Three major changes in medical insurance negotiation in 2021｜Annual

At the end of the year, the most sensational event in the medical circle is the medical insurance negotiation

94 of the 117 drugs that participated in the negotiation were successfully negotiated, with an overall success rate of 80.

Breakthrough: Inclusion of high-value orphan drugs

This negotiation added 7 rare disease drugs to the NRDL, and 8 rare disease drugs were successfully renewed.

In addition to the number of admissions, the breakthrough of this negotiation is more reflected in the inclusion of high-value rare disease drugs

Also a high-value drug for rare diseases is Takeda's agalsidase alpha concentrated solution for injection for the treatment of Fabry disease

For rare disease drugs, the key factor in achieving breakthroughs is price

In fact, since the normalization of medical insurance negotiations, medical insurance has been paying close attention to drugs for rare diseases, more and more varieties have been included, and the coverage of diseases has also increased significantly

In 2020, Nosinagen Sodium Injection was also negotiated, but it was not included in the end

This time, Bojian, the manufacturer of Nosina, made a deal at a more sincere price.

Timely: Innovative drugs accelerate from launch to access

According to the statistics of the "Blue Book on the Progress and Effectiveness of China's Medical Insurance Drug Administration Reform" (hereinafter referred to as the "Blue Book"), the interval between the approval and inclusion of the medical insurance product on the market in recent years has been shortened year by year

The time from listing to entering medical insurance for the 2017 version of the medical insurance catalogue ranges from 4 to 9 years, with an average of 54.

Undoubtedly, the timely adjustment of the medical insurance catalogue gives innovative drugs the opportunity to enter medical insurance faster, and improves the accessibility and affordability of innovative drugs to patients

However, it is worth noting that the clinical data obtained when some new drugs are approved for marketing are still relatively limited, and only conditional approval is obtained, not full approval, so there is the possibility of being withdrawn

Then, the conditionally approved varieties will be eligible for the national medical insurance negotiation that year, will it be too soon?

In this regard, industry experts said: It is recommended that a real-world study period of at least one year be given to the varieties that are conditionally approved for marketing and marketed with limited controlled data to observe their safety and efficacy, and then decide whether to grant negotiation qualifications

Landing: "Dual Channel" Management Mechanism

Judging from the overall clinical use data, the sales amount and usage of innovative drugs have risen sharply in a short period of time after they entered the medical insurance

According to the "Blue Book", the growth rate of negotiated drug consumption in 2017 peaked from the first quarter of 2018 to the first quarter of 2019, with a year-on-year growth rate of 100% to 135% in each quarter; 2018 negotiation (special negotiation on anticancer drugs) drugs The dosage increased rapidly from the fourth quarter of 2018 to the fourth quarter of 2019, reaching a maximum of 1582%; even under the influence of the new crown epidemic, the dosage of newly negotiated drugs in 2019 still increased significantly, reaching 1,582% in the fourth quarter of 2020.
768.
6%
.

However, objectively speaking, some negotiated drugs still face the dilemma of "difficulty in entering the hospital".
This is because the "advanced medical insurance, and then entering the hospital" model puts forward higher requirements for the rapid access of medical institutions and the widespread use of clinicians in the short term.

.
In this regard, the National Medical Insurance Bureau issued the "Guiding Opinions on Establishing and Improving the "Dual-Channel" Management Mechanism of National Medical Insurance Negotiated Drugs" on May 10, 2021, to promote the smooth landing of negotiated drugs
.

"Dual-channel" refers to the two channels of designated medical institutions and designated retail pharmacies to meet the reasonable needs of negotiating drug supply security, clinical use, etc.
, and simultaneously include the mechanism of medical insurance payment
.
Drugs included in the "dual-channel" management scope need to focus on the varieties with high clinical value, urgent needs of patients, and low substitution
.

In principle, the “dual-channel” management catalog is determined by the provincial medical insurance department based on factors such as the level of economic development in the region, the affordability of medical insurance funds, and the needs of patients for medication.
Therefore, there may be inconsistencies in the catalogs of different provinces
.
However, according to the emergency notice issued by the National Medical Insurance Bureau recently, the 67 new negotiated drugs required in 2021 should be included in the "dual channels" of each province in principle
.
At present, Guangdong, Shanghai, Zhejiang, Guangxi and other places have announced the list of "dual-channel" managed drugs in 2022
.

Whether it is the access or landing of drugs, it is closely related to the payment ability of the medical insurance fund
.
Affected by the epidemic in the past two years, the expenditure of medical insurance funds has increased.
Under such circumstances, the National Medical Insurance Administration still carried out negotiation work as scheduled and included many high-value drugs and innovative drugs, which greatly benefited patients.
Health insurance funds bring more pressure
.

In this regard, Cai Haiqing, former director of the Treatment and Guarantee Division of the Jiangxi Provincial Medical Insurance Bureau, said that the triple system of "basic medical insurance + serious illness insurance + medical assistance" should be further strengthened, and at the same time, it should be developed and effectively connected with charitable assistance and commercial health insurance to give full play to The synergy of multi-level security
.
For rare diseases, it is even more necessary to carry out a separate system design on the basis of the multi-level medical security system, and establish a special security fund for the diagnosis and treatment of rare diseases that brings together various forces
.