那他珠单抗(Natalizumab)国内价格是多少

Natalizumab is an α4-integrin inhibitor that can effectively inhibit immune cells from entering the central nervous system or intestinal tissue, thereby controlling inflammation and disease recurrence.

Natalizumab domestic price reference

As for the exact price in mainland China, due to factors such as medical insurance negotiations and hospital purchase prices, the public information is not uniform and changes frequently.

Currently, it is understood that the price of natalizumab 300mg/15mL (20mg/mL)/box is approximately US$3,400. It is only a reference price for the Japanese market. The actual selling price in mainland China will be different. Prices only reflect overseas legal information, do not make any purchase recommendations or price commitments, and are not used for domestic sales.

Factors affecting the price of natalizumab

1. High R&D and production costs

As a biological agent, its R&D process is long and technically complex, its production cost is much higher than that of chemical generics, and its production line and quality control requirements are extremely high.

2. Patent and market exclusivity period

The original drug Tysabri enjoys patent protection in the early stages of its launch, allowing it to be priced to recover R&D costs.

3. Medical insurance policy and negotiation

Whether a drug is included in the national or local medical insurance catalog is the most critical factor affecting the actual price paid by patients. The medical insurance reimbursement ratio directly determines the patient's out-of-pocket expenses.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

How to use Natalizumab

1. Pre-medication assessment

(1) Risk assessment: Doctors must fully discuss the risks of PML with patients and conduct anti-JCV antibody testing before medication. Antibody positivity, previous use of immunosuppressants, and drug use for more than 2 years are the main risk factors for PML.

(2) Registration: Doctors, patients and infusion centers must join a specific risk management plan (REMS) to ensure that the medication process is strictly monitored.

(3) Baseline examination: It is recommended to conduct a brain MRI examination before starting treatment to facilitate the identification of PML symptoms in the future.

2. Dosage and administration

(1). Standard dose: The recommended dose for adults is 300 mg each time.

(2) Dosing frequency: once every four weeks (about one month).

(3) Route of administration: intravenous infusion only. The drug must be diluted in 100 mL of 0.9% sodium chloride injection, and the infusion time needs to last approximately 1 hour. Intravenous injection or rapid infusion is strictly prohibited.

3. Infusion process and monitoring

(1) Full monitoring: During the entire infusion process, medical staff need to monitor the patient.

(2) Observation after infusion: For the first 12 infusions, the patient should continue to be observed for at least 1 hour after the infusion to prevent hypersensitivity reactions. If there is no response after 12 infusions, the observation time for subsequent infusions can be determined based on clinical judgment.

4. Principles of efficacy evaluation and discontinuation

(1) Multiple sclerosis (MS): long-term treatment is required, and the doctor will regularly evaluate the efficacy and risks to decide whether to continue medication.

(2). Crohn's disease (CD):

Induction therapy: If no effect is seen after the initial 12 weeks of treatment, use should be discontinued.

Maintenance therapy: For patients taking corticosteroids at the time of treatment, dose reduction should be initiated as soon as possible after onset of effect. If corticosteroids cannot be discontinued within six months of starting treatment, natalizumab should be discontinued.

5. Adverse reaction monitoring

Patients should be clearly informed that they must notify their physician immediately if they develop any new symptoms that may be related to PML (eg, confusion lasting several days, blurred vision, weakness on one side of the body, etc.), signs of infection, liver damage (eg, jaundice), severe allergic reactions (eg, hives, difficulty breathing), or unusual bleeding/bruising.