CurrentNeighborhood Health Plan of Rhode IslandPolicy 2288-A

decitabine (treatment indications and authorization)

This policy governs payer coverage and prior authorization requirements for decitabine for adults when used for FDA-approved indications and select compendial oncology uses under Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policydecitabine (treatment indications and authorization)

Policy CodePolicy 2288-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals up to 12 months may be granted when approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MDSprimary FDA indication listed

12 monthstypical authorization duration

Multiplecompendial indications

Coverage Criteria for Decitabine

FDA-approved Indication: Myelodysplastic syndromes (MDS)

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

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FDA-approved MDS coverage: Patient is an adult with myelodysplastic syndromes (MDS), including previously treated or untreated; de novo or secondary MDS of all French-American-British (FAB) 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 is in an intermediate-1, intermediate-2, or high‑risk International Prognostic Scoring System (IPSS) group.

Based on FDA indication per product labeling.

Compendial Indications

Covered compendial uses when approval criteria are met:

Compendial hematologic malignancies: Use for acute myeloid leukemia (AML); accelerated phase or blast phase myeloproliferative neoplasms; lower‑risk myelodysplastic syndromes associated with thrombocytopenia, neutropenia, symptomatic anemia, or increased marrow blasts; blastic plasmacytoid dendritic cell neoplasm (BPDCN); myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasms (e.g., chronic myelomonocytic leukemia [CMML], BCR‑ABL negative atypical CML, MDS/MPN with neutrophilia, unclassifiable MDS/MPN, MDS/MPN NOS, MDS/MPN with ring sideroblasts and thrombocytosis, MDS/MPN with SF3B1 mutation); and classic Hodgkin lymphoma.

All listed compendial uses are covered only when the specific approval criteria for the chosen indication are met. All other indications are considered experimental/investigational and not medically necessary.

BPDCN combination therapy

Covered with specified combinations/settings:

BPDCN with venetoclax: Decitabine in combination with venetoclax is authorized for blastic plasmacytoid dendritic cell neoplasm (BPDCN) when used for either: (1) treatment of relapsed or refractory disease, or (2) treatment of systemic disease with palliative intent.

Authorization duration: up to 12 months when criteria are met.

Hodgkin lymphoma subsequent-line therapy

Covered with line-of-therapy requirement:

Classic Hodgkin lymphoma: Decitabine in combination with pembrolizumab may be authorized for subsequent treatment of classic Hodgkin lymphoma when the disease is refractory to at least three prior lines of therapy.

Authorization duration: up to 12 months when criteria are met.

Continuation of therapy

Continuation/reauthorization criteria:

Continuation therapy: Reauthorization may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen for an indication listed in the Coverage Criteria section.

Authorization typically available for up to 12 months per approval.

Regimen	Indication / Setting	Authorization Duration	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":"12 months","status":""},{"text":"Covered with criteria","status":"covered"}
{"text":"Decitabine + Pembrolizumab","status":""},{"text":"Classic Hodgkin lymphoma — subsequent treatment when disease is refractory to at least 3 prior lines of therapy","status":""},{"text":"12 months","status":""},{"text":"Covered with criteria","status":"covered"}

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for decitabine. Approvals up to 12 months may be granted when approval criteria are met.

Prior Authorization

Line-of-Therapy Requirement for Hodgkin Lymphoma

Authorization for decitabine in combination with pembrolizumab for classic Hodgkin lymphoma is limited to subsequent-line use. Authorization may be granted for up to 12 months when the disease is refractory to at least 3 prior lines of therapy and all other approval criteria are met.

Documentation Required

Necessary Documentation

Requests for authorization must include documentation of the treated indication and relevant clinical information demonstrating medical necessity. For initial requests, provide diagnosis, prior therapies and responses, line of therapy, and any supporting pathology, lab, or imaging reports. For reauthorization requests, document clinical benefit (no evidence of disease progression) and absence of unacceptable toxicity while on the current regimen. Approval durations (when granted) and reauthorization should align with the criteria in the Coverage Criteria and Continuation of Therapy sections.

Denial Risk

Experimental / Investigational Exclusions

Use of decitabine for indications not listed in the Coverage Criteria (including uses outside the FDA-approved and compendial indications such as AML, BPDCN, MDS/MPN overlap, and classic Hodgkin lymphoma only when criteria are not met) is considered experimental/investigational and not medically necessary.

Line-of-Therapy Definitions

subsequent-line

Subsequent-line requirement: For classic Hodgkin lymphoma, treatment with decitabine plus pembrolizumab is limited to subsequent‑line therapy when disease is refractory to ≥3 prior lines of therapy.

See line‑of‑therapy requirements for authorization.

salvage

Salvage setting: For BPDCN, decitabine in combination with venetoclax is authorized in the salvage setting for relapsed or refractory disease or for systemic disease with palliative intent.

Authorization duration: up to 12 months when criteria are met.

Regimens and Combination Therapies

Regimen	Clinical Details / Required Context	Documentation / Prior Auth Notes	Coverage Status
{"text":"Decitabine + Venetoclax","status":""},{"text":"Authorized for BPDCN when used for relapsed or refractory disease, or for systemic disease with palliative intent","status":""},{"text":"Prior authorization required; requests should document the treated indication and that the regimen is for relapsed/refractory or palliative systemic BPDCN. Authorization may be for up to 12 months.","status":""},{"text":"Covered with criteria","status":"covered"}
{"text":"Decitabine + Pembrolizumab","status":""},{"text":"Authorized for classic Hodgkin lymphoma as subsequent-line therapy when disease is refractory to at least 3 prior lines of therapy","status":""},{"text":"Prior authorization required; requests should document prior lines of therapy and that disease is refractory to ≥3 prior lines. Authorization may be for up to 12 months.","status":""},{"text":"Covered with criteria","status":"covered"}

Key Definitions

Myelodysplastic syndromes (MDS) — definition and included subtypes

DefinitionMyelodysplastic syndromes (MDS): Decitabine is indicated for treatment of adult patients with MDS, including previously treated and untreated; de novo and secondary MDS of all French‑American‑British (FAB) 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 IPSS intermediate‑1, intermediate‑2, and high‑risk groups.

Included FAB subtypesRefractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia (CMML).

Risk groupsIncludes patients in IPSS intermediate‑1, intermediate‑2, and high‑risk categories.

Prior treatment statusApplies to both previously treated and untreated adult patients.

MDS/MPN overlap neoplasms — includes CMML, aCML, and related entities

DefinitionMDS/MPN overlap neoplasms include chronic myelomonocytic leukemia (CMML); BCR‑ABL negative atypical chronic myeloid leukemia (aCML); MDS/MPN with neutrophilia; unclassifiable MDS/MPN; MDS/MPN not otherwise specified (NOS); MDS/MPN with ring sideroblasts and thrombocytosis; and MDS/MPN with SF3B1 mutation.

Includes CMMLChronic myelomonocytic leukemia (CMML) is explicitly listed as an included entity.

Includes aCMLBCR‑ABL negative atypical chronic myeloid leukemia (aCML) is included.

Other specified entitiesMDS/MPN with neutrophilia; unclassifiable MDS/MPN; MDS/MPN NOS; MDS/MPN with ring sideroblasts and thrombocytosis; MDS/MPN with SF3B1 mutation.

Background

Decitabine is a hypomethylating agent used primarily for hematologic malignancies. In this policy it is indicated for myelodysplastic syndromes (MDS) per the FDA-approved indication and is also supported for select compendial uses (for example, AML, accelerated/blast-phase myeloproliferative neoplasms, lower-risk MDS with cytopenias or increased marrow blasts, BPDCN, MDS/MPN overlap neoplasms, and classic Hodgkin lymphoma). The policy limits coverage to those listed FDA-approved and compendial indications; all other uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policydecitabine (treatment indications and authorization)

Policy CodePolicy 2288-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals up to 12 months may be granted when approval criteria are met.

SourceLink

On This Page

OpenPayer

decitabine (treatment indications and authorization)

Coverage Criteria for Decitabine

Covered Drug Coding

Provider Requirements and Prior Authorization

Line-of-Therapy Definitions

Regimens and Combination Therapies

Key Definitions

Background

Revision History