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Drug - Idhifa®  (enasidenib tablets) [Celgene Corporation]

December 2018

Therapeutic area - Oral Oncology

Initial approval criteria

  • Patient is 18 years of age or older AND
  • Patient has diagnosis of acute myeloid leukemia (AML)† AND
  • Patient has an isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA approved test (e.g., RealTime™ IDH2 Assay) AND
  • Must be used as single agent therapy AND
    • Patient has relapsed or refractory disease OR
    • Patient who is ≥ 60 years old and used in place of or is not a candidate for intensive therapy OR will undergo post-remission therapy following response to a previous lower intensity therapy
  • Initial approval is for 6 moths

Renewal criteria

  • Patient continues to meet the criteria above AND
  • Absence of unacceptable toxicity from the drug AND
  • Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
  • Renewal approval is for 6 months

Quantity limits

  • 50 mg tablets: 1 tablet/day
  • 100 mg tablets: 1 tablet/day


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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