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

Decitabine (Dacogen; Decitabine) Prior Authorization Criteria

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Prior authorization, dosing limits, initial approval, renewal, administration, billing, and covered diagnoses for intravenous decitabine in adults with selected myeloid malignancies.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyDecitabine Prior Authorization Criteria

Policy CodePolicy IC-0030

Change TypeNo material change

Effective DateN/A

Last ReviewAug 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for intravenous decitabine and document that the patient is at least 18 years old with a covered indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAuthorization period

18 yearsMinimum patient age

10 vialsVial quantity limit

5Covered disease categories

4 cycles

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

Decitabine (Dacogen; Decitabine) Prior Authorization Criteria

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Sign up for security_health_plan_of_wisconsin_inc Policy IC-0030 alerts

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Prior authorization, dosing limits, initial approval, renewal, administration, billing, and covered diagnoses for intravenous decitabine in adults with selected myeloid malignancies.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyDecitabine Prior Authorization Criteria

Policy CodePolicy IC-0030

Change TypeNo material change

Effective DateN/A

Last ReviewAug 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for intravenous decitabine and document that the patient is at least 18 years old with a covered indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAuthorization period

18 yearsMinimum patient age

10 vialsVial quantity limit

5Covered disease categories

4 cycles

Minimum MDS treatment

23Covered diagnosis codes

Coverage Criteria

Initial Therapy

Coverage is provided when all of the following are met:

Initial approval

ALL of the following
- Covered disease indication
  - Myelodysplastic syndromes (MDS).
  - Acute myeloid leukemia (AML).
  - Blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  - Accelerated/blast-phase myeloproliferative neoplasms (MPN-AP/BP).
  - MDS/MPN overlap neoplasm, including chronic myelomonocytic leukemia type 1 or 2 (CMML-1 or 2), MDS/MPN with neutrophilia, MDS/MPN not otherwise specified (NOS) (overlap syndrome), MDS/MPN with SF3B1 mutation and thrombocytosis, or MDS/MPN with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) with wildtype SF3B1 mutation.

Continuation/Renewal Therapy

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

Renewal criteria

The patient continues to meet relevant indication-specific criteria identified in the initial approval criteria, such as applicable concomitant therapy requirements and performance status requirements (not including prerequisite therapy).
There is no unacceptable toxicity from decitabine.
Examples of unacceptable toxicity include serious myelosuppression, such as anemia, neutropenia, and thrombocytopenia.
Evidence of disease stability or improvement
- Decrease in bone marrow blast percentage.
- Increase in platelet count over the pretreatment value.

Billing and Coding Requirements

Covered HCPCS CodesHCPCSCovered

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

Covered NDCNDCCovered

59148-0046-xx

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

Covered Diagnosis CodesICD-10Covered

C86.4	Blastic NK-cell lymphoma
C92.00	Acute myeloblastic leukemia, not having achieved remission
C92.01	Acute myeloblastic leukemia, in remission
C92.02	Acute myeloblastic leukemia, in relapse
C92.20	Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.22	Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
C92.50	Acute myelomonocytic leukemia, not having achieved remission
C92.51	Acute myelomonocytic leukemia, in remission
C92.52	Acute myelomonocytic leukemia, in relapse
C92.60	Acute myeloid leukemia with 11q23-abnormality, not having achieved remission

1–10 of 40

1/4

Covered Diagnosis CodesICD-10Covered

C93.02	Acute monoblastic/monocytic leukemia in relapse
C93.10	Chronic myelomonocytic leukemia, not having achieved remission
C93.11	Chronic myelomonocytic leukemia, in remission
C93.12	Chronic myelomonocytic leukemia, in relapse
C94.40	Acute panmyelosis with myelofibrosis, not having achieved remission
C94.41	Acute panmyelosis with myelofibrosis, in remission
C94.42	Acute panmyelosis with myelofibrosis, in relapse
C94.6	Myelodysplastic disease, not elsewhere classified
D46.0	Refractory anemia without ring sideroblasts, so stated
D46.1	Refractory anemia with ring sideroblasts

1–10 of 23

1/3

50 mg Single-Dose Vial Quantity Limit

ProductDecitabine 50 mg single-dose vial

Quantity limit10 vials

Limit periodPer 28 days

MDS Maximum Units

IndicationMyelodysplastic syndromes (MDS)

Maximum900 billable units (900 mg)

Limit period

Authorization and Documentation

Prior Authorization

Prior Authorization and Initial Approval

Prior authorization is required for decitabine coverage. For initial approval, document that the patient is at least 18 years of age and has a covered indication listed in the policy.

Submit the diagnosis, disease subtype, and clinical documentation supporting the applicable indication.
Covered indications include MDS, AML, BPDCN, MPN-AP/BP, and MDS/MPN overlap neoplasms.

Documentation Required

Diagnosis and Age

Document that the patient is at least 18 years of age and identify the specific diagnosis and disease subtype supporting treatment.

Myelodysplastic syndromes (MDS)
Acute myeloid leukemia (AML)

Policy Background

Decitabine is an intravenous hypomethylating antineoplastic agent used for selected myeloid malignancies. This policy addresses coverage for myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), accelerated/blast-phase myeloproliferative neoplasms (MPN-AP/BP), and eligible MDS/MPN overlap neoplasms.

For continued coverage, treatment must remain appropriate for the disease-specific indication, be tolerated without unacceptable toxicity, and demonstrate objective disease stability or improvement, such as decreased bone marrow blasts or increased platelets, hemoglobin, WBC, or ANC compared with pretreatment values.

Definitions

Eligible MDS/MPN Overlap Neoplasms

Chronic myelomonocytic leukemiaCMML-1 or CMML-2

MDS/MPN with neutrophiliaEligible overlap neoplasm subtype

MDS/MPN NOSMDS/MPN not otherwise specified (NOS), also called overlap syndrome

MDS/MPN with SF3B1 mutationMDS/MPN with SF3B1 mutation and thrombocytosis

MDS/MPN-RS-TMDS/MPN with ring sideroblasts and thrombocytosis with wildtype SF3B1 mutation

505(b)(2) Product

Approval pathwayFDA-approved 505(b)(2) new drug application (NDA)

Disease-Specific Treatment Regimens

Indication	Covered decitabine regimen	Coverage
Myelodysplastic syndromes (MDS)	Treat for a minimum of 4 cycles using either: (1) 15 mg/m² IV over 3 hours every 8 hours for 3 days (45 mg/m²/day), repeating every 6 weeks; or (2) 20 mg/m² IV over 1 hour daily for 5 days, repeating every 4 weeks.	Covered

Indication	Covered decitabine regimen	Coverage
MDS/MPN overlap neoplasms	Either: (1) 20 mg/m² IV over 1 hour on days 1–5 of every 28-day cycle until disease progression or unacceptable toxicity; or (2) 20 mg/m² IV over 1 hour on days 8–12 of a 35-day cycle for cycle 1, followed by 20 mg/m² IV on days 1–5 of every 28-day cycle beginning with cycle 2 until disease progression or unacceptable toxicity.	Covered

Indication	Covered decitabine regimen	Coverage
Acute myeloid leukemia (AML)	Either: (1) 20 mg/m² IV over 1 hour on days 1–5 of every 28-day cycle until disease progression or unacceptable toxicity; or (2) 20 mg/m² IV over 1 hour on days 1–10 of every 28-day cycle until disease progression or unacceptable toxicity.	Covered

Indication	Covered decitabine regimen	Coverage
Blastic plasmacytoid dendritic cell neoplasm (BPDCN)	20 mg/m² IV over 1 hour on days 1–5 of every 28-day cycle until disease progression or unacceptable toxicity.	Covered

Indication	Covered decitabine regimen	Coverage
Accelerated/blast-phase myeloproliferative neoplasms (MPN-AP/BP)	20 mg/m² IV over 1 hour on days 1–5 or days 8–12 of every 28-day cycle until disease progression or unacceptable toxicity.	Covered

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyDecitabine Prior Authorization Criteria

Policy CodePolicy IC-0030

Change TypeNo material change

Effective DateN/A

Last ReviewAug 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for intravenous decitabine and document that the patient is at least 18 years old with a covered indication.

SourceLink

On This Page

Increase in hemoglobin over the pretreatment value.

Increase in WBC or ANC over the pretreatment value.

AML Maximum Units

IndicationAcute myeloid leukemia (AML)

Maximum500 billable units (500 mg)

Limit periodPer 28 days

MDS/MPN, BPDCN, and MPN-AP/BP Maximum Units

Applicable indicationsMDS/MPN overlap neoplasms, blastic plasmacytoid dendritic cell neoplasm (BPDCN), and accelerated/blast-phase myeloproliferative neoplasms (MPN-AP/BP)

Maximum250 billable units (250 mg)

Limit periodPer 28 days

Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Accelerated/blast phase myeloproliferative neoplasms (MPN-AP/BP)

Myelodysplastic/myeloproliferative (MDS/MPN) overlap neoplasms, including CMML-1 or 2, MDS/MPN with neutrophilia, MDS/MPN NOS, MDS/MPN with SF3B1 mutation and thrombocytosis, and MDS/MPN-RS-T with wildtype SF3B1 mutation.

Documentation Required

Renewal Response and Toxicity Documentation

For renewal, document that the patient continues to meet the indication-specific criteria, has no unacceptable toxicity, and demonstrates disease stability and/or improvement.

Address relevant indication-specific requirements, such as concomitant therapy and performance status, when applicable.
Document absence of unacceptable toxicity, including serious myelosuppression such as anemia, neutropenia, or thrombocytopenia.
Provide evidence of disease stability or improvement, such as decreased bone marrow blasts or increased platelets, hemoglobin, or WBC/ANC compared with pretreatment values.

Documentation Required

Disease-Specific Treatment Regimen

Document the disease-specific decitabine regimen, including dose, intravenous administration, schedule, cycle length, minimum treatment duration when applicable, and continuation criteria.

MDS: 15 mg/m² IV over 3 hours every 8 hours for 3 days, repeated every 6 weeks; or 20 mg/m² IV over 1 hour daily for 5 days, repeated every 4 weeks. Treat for a minimum of 4 cycles.
MDS/MPN: 20 mg/m² IV over 1 hour on days 1–5 of each 28-day cycle; or days 8–12 of a 35-day first cycle followed by days 1–5 of each 28-day cycle from cycle 2, until progression or unacceptable toxicity.
AML: 20 mg/m² IV over 1 hour on days 1–5 or days 1–10 of each 28-day cycle, until progression or unacceptable toxicity.
BPDCN: 20 mg/m² IV over 1 hour on days 1–5 of each 28-day cycle, until progression or unacceptable toxicity.
MPN-AP/BP: 20 mg/m² IV over 1 hour on days 1–5 or days 8–12 of each 28-day cycle, until progression or unacceptable toxicity.

Note

Apply Applicable CMS Coverage Policies

For Medicare determinations, apply the applicable CMS coverage requirements for outpatient Part B drugs in addition to this policy.

Review Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50, Drugs and Biologicals.
Comply with applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs).
Search applicable CMS policies through the Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx.

Denial Risk

Age or Indication Outside Criteria

Initial coverage criteria require the patient to be at least 18 years of age and to have one of the listed covered indications. Requests for patients younger than 18 or for an indication outside those listed may be denied.

Confirm age and the specific covered diagnosis before submitting the request.
Document the applicable disease subtype and, for MDS/MPN overlap neoplasms, the qualifying subtype.

Denial Risk

Failure to Meet Renewal Criteria

Renewal may be denied when indication-specific requirements are not maintained, unacceptable toxicity is present, or the required documentation of disease stability or improvement is not submitted.

Document continued fulfillment of relevant indication-specific criteria.
Document absence of unacceptable toxicity, including serious myelosuppression.
Submit objective evidence of response or stability compared with pretreatment values.

Denial Risk

Dosing or Quantity Limit Exceeded

Requests exceeding the applicable quantity or disease-specific billable-unit limits may be denied. Verify both the NDC vial limit and the HCPCS-unit limit before submitting or billing.

50 mg single-dose vial: maximum 10 vials per 28 days.
MDS: maximum 900 billable units (900 mg) per 84 days.
AML: maximum 500 billable units (500 mg) per 28 days.
MDS/MPN, BPDCN, and MPN-AP/BP: maximum 250 billable units (250 mg) per 28 days.

Reference-listed-drug conditionThe product is not rated therapeutically equivalent to its reference listed drug in the FDA Orange Book

Product classificationConsidered a single-source product under the statutory definition of single-source drug