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Clinical Policy Bulletin:
Decitabine (Dacogen)
Number: 0868


Policy

Decitabine (Dacogen) is considered medically necessary for members with myelodysplastic syndrome (MDS) and for acute myeloid leukemia (AML).



Background

Dacogen has been approved by the FDA for myelodysplastic syndromes: "Decitabine for injection is indicated for treatment of patients 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 intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.”

Guidelines from the National Comprehensive Cancer Network indicate Dacogen for the following indications:

  • Myelodysplastic Syndromes (MDS) - Treatment in higher risk patients who

    • are not candidates for high-intensity therapy
    • are high-intensity therapy candidates awaiting improved patient status or donor availability
    • relapse after allogeneic hemopoietic stem cell transplant [2A]

  • Myelodysplastic syndromes -- Treatment in lower risk patients with symptomatic anemia, del(5q) with or without other cytogenetic abnormalities, and serum erythropoietin levels >500 mU/mL with no response or intolerance to lenalidomide and low probability of response to immusuppressive therapy [2A]

  • Myelodysplastic syndromes -- Initial treatment in lower risk patients with

    • symptomatic anemia and serum erythropoietin levels >500 mU/mL with no del(5q) with or without other cytogenetic abnormalities and a low probability of response to immunosuppressive therapy
    • clinically relevant thrombocytopenia or neutropenia, or increased marrow blasts [2A]
  • Acute Myeloid Leukemia (AML) - Used as a single agent for low-intensity therapy in patients age ≥60 years as

    • induction therapy
    • postremission therapy [2A]
  • Acute Myeloid Leukemia (AML) - Used as a single agent in patients who cannot tolerate more agressive regimens for

    • postinduction therapy in patients age <60 years with induction failure
    • salvage chemotherapy [2A]

 Appendix

Table 1. French-American- British (FAB) Classification of MDS

Subtype

% Blasts in Peripheral Blood

% Blasts in Bone Marrow

Survival in Months

Refractory Anemia (RA)

<1

<5

19-64

Refractory Anemia with Ringed Sideroblasts (RARS)

<1

<5

21-76

Refractory Anemia with Excess Blasts (RAEB)

<5

5-20

7-15

Refractory Anemia with Excess Blasts in Transformation (RAEB-t)

>5

21-30

5-12

Chronic Myelomonocytic Leukemia (CMML)

<5

5-20

8-60+

Source: NCCN, 2013; Dacogen prescribing information.

Table 2: International Prognostic Scoring System (IPSS) for MDS

Score Values

Prognostic Variable

0

0.5

1.0

1.5

2

BM Blast (%)

<5

5-10

N/A

11-20

21-30

Karyotype

Good

Intermediate

Poor

 

 

Cytopenias

0-1

2 or 3

 

 

 

 

Outcomes According to IPSS 

 

 

N=816

 

N=759

 

Prognosis Score

IPSS Subgroup

Patients (%)

Median Survival (yrs) in absence of therapy

Patients (%)

Median AML transformation (yrs)

0

Low

33

5.7

31

9.4

0.5-1.0

Int-1

38

3.5

39

3.3

1.5-2.0

Int-2

22

1.2

22

1.1

≥2.5

High

7

0.4

8

0.2

Source: NCCN, 2013, Dacogen prescribing information.  

Table 3:  Supportive Care Measures for Myelodysplastic Syndrome

Observation:

  • Clinical monitoring
  • Psychosocial support
  • Quality-of-life assessment

Iron Chelation:

  • If >20-30 RBC transfusions received
  • If ongoing RBC transfusions are anticipated
  • If serum ferritin > 2,500ng/mL (aiming to decrease serum ferritin to <1,000ng/mL)

Transfusion:

  • RBC transfusions for symptomatic anemia
  • Platelet transfusions for thrombocytopenic bleeding
  • Irradiated products suggested for transplant candidates

Hematopoeitic Cytokines:

  • EPO
  • GCSF: platelet count monitored
  • Not recommended for routine use
  • Aminocaproic acid or other antifibrinolytic agents may be considered for bleeding refractory to platelet transfusions or profound cytopenias
Aminocaproic acid or other antifibrinolytic agents may be considered for bleeding refractory to platelet transfusions or profound cytopenias

Antibiotics for bacterial infections

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96360 - 96368
96374 - 96379
HCPCS codes covered if selection criteria are met:
J0894 Injection, decitabine, 1 mg
ICD-9 codes covered if selection criteria are met:
205.00 - 205.02 Myeloid leukemia
205.10 Chronic myeloid leukemia, without mention of having achieved remission
205.12 Chronic myeloid leukemia, in relapse
205.20 Subacute myeloid leukemia, without mention of having achieved remission
238.72 - 238.75 Myelodysplastic syndrome


The above policy is based on the following references:
  1. National Comprehensive Cancer Network (NCCN). Myelodysplastic Syndromes (MDS). Clinical Practice Guidelines in Oncology-.v.2.2013 Available at http://www.nccn.org.  Accessed June 2011, March 2013
  2. Dacogen™ [package insert]. Bloomington, MN: MGI Pharma, Inc.; October 2010.
  3. Dacogen™ Formulary Dossier. Bloomington, MN. MGI Pharma, Inc. September 2006.
  4. Dacogen [NCCN Drugs and Biologics Compendia]. http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=137. Accessed June 2011, March 2013
  5. Dacogen. [DrugDex Compendia] http://www.micromedexsolutions.com/micromedex2. Accessed June 2011, March 2013
  6. Dacogen [Clinical Pharmacology Compendia] http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=2649&n=Dacogen. Accessed March 2013


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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