COVERED USES:

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

1. Anemia due to chronic renal failure (Aranesp®/Epogen®/Procrit®)
2. Anemia due to chemotherapy for cancer and related neoplastic conditions (Aranesp®/Epogen®/Procrit®)
3. Anemia due to Myelodysplastic Syndrome (MDS) (Aranesp®/Epogen®/Procrit®)
4. Anemia associated with zidovudine-treated HIV-infection patients (Epogen/Procrit)
5. Anemia associated with the treatment of specific chronic diseases with agents known to cause anemia (rheumatoid arthritis, hepatitis C, regional enteritis (or Chron's Disease), and ulcerative colitis (Epogen®/Procrit®)
6. Preoperative use in anemic patients scheduled for elective hip or knee surgery (Epogen®/Procrit®)

Unless otherwise stated in this policy, requests for a non-FDA approved ("off-label") uses of this medication will be considered on a case-by-case basis subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

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. For 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,
AND
2. Must meet listed criteria below each specific diagnosis:
   1. Treatment of Anemia in Chronic Renal Failure (CRF)
      1. Aranesp®/Epogen®/Procrit® may be covered
      2. See appendix for dosing considerations (subject to audit)
   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)
      4. See appendix for dosing considerations (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. ii. 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.

• Covered range during treatment: HGB 10-12g/dL or HCT 30-36%
  • Dosing should be adjusted for patients to achieve and maintain target HGB not to exceed 12g/dL
• HCT and HCT levels must be drawn and documented within 30 days of the requested date of service

EXCLUSION CRITERIA:

• Patients with uncontrolled hypertension
• Anemia due to folate, B-12 or iron deficiency, hemolysis, bleeding, or bone marrow fibrosis
• Anemia associated with CML, AML or erythroid cancers
• Anemia of cancer not related to cancer treatment

COVERAGE DURATION:

Initial auth. approval for 2 mo. Reauth. approval for 1 mo as outlined in Criteria section