The annual medical insurance catalogue adjustment work has kicked off.

  On June 30, the National Medical Insurance Administration officially announced the "2021 National Medical Insurance Drug List Adjustment Work Plan" (hereinafter referred to as the "work plan"). The adjustment scope mainly involves two parts: Western medicines and Chinese patent medicines outside the catalog, and Western medicines and Chinese patent medicines in the catalog. .

Listing before June 30 is the deadline for the drug to be included in the medical insurance catalogue.

Recently, new drugs approved for marketing have ushered in a "blowout" situation.

A variety of new drugs "grab the gate" approved

  In this round of adjustments, how to include Western medicines and proprietary Chinese medicines out of the catalog has attracted much attention.

  According to reports, the conditions for drugs not in the catalogue to be included are as follows: first, new generic drugs approved for marketing by the national drug regulatory authority during the period from January 1, 2016 to June 30, 2021 (inclusive, the same below); second, During the period from January 1, 2016 to June 30, 2021, drugs with major changes in indications or functions and indications approved by the National Drug Administration; third, drugs for the treatment of respiratory diseases related to new coronary pneumonia; fourth, included in the " National Essential Medicines List (2018 Edition)" medicines.

  In the past June, a number of new drugs were approved for "snap-stopping".

  According to statistics from a reporter from China Business News, a total of 10 innovative drugs were approved for listing in China for the first time, covering antiviral, anti-tumor, rare disease and other therapeutic drugs. The listed pharmaceutical companies involved include Hisun Pharmaceutical (600267.SH), Hutchison Pharmaceutical (00013.HK), Hengrui Pharmaceutical (600276.SH), Hansen Pharmaceutical (03692.HK), etc.

  On the day of June 23, three new drugs were approved for the market, namely Fosun Kate’s CAR-T drug Akirensai injection, Hutchison’s Saivotinib tablets, and Hansen’s Aiqi. Mitenofovir tablets.

  Specifically, Akirensai injection is the first cell therapy drug approved for marketing in China for the treatment of patients with relapsed or refractory large B-cell lymphoma after second-line or above systemic treatment.

  Saivotinib tablet is an innovative drug with independent intellectual property rights in my country. It was also registered for the first time in the world. It is used for disease progression after platinum-containing chemotherapy or intolerance to standard platinum-containing chemotherapy, with mesenchymal-epithelial transformation Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with exon 14 skipping of factor (MET).

  Imitenofovir tablets are also an innovative drug independently researched and developed by my country with independent intellectual property rights for the treatment of adult patients with chronic hepatitis B.

  In addition, in June, a number of new drugs were launched with new indications. For example, another drug of Hutchison Medicine, Sofatinib, was newly added for the treatment of advanced pancreatic neuroendocrine tumors. The previous indications of this drug were used for the treatment of advanced pancreatic neuroendocrine tumors. Advanced non-pancreatic neuroendocrine tumors.

  It is worth mentioning that a number of PD-1 anticancer drugs have also been approved for new indications. Take Cinda Bio (01801.HK) as an example, its PD-1 "Daboshu" has been added in June. The first-line treatment of advanced squamous NSCLC and the first-line treatment of liver cancer patients have been marketed for two indications.

  A number of pharmaceutical companies revealed to China Business News that they have plans to declare relevant new drugs to be included in the 2021 medical insurance catalogue.

  However, with so many new drugs approved for listing, it is self-evident that pharmaceutical companies face fierce competition with limited medical insurance funds.

Medical insurance negotiation drug reimbursement opens "dual channel"

  The National Medical Insurance Administration stated that in recent years, with the reform of the drug review and approval system, the number of new drugs approved in my country has increased year by year. From the perspective of the medical insurance department, on the one hand, it is hoped that more and better drugs can be marketed as soon as possible and included in the scope of medical insurance payment as soon as possible. , Benefit patients as soon as possible; on the other hand, in 2020, the per capita financing of resident medical insurance is only about 800 yuan, of which two-thirds will also come from financial subsidies. Therefore, we must firmly grasp the system positioning of "guarantee basic" and focus on clinical value Drugs that are high, reasonably priced, and able to meet basic medical needs are included in the catalog.

  In the past, although innovative drugs successfully entered the medical insurance list through negotiations, there were still many obstacles to entering the "last mile" of hospitals.

  Since the beginning of this year, the National Medical Insurance Administration and the National Health Commission have been exploring the inclusion of designated retail pharmacies in the scope of the supply of medical insurance drugs, and implementing a unified payment policy with medical institutions.

The industry generally believes that the "dual channel" is another way to bypass the hospital and solve the problem of negotiating drugs through pharmacies.

  When the work plan was issued, the National Medical Insurance Bureau also emphasized the "dual channel" supply guarantee mechanism.

  The National Medical Insurance Bureau stated that it will actively take measures to promote the implementation of negotiated drugs. First, urge all localities to promote the implementation of negotiated drugs through direct connection to the Internet, rational adjustment of the annual total amount of medical insurance, and strengthening supervision; second, in conjunction with the Health Commission to promptly introduce the "dual channel" "The policy opens up new channels for negotiating drug supply guarantees.

For the first time at the national level, designated retail pharmacies will be included in the negotiated drug supply guarantee system, and the same payment policy will be implemented as designated hospitals. A "dual-channel" supply guarantee mechanism for designated retail pharmacies and designated medical institutions will be established, so that negotiated drugs that temporarily cannot enter the hospital are advanced The pharmacy allows the masses to buy, use, and reimburse at the first time; the third is to dynamically release the list of negotiating drug allocation agencies, strengthen monitoring, evaluation, and supervision and guidance in various regions, and vigorously promote the implementation of negotiated drugs.

  In addition, the National Medical Insurance Bureau stated that the solution to the availability of new drugs cannot only rely on basic medical insurance, but can also give full play to various supplementary insurance, commercial health insurance and other channel functions to meet different levels of drug demand.

  Author: Lin Zhiyin