Bosutinib’s medical insurance coverage and interpretation of patient reimbursement policies

Bosutinib is a second-generation BCR-ABL tyrosine kinase inhibitor mainly used to treat patients with chronic myeloid leukemia (CML) who are resistant or intolerant to first-generation TKIs such as imatinib. Although the drug has been approved and widely used in many countries such as Europe and the United States, bosutinib has not yet received marketing approval from the National Medical Products Administration (NMPA) in mainland China, nor has it been included in the Chinese Medical Insurance Drug Catalogue, which means that patients cannot be reimbursed through the domestic medical insurance system and can only obtain drugs from overseas at their own expense.

Since it is not marketed in China, bosutinib cannot participate in national medical insurance negotiations and does not have a medical insurance code. Public hospitals and medical insurance systems cannot purchase or reimburse the drug. If patients want to use bosutinib, they need to purchase it through overseas medical treatment, overseas purchasing or cross-border medical platforms, and the cost must be fully paid by themselves. This may cause greater financial pressure for some chronic leukemia patients who require long-term medication, especially when choosing original drugs.

According to public price information, the European version of the original bosutinib (specification: 500 mg × 28 tablets) sells for about more than 30,000 yuan per box, which is a high-cost drug. In contrast, the price of the generic version of bosutinib produced by India's Mylan Pharmaceuticals has been significantly reduced, with each box only costing about more than 1,000 yuan, which has greatly alleviated the financial pressure on some patients. Although there is a gap between generic drugs and original drugs in terms of quality control, most patients report that the clinical effects of Indian generic drugs are relatively stable, making them an alternative choice for many patients.
In general, since bosutinib has not yet been approved for marketing in China and has not been included in the scope of medical insurance, domestic patients are currently unable to reimburse the drug through medical insurance. For CML patients with clear indications for medication, it is recommended to evaluate the necessity of medication under the guidance of professional doctors, weigh the efficacy, safety and economic burden of original and generic drugs, and choose formal channels to obtain drugs. If the drug is approved to enter the Chinese market and enters the medical insurance catalog in the future, it is expected to significantly improve patients' accessibility and affordability.
Reference: https://www.drugs.com/