The medical insurance negotiation declaration is in full swing!

With the official announcement of the "2022 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog Adjustment Work Plan" (referred to as the "Plan"), since July, the fifth round of the national medical insurance drug catalog adjustment has officially entered the stage of enterprise variety declarati.

Since the official establishment of the National Medical Insurance Bureau in 2018, the adjustment of the medical insurance catalogue has become normalized, and the adjustment rules of the medical insurance catalogue have also been continuously improved:

In 2019, the work plan for the adjustment of the medical insurance catalogue clearly divided the admission into two methods: conventional access and negotiation access, and the catalogue added the category of "negotiated drugs during the agreement perio.

In 2020, the adjustment of the medical insurance catalogue will officially start the self-declaration mechanism of enterprises, and it is clarified that the national medical insurance agency will organize experts in pharmacoeconomics, medical insurance management and other fields to conduct negotiations or access bidding according to regulatio.

In 2021, the medical insurance catalog adjustment rules will be basically mature, further highlighting the role of comprehensive clinical evaluation of drugs and pharmacoeconomics in medical insurance negotiati.

This year, the officially released "Plan" added more details to the work procedures for adjusting the drug catalog, not only requiring the submission of application materials and summary slides for the application content, but also publicizing the "Rules for Negotiating Drug Renewal" and "Non-exclusive Drugs" for the first ti.

The market generally believes that the focus of medical insurance negotiation is not only to reduce drug prices, but to adjust the new round of medical insurance catalogues, and to standardize the price system by improving the system construction; at the same time, comprehensively consider the new generics that have passed the formal examination in 2021 and have not entered medical insuran.

Reasonable competition and standard price

Encourage horizontal comparison of products

As in previous years, this year's medical insurance negotiation work is still divided into five stages: preparation, declaration, expert review, negotiation/bidding, and announcement of resul.

It is reported that in terms of declaration preparation, compared with previous years, the biggest difference this year is that declaration enterprises need to submit application materials and summary slides (PPT) before 17:00 on July 14, and clearly fill in the basic information, safety and effectivene.

According to the rules, the National Medical Insurance Administration requires enterprises to fill in the basic information of the declared varieties in the PPT, the sales amount in mainland China from January 1, 2020 to June 30, 2022, the main innovation points, e.

Industry experts believe that this move is tantamount to corroborating or even "exposing" each other through the application materials between companies, allowing companies to compete in the same therapeutic area and the same indications, which may increase the price between products and treatment optio.

At the same time, in order to prevent behaviors such as "bid colluding" and "bid rigging", the policy also further restricts the compliance bidding behavior of enterpris.

The National Medical Insurance Administration also stipulates that the names, photos, images, e.

In order to further increase the competition among enterprises, the "Non-exclusive Drug Bidding Rules" has made adjustments to the design of the medical insurance access system for non-exclusive varieties, which will help to change the problem of the lack of a reasonable access mechanism for non-exclusive varieties with high clinical prices in the pa.

On July 30, 2020, the National Medical Insurance Administration issued the "Interim Measures for the Administration of Medication for Basic Medical Insurance", which stipulates that in addition to the purchase of selected drugs with volume, other non-exclusive drugs shall be paid according to access bidding and other metho.

The non-exclusive drug bidding rules in this medical insurance negotiation are mainly:

The medical insurance party calculates and proposes the willingness to pay for the medical insurance as the entry threshold for the generic drug;

The companies participating in the declaration quote separate.

The payment standard for bidding drugs included in the medical insurance catalogue shall be the lowest price quoted by each enterpri.

This means that for "non-exclusive drugs", whether in the process of data declaration or on-site bidding, companies are at risk of being dragged down by competito.

However, considering supply guarantee and encouraging innovation, the core orientation of medical insurance negotiation and bidding is still to insist on "reasonable pric.

The policy shows that if the company's offer is lower than 70% of the willingness to pay for medical insurance, it will be 70% of the willingness to pay for medical insuran.

At this moment, the curtain of a new round of medical insurance negotiations has been open.

Last year, a total of 117 drugs were negotiated for the adjustment of the medical insurance drug list, and 94 were successfully negotiated, with an overall success rate of 83
It can be described as a remarkable achievement; this year's medical insurance negotiation, which blockbuster varieties will be shortlisted and finally achieve "price for volume", is obviously worth the market's expectatio.

PD-1 products still attract attention

The country talks about adding another member of CAR-T?

According to industry data, there are currently more than 250 potential types of national medical insurance negotiation, including more than 90 new generic drugs that have passed the formal review in 2021 and have not entered medical insurance, and about 60 new generic drugs approved in 2022, as well as the medical insurance catal.

More than 100 drugs with new indications and expired contract renewals have been approved in Chi.

There are a lot of interesting items that may be involved in the negotiation this ye.

Hengrui has 3 new products impacting the medical insurance negotiation, and Baiji also has 2 innovative drugs to be discuss.

The major domestic PD-1 indications have further increas.

Fosun Kite and WuXi Whether Junuo's CAR-T can enter the negotiation has also attracted much attenti.

As the "cornerstone" of tumor immunotherapy, the domestic PD-1/L1 field has always been the "red ocean" of tumor market competition, and it is also an important point of interest in the annual medical insurance negotiati.

As a blockbuster drug in the field of oncology, PD-1 is highly anticipated due to its broad market prospects, and because of the "involution" of pharmaceutical companies, the price of PD-1 has been pushed to the forefront in previous medical insurance negotiatio.

On March 4, Henlius’ PD-1 monoclonal antibody slulimumab was approved for marketing for unresectable or metastatic highly microsatellite unstable solid tumors that have failed standard thera.

Since then, there have been as many as 13 kinds of PD-1/PD-L1 listed in China, and the competition pressure has been increasi.

On June 23, Innovent Bio's PD-1 sintilimab new indication marketing application was approv.

Official information shows that the new indications for sintilimab approved this time are: first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma in combination with fluorouracil and platinum-based chemothera.

G/GE.

Successfully caught the "last train" of this medical insurance negotiati.

After June 30 last year, the four major domestic PD-1s have been approved for 8 new indicatio.

In 2022, with the further increase of domestic PD-1 indications, medical insurance negotiations seem to attract more attenti.

In addition to PD-1, the performance of some high-priced drugs in medical insurance negotiations is also worthy of the industry's expectatio.

Last year, Fosun Kite's CAR-T therapy Akilance injection and WuXi Junuo's CAR-T therapy Ruikiorenza injection were approved for listing, with unit prices of 2 million yuan and 29 million yuan respective.

Subsequently, Akilence appeared in the "List of Drugs Through Formal Review" of the medical insurance negotiation in 2021, which caused heated discussions; however, according to reports, Fosun Kite did not appear at the medical insurance negotiation site during the final medical insurance negotiati.

Expert analysis believes that the currently approved CAR-T products are all late-line treatments, which means that patients must be treated with two or more other therapies before receiving CAR-T therapy; therefore, although CAR-T clinical The efficacy has been fully verified in the treatment of hematological tumors, but the application scenarios are still limit.

"Last year, Fosun Kite's Achilles injection passed the qualification review and can participate in the medical insurance negotiation, but since there are no competing products, the actual market significance of price reduction and negotiation is not gre.

"

With the approval of WuXi Junuo's CAR-T products, how will the two "2 million injections" CAR-T anti-cancer "magic drugs" be selected? Which new PD-1/L1 products will change the market landscape? "Medical Economic News" will continue to pay attenti.