CurrentEmblemHealthPolicy N/A

Dacogen (decitabine) IV for Myelodysplastic Syndrome

Defines medical necessity, dosing limits, and authorization requirements for intravenous decitabine (Dacogen) for treatment of myelodysplastic syndromes (MDS) for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyDacogen (decitabine) IV for Myelodysplastic Syndrome

Policy CodePolicy N/A

Change TypeMaterial clinical and operational updates (prescriber requirement, dosing/renewal clarifications, J-code added)

Effective DateN/A

Next Review DateMar 26, 2025

Key ActionSubmit clinical evidence that the member meets the criteria and obtain prior authorization showing the medication is prescribed by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

The medication is prescribed by or in consultation with an oncologist to criteria.

Updated dosing limits and removed a redundant statement from renewal criteria; added absence of unacceptable toxicity (examples: serious myelosuppression) to renewal criteria.

Added J-code J0893 (decitabine, 1 mg - Sun Pharma) as not therapeutically equivalent to J0894.

6 monthsinitial length of authorization

20 mg/m2maximum per-dose mg/m2

450 mgHCPCS billable units limit per 42 days (MDS)

J0894, J0893

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Coverage Criteria for Decitabine (Dacogen)

Initial Approval Criteria — Myelodysplastic Syndrome (MDS)

Covered when ALL of the following are met:

MDS indication and prescriber: Member has a diagnosis of myelodysplastic syndrome (MDS) of any subtype (including refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) classified as IPSS intermediate-1, intermediate-2, or high risk; and medication is prescribed by or in consultation with an oncologist.

Includes previously treated and untreated, de novo and secondary MDS

Renewal Criteria

Renewal is approved when ALL of the following are met:

Renewal conditions: Patient continues to meet initial approval criteria; there is tumor response defined as disease stabilization or reduction of tumor size/spread; and there is absence of unacceptable toxicity from the drug (examples include serious myelosuppression such as anemia, neutropenia, or thrombocytopenia).

Documentation should demonstrate continued benefit and acceptable toxicity profile

This policy excludes pediatric patients: Dacogen (decitabine) is not considered medically necessary for patients <18 years of age.

Use of Dacogen (decitabine) in patients under 18 years old is explicitly listed as not medically necessary and may be denied when submitted for coverage.

Regimen	Dose & Administration	Cycle Timing / Minimum
3-day regimen
15 mg/m2 administered by continuous IV infusion over 3 hours, repeated every 8 hours for 3 days
Repeat cycle every 6 weeks

Coding and Billing Information

Applicable HCPCS/J-codesHCPCS

J0894	Injection, decitibine, 1 mg
J0893	Injection, decitabine, 1 mg - (sun pharma) not therapeutically equivalent to J0894

Applicable NDCsNDC

59148-0046-70

Dacogen single use vial; 50 mg powder for solution

Applicable ICD-10 DiagnosesICD-10Covered

D46.0-D46.9

Myelodysplastic syndrome (MDS)

HCPCS billing limit (MDS)

HCPCS billing limit (MDS)450 billable units (450 mg) per 42 days

Maximum per-dose mg/m2

Maximum per-dose mg/m220 mg/m2 per dose

Provider Requirements and Actions

Prior Authorization

Prior authorization required for decitabine

Prior authorization required. Decitabine (Dacogen) requests must include evidence that the member meets the initial approval criteria for MDS and that the medication is prescribed by or in consultation with an oncologist.

Applicable J-codes: J0894, J0893

Step Therapy

Step therapy not required vs Vidaza

No prior failure or intolerance to azacitidine (Vidaza) is required before authorization; the prior requirement for physician documentation of failure/intolerance to Vidaza was removed.

Documentation Required

Background

Decitabine (Dacogen) is a hypomethylating agent that undergoes intracellular phosphorylation and inhibits DNA methyltransferase, resulting in DNA hypomethylation which can lead to cellular differentiation or apoptosis and cytotoxicity in rapidly dividing cells. It is indicated for treatment of various subtypes of myelodysplastic syndromes (MDS) and is relatively less active in non-proliferating cells.

Definitions

Decitabine mechanism

Mechanism of actionUndergoes phosphorylation and inhibits DNA methyltransferase leading to DNA hypomethylation, cellular differentiation or apoptosis; cytotoxicity in rapidly dividing cells via covalent adducts between decitabine and DNA methyltransferase incorporated into DNA.

Line of Therapy

Mixed — Line of therapy determination

Line of therapy: Covers previously treated and untreated MDS (de novo and secondary).

No explicit line restriction (first-line or later).