Medical insurance situation and price analysis of Apelvis

Alpelisib (Alpelisib), as an innovative oral phosphatidylinositol 3-kinase (PI3K) inhibitor, used in combination with fulvestrant, provides a new treatment option for patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer with PIK3CA mutations. This treatment option is particularly suitable for postmenopausal women and men whose disease has progressed despite endocrine therapy.

In the combined treatment of apelvis and fulvestrant, patients need to follow a specific medication regimen: Fulvestrant 500 mg is injected intramuscularly (IM) on day 1, 15 and 29 and every 28 days thereafter, while apellis 300 mg is taken orally continuously every day. To ensure patient medication safety, when adverse drug reactions occur, doctors can adjust the dose of Apelvis to 250 mg or 200 mg daily. Phosphatidylinositol-3-kinase-α (PI3Kα) plays a key role in cell proliferation in response to activation of the growth factor-tyrosine kinase pathway. However, in some cancers, the p110α catalytic subunit of PI3Kα is mutated, causing it to be abnormally active, thereby promoting the growth of cancer cells. Apelvis exerts anti-cancer effects by precisely inhibiting the activity of PI3Kα, and has the highest specificity for PI3Kα without prolonging the QTcF interval.

However, unfortunately, the original drug of Apelis has not yet been launched in China, so it has not been included in the National Medical Insurance Drug List. This also means that for domestic patients, the price of Apelvis and the cost after medical insurance are still unknown. However, with the continuous optimization and acceleration of the domestic drug review and approval process, and patients' growing demand for innovative drugs, there is reason to expect that Apelvis will enter the domestic market in the future, and is expected to pass medical insurance negotiations, ultimately benefiting more patients.