CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inqovi (decitabine and cedazuridine) — Coverage Criteria

Defines accepted indications, coding, and utilization management requirements for Inqovi (oral decitabine/cedazuridine) for members receiving care through Neighborhood Health Plan of Rhode Island (processed by Evolent). Affects prescribing providers submitting medication requests and utilization management reviewers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInqovi (decitabine and cedazuridine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionreference update

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documenting the indication, prior authorization history for continuation, and evidence supporting use per FDA labeling or accepted compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1410 Inqovi guideline.

Updated references to current compendia and literature.

J8999billing code listed for Inqovi

5/momaximum treatment limit

35/100 mgdose per tablet

Commercial, Exchange, Medicaidapplicable lines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Inqovi

inv-01: Initial and Subsequent Therapy Criteria

Covered when ALL of the following are met

Indication: Member has a diagnosis of myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML)

Inqovi may be used as first-line or subsequent treatment; oral fixed-dose combination of decitabine 35 mg and cedazuridine 100 mg.

Evidence support: Use is supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature

Per Purpose: required supporting sources for coverage.

Dosing limits: Prescribed dosing does not exceed the single tablet strength (decitabine 35 mg / cedazuridine 100 mg) and does not exceed 5 tablets per month<= 5 tablets/month

Exceeding single dose limit or monthly maximum is an exclusion/denial trigger.

inv-02: Continuation Therapy

Continuation therapy covered when ALL of the following are met

No disease progression: Member has not experienced disease progression on the requested medication

Continuation exemption applies per policy.

Recent therapy: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<=30 day lapse

Documents should show prior active authorization within past year.

No regimen changes: No additional medication(s) are being added to the continuation request

If additional agents are added, standard review applies.

Coverage is limited to dosing that does not exceed the single-tablet strength of Inqovi, which is decitabine 35 mg / cedazuridine 100 mg. Requests that propose dosing above this single-dose limit will be excluded. Additionally, treatment that would result in more than 5 tablets per month is not covered. Investigational use or off‑label indications for Inqovi that lack sufficient evidence or are not generally accepted by the medical community are excluded from coverage; sufficiency is assessed against CMS‑recognized compendia and acceptable peer‑reviewed literature.

Off‑label uses of Inqovi are considered not approvable unless there is adequate supporting evidence. Evidence is required from FDA labeling, CMS‑recognized compendia, authoritative guidelines, or acceptable peer‑reviewed literature that appropriately represents the patient population, regimen, and clinically meaningful outcomes. Case reports, meeting abstracts without a full peer‑reviewed publication, or other anecdotal/uncontrolled data are generally insufficient to support coverage of off‑label indications.

Regimen	Indication	Coverage status	Notes
Oral decitabine 35 mg / cedazuridine 100 mg fixed‑dose tablet (Inqovi)
Myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML)
Covered with criteria
Use per FDA labeling and supported compendia/guidelines; dosing must not exceed single tablet strength and maximum of 5 tablets per month

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J8999

decitabine 35mg-cedazuridine 100mg

Maximum tablets per month

Maximum monthly quantity5 tablets per month

Single dose strength limitDo not exceed single tablet strength: decitabine 35 mg / cedazuridine 100 mg

Exclusion if exceededRequests exceeding the single dose limit or >5 tablets/month will be excluded/denied

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Inqovi (decitabine and cedazuridine). Providers must submit clinical documentation that supports medical necessity consistent with FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature. Evolent will process medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Submit prior authorization request to Evolent per payer instructions
Include clinical notes, diagnosis, prior therapies, and treatment intent

Step Therapy

Continuation / Step Therapy Notes

Continuation (renewal) requests may be approved without re‑establishing full initial-authorization criteria when all of the following are met: the member has not experienced disease progression on the requested medication; the same medication was used within the last year with no lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request. If these conditions are not met, submit full supporting documentation for initial review.

Covered Regimens and Dosing

Regimen component	Strength / dosing per tablet	Maximum allowed per month	Supporting references / notes
Decitabine (component of fixed‑dose tablet)
35 mg per oral tablet (fixed‑dose combination)
Not to exceed 5 tablets per month
FDA prescribing information and compendia (NCCN, Clinical Pharmacology, Micromedex) support use for MDS/CMML; prior authorization required with documentation per policy

Line(s) of Therapy

inv-13: first-line

Line: Inqovi may be used as first-line or subsequent treatment for MDS/CMML

Policy allows use in any line as clinically indicated (oral fixed-dose decitabine 35 mg / cedazuridine 100 mg).

Definitions

Inqovi — product definition

Product descriptionInqovi is an oral fixed‑dose combination tablet containing decitabine 35 mg and cedazuridine 100 mg

IndicationsUsed to treat myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML); may be used as first‑line or subsequent therapy

Reference prescribing informationSee Inqovi prescribing information (Taiho Oncology, Inc., 2022) and cited clinical literature

Background

Inqovi is an oral fixed‑dose combination tablet containing decitabine 35 mg and cedazuridine 100 mg indicated for treatment of myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). Use may be as first‑line or subsequent therapy when supported by applicable labeling or accepted compendia/guidelines.

Revision History and Changes

2025-04template_conversion_and_policy_replacementLatest

Converted to the new Evolent guideline template and replaced prior policy identifier UM ONC_1410 for Inqovi (decitabine and cedazuridine).

2024-04verbiage_update

Updated organizational verbiage from NCH to Evolent.

2025references_refresh

References updated to include current compendia and literature (2025 compendia and resources).