Inqovi

Decitabine and Cedazuridine

• Brand(s): Inqovi
• Dosage Form/Strength: 35 mg/100mg tablet
• Effective date: December 19, 2022

For the treatment of adult patients with myelodysplastic syndromes (MDS) who meet ALL the following criteria:

1. 18 years of age or older; AND

2. Has International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2, and/or high-risk MDS (see Note 1); AND

3. Has adequate organ function; AND

4. Inqovi is used as monotherapy; AND

5. Prescribed by a clinician with experience in the diagnosis and treatment of MDS.

Notes:

1. Patient may have previously treated or untreated, de novo or secondary MDS, including all French-American-British (FAB) subtypes (Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), and chronic myelomonocytic leukemia (CMML).

2. Inqovi may be used as a bridge to hematopoietic stem cell transplant (HSCT) in patients with MDS who are transplant eligible.

3. Inqovi can be used as a bridge to intensive chemotherapy (with curative intent) for MDS.

4. In patients with MDS with deletion 5q chromosome, Inqovi should be used only if lenalidomide is not appropriate or after progression on lenalidomide.

5. Time-limited access to Inqovi will be provided for patients currently receiving treatment with azacitidine for MDS who wish to switch to Inqovi as long as criteria are met and there is no evidence of disease progression on azacitidine.

Renewal Criteria: Renewals will be considered until disease progression or development of unacceptable toxicities requiring discontinuation.

Exclusion Criteria:

• Patients with MDS who have experienced disease progression while on a hypomethylating agent (e.g. azacitidine, decitabine) for MDS will not be eligible for treatment with Inqovi.
• Inqovi is not funded for the treatment of acute myeloid leukemia (AML).
• Inqovi is not funded for patients with low-risk MDS.

Recommended dose: 1 tablet containing (35 mg of decitabine and 100 mg of cedazuridine) orally once daily on Days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity

Approval duration (initials and renewals): 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests