What are the specific conditions for medical insurance reimbursement of Alpelisib?

Alpelisib（Alpelisib）-Piqray’s original drug has not yet been officially launched in mainland China, so it does not currently meet the basic conditions for inclusion in the national medical insurance directory. In other words, there is currently no clear scope of medical insurance reimbursement or specific reimbursement ratio in China. However, judging from international experience and policy trends, the conditions for Apelvis' future inclusion in medical insurance can be analyzed from three dimensions: drug attributes, clinical value and economic evaluation.

Apelix is a highly selective targeted drug that treats patients with advanced or metastatic breast cancer who carry PIK3CA gene mutations. This group accounts for approximately 30% to 40% of breast cancer patients and has clear molecular targets and evidence of clinical benefit. Therefore, from the perspective of disease characteristics, the drug has the potential to enter medical insurance negotiations.

From the medical insurance access process, China usually requires drugs to complete NMPA marketing registration, obtain clear clinical indications, and undergo cost-benefit evaluation. Apellis has been on the market for many years in the United States, the European Union, Japan and other places, and its efficacy and safety have been widely confirmed. If it is launched domestically in the future and is approved by the National Center for Drug Evaluation, the manufacturer will need to submit pharmacoeconomic data and negotiation applications before entering the medical insurance catalog evaluation stage.

In addition, another key condition for medical insurance reimbursement is the price accessibility and substitutability of drugs. Since Apelis is an imported innovative drug, its original research price is relatively high. The overseas price of each box (200mg × 56 tablets) is approximately RMB 30,000 to 40,000. If they are introduced to the Chinese market, pharmaceutical companies will usually lower prices through price reduction negotiations or the introduction of domestic generic drugs. Referring to the medical insurance negotiation experience of other targeted drugs, such as pembrolizumab, alectinib, etc., the price can often be reduced by more than 50% before they have the opportunity to be included in the medical insurance payment system.

Reference materials:https://www.piqray.com/