Idhifa®
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
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411