去纤苷在中国上市了吗?好购买吗

Defitelio is an oligonucleotide mixture for intravenous injection, and its active ingredient is sodium defitelio. It exerts a profibrinolytic effect by enhancing plasmin activity and regulating endothelial cell function (such as increasing the expression of tissue plasminogen activator t-PA and thrombomodulin, reducing von Willebrand factor vWF and plasminogen activator inhibitor PAI-1), and protecting endothelial cells from chemotherapy or inflammatory damage.

Is defibrotide available in China?

The approval situation in the international market is in sharp contrast with its approval progress in China. Understanding this difference can help patients develop a reasonable treatment plan.

International approval process

On October 18, 2013, the European Medicines Agency approved defibrotide for the treatment of severe hepatic veno-occlusive disease after hematopoietic stem cell transplantation. On March 30, 2016, the US FDA also approved the same indication.

Domestic Approval Status

As of now, the National Medical Products Administration has not approved the domestic marketing of defibrotide. A search of the drug registration database shows that the drug is still in the clinical approval stage.

Special use channels

Some hospitals can apply for temporary import through the "compassionate use" procedure. This process requires complete medical records, and the approval cycle usually takes 4-8 weeks.

Patients can learn about the latest approval progress through the hospital’s Pharmacy Committee, or consult the attending physician about the feasibility of applying for special medications.

Is defibrotide easy to buy?

Since it has not been officially approved, the domestic access to defibrotide is strictly restricted. Understanding actual purchase difficulty has practical implications for patient treatment selection.

Formal purchasing channels

There are no legal sales channels in China. Individual qualified hospitals may temporarily import them, but they need to meet strict conditions and the quantity is limited.

Risks of cross-border purchasing

Purchasing by individuals from overseas involves risks such as cold chain breakage and difficulty in distinguishing the authenticity of drugs. Customs has strict controls on the entry of biological agents and may be seized.

Alternative Considerations

In situations where defibrotide is not available, the medical team may recommend other supportive care options. Specific choices require evaluation of the individual patient's circumstances.

Patients are advised to obtain treatment advice through formal medical channels and avoid purchasing drugs that may have safety hazards through informal channels.

Is defibrotide included in the national medical insurance?

The medical insurance coverage directly affects the accessibility of the drug. For high-priced orphan drugs, medical insurance reimbursement is particularly important.

Current status of medical insurance

Since it has not yet been marketed in China, defibrotide has not been included in any version of the medical insurance drug catalog, and patients must bear the full cost of treatment out of their own pocket.

Local medical insurance policy

Some provinces and cities have special protection policies for rare disease drugs, but inquiries show that no region has yet included defibrotide in local supplementary medical insurance.

Cost Support Program

Pharmaceutical companies may provide patient assistance programs, but specifically for defibrotide, there is currently no public domestic patient support program.

Patients in need can pay attention to the adjustment of the national medical insurance catalog and consult the attending physician for the latest cost support information.