CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0030

Decitabine

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This policy governs coverage, authorization duration, dosing limits, administration, renewal, and billing for intravenous decitabine in adults with specified hematologic malignancies, including MDS, AML, adult classic Hodgkin lymphoma, BPDCN, accelerated/blast-phase MPN, and MDS/MPN overlap neoplasms.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyDecitabine

Policy CodePolicy IC-0030

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewFeb 4, 2025

Next Review DateN/A

Key ActionDocument the patient's age, diagnosis and disease subtype, applicable treatment requirements, toxicity status, and objective evidence of disease stability or improvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

18+Minimum patient age

6Covered disease categories

250–900 mgMaximum dosing range

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Coverage Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age.
ONE of the following covered conditions
- Myelodysplastic syndromes (MDS).
- Myeloid leukemia (AML).
- Adult classic Hodgkin lymphoma (cHL).
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- Accelerated/blast phase myeloproliferative neoplasms (MPN-AP/BP).
- Myelodysplastic/myeloproliferative (MDS/MPN) overlap neoplasms, including ONE of the following
  - Chronic myelomonocytic leukemia type 1 or 2 (CMML-1 or CMML-2).
  - MDS/MPN with neutrophilia.
  - MDS/MPN not otherwise specified (NOS).
  - MDS/MPN with SF3B1 mutation and thrombocytosis.

Renewal Criteria

Coverage can be renewed when ALL of the following are met:

ALL of the following

The patient continues to meet the relevant indication-specific criteria identified in the Initial Approval Criteria, such as concomitant therapy requirements (not including prerequisite therapy), performance status, and other applicable requirements.
There is no unacceptable toxicity from the drug.
Examples of unacceptable toxicity include serious myelosuppression, such as anemia, neutropenia, and thrombocytopenia.
- Decrease in bone marrow blast percentage.
- Increase in platelets.
- Increase in hemoglobin.

Medicare Part B Coverage

Medicare coverage determinations for outpatient Part B drugs must follow applicable CMS requirements, including any existing National Coverage Determination (NCD), Local Coverage Determination (LCD), and Local Coverage Article (LCA).

Medicare Part B requirements

The preceding policy information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Publication 100-2), Chapter 15, Section 50, Drugs and Biologicals.
Compliance with applicable NCDs and LCDs is required. LCAs may also apply for claims payment purposes or to clarify benefit eligibility under Part B for drugs that may be self-administered.
Search applicable NCD, LCD, or LCA documents in the CMS Medicare Coverage Database: https://www.cms.gov/medicare-coveragedatabase/search.aspx
Medicare Part B covered diagnosis codes applicable to existing NCDs, LCDs, or LCAs: N/A.
Applicable Medicare Part B Administrative Contractor (MAC) jurisdictions and contractors include: E (1)—CA, HI, NV, American Samoa, Guam, and Northern Mariana Islands—Noridian Healthcare Solutions, LLC; F (2 & 3)—AK, WA, OR, ID, ND, SD, MT, WY, UT, and AZ—Noridian Healthcare Solutions, LLC; 5—KS, NE, IA, and MO—Wisconsin Physicians Service Insurance Corp (WPS); 6—MN, WI, and IL—National Government Services, Inc. (NGS); H (4 & 7)—LA, AR, MS, TX, OK, and CO—Novitas Solutions, Inc., and NM—Wisconsin Physicians Service Insurance Corp (WPS); N (9)—FL, Puerto Rico, and U.S. Virgin Islands—First Coast Service Options, Inc.; J (10)—TN, GA, and AL—Palmetto GBA; M (11)—NC, SC, WV, and VA, excluding areas otherwise specified—Palmetto GBA; L (12)—DE, MD, PA, NJ, and DC, including Arlington and Fairfax—Novitas Solutions, Inc.; K (13 & 14)—NY, CT, MA, RI, VT, ME, and NH—National Government Services, Inc. (NGS); and 15—KY and OH—CGS Administrators, LLC.

Covered Treatment Regimens

Coverage	Regimen
Covered	Treat for a minimum of 4 cycles: decitabine 15 mg/m² IV over 3 hours, repeated every 8 hours (45 mg/m²/day) for 3 days; repeat cycles every 6 weeks.
Covered	Treat for a minimum of 4 cycles: decitabine 20 mg/m² IV over 1 hour daily for 5 days; repeat cycles every 4 weeks.

Coverage	Regimen
Covered	Decitabine 20 mg/m² IV over 1 hour on days 1 through 5 of every 28-day cycle until disease progression or unacceptable toxicity.
Covered	Decitabine 20 mg/m² IV over 1 hour on days 8 through 12 of a 35-day cycle for 1 cycle, followed by days 1 through 5 of every 28-day cycle beginning with cycle 2 until disease progression or unacceptable toxicity.

Coverage	Regimen
Covered	Decitabine 20 mg/m² IV over 1 hour on days 1 through 5 of every 28-day cycle until disease progression or unacceptable toxicity.
Covered	Decitabine 20 mg/m² IV over 1 hour on days 1 through 10 of every 28-day cycle until disease progression or unacceptable toxicity.

Coverage	Regimen
Covered	Decitabine 20 mg/m² IV over 1 hour on days 1 through 5 of every 28-day cycle until disease progression or unacceptable toxicity.

Coverage	Regimen
Covered	Decitabine 20 mg/m² IV over 1 hour on days 1 through 5 of every 28-day cycle until disease progression or unacceptable toxicity.
Covered	Decitabine 20 mg/m² IV over 1 hour on days 8 through 12 of every 28-day cycle until disease progression or unacceptable toxicity.

Coverage	Regimen
Covered	Decitabine 10 mg IV over 1 hour on days 1 through 5 of a 21-day cycle until disease progression or unacceptable toxicity.

Billing Codes and Dose Limits

HCPCS CodesHCPCS

J0894	Injection, decitabine, 1 mg; 1 billable unit = 1 mg
J0893	Injection, decitabine (sun pharma), not therapeutically equivalent to J0894, 1 mg; 1 billable unit = 1 mg
J9999	Not otherwise classified, antineoplastic

NDCNDC

59148-0046-xx

Dacogen 50 mg powder in a single-dose vial for injection