Inqovi®

Drug - Inqovi® (cedazuridine and decitabine tablet) [Taiho Pharmaceutical Co., Ltd.]

March 2021

Therapeutic area - Myelodysplatic syndromes

Initial approval criteria

Patient is 18 years or older AND
Patient has a confirmed diagnosis of myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS AND
Patient is under the care of an oncologist/hematologist AND
Patient should have received ≤ 1 previous cycle of decitabine or 1 cycle of azacitidine AND
Patient has 1 of the following French-American-British (FAB) sub-types with an International Prognostic Scoring System (IPSS) group risk classification of Intermediate-1, Intermediate-2, or High:
- Patient has refractory anemia OR
- Patient has refractory anemia with ringed sideroblasts OR
- Patient has refractory anemia with excess blasts OR
- Patient has chronic myelomonocytic leukemia (CMML) AND
Patient does not have a diagnosis of acute myelogenous leukemia (AML) AND
Therapy will not be substituted for IV decitabine within the same cycle AND
Decitabine/cedazuridine will be used as a single agent therapy
Initial approval is for 6 months

Patient must continue to meet the above criteria and other indication-specific relevant criteria (e.g., concomitant therapy requirements [not including prerequisite therapy], performance status) AND
Patient must have adequate documentation of disease stability and/or improvement as indicated by the following:
- Patient has a decrease in bone marrow blasts percentage OR
- Patient has an increase in platelets OR
- Patient has an increase in hemoglobin OR
- Patient has a decrease in transfusions (if transfusion dependent) OR
- Patient has an increase in white blood cell (WBC) and absolute neutrophil counts (ANC) over pretreatment values OR
- Patient has a reduction in abnormal cytogenetic metaphases AND
Patient has an absence of unacceptable toxicity from the drug (e.g., severe myelosuppression, serious infectious complications)
Renewal approval is for 6 months

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