卢非酰胺价格一览

Rufinamide is an important anti-epileptic drug for the treatment of Lennox-Gastaut syndrome. The price difference between its original drug and generic drugs directly affects patients' medication choices. This article will analyze it from three dimensions: price comparison, domestic listing status and possibility of medical insurance reimbursement. Currently, the original drug of Japan Eisai Company is priced at US$112 for 100mg*100 tablets and US$166 for 200mg*100 tablets. However, the price of generic drugs has not yet formed a unified standard.

Prices of original drugs and generic drugs of rufinamide

Global market prices show a pattern in which original drugs dominate and generic drugs gradually develop. Drug prices are affected by multiple factors such as patent protection, production costs and regional policies, and there are significant price differences between different specifications and brands.

Original drug price

The market reference price of the brand drug rufinamide produced by Japan Eisai Company is US$112 for 100mg*100 tablets and US$166 for 200mg*100 tablets.

Current situation of the generic drug market

Indian pharmaceutical companies have launched generic products, and the price of 100mg is about 40%-60% of the original drug. Because generic drugs have been on the market for a short period of time, the price system has not yet been fully stabilized, and there is a 10%-15% price difference between different manufacturers.

When purchasing drugs, manufacturer qualifications and product batch numbers should be checked, and generic products that have passed bioequivalence certification should be given priority.

Domestic marketing status of rufinamide

The drug approval progress of rufinamide in mainland China is relatively lagging behind, and it has not yet received marketing approval from the National Medical Products Administration. This situation directly affects the accessibility of the drug to domestic patients.

Approval progress update

According to public information inquiry, rufinamide has not yet submitted a domestic marketing application. Within the same class of antiepileptic drugs, only some traditional products have been approved. The approval of innovative dosage forms usually requires the completion of domestic clinical trials and is expected to be difficult to market in the short term.

Patient acquisition channels

Domestic patients are currently mainly acquired through three methods: participating in international multi-center clinical trials, importing through the Hainan Boao Lecheng International Medical Tourism Pilot Zone, or purchasing through professional cross-border medical service institutions. Each method requires complete medical certification documents.

There are certain legal risks associated with the use of unapproved drugs. It is recommended that patients choose compliant access channels under the guidance of professional physicians and pay attention to the latest approval developments from the Drug Evaluation Center of the State Food and Drug Administration.

The medical insurance reimbursement situation of rufinamide

Since it has not yet obtained domestic marketing approval, rufinamide has naturally not been included in any medical insurance reimbursement catalogue. This situation has brought greater financial pressure to patients who need long-term medication.

Current medical insurance policy

China’s medical insurance catalog only includes domestically approved drugs, and rufinamide does not meet the basic access conditions. Critical illness insurance in some provinces and cities may cover other anti-epileptic drugs with similar indications, but the specific reimbursement ratios and limits vary from place to place.

Possibility of future inclusion

Based on the approval experience of similar drugs, even if it is approved for marketing in the future, it usually takes 2-3 years from listing to entering the medical insurance catalog. Innovative drugs may be included at an accelerated pace through national medical insurance negotiations, but sufficient pharmacoeconomic evidence needs to be provided.

At this stage, patients need to bear the full cost of the medicine themselves. They can pay attention to the patient assistance projects of pharmaceutical companies and the medication support plans of charitable foundations. It is recommended to keep the complete drug purchase receipt for possible retroactive reimbursement.