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

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

Source: NCCN, 2013; Dacogen prescribing information.

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

Score Values

Outcomes According to IPSS 

Source: NCCN, 2013, Dacogen prescribing information.  

Table 3:  Supportive Care Measures for Myelodysplastic Syndrome