List of drugs that are expected to be negotiated for medical insurance in 2021! Qilu, Hengrui, Rongchang Biological...
June 29, 2021
Since 2016, the country has negotiated drug prices every year, and 5 rounds of medical insurance negotiations have been conducted. The first round of medical insurance negotiations was led by the former National Health and Family Planning Commission in 2016. Before the establishment of the National Medical Insurance Administration in 2018, the adjustment of the medical insurance catalog was managed by the Ministry of Human Resources and Social Security. Since 2018, the National Medical Insurance Administration has adjusted the medical insurance drug catalog for three consecutive years. Included 433 new and good drugs, and the average price of 233 negotiated drugs dropped by an ultra-high 50%.
Overview of National Medical Insurance Negotiations
Data source: Yaozhi data
Recently, the National Medical Insurance Administration issued the "Work Plan for 2021 National Medical Insurance Drug Catalog Adjustment (Consultation Draft)" and "2021 National Medical Insurance Drug Catalog Adjustment Application Guidelines (Consultation Draft)", which means the annual medical insurance catalog drug adjustment Kick off, the sixth round of medical insurance negotiations is about to begin. The "Draft for Solicitation of Comments" clarifies the scope of the adjustment of the 2021 medical insurance catalogue, and which varieties will be adjusted. You can click to view the in-depth article "Adjustment of the 2021 medical insurance catalogue, which varieties are imported and exported? 》; The most notable one is that the deadline for new varieties or new indications in the 2021 medical insurance catalogue adjustment scope is June 30 this year, which means that new drugs or new indications approved before June 30 this year can be declared. The opportunity to participate in medical insurance negotiations has further expanded the scope of inclusion in the medical insurance adjustment catalog. At the same time, if innovative drugs can smoothly enter the medical insurance catalog, through price-for-volume, new drugs can also be rapidly increased in volume.
33 innovative drugs or will negotiate medical insurance
The deadline for new drug declarations in the 2020 medical insurance negotiations is August 17, 2020. From that moment last year to June 18 this year, according to the data of drug intelligence, 33 innovative drugs approved for marketing or new indications are expected to enter A new round of medical insurance negotiations is in progress. In terms of drug types, it includes 7 therapeutic biological products, 17 chemical medicines, category 1 innovative drugs, and 9 improved new drugs. Including PD-1 monoclonal antibody, PARP inhibitor, EGFR-TKI, ADC and many other market hotspots. Among them, it is worth mentioning that as of the end of 2020, the four major domestic PD-1s have all been included in the catalog through medical insurance negotiations, and the overall decline of each company is about 70% in exchange for the amount of protection. According to the financial reports of Hengrui, Cinda, Junshi, and BeiGene in the first quarter, overall, the sales of the four major domestic PD-1s have increased significantly: the sales of Sindili monoclonal antibody exceeded 700 million yuan, year-on-year An increase of 75%; tislelizumab’s revenue in China was approximately 315 million yuan, a year-on-year increase of 132%; terelizumab and carrelizumab have not yet been disclosed; but according to industry insiders’ predictions for teripril The increase in resistance was over 103%, and the increase in carrelizumab was nearly 130%. This shows that after being included in medical insurance, innovative drugs entered the medical insurance catalog through medical insurance negotiations, quickly occupying the market, achieving greater volume, and obtaining more commercial benefits. However, for the current severely homogenized PD-1, expanding the indications has become an important direction for PD-1 competition. After the 2020 medical insurance catalogue is adjusted, the four major products have been approved for new indications. In today's medical insurance catalogue adjustment, can all the remaining indications of the four major PD-1 be included in medical insurance? What kind of price cuts will there be? Worthy of attention.
Innovative drugs that are expected to enter medical insurance negotiations in 21 years
Data source: Yaozhi data
From the perspective of approved innovative drug companies, it is worth noting that BeiGene, Hengrui, and Yichang Renfu each have 3 new drugs. BeiGene is tislelizumab injection and Zelelizumab with new indications. Butinib and the newly approved class 1 innovative drug Pamipali Capsules; Hengrui Pharmaceuticals, in addition to Carrelizumab, includes fluzoparil Capsules and Hetropopaethanolamine Tablets 1 Class-innovative drug, and Hetropopapa ethanolamine tablets have just been approved recently. In addition, Rongchang Biological, Qilu Pharmaceutical, and Betta Pharmaceuticals each have two new drugs; Qilu Pharmaceuticals is mainly two improved new drugs. It is worth mentioning that Rongchang Biological’s two Class 1 biological innovative drugs, tytacept for injection It is conditionally marketed with vedicutuzumab for injection, and vedicutuzumab for injection is the first ADC drug approved in China, and tytaxacept for injection is the first in the world for the treatment of systemic erythema. Lupus (SLE) is a "dual target" type of new biological drug, and experts have previously called for the inclusion of tytacept for injection into medical insurance as soon as possible, and tytacept for injection is the first of Rongchang Biotech's successful listing in November 2020. A blockbuster product, the listing of this product marks the beginning of the company's commercialization journey; if it successfully enters the medical insurance catalog in 2021, it will surely achieve market growth.
Promote the transformation of achievements, the "three parties" may enter the medical insurance
According to the 2021 National Medical Insurance Drug List Adjustment Work Plan, the drugs that can be included in the negotiation scope are worthy of new drugs approved for marketing or new indications during the period from January 1, 2016 to June 30, 2021. It should be noted that "therapeutic drugs for respiratory diseases related to new coronary pneumonia" have also been included in the negotiation. According to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Eighth Revised Edition)" previously issued by the National Health and Family Planning Commission, nearly 20 drugs have been recommended for pneumonia caused by new coronavirus infection, including ribavirin, chloroquine phosphate, Abidol, Tocilizumab, Xiyanping injection, and the three drugs in the "three-drug three prescriptions" "Jinhua Qinggan Granules, Lianhua Qingwen Capsules (granules), and Xuebijing Injection"; and In response to the new crown pneumonia epidemic, almost all of them have been included in the national medical insurance drug list. However, the most noteworthy thing is that in March of this year, the State Food and Drug Administration approved the new drug status of the "triple" that emerged in the treatment of patients with new coronary pneumonia. This is the first time after the reform of the classification of Chinese medicines in accordance with the "Classification and Application of Chinese Medicine Registration" Data Requirements" (No. 68 of 2020) "3.2 Other Chinese Medicine Compound Preparations Derived from Ancient Classical Prescriptions" review and approved varieties. At the same time, it meets the requirements of being included in the scope of medical insurance negotiations in 2021. If it is successfully included, it is expected to promote the transformation of "triple" results at the current time when the new coronary pneumonia continues to spread.
"Tripartite" Approval Details Table
Data source: Yaozhi data
With the normalization of the adjustment of the medical insurance catalogue, the connection between medical insurance access and drug review and approval has become increasingly close. Domestic innovative drugs will quickly obtain the qualifications for medical insurance negotiations after they are approved for marketing. Whether biological innovative drugs or proprietary Chinese medicines, if they can The smooth entry of medical insurance will greatly improve the accessibility of patients, and at the same time bring a very favorable opportunity for innovative drugs to open up the market, help quickly occupy the market, and reduce the cost of market construction and market development for enterprises.