ONUREG (azacitidine)
SELF ADMINISTRATION - ORAL
Indications for Prior Authorization:
- Indicated for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (Cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Patients must meet the following criteria for the indication(s) above:
- Initial Criteria:
- Diagnosis of acute myeloid leukemia (AML), AND
- Prescribed by or in consultation with a hematologist/oncologist, AND
- Patient has received previous treatment with an intensive induction chemotherapy regimen (e.g., cytarabine + daunorubicin, cytarabine + idarubicin, etc.), AND
- Patient has received ONE of the following:
- First complete remission (CR), OR
- Complete remission with incomplete blood count recovery (Cri), AND
- Patient is not able to complete intensive curative therapy
- Reauthorization criteria:
- Documentation showing absence of disease progression while on therapy
Dosing:
- 300 mg once daily on days 1 through 14 of a 28-day treatment cycle
Coverage Duration:
- Initial:
- 1 year
- Reauthorization:
- 1 year
Additional Information:
- If absolute neutrophil count (ANC) is less than < 500/mm3 on day 1 of cycle, do not administer Onureg®
- Delay the start of the cycle until the ANC is ≥ 500/mm3
Authorization is Not Covered for the Following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.
Review History:
- October 27, 2020 - Original review
References:
- Onureg® prescribing information. Celgene Corporation. Summt, NJ. September 2020.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia. v4.2020. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed October 7,2020.
Last review date: February 16, 2021