administration issued the "Announcement on the Phased Results of Expert Review of Declared Drugs Approved by the Formal Review of the National Medical Insurance Drug Catalogue in 2022
".
This means that the expert review of national medical insurance negotiations in 2022 has been completed, the high-profile negotiation stage has entered the "countdown", and the most exciting part is coming soon
.
"Same and different" from last year
"Same and different" from last year At present, China has carried out a total of 6 rounds of medical insurance drug negotiations for innovative drugs, and the average reduction rate of innovative drugs selected for the first time is basically between
40-62%.
Table 1 Analysis of the negotiation of China's medical insurance catalogue from 2016 to 2021
Data source: Public data of the Health and Family Planning Commission, the Human Resources and Social Security Bureau, and the Medical Insurance Bureau
The vast majority of innovative drugs have achieved price increases
after entering medical insurance.
In terms of medical insurance negotiation varieties in 2018, the 17 varieties that were successfully negotiated in the end decreased by an average of 57%, all of which achieved positive growth, and the average sales increase in the first year was as high as 1024%.
The "price for volume" of medical insurance negotiations ultimately increased sales, which is the fundamental reason for
attracting many innovative pharmaceutical companies to participate in medical insurance negotiations.
Table 2 Sales of medical insurance negotiation varieties in sample hospitals in 2018 (100 million yuan)
Source: Southwest Securities
The formation mechanism of medical insurance payment price in China is complex, which is affected
by factors such as the clinical value of drugs, market competition pattern, corporate marketing strategy and medical insurance fund budget.
In the domestic market, the Medicare, as the largest, single payer, dominates the formation
of negotiated prices.
of negotiated prices.
The national price is mainly based on internal reference pricing, that is, referring to the domestic price of the same, similar or treatment-equivalent drugs to determine the drug price or reimbursement range, and will also be affected
by the medical insurance fund budget and pharmacoeconomic evidence.
The general medical insurance floor price, enterprise floor price, and drug results cannot be known, which will affect the drug price forecast of the national negotiation, which is also the most moving part of
the medical insurance negotiation process.
In 2022, there have also been some new rule changes
in the health insurance negotiations.
in the health insurance negotiations.
On June 13, the Medical Insurance Bureau issued the "2022 National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug Catalogue Adjustment Work Plan"
.
The plan announces for the first time the exclusive product renewal rules and non-exclusive product bidding rules in the catalog, for exclusive varieties, there is still pressure to reduce prices, but the pressure to reduce prices is relatively eased, which is conducive to innovative pharmaceutical companies, and improving innovation capabilities may be the best choice
for pharmaceutical companies.
For non-exclusive products, the competition of enterprise price war will be extremely fierce
.
.
From the rules of the adjustment of the declaration catalog, drugs with major changes in indications or functional indications can also be declared, and enterprises are encouraged to increase innovation to increase patient drug benefits, rather than blindly imitating, resulting in waste of industry resources and price involvement
.
Big variety to watch
Big variety to watch This year, 343 drugs passed the formal examination, including 183 new varieties of western medicines and 15 proprietary Chinese medicines.
There are 111 renewals of Western medicines and 34 proprietary Chinese medicines in the catalog
.
(1) Tilt towards rare diseases and children's drugs
(1) Tilt towards rare diseases and children's drugs 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 are encouraged (3 of which are also encouraged children's drugs/generic drugs), 5 encouraged children's drugs/generic drugs, and 2 new crown drugs
.
Table 3 Drugs for rare diseases that passed the preliminary form review in 2022
Source: National Health Insurance Administration
In 2021, a total of 7 new rare disease drugs were successfully negotiated, with indications involving Fabry disease, hemophilia B, hereditary angioedema (HAE), homozygous familial hypercholesterolemia (HoFH), spinal muscular atrophy (SMA), protein amyloid cardiomyopathy and multiple sclerosis
.
Among them, the soul negotiation of Biogen's SMA treatment drug noxinaxen sodium is still vividly remembered, and finally entered medical insurance coverage at a price of about 33,000 yuan / needle, with a unit price of 550,000 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.
(2) Multiple target tracks with fierce competition are expected to achieve catalog coverage
(2) Multiple target tracks with fierce competition are expected to achieve catalog coverage The competition must be indispensable for PD-1 drugs
.
Unlike in 2021, multinational pharmaceutical companies did not appear in the list of passed the preliminary review, and four domestic PD-1 companies passed the preliminary review
for new indications.
Some indications are highly competitive, and the four companies will compete for first-line indications for advanced esophageal squacell carcinoma; BeiGene, Hengrui and Junshi Biologics will jointly compete for first-line indications for
nasopharyngeal carcinoma.
nasopharyngeal carcinoma.
In addition to PD-1 drugs, there are CDK4/6 inhibitors, JAK inhibitors, ADCs, AR inhibitors, third-generation EGFR TKIs and other mechanisms/technical types.
A number of drugs have passed the preliminary review of this national negotiation and are about to usher in the same competition
.
(3) "Sky-high" products are expected to achieve breakthroughs
(3) "Sky-high" products are expected to achieve breakthroughs This round has an eye-catching and sky-high product appearance catalog, namely JW Therapeutics relma-cel injection (Carteyra).
Carteycarda is an autologous CAR-T cell immunotherapy drug independently developed by JW Therapeutics targeting CD19, which was approved for marketing in China on September 1, 2021, and it is the second CAR-T therapy
approved in China after Fosun Kite Aquilenxel injection (trade name: iKaida).
Last year, due to its high pricing, it did not meet the principle of "basic insurance" in the medical insurance catalogue and was finally defeated
.
This year, Tenoda is the representative of expensive new technologies, and the results of the negotiations will closely affect the pricing
of this new series of technology products.
(4) Will the new crown oral drug officially enter the medical insurance?
(4) Will the new crown oral drug officially enter the medical insurance? The first domestic new crown oral drug Azvudine tablets and Pfizer Paxlovid (nematevir tablets/ritonavir tablets) also appeared in
the list that passed the formality review.
However, Azvudine tablets show that the declared indication is HIV-1 infection with high viral load, and the medical insurance negotiations for the first domestic new crown drug may not happen
this year.
Paxlovid was conditionally approved for import registration by the NMPA in February 2022 and included in temporary medical insurance
.
Can "temporary workers" be "regularized" this year? We'll see
.
brief summary
brief summary Every year, the medical insurance negotiations for innovative drugs and new indications continue to improve the accessibility of new drugs and promote the penetration
rate.
In the future, multiple policies such as medical insurance negotiation, payment methods, review and approval, volume procurement and commercial insurance will have a profound impact on the development of the pharmaceutical industry during the 14th Five-Year Plan period, and will also bring many opportunities
to enterprises.
Which companies and products can seize strategic opportunities and stand out? We look forward to
it together.
it together.
Appendix I: 2022 National Talks Preliminary Review of Western Medicines and Chinese Patent Medicines
Appendix II: Western medicines and proprietary Chinese medicines in the 2022 National Talks Preliminary Review Catalogue
Appendix II: Western medicines and proprietary Chinese medicines in the 2022 National Talks Preliminary Review Catalogue
