CurrentUnitedHealthcarePolicy N/A

Inqovi (decitabine and cedazuridine) prior authorization

Prior authorization and notification program for Inqovi (decitabine and cedazuridine) tablets for treatment of adults with myelodysplastic syndromes; includes initial and reauthorization criteria and pediatric auto-approval rules.

Policy Summary

PayerUnitedHealthcare

PolicyInqovi (decitabine and cedazuridine) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionDocument diagnosis of myelodysplastic syndrome and IPSS risk (intermediate-1, intermediate-2, or high) to support initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

age <19pediatric auto-approve

IPSS intermediate-1+required risk groups

P&T 2020-2026policy review history

Coverage Criteria for Inqovi (decitabine and cedazuridine)

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization: (1) Diagnosis of myelodysplastic syndrome (including previously treated and untreated, de novo and secondary MDS with FAB subtypes: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) AND (2) Patient is intermediate-1, intermediate-2, or high-risk per the International Prognostic Scoring System (IPSS)

Patients less than 19 years of age

Automatic approval condition

Pediatric auto-approval: Patient is less than 19 years of age; prescriptions will automatically process without a coverage review

Authorization will be issued for 12 months

This policy establishes prior authorization requirements for Inqovi (decitabine and cedazuridine) tablets used to treat adults with myelodysplastic syndromes (MDS). It applies where the member’s benefit plan requires prior authorization or notification and is subject to applicable state mandates. Historical policy maintenance is noted: the program was created in 12/2020 and has undergone annual reviews; in 2/2025 chronic myelomonocytic leukemia (CMML) was removed as a separate category because it is considered under MDS, and references were periodically updated through the 2/2026 review with no changes to the clinical criteria.

Coding and Risk Group Requirements

IPSS risk requirement

Required IPSS risk groupsIntermediate-1, Intermediate-2, or High-risk per the International Prognostic Scoring System (IPSS)

PurposeEligibility criterion for initial authorization of Inqovi for MDS

Policy consequenceRequests lacking documentation of one of these IPSS risk groups may be denied

IPSS risk groups — definitions

IPSS designations usedIntermediate-1, Intermediate-2, High-risk

Context in policyUsed to determine eligibility for Inqovi in adults with myelodysplastic syndromes (MDS)

Clinical noteNCCN recognizes Inqovi as a substitution for IV decitabine in patients with IPSS intermediate-1 and above

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy. Initial authorization requires documentation of a diagnosis of myelodysplastic syndrome (MDS) and evidence that the patient is intermediate-1, intermediate-2, or high‑risk by the International Prognostic Scoring System (IPSS). For reauthorization, documentation must show the patient does not have progressive disease while on Inqovi therapy.

Initial authorization: documented MDS diagnosis and IPSS risk group (intermediate-1, intermediate-2, or high-risk).
Reauthorization: documentation of no evidence of progressive disease on Inqovi.
Supply limits may apply and will be enforced where configured.

Step Therapy

Step-Therapy Guidance

There is no formal step-therapy requirement specified; however, NCCN guidance notes Inqovi may be used as an oral substitution for intravenous decitabine in patients with IPSS intermediate-1 and above. Providers should reference NCCN substitution guidance when considering alternatives but should not assume an administrative step-therapy pathway is mandated by this policy.

NCCN: Inqovi may substitute for IV decitabine for patients with IPSS intermediate-1 or higher.
No policy-level mandatory step-therapy sequence is specified.

Documentation Required

Supporting Documentation and Denial Risks

UnitedHealthcare may use previous claim or medication history, diagnosis codes (ICD-10), and automated claim logic to approve initial authorizations or reauthorizations. Approvals via these automated processes depend on program configuration. Missing required documentation of diagnosis or IPSS risk group may lead to denial.

Automated approval possible when prior claims/medication history and diagnosis codes support the request.
Ensure submitted documentation includes MDS diagnosis and IPSS risk group; absence of these elements is a common basis for denial.
Supply limits noted in system may restrict approved quantity or duration.

Step Therapy Guidance

Step	Requirement / Guidance
No formal step-therapy required	Policy does not specify a required prior agent or failure of therapy before Inqovi may be approved; initial authorization is based on diagnosis and IPSS risk (see coverage criteria).
NCCN substitution guidance	NCCN notes Inqovi may be considered as a substitution for intravenous decitabine in patients with IPSS intermediate-1 and above.

Quantity Limits and Dispensing Rules

Inqovi — quantity limits

Quantity limit statementSupply limits may be in place per program

Automated approval impactUnitedHealthcare may approve based on previous claim/medication history and claim logic; supply limits still may apply

Program variationUse of automated approval and re-approval processes and any supply limits varies by program and/or therapeutic class

Background on Inqovi and Indication

Inqovi is a fixed-oral combination of decitabine (a nucleoside metabolic inhibitor) and cedazuridine (a cytidine deaminase inhibitor) that provides an oral alternative to intravenous decitabine for appropriate patients with myelodysplastic syndromes. The product labeling and compendia are cited as the primary clinical references for the mechanism and indication; UnitedHealthcare’s program references these sources in periodic reviews and incorporates NCCN guidance when considering site-of-care and substitution of oral for IV decitabine.