CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inqovi (decitabine and cedazuridine) — Coverage Criteria

Defines accepted indications, coverage criteria, coding, and limits for Inqovi in treating cancer (notably MDS/CMML) for members whose medication requests are processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInqovi (decitabine and cedazuridine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionreferences updated

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with documentation showing FDA labeling, CMS-recognized compendia, or accepted oncology guideline support and ensure dosing does not exceed 5 tablets per month.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template.

5/monthmaximum treatment limit specified

35/100 mgdose per tablet

J8999billing code

Apr 2025last review

Coverage Criteria for Inqovi

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Covered Indications

Covered when ALL of the following are met

MDS indication: Member has myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) subtypes.

Supports first-line or subsequent treatment with Inqovi (decitabine 35 mg / cedazuridine 100 mg per tablet).

Evidence support: Use is supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature as defined in the policy.

Documentation should demonstrate adequacy of evidence and that clinical characteristics align with the cited references.

Dose limits: Requested dosing must not exceed the fixed single-tablet dose (decitabine 35 mg / cedazuridine 100 mg) and total treatment must not exceed 5 tablets per month.<= 5 tablets/month

Exceeding single-tablet dose or monthly tablet limit is excluded from coverage.

Coverage will be denied when any of the following exclusion criteria are met: dosing that exceeds the single-tablet composition of decitabine 35 mg / cedazuridine 100 mg; treatment that exceeds the maximum of 5 tablets per month; or use that is investigational for an off‑label indication lacking sufficient supporting evidence or general acceptance by the medical community.

Regimen	Indication	Coverage status
Decitabine 35 mg / cedazuridine 100 mg oral tablets (Inqovi)	Myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) subtypes; may be used as first-line or subsequent treatment.	Covered (with criteria)

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization through Evolent is required for Inqovi (decitabine and cedazuridine). Coverage is limited to specified indications and is subject to dosing, quantity, and other rules. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization required through Evolent
Coverage limited to specified indications; subject to dosing and quantity limits
Unauthorized medications may be not approvable and not reimbursable

Documentation Required

Continuation Exemption Criteria

Continuation requests may be exempt from prior authorization denial risk when continuity criteria are met. Exemption applies only if all specified continuity conditions are satisfied.

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of >30 days of active authorization
No additional medications are being added to the continuation request

Documentation Required

Evidence Requirements

Use of Inqovi must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Off-label or investigational requests without such support may be not approvable.

Supportive sources: FDA labeling, CMS compendia, NCCN, ASCO, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Ch. 15
Off-label or investigational uses require sufficient supporting evidence as defined by the policy (representation of patient/cancer characteristics, appropriate regimen representation, clinically meaningful outcomes, and acceptable study design)
Case reports and abstracts without full peer-reviewed articles generally do not provide adequate evidence

Denial Risk

Non-Approvable Requests

Requests for Inqovi may be not approvable and not reimbursable if not authorized by Evolent, if dosing or quantity limits are exceeded, or if the indication is investigational/off-label without adequate supporting evidence.

Not approvable if not authorized by Evolent
Not approvable if dosing exceeds single dose limit (decitabine 35 mg and cedazuridine 100 mg) or treatment exceeds maximum of 5 tablets per month
Not approvable if investigational/off-label indication lacks sufficient evidence per policy criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInqovi (decitabine and cedazuridine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionreferences updated

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Inqovi (decitabine and cedazuridine) — Coverage Criteria

Coverage Criteria for Inqovi

Billing and Coding

Provider Actions and Prior Authorization

Key Definitions

Line of Therapy Criteria

Background

Policy Revision History