Aranesp — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years (unless otherwise specified); AND
• Initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30%; AND
• Lab values obtained within 30 days of administration; AND
• Patient has adequate iron stores (serum ferritin ≥ 100 ng/mL AND TSAT ≥ 20%); AND
• Other causes of anemia ruled out; AND
• Patient does not have uncontrolled hypertension; AND
• For MDS: Patient has symptomatic anemia AND serum erythropoietin level ≤ 500 mU/mL AND lower risk disease (IPSS-R Very Low, Low, Intermediate) AND therapy used as single agent or in combination as specified AND patient had no response or relapse after ESA or luspatercept; OR patient criteria with ring sideroblasts and del(5q) status as specified.
• For MPN-Myelofibrosis: Patient has myelofibrosis-associated anemia with serum erythropoietin < 500 mU/mL; AND either used in combination with ruxolitinib if symptomatic, or used as single agent if asymptomatic.
• For Chemotherapy-induced anemia: Patient has anemia due to concomitant myelosuppressive chemotherapy for a non-myeloid malignancy; AND chemotherapy not intended to cure (palliative); AND ≥ 2 additional months of planned chemotherapy.
• For CKD Non-Dialysis: Patient age ≥ 1 month.
• For CKD Dialysis: Patient age ≥ 1 month AND patient does not have ESRD or stage 5 CKD.

Reauthorization criteria

• Patient continues to meet universal and indication-specific criteria; AND
• Previous dose administered within past 60 days; AND
• Disease response with treatment as defined by improvement in anemia compared to pretreatment baseline; AND
• Absence of unacceptable toxicity (examples: pure red cell aplasia, severe allergic reactions, severe cardiovascular events, uncontrolled hypertension, seizures, tumor progression risk, severe cutaneous reactions, etc.); AND
• For MDS: Hemoglobin < 12 g/dL and/or Hematocrit < 36%;
• For MPN-Myelofibrosis: Hemoglobin < 10 g/dL and/or Hematocrit < 30%;
• For Chemotherapy: Refer to initial criteria;
• For CKD Non-Dialysis: Pediatric: Hb < 12 g/dL and/or Hct < 36%, Adult: Hb < 11 g/dL and/or Hct < 33%;
• For CKD Dialysis: Pediatric: Hb < 12 g/dL and/or Hct < 36%, Adult: Hb < 11 g/dL and/or Hct < 33%

Approval duration

60 days initial, renew every 6 months