Benefit standards of Zometa Ready & Xgeva are expanded

The HIRA removes recommendation for disregarding bone metastases as a result of bone scan

Zometa Ready, recognized as the first administration of multiple myeloma

The administration conditions for Zometa Ready (Zoledronic acid) of SciGen Korea and Xgeva (Denosumab) of Amgen Korea, which are used to treat patients with multiple myeloma and solid cancer bone metastasis, will be changed.

 

Previously, both drugs were reimbursed only when they showed lytic findings on plain X-rays, normal on X-rays, or when bone destruction was clearly demonstrated by CT or MRI.

 

Reimbursement was not recognized when abnormal findings were confirmed only by bone scan.

 

However, from January 1 of next year, Zometa Ready will be able to reimbursed if bone metastases and bone lesions are clearly demonstrated through radiological examinations, and Xgeva is clearly proven through radiological examinations.

 

The HIRA publishes a revision of the announcement regarding drugs prescribed/administered to cancer patients containing such contents and receives an inquiry until the 24th.

 

In the breast and prostate cancer guidelines, Zometa Ready and Xgeva are recommended for patients with bone metastasis regardless of osteolytic and osteoblastic lesions, and the approved clinical trial did not limit the subject to osteolytic lesions.

 

It includes all imaging tests such as X-ray, CT, and MRI.

 

The HIRA said, "As many guidelines such as multiple myeloma related guidelines recommend drug administration regardless of osteolysis and osteoblastic sarcoma, it is reasonable not to limit it to lytic lesions.

 

Bone metastasis and bone lesions must be clearly demonstrated in radiology to enable reimbursement." The recommendation that bone metastasis is not recognized only by bone scan results, which was set as the ASCO breast cancer guidelines, has been deleted.

 

In addition, the multiple myeloma NCCN guideline recommended Zometa Ready and Panorin (Pamidronate) as Category 1 for all patients receiving myeloma treatment equally.

 

In a randomized clinical trial, the two drugs had the same effect on reducing the risk of skeletal symptoms, and the benefits of Zometa Ready were lowered than at the time of the HIRA's review.

 

In the case of Xgeva, it was confirmed that only the bone metastasis of castration-resistant prostate cancer was evaluated for its clinical usefulness and feeding adequacy.

 

Therefore, among the criteria applied for each cancer type, the standard for prostate cancer has been changed from being recognized when properly administered as necessary within the scope of the approval requirements to be recognized when properly administered to castration-resistant prostate cancer.