CurrentNeighborhood Health Plan of Rhode IslandPolicy 2288-A

Decitabine (drug coverage) — Coverage Criteria

Coverage criteria for decitabine for FDA-approved indications and compendial uses for members of Neighborhood Health Plan of Rhode Island when approval criteria and member eligibility are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDecitabine (drug coverage) — Coverage Criteria

Policy CodePolicy 2288-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document the decitabine product, indication, and that the member meets approval criteria; authorizations may be granted up to 12 months for listed indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration per indication

FDA & compendiacoverage limited to FDA-approved and compendial uses

Multipleindications listed

Coverage Criteria for Decitabine

MDS (FDA-approved)

Covered when ALL of the following are met for FDA-approved MDS indication

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MDS (FDA-approved): Patient is an adult with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; and chronic myelomonocytic leukemia) and with International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2, or high-risk groups.

Compendial indications

Covered compendial uses when approval criteria met

Compendial indications list: Indication is one of: acute myeloid leukemia (AML); accelerated phase or blast phase myeloproliferative neoplasms; lower‑risk myelodysplastic syndromes (MDS) associated with thrombocytopenia, neutropenia, symptomatic anemia, or increased marrow blasts; blastic plasmacytoid dendritic cell neoplasm (BPDCN); myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasms; or classic Hodgkin lymphoma.

All other indications are considered experimental/investigational and not medically necessary.

Specified combination and line requirements

Covered usage specifics

BPDCN use: For blastic plasmacytoid dendritic cell neoplasm (BPDCN), authorization may be granted for up to 12 months when decitabine is used in combination with venetoclax for either relapsed or refractory disease, or for systemic disease with palliative intent.12 months

Classic Hodgkin lymphoma use: For classic Hodgkin lymphoma, authorization may be granted for up to 12 months for subsequent treatment when decitabine is used in combination with pembrolizumab and the disease is refractory to at least 3 prior lines of therapy.12 months

Continuation / Reauthorization

Continuation of therapy

Reauthorization: Authorization of up to 12 months may be granted for continued treatment when the member is receiving decitabine for an indication listed in the Coverage Criteria and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

Coverage is provided for uses of decitabine that are either FDA‑approved or listed in accepted compendia. Compendial indications included in this policy are: acute myeloid leukemia (AML); accelerated phase or blast phase myeloproliferative neoplasms; lower‑risk MDS associated with thrombocytopenia, neutropenia, symptomatic anemia, or increased marrow blasts; blastic plasmacytoid dendritic cell neoplasm (BPDCN); MDS/MPN overlap neoplasms; and classic Hodgkin lymphoma (in specified combination and line). Uses must meet the approval criteria to be eligible for coverage.

Covered Regimens and Combinations

Regimen	Indication / Setting	Line	Coverage status
{"text":"decitabine + venetoclax","status":""},{"text":"Blastic plasmacytoid dendritic cell neoplasm (BPDCN): for relapsed or refractory disease, or for systemic disease with palliative intent","status":""},{"text":"salvage / relapsed or palliative","status":""},{"text":"Covered","status":"covered"}
{"text":"decitabine + pembrolizumab","status":""},{"text":"Classic Hodgkin lymphoma: for subsequent treatment when disease is refractory to at least 3 prior lines of therapy","status":""},{"text":"subsequent (after ≥3 prior lines)","status":""},{"text":"Covered","status":"covered"}

Line of Therapy Specifications

subsequent

Subsequent-line requirement: Decitabine in combination with pembrolizumab is covered as subsequent therapy for classic Hodgkin lymphoma when the disease is refractory to at least 3 prior lines of therapy.

salvage

Salvage-line settings: Combination use of decitabine with venetoclax for BPDCN may be authorized in relapsed or refractory disease or for systemic disease with palliative intent (salvage settings).

Provider Actions and Requirements

Prior Authorization

Prior authorization duration and indications

Authorization of up to 12 months may be granted for the listed indications when all coverage criteria are met and the member has no exclusions to the prescribed therapy. This includes initial and continuation requests when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Authorization duration: up to 12 months for listed indications
Continuation: reauthorization allowed for listed indications with no unacceptable toxicity or disease progression

Prior Authorization

Line requirement for Hodgkin lymphoma

For classic Hodgkin lymphoma, prior authorization may be granted for subsequent treatment with decitabine in combination with pembrolizumab only when the disease is refractory to at least three prior lines of therapy.

Indication: classic Hodgkin lymphoma — subsequent treatment in combination with pembrolizumab
Requirement: refractory to ≥3 prior lines of therapy

Documentation Required

Required documentation

Prescribers must provide documentation consistent with the approved indication and dosing information. Include relevant prior treatment history, pathology reports, and rationale for use (including combination therapy details when applicable). For continuation requests include documentation of clinical benefit and absence of unacceptable toxicity or disease progression.

Required documentation: prior treatment history, pathology reports, dosing and regimen details
Continuation requests: evidence of clinical benefit and no unacceptable toxicity or disease progression

Denial Risk

Non‑covered indications

Requests for use of decitabine for indications that are not listed as FDA‑approved or compendial in this policy are considered experimental/investigational and are not medically necessary. Such requests will be denied.

Non‑covered: any indication not listed as FDA‑approved or compendial (experimental/investigational)

Definitions and Disease Categories

MDS/MPN overlap neoplasms — examples

Included conditionsChronic myelomonocytic leukemia (CMML)

Included conditionsBCR-ABL negative atypical chronic myeloid leukemia (aCML)

Included conditionsMDS/MPN with neutrophilia

Included conditionsUnclassifiable MDS/MPN (MDS/MPN NOS)

Included conditionsMDS/MPN with ring sideroblasts and thrombocytosis

Included conditionsMDS/MPN with SF3B1 mutation

Background

Decitabine is a hypomethylating agent used in hematologic malignancies. The policy recognizes its primary role in treating adult patients with myelodysplastic syndromes (MDS) and also includes compendial uses in related disorders such as acute myeloid leukemia (AML), accelerated or blast‑phase myeloproliferative neoplasms, BPDCN, and MDS/MPN overlap neoplasms. Specific combination regimens and line‑of‑therapy requirements are detailed elsewhere in the policy.

Provider-Facing Summary

Note

Prior authorization at a glance — 12‑month authorizations for listed indications

Quick summary: prior authorization may be issued for up to 12 months for the covered indications (MDS, AML, accelerated/blast‑phase MPN, BPDCN with venetoclax for relapsed/refractory or palliative systemic disease, and MDS/MPN overlap neoplasms).

BPDCN authorization requires use in combination with venetoclax and is limited to relapsed/refractory or palliative systemic settings.
Classic Hodgkin lymphoma coverage (decitabine + pembrolizumab) has a separate line requirement (see policy).