Amgen - Medical Professionals - Reimbursement

Using Reimbursement Connection®

Understanding Your Questions

The Reimbursement Connection® from Amgen provides a broad range of coverage and reimbursement assistance to help you avoid and resolve billing-related problems. Insurance coverage can vary greatly, as can insurer billing requirements. The Reimbursement Connection® is designed to assist you in navigating through the insurance maze.

How Can the Reimbursement Connection® Help You?

Review coverage requirements for Amgen Products
Provide coding and billing-related assistance
Explain payor reimbursement policies
Provide prior authorization support
Provide information regarding claims appeal procedures
Help identify alternative funding sources
Provide information regarding the SAFETY NET® Foundation for medically needy patients

The Reimbursement Connection® has more than fifteen years of experience providing personalized support regarding reimbursement policies, coding and billing procedures, insurance verifications, prior authorization and claims appeals for Amgen products. Our reimbursement experts can answer questions about Medicare, Medicaid, and private insurers, including managed care. One call helps you resolve issues and obtain reimbursement results.

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.

Please click here for accompanying Aranesp® package insert for full prescribing information, including Boxed WARNINGS.

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