Epogen — Medical Mutual

Preferred products

• Retacrit

Initial criteria

• Patient is at least 18 years of age (unless otherwise specified); AND
• Initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30% (unless otherwise specified); AND
• Lab values are obtained within 30 days of the date of administration (unless otherwise indicated); AND
• Patient has adequate iron stores as demonstrated by serum ferritin ≥ 100 ng/mL and TSAT ≥ 20%; AND
• Other causes of anemia have been ruled out; AND
• Patient does not have uncontrolled hypertension
• MDS: Patient has symptomatic anemia AND serum erythropoietin ≤ 500 mU/mL with lower risk disease AND appropriate mutation/ring sideroblast criteria AND no response to or relapse after ESA or luspatercept depending on scenario
• Myelofibrosis: Serum erythropoietin < 500 mU/mL AND used as single agent or in combination with ruxolitinib based on splenomegaly/constitutional symptoms
• Chemotherapy-induced anemia: Patient age ≥ 5 years AND anemia due to myelosuppressive non-myeloid chemotherapy AND chemotherapy not intended as curative (palliative) AND ≥ 2 additional months of planned chemotherapy
• Chronic Kidney Disease anemia (non-dialysis): Patient age ≥ 1 month
• Chronic Kidney Disease anemia (dialysis): Patient age ≥ 1 month AND patient does not have ESRD or stage 5 CKD
• HIV + Zidovudine anemia: Age ≥ 8 months AND endogenous serum erythropoietin ≤ 500 mU/mL AND zidovudine dose ≤ 4200 mg/week
• Surgery transfusion reduction: Hb 10–13 g/dL or Hct 30–39% AND high risk of blood loss in elective, non-cardiac, non-vascular surgery AND patient unwilling or unable to participate in autologous donation

Reauthorization criteria

• Patient continues to meet universal and other indication-specific relevant criteria; AND
• Previous dose administered within the past 60 days; AND
• Disease response with treatment as defined by improvement in anemia compared to pretreatment; AND
• Absence of unacceptable toxicity; AND
• MDS: Hb <12 g/dL and/or Hct <36%
• Myelofibrosis: Hb <10 g/dL and/or Hct <30%
• Chemotherapy-induced anemia: Continue per initial criteria
• CKD (non-dialysis): Pediatric: Hb <12 g/dL and/or Hct <36%; Adult: Hb <11 g/dL and/or Hct <33%
• CKD (dialysis): Pediatric: Hb <12 g/dL and/or Hct <36%; Adult: Hb <11 g/dL and/or Hct <33%
• HIV + Zidovudine anemia: Hb <12 g/dL and/or Hct <36% AND zidovudine ≤ 4200 mg/week
• Surgery transfusion reduction: Coverage may not be renewed

Approval duration

60 days initial, 6 months renewal