Whether seripase (BRINEURA) has been included in the medical insurance policy and the introduction of medical insurance reimbursement

Up to now, seripase (BRINEURA, generic name cerliponase alfa) has not been officially approved for marketing in mainland China, so it has not yet been included in the national medical insurance directory or the scope of local medical insurance reimbursement. Because it is not on the market, patients cannot purchase the drug through the medical insurance system in China and can only obtain it through regular overseas channels. This means that patients need to bear all the cost of purchasing drugs themselves, and there is no reimbursement support from medical insurance.

According to market information, seripase is extremely expensive in the international market. Each bottle of 150 mg/5 mL is priced at 16,190.17 USD. The total price of a package of two bottles is approximately 32,380.33 USD. This high price also makes health insurance negotiation and enrollment a challenge. Since it has not yet been launched in China, there is no medical insurance negotiation pricing or inclusion process. Therefore, domestic patients still need to pay the full amount out of pocket if they purchase it.

For rare disease drugs, the country’s medical insurance policy has shown a gradual relaxation trend in recent years. China has included some rare disease drugs in the medical insurance catalog, but it takes into account multiple factors such as strict examination of clinical evidence, cost-effectiveness, budget impact and bargaining power. Since seripalase is an extremely rare indication for a rare disease, the number of users is extremely small and the cost is extremely high. In addition, it has not yet been launched in the country, and its inclusion in medical insurance still faces multiple obstacles such as approval, price negotiation, and supply guarantee. In the future, only if manufacturers start negotiations with the national medical insurance department or local medical insurance agencies and provide affordable pricing strategies and clinical evidence, they may be included in the reimbursement system.

For patients who need to be treated with seripatin, it is recommended to give priority to purchasing drugs legally through formal overseas medical channels, and to keep complete drug purchase vouchers, logistics records and standardized prescriptions so that they can have evidence to rely on when policies change, apply for compensation or be included in local assistance in the future. At the same time, attention should be paid to the approval status of domestic and foreign drug regulatory authorities and the progress of medical insurance negotiations. If Seripase enters China's medical insurance catalog in the future, the patient's out-of-pocket payment ratio may drop significantly, but at this stage, all self-pay preparations and economic assessments should still be made.

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