Pharmacy Prior Authorization Criteria

Inqovi (decitabine and cedazuridine) - PA, NF

Indications for Prior Authorization

Inqovi (decitabine and cedazuridine)

• For diagnosis of Myelodysplastic Syndromes (MDS)
  Indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

• For diagnosis of Acute Myeloid Leukemia (AML)
  Indicated in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Criteria

Inqovi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes

• Diagnosis of myelodysplastic syndrome
AND
• Patient is intermediate-1, intermediate-2, or high-risk per the International Prognostic Scoring System (IPSS)

Inqovi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes

• Patient does not show evidence of progressive disease while on therapy

Inqovi

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes

• Submission of medical records (e.g., chart notes) confirming diagnosis of myelodysplastic syndrome
AND
• Submission of medical records (e.g., chart notes) confirming patient is intermediate-1, intermediate-2, or high-risk per the International Prognostic Scoring System (IPSS)

Inqovi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acute Myeloid Leukemia

• Diagnosis of newly-diagnosed acute myeloid leukemia
AND
• Used in combination with venetoclax
AND
• One of the following:
• Patient is 75 years of age or older
OR
• Patient has comorbidities that preclude use of intensive induction chemotherapy [A]

Inqovi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Acute Myeloid Leukemia

• Patient does not show evidence of progressive disease while on therapy

Inqovi

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Acute Myeloid Leukemia

• Submission of medical records (e.g., chart notes) confirming diagnosis of newly diagnosed acute myeloid leukemia (AML)
AND
• Submission of medical records (e.g., chart notes) confirming that requested product will be used in combination with venetoclax
AND
• One of the following:
• Patient is 75 years of age or older
OR
• Submission of medical records (e.g., chart notes) confirming that patient has comorbidities that preclude use of intensive induction chemotherapy [A]

P & T Revisions

2026-06-24, 2025-08-06, 2024-07-31, 2024-01-09, 2023-08-08, 2022-07-05, 2022-02-09, 2021-11-22, 2021-07-28, 2021-05-19, 2020-10-07, 2020-07-27, 2019-08-09

References

1. Inqovi prescribing information. Taiho Oncology, Inc. Princeton, NY. June 2026
2. Acute Myeloid Leukemia NCCN Guidelines version 3.2026. June 2026.
3. Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML). NCT04657081. ClincialTrials.gov. June 2026.

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End Notes

1. Examples of comorbid conditions include severe cardiac disorders, severe pulmonary disorders, moderate renal impairment, moderate hepatic impairment, baseline ECOG performance status of greater than or equal to 2 [2] [3]

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Revision History

• 2026-06-24: Guideline updated to include new PA and NF criteria for new indication of Acute Myeloid Leukemia.
• 2025-08-06: 2025 Annual Review. Updated NF criteria with standard language. Updated references.
• 2024-07-31: 2024 Annual Review. No criteria changes.
• 2024-01-09: Program Update
• 2023-08-08: Annual Review
• 2022-07-05: Annual Review
• 2022-02-09: Addition of EHB formulary to guideline, no changes to criteria
• 2021-11-22: Updated guideline name, added NF section to Inqovi
• 2021-07-28: Annual Review
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2020-10-07: Added new criteria for Inqovi and renamed guideline to Dacogen (decitabine)/Inqovi (decitabine and cedazuridine) tablets
• 2020-07-27: Annual Review: no criteria changed, updated references and background
• 2019-08-09: Annual review. No changes to clinical criteria. Updated references. XC 8/9/19.

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