Novartis Submits Inclisiran for China's 2024 National Reimbursement Drug Negotiation as the First siRNA Chronic Disease Therapy

Recently, Novartis announced that its developedThe world's first and only siRNA long-acting lipid-lowering drug, Inclisiran Sodium Injection(Inclisiran, trade name: Leqvio) has officially submitted an application to the National Healthcare Security Administration of China for participation in the 2024 national healthcare negotiation. This drug serves as a long-acting lipid-lowering therapy for patients with chronic conditions.Its first attempt to enter the National Medical Insurance Catalog, attracting widespread attention.

Inclisran is a small interfering RNA (siRNA) therapy targeting PCSK9, which reduces the mRNA levels encoding PCSK9 protein, thereby preventing the liver from synthesizing PCSK9 protein. This mechanism differs from traditional PCSK9 monoclonal antibody drugs, and data showsPCSK9 Monoclonal Antibody DrugsDue to potential immunogenicity, long-term use may lead to issues such as drug resistance, affecting its efficacy. Currently, there are five PCSK9 monoclonal antibody drugs available on the Chinese market, including Repatha (Evolocumab Injection), Praluent (Alirocumab Injection), Xinbile (Tollecumab Injection), Yixining (Inucumab Injection), and Junshida (Angorecimab Injection).

The advantage of Inclisran lies in its site of action within hepatocytes. Current research indicates that it does not have significant issues with drug resistance. The efficacy of the drug does not depend on blood concentration, nor is it affected by statins. Additionally, Inclisran has a lower dosing frequency and can be stored at room temperature, further enhancing its convenience of use.

This drug is priced at 9,988 RMB per injection in China (specification: 1.5ml:284mg). The recommended administration method is a single subcutaneous injection of 284mg. After the first dose, it should be administered again after 3 months, followed by once every 6 months. According to this dosing regimen, an average patient needs to receive two to three injections annually, with an annual treatment cost of approximately 20,000 to 30,000 RMB. In comparison, the annual treatment costs for the two PCSK9 monoclonal antibody drugs already included in the national medical insurance catalog—Repatha and Praluent—are less than 10,000 RMB. Additionally, Innovent Biologics’ Toripalimab Injection is also currently applying for negotiation to enter the medical insurance program.

Inclisran's launch in China is supported by rigorous clinical trials, including "real-world studies" conducted on Chinese patients. Research shows that the drug has been applied to more than 170,000 patients globally and over 10,000 patients in China, with no additional adverse reactions found, demonstrating good safety.

The Medicare negotiation application for Inclisran not only concerns whether the drug can further reduce the economic burden on patients but will also influence the future development trend of the PCSK9 lipid-lowering drug market.