Medicaid coverage and reimbursement varies by state.

Many state Medicaid programs cover and reimburse drugs when administered in the physician office.

Many Medicaid programs also pay for the administration of the drug, but may require providers to secure prior authorization before the administration of Aranesp® (darbepoetin alfa).

For dates of service on or after January 1, 2006, Aranesp® use for non-ESRD patients is to be billed using J0881 per 1 mcg. J0881 continues to be in effect in 2007.

Hospital Outpatient

Some Medicaid programs allow coverage for Aranesp® administered in the hospital outpatient department.

• Generally, reimbursement is based on costs or charges. However, some states may reimburse for services on a per diem basis, which typically includes drugs like Aranesp®.
• Some programs limit outpatient benefits to a specified dollar amount per year, per patient
• For dates of service on or after January 1, 2006, Aranesp® use for non-ESRD patients is to be billed using J0881 per 1 mcg. J0881 continues to be in effect in 2007.

Hospital Inpatient

Medicaid programs should allow coverage for Aranesp® administered in the hospital inpatient setting.

• In this setting, some states reimburse on a per diem basis, others use DRGs (like Medicare), and others pay based on allowable costs
• Some programs may limit inpatient benefits by capping the number of inpatient days per year, per patient, by setting, or by a specified dollar amount per year, per patient

Pharmacy

State Medicaid programs are likely to cover Aranesp® for its approved indication when dispensed in the retail pharmacy.

Certain states may have prior authorization requirements for Aranesp®.

• Some states restrict the number of monthly prescriptions for Aranesp®

Medicaid reimbursement for Aranesp® varies by state.

• The national drug code (NDC) for Aranesp® will be required by most Medicaid agencies to determine reimbursement
• For pharmacy-dispensed products, Medicaid payment is usually based on either the AWP minus a percentage or the wholesale acquisition cost (WAC) plus a percentage
• Pharmacies generally also receive a dispensing fee, which varies from state to state

Medicaid coverage, coding, and payment policies for Aranesp® vary by setting and by state. The Reimbursement Connection® (1-800-272-9376) can assist you with identifying your state's policies and coding requirements.

The information provided in this section is of a general nature and for informational purposes only. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters and appropriate coding for a particular patient and/or procedure is always the responsibility of the provider or physician. The information provided in this section should in no way be considered a guarantee of coverage or reimbursement for any product or service.

Aranesp® (darbepoetin alfa) Indications and Important Safety Information including Boxed WARNINGS

Indications

Aranesp® is indicated for the treatment of anemia:

• associated with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis.
• in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Aranesp® use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being. Aranesp® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.

Important Safety Information including Boxed WARNINGS

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL. Cancer: ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL. The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL. To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions. Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy. Discontinue following the completion of a chemotherapy course.

Aranesp® is contraindicated in patients with uncontrolled hypertension. Patients with chronic renal failure (CRF) experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels in two clinical studies. Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients. Aranesp® and other ESAs increased the risks for death and serious cardiovascular events in controlled clinical trials of patients with cancer. These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks. Seizures have occurred in patients with CRF participating in Aranesp® clinical trials.

Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®. This has been reported predominantly in patients with CRF receiving Aranesp® by subcutaneous administration. A sudden loss of response to Aranesp®, accompanied by severe anemia and low reticulocyte count, should be evaluated. If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp® and other erythropoietic proteins. Aranesp® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other erythropoietic proteins as antibodies may cross-react.

The most commonly reported side effects in clinical trials in patients with CRF were infection, hypertension, hypotension, myalgia, headache, and diarrhea. The most commonly reported side effects in clinical trials in patients with anemia due to concomitant chemotherapy were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.

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