ModifiedCentenePolicy CP.PHAR.479

Decitabine/Cedazuridine (Inqovi)

Medical necessity and prior authorization criteria for use of oral decitabine/cedazuridine (Inqovi) in adults with myelodysplastic syndromes (MDS) across Centene lines of business (Commercial, HIM/ICHRA, Medicaid).

Policy Summary

PayerCentene

PolicyDecitabine/Cedazuridine (Inqovi)

Policy CodePolicy CP.PHAR.479

Change TypeMaterial updates to approval durations and step therapy exceptions

Effective Date07.07.20

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition and added ICHRA line of business.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Modified commercial approval duration to '12 months or duration of request, whichever is less'.

Updated Appendix D with revised language and exception for Tennessee and Indiana.

Added ICHRA line of business.

35 mg/100 mgtablet strength

Days 1-5 q28ddosing schedule

≥18minimum age

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Coverage Criteria for Decitabine/Cedazuridine (Inqovi)

Initial Therapy (MDS)

Covered when ALL of the following are met:

Initial MDS criteria: 1. Diagnosis of MDS; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age >= 18 years; 4. Member must use decitabine unless one of the following applies: (a) decitabine is contraindicated or clinically significant adverse effects are experienced; or (b) request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix D). For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395; 5. Request meets one of the following: (a) dose does not exceed 35 mg decitabine/100 mg cedazuridine (1 tablet) per day on Days 1 through 5 of each 28-day cycle; or (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy (MDS)

Covered when ALL of the following are met:

Continued therapy criteria: 1. Currently receiving medication via Centene benefit, or documentation supports current use for a covered indication and member has received Inqovi for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, request meets one of the following: (a) new dose does not exceed 35 mg decitabine/100 mg cedazuridine (1 tablet) per day on Days 1 through 5 of each 28-day cycle; or (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: Medicaid/HIM/ICHRA - 12 months; Commercial - 12 months or duration of request, whichever is less.

Requests for indications that are not FDA-approved and not explicitly addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. For Commercial lines follow CP.CPA.09, for HIM/ICHRA follow HIM.PA.154, and for Medicaid follow CP.PMN.53; evidence of coverage documents may also apply.

For Medicaid members, state Medicaid coverage provisions take precedence and will supersede any conflicting statements in this clinical policy. Providers should consult the applicable state Medicaid manual for specific coverage rules and requirements. Coverage decisions and administration of benefits remain subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents and applicable state and federal requirements.

Uses or diagnoses that are not listed under the authorized sections of this policy are considered not medically necessary unless the request is supported by the off‑label use policies or other evidence documents referenced in this policy (see CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating sufficient efficacy and safety.

Dosing and Regimen Information

Regimen	Indication	Minimum duration	Maximum daily dose
1 tablet (35 mg decitabine/100 mg cedazuridine) PO QD on Days 1–5 of each 28-day cycle
MDS (myelodysplastic syndromes, including CMML and specified IPSS risk groups)
Minimum of 4 cycles (continue until disease progression or unacceptable toxicity).
1 tablet (35 mg decitabine/100 mg cedazuridine) per day

Relevant Codes and Dosing Key Values

Codes referencedmixed

N/A	Document does not list CPT/HCPCS/ICD-10/NDC codes in this section

Maximum daily dose

Maximum daily dose1 tablet (35 mg decitabine/100 mg cedazuridine) per day

Recommended dosing schedule1 tablet PO QD on Days 1–5 of each 28-day cycle (minimum 4 cycles)

Tablet strength35 mg decitabine / 100 mg cedazuridine

Use untilContinue until disease progression or unacceptable toxicity

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is contingent on a valid diagnosis, prescriber specialty, age ≥ 18 years, step therapy requirements (member must use decitabine unless contraindicated or prohibited by state regulation), and dosing within specified limits or supported by guidelines/literature.

PA required
Prescriber: oncologist or hematologist (or in consultation)
Age ≥ 18 years
Step therapy: trial of decitabine required unless contraindicated or state law prohibits redirection
Dose limit: ≤ 35 mg decitabine/100 mg cedazuridine (1 tablet) QD Days 1–5 per 28-day cycle, unless supported by guidelines/literature

Step Therapy

Step Therapy / Redirection

Member must use decitabine prior to decitabine/cedazuridine (Inqovi) unless one of the following applies: decitabine is contraindicated or causes clinically significant adverse effects, or the request is for a state with regulations that prohibit step therapy/redirection in oncology. Illinois HIM exceptions apply per IL HB 5395 (effective 1/1/2026).

Therapy Line and Informational Notes

Line of Therapy (informational)

FDA indication scope: Inqovi is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS and chronic myelomonocytic leukemia (CMML) across specified FAB subtypes and IPSS intermediate-1, intermediate-2, and high-risk groups.

Informational: describes the FDA-approved indication and scope; not itself a coverage condition.

Definitions

Definition — Myelodysplastic Syndromes (MDS) and covered disease groups

FDA‑approved disease groupsMyelodysplastic syndromes (MDS) including de novo and secondary MDS and chronic myelomonocytic leukemia (CMML)

FAB subtypes includedRefractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; CMML

IPSS risk groups includedIntermediate‑1, Intermediate‑2, and High‑risk groups

Definition — Health Plan

DefinitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable.

RoleProvides the administrative and coverage framework under which this clinical policy is applied

Background

Inqovi is an oral combination of decitabine (a nucleoside metabolic inhibitor) and cedazuridine (a cytidine deaminase inhibitor) formulated to provide systemic exposure to decitabine when given orally for the treatment of adult patients with myelodysplastic syndromes. As an oral fixed‑dose tablet, the drug delivers decitabine exposure comparable to intravenous decitabine by inhibiting cytidine deaminase to prevent presystemic metabolism of decitabine.

Policy Revision History

03.26.26annual_review

2Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months for maintenance therapy; updated Appendix D with revised language and exception for Tennessee and Indiana; added ICHRA line of business.

05.26P&T_approvalLatest

P&T approval of 2Q 2026 annual review updates.

06.27.25policy_clarification

Added step therapy bypass for Illinois HIM per IL HB 5395 (applies to Illinois HIM requests as of 01/01/2026).