Mircera — Medical Mutual

Anemia due to chronic kidney disease (non-dialysis patients)

Initial criteria

Patient does not have end stage renal disease (ESRD) or stage 5 chronic kidney disease; 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 (mcg/L) and transferrin saturation (TSAT) ≥ 20% (measured within the previous 3 months for renewal); AND
Other causes of anemia (e.g. hemolysis, bleeding, vitamin deficiency, etc.) have been ruled out; AND
Patient does not have uncontrolled hypertension; AND
For anemia due to chronic kidney disease (non-dialysis patients): Initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30%; AND patient is age ≥ 18 years OR patient is age ≥ 3 months AND converting from another erythropoietin stimulating agent (ESA) (epoetin or darbepoetin) after stabilization with an ESA; AND
For anemia due to chronic kidney disease (dialysis patients): Initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30%; AND adult patients (age ≥ 18 years) receiving dialysis OR pediatric patients (age ≥ 5 years); AND patient is receiving hemodialysis; AND patient is converting from another ESA after stabilization of hemoglobin

Patient continues to meet the universal and other indication-specific criteria identified in section III; AND
Previous dose was administered within the past 60 days; AND
Disease response with treatment as defined by improvement in anemia compared to pretreatment baseline; AND
Absence of unacceptable toxicity from the drug (examples: pure red cell aplasia, severe allergic reactions including anaphylaxis, angioedema, bronchospasm, severe cutaneous reactions including erythema multiforme, SJS/TEN, severe cardiovascular events including stroke, myocardial infarction, congestive heart failure, thromboembolism, uncontrolled hypertension, seizures); AND
For anemia due to chronic kidney disease (non-dialysis patients): Pediatric patients must have Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%; Adult patients must have Hemoglobin (Hb) < 11 g/dL and/or Hematocrit (Hct) < 33%; AND
For anemia due to chronic kidney disease (dialysis patients): Pediatric patients must have Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%; Adult patients must have Hemoglobin (Hb) < 11 g/dL and/or Hematocrit (Hct) < 33%

60 days initial, 6 months renewal