Prior authorization criteria for:

Aranesp®


(darbepoetin alfa)



Epogen®,

Procrit®


(erythropoietin)

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COVERED USES:

FDA Approved Indications:

Aranesp®

  1. Anemia due to chronic renal failure
  2. Anemia due to chemotherapy for cancer and related neoplastic conditions

Epogen®/Procrit®

  1. Anemia due to chronic renal failure
  2. Anemia due to chemotherapy for cancer and related neoplastic conditions
  3. Anemia associated with zidovudine-treated HIV-infection patients
  4. Reduction of allogenic blood transfusion in surgery patients.

All FDA-approved indications not otherwise excluded from Part D.

Off-Label Indications:

Procrit®, Epogen®:

  1. Anemia associated with the treatment of specific chronic diseases with agents known to cause anemia (rheumatoid arthritis, hepatitis C, regional enteritis (or Crohn's Disease), and ulcerative colitis)
  2. Treatment of Anemia in Myelodysplastic Syndrome (MDS)

Aranesp®:

  1. Treatment of Anemia in Myelodysplastic Syndrome (MDS)

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

Hemoglobin and Hematocrit levels within 30 days prior to initiation of therapy.

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

  1. All diagnoses (with the exception of 2.f) must have documented Hemoglobin (HGB) levels of less than or equal to 10g/dl or Hematocrit levels of less than or equal to 30% within 30 days prior to initiation of therapy,
    2. AND
  2. Must meet listed criteria below for each specific diagnosis:
    1. Treatment of Anemia in Chronic Renal Failure (CRF)
      1. Aranesp®/Epogen®/Procrit® may be covered
    2. Treatment of anemia due to chemotherapy in cancer and related neoplastic conditions (see exclusion criteria for non-covered indications)
      1. Aranesp®/Epogen®/Procrit® may be used
      2. Must be secondary to myelosuppressive anticancer chemotherapy
      3. May only be used up to 8 weeks following the final dose of myelosuppressive chemotherapy (subject to audit)
    3. Treatment of Anemia in Myelodysplastic Syndrome (MDS)
      1. Aranesp®/Epogen®/Procrit® may be approved
      2. Must have documented endogenous erythropoietin levels of less than 500 mIU/ml.
    4. Anemia associated with zidovudine-treated HIV-infection patients:
      1. Coverage is for epoetin only (Procrit®, Epogen®)
      2. Documented endogenous serum erythropoietin level is less than or equal to 500 mIU/ml
      3. Zidovudine dose is less than or equal to 4200mg/week
    5. Anemia associated with the treatment of specific chronic diseases with agents known to cause anemia (rheumatoid arthritis, hepatitis C, regional enteritis (or Crohn's Disease), and ulcerative colitis):
      1. Coverage is for epoetin only (Procrit®, Epogen®)
      2. Treatment may not be continued beyond 8 weeks after therapy with agent known to cause anemia is complete
    6. Preoperative use in anemic patients scheduled for elective hip or knee surgery
      1. Coverage is for epoeitin only (Procrit®, Epogen®)
      2. All of the following must be met
        1. Member must be scheduled to undergo elective hip or knee surgery
        2. Member has preoperative anemia with pretreatment HGB between 10 and 13 g/dL
        3. Member is expected to lose more than 2 units of blood
        4. Member has received an appropriate preoperative workup revealing that the anemia appears to be that of chronic disease.

For all diagnoses, initial 2 month therapy duration will be authorized. Additional therapy will be authorized on a month to month basis through claims audit if a response to therapy has been demonstrated.

EXCLUSION CRITERIA:

COVERAGE DURATION:

Initial authorization will be approved for up to 2 months. Reauthorization will be approved for up to 1 month as outlined in Criteria section.

How to use this information: