CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inqovi (decitabine and cedazuridine) — Coverage Criteria

Defines accepted indications, authorization requirements, dosing limits, and evidence standards for coverage of Inqovi for members across applicable lines of business. Applies to providers submitting medication requests to Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInqovi (decitabine and cedazuridine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent and include supporting evidence from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5/monthmaximum monthly tablet limit for Inqovi

J8999billing code listed

MDS/CMMLcovered indication

CMS/NCCN/ASCOacceptable evidence sources

≤30 dayscontinuation lapse threshold

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Coverage Criteria for Inqovi

Medical necessity criteria — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial therapy / general medical necessity

The member has MDS, including chronic myelomonocytic leukemia subtypes.
Inqovi is being used as an oral fixed‑dose combination therapy (decitabine 35 mg and cedazuridine 100 mg).
Requested use is supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Continuation therapy criteria — Continuation authorization exemption when ALL of the following are met

Continuation authorization exemption when ALL of the following are met:

Continuation therapy criteria

The member has not experienced disease progression on the requested medication.
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
Additional medication(s) are not being added to the continuation request.

Documentation Required

Covered regimen note — oral fixed‑dose combination decitabine 35 mg and cedazuridine 100 mg

Provider actions and billing limits to watch for: single‑dose and monthly quantity limits and required documentation for continuation requests.

Dose/quantity limit: Dosing must not exceed the single‑dose strength of the fixed combination (decitabine 35 mg and cedazuridine 100 mg) and treatment must not exceed 5 tablets per month.
Provider action — Dose or quantity limit exceeded: Requests that exceed the single‑dose or monthly quantity limits may be denied; verify prescribed dose and quantity against the fixed‑dose tablet strength and the 5 tablets/month limit before submission.
Provider action — Continuation request documentation: For continuation authorization exemption, include documentation that the member has not progressed on therapy, evidence of continuous use within the past year without a >30‑day lapse, and confirmation that no additional medications are being added.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J8999

decitabine 35mg-cedazuridine 100mg

Maximum monthly tablets

Maximum monthly tablets<= 5 tablets per month

Source regimen single-dose limitSingle dose = decitabine 35 mg + cedazuridine 100 mg

Coverage consequenceRequests exceeding the 5 tablets/month limit may be excluded from coverage

Provider Requirements and Authorization

Prior Authorization

Prior authorization required; billing code J8999

Prior authorization is required through Evolent for medication requests. Use billing code J8999 for decitabine 35 mg–cedazuridine 100 mg.

Submit authorization requests to Evolent per policy
Bill using HCPCS code J8999 for decitabine 35mg‑cedazuridine 100mg

Step Therapy

Line of therapy: first‑line or subsequent allowed

Inqovi may be used as first‑line or subsequent (later‑line) treatment for MDS, including CMML; no step‑therapy sequencing restrictions are specified in the guideline.

Use is permitted in first‑line or subsequent therapy settings for MDS/CMML

Regimens and Dosing

Regimen	Indication	Coverage status
Oral fixed-dose combination: decitabine 35 mg + cedazuridine 100 mg	Treatment of myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML)	Covered when medical necessity criteria are met

Position in Treatment Pathway

first-line | subsequent

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

No further sequencing restrictions specified

Key Definitions

MDS including CMML — definition

TermMyelodysplastic Syndromes (MDS), including chronic myelomonocytic leukemia (CMML)

Regimen describedOral fixed-dose combination therapy: decitabine 35 mg + cedazuridine 100 mg

Line of therapyMay be used as first-line or subsequent treatment

Background

Inqovi is an oral fixed‑dose combination of decitabine 35 mg and cedazuridine 100 mg indicated for treatment of myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). Prior authorization is required for medication requests submitted through Evolent, and billing is captured under HCPCS code J8999 for decitabine 35 mg–cedazuridine 100 mg. Coverage requires that dosing not exceed the single‑dose combination and that total treatment not exceed 5 tablets per month unless supported by acceptable evidence per policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInqovi (decitabine and cedazuridine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent and include supporting evidence from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

On This Page

Documentation Required

Supporting evidence required from accepted sources

Use must be supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature consistent with the Medicare Benefit Policy Manual Chapter 15.

Provide references to FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS Chapter 15 standards to support the request

Documentation Required

Continuation requests: required documentation

For continuation (renewal) requests, documentation must show no disease progression, prior use within the last year without a lapse >30 days of active authorization, and that no additional medications are being added to the request.

Document no disease progression on the requested medication
Confirm medication was used within the last year with ≤30‑day lapse in authorization
Confirm no additional medication(s) are being added to the continuation request

Denial Risk

Denial risk: insufficient evidence for investigational/off‑label use

Requests for investigational or off‑label indications lacking sufficient supporting evidence per CMS‑recognized compendia or acceptable peer‑reviewed literature may be deemed not approvable and not reimbursable.

If evidence does not meet CMS compendia, NCCN/ASCO, FDA labeling, or CMS Chapter 15 peer‑review standards, the request may be denied

Billing Rule

Denial risk: dose or monthly quantity limits exceeded

Requests that exceed the single‑dose limit (decitabine 35 mg and cedazuridine 100 mg) or the maximum of 5 tablets per month may be excluded from coverage.

Do not request dosing greater than decitabine 35 mg / cedazuridine 100 mg per single dose
Do not exceed a total of 5 tablets per month for coverage