Diagnosis: Relapsed Or Refractory Acute Myeloid Leukemia.
Treatment: Xospata, Pre-service.

The insurer denied the Xospata, Pre-service.
The denial is upheld.

The patient in this case is a male. The patient has a prior history of Burkitt lymphoma. He was treated with combination chemotherapy and autologous transplantation. He now has FLT3+ (fms-like tyrosine kinase 3 positive) AML (acute myelogenous leukemia). He was treated with Vyxeos plus midostaurin. He had residual disease and was changed to azacitidine plus venetoclax. His physician has recommended addition of Xospata.

No, the requested Xospata is not medically necessary.

Xospata is FDA (United States Food and Drug Administration)-approved for treatment of AML (acute myelogenous leukemia) with a FLT3 (fms-like tyrosine kinase 3) mutation. However, it has not been shown to be safe and effective when used in combination with venetoclax and azacitidine. This use of Xospata is not endorsed by NCCN (National Comprehensive Cancer Network) guidelines and has not been shown to be effective in any published study. Given that there is no evidence supporting the ability of Xospata to improve health outcomes when combined with venetoclax and azacitidine, this treatment cannot be considered to be medically necessary.

Yes, the health plan did act reasonably, with sounds medical judgment, and in the best interest of the patient.