National Healthcare Security Administration Revises "Second-Line Use Restriction" Guidelines, Adding 8 Drugs Including Tirzepatide and Inclisiran: What Are the Implications?

Deep News
08/20

The National Healthcare Security Administration issued a notice on August 20, stating that it had recently received various opinions and suggestions regarding the intelligent monitoring "two databases." After review, the corresponding knowledge points for the "drug second-line use restriction" rule have been adjusted, adding 8 drugs and removing 1 drug. "Second-line use" refers to treatment options relative to first-line therapy, which is the preferred regimen. Generally, when patients do not respond adequately to first-line treatment or cannot tolerate its side effects, doctors will consider using drugs or strategies in the "second tier."

According to a report by The Paper, the 8 newly added drugs include high-profile products such as Eli Lilly's tirzepatide injection and Novartis's inclisiran sodium injection. Both of these medications were included in the 2025 National Reimbursement Drug List, but with strict indication restrictions. Tirzepatide is a globally renowned GLP-1 drug, approved in China for diabetes and weight management, with the diabetes indication covered by medical insurance. Based on the newly added knowledge points, reimbursement for tirzepatide is limited to glycemic control in adult patients with type 2 diabetes: specifically, those who, on a background of diet and exercise, have inadequate glycemic control despite treatment with metformin and/or sulfonylureas.

Inclisiran sodium injection is a long-acting lipid-lowering product, administered at most once every six months. This drug was also included in the 2025 medical insurance catalog. The newly released information emphasizes that this product is limited to the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, and payment is only made under the following two conditions: for patients who fail to reach their LDL-C (low-density lipoprotein cholesterol) goals despite treatment with maximally tolerated statin therapy; and for patients who are intolerant to statins or have contraindications to their use.

Industry analysts suggest that this adjustment of knowledge points can be interpreted as the National Healthcare Security Administration further clarifying the reimbursement scope of related insured drugs to regulate the use of medical insurance funds. Although the above two star drugs have been approved for monotherapy, medical insurance reimbursement is limited to second-line use only, and monotherapy is not within the scope of insurance payment. In recent years, the National Healthcare Security Administration has actively promoted the application of big data and intelligent monitoring methods in fund supervision. The aforementioned "two databases" refer to the rule base and knowledge base of intelligent monitoring. In May 2025, the National Healthcare Security Administration publicly released the first batch of intelligent monitoring rules and knowledge points for medical insurance funds. At that time, the administration explained that the "two databases" are the core of intelligent monitoring work. During the process of implementing pre-reminder functions for intelligent monitoring, for large medical institutions with significant business scale, high complexity, and strong information technology capabilities, the administration allows the direct local deployment and integration of the "two databases" into HIS (Hospital Information System) systems through the opening and sharing of these databases, thereby further improving the efficiency and accuracy of pre-reminders. Attached: Detailed list of newly added knowledge points for the "drug second-line use restriction" rule and corresponding drug codes.

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