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PrAranesp® (darbepoetin alfa) Reimbursement/ Coverage For Cancer Patients
Aranesp® (darbepoetin alfa)
 DIN(s)
| DIN | Quantity of Aranesp® | Volume | Aranesp® Concentration |
|---|
| 02246354 | 10mcg | 0.4mL | 25mcg/mL | | 02246355 | 20mcg | 0.5mL | 40mcg/mL | | 02246357 | 30mcg
40mcg
50mcg | 0.3mL
0.4mL
0.5mL | 100mcg/mL
100mcg/mL
100mcg/mL | | 02246358 | 60mcg
80mcg
100mcg
130mcg | 0.3mL
0.4mL
0.5mL
0.65mL | 200mcg/mL
200mcg/mL
200mcg/mL
200mcg/mL | | 02246360 | 150mcg
200mcg
300mcg
500mcg | 0.3mL
0.4mL
0.6mL
1.0mL | 500mcg/mL
500mcg/mL
500mcg/mL
500mcg/mL |
Aranesp® Product Monograph
Aranesp® is an eligible benefit through most private insurance plans, provincial drug benefit programs/ provincial cancer agencies and federal drug programs. The sidebar menu allows you to access specific information on coverage of Aranesp® including coverage/ reimbursement criteria and guidelines, limited use codes and criteria, special authorization forms, instructions and other resources.
Click on the plan or program name in the left sidebar menu to access more information.
This information pertains to Aranesp® prescribed for Cancer patients. For a full list of indications, please see the Aranesp® Product Monograph
The indication for Aranesp® use in cancer patients is:
Treatment of Anemia Due to Chemotherapy in Patients With Non-Myeloid Malignancies:
Aranesp® is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell (RBC) transfusions in patients with advanced or metastatic, non-myeloid malignancies. Studies to determine whether Aranesp® increases mortality or decreases progression-free/recurrence-free survival are ongoing.
- In patients with a long life expectancy, the decision to administer erythropoiesis-stimulating agents (ESAs) should be based on a benefit-risk assessment with the participation of the individual patient. This should take into account the specific clinical context such as (but not limited to) the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is being treated and known risks of transfusions and ESAs.
- If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy.
- Aranesp® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
Aranesp® is contraindicated in patients: with uncontrolled hypertension; who develop Pure Red Cell Aplasia (PRCA) following treatment with any ESAs; with known hypersensitivity to the active substance or any of the excipients; with sensitivity to mammalian cell-derived products or albumin. (Note: Albumin formulation not currently available in Canada.)
Serious Warnings and Precautions All Patients- To minimize the risks for death and serious cardiovascular events, follow the recommended dosage for each indication for Aranesp® and other erythropoiesis-stimulating agents (ESAs) (See WARNINGS AND PRECAUTIONS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and DOSAGE AND ADMINISTRATION in the Product Monograph).
- Patients with uncontrolled hypertension should not be treated with Aranesp®; blood pressure should be adequately controlled before initiation of therapy with Aranesp®.
- Aranesp® should be used with caution in patients with a history of seizures.
- Antibody-mediated Pure Red Cell Aplasia (PRCA) has been reported after months to years of treatment with ESAs.
Chronic Kidney Disease Patients- Patients experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower hemoglobin levels (135 vs. 113 g/L; 140 vs. 100 g/L) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 100 to 120 g/L.
Cancer Patients- ESAs increased the risks for death, serious cardiovascular and thromboembolic events in some controlled clinical trials.
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin level of ≥ 120 g/L.
- To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a reasonable long life expectancy and who are receiving myelosuppressive chemotherapy.
- Discontinue Aranesp® following the completion of a chemotherapy course.
Patients with chronic kidney disease and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients. Serious cardiovascular events included myocardial infarction, stroke, congestive heart failure, and an increased risk of serious arterial and venous thromboembolic events including hemodialysis vascular access thrombosis. A rate of hemoglobin rise of >10 g/L over 2 weeks may contribute to these risks.
Aranesp® and other ESAs increased the risks for death and serious cardiovascular and thromboembolic events in some controlled clinical trials of patients with cancer. A rate of hemoglobin rise of >10 g/L over 2 weeks may contribute to these risks.
CKD patients with hypo-responsiveness to ESAs may be at an increased risk for mortality and cardiovascular events. These patients should be evaluated for treatable conditions. These risks should be carefully weighed against the benefit to be derived from treatment with ESAs, particularly in cancer patients with increased risk factors of thrombotic events, such as patients with a prior history of VTEs (e.g., deep venous thrombosis or pulmonary embolism).
The safety and efficacy of Aranesp® therapy has not been established in patients with underlying hematologic diseases (e.g., hemolytic anemia, sickle cell anemia, thalassemia, porphyria). In order to ensure effective erythropoiesis, iron status should be evaluated for all patients before and during treatment as the majority of patients will eventually require supplemental iron therapy. Supplemental iron therapy is recommended for all patients whose serum ferritin is below 100 mcg/L or serum transferrin saturation is below 20%.
Use with caution in patients with a history of seizures. Seizures have occurred in patients participating in clinical trials of Aranesp® and rHuEPO. During the first several months of therapy, blood pressure and the presence of premonitory neurologic symptoms should be monitored closely. Patients should be cautioned to avoid potentially hazardous activities such as driving heavy machinery during this period. While the relationship between seizures and the rate of rise of hemoglobin is uncertain, it is recommended that the dose of Aranesp® be decreased if the hemoglobin increase exceeds 10 g/L in any 2-week period in CKD patients or 15 g/L in any 3-week period in cancer patients.
There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, skin rash, urticaria and allergic bronchospasm associated with Aranesp®. Symptoms have recurred with rechallenge, suggesting a causal relationship exists in some instances. If a serious allergic or anaphylactic reaction occurs, appropriate therapy should be administered and Aranesp® should be immediately and permanently discontinued.
ESAs, when administered to target a hemoglobin level of >120 g/L, shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy. ESAs also shortened survival in patients with metastatic breast cancer and in patients with lymphoid malignancy receiving chemotherapy when administered to target a hemoglobin level of ≥120 g/L.
In addition, ESAs shortened survival in patients with non-small cell lung cancer and in a study enrolling patients with various malignancies who were not receiving chemotherapy or radiotherapy; in these two studies, ESAs were administered to target a hemoglobin level of ≥120 g/L.
An increased risk of death was observed in a clinical study when ESAs were administered to target hemoglobin of 120 g/L in patients with active malignant disease who were not being treated with either chemotherapy or radiation therapy. Aranesp® is not indicated for use in patients with cancer who have anemia that is not associated with chemotherapy.
The most frequently reported serious adverse events in cancer patients receiving chemotherapy included death (10%), fever (4%), pneumonia (3%), dehydration (3%), vomiting (2%), and dyspnea (2%). The most commonly reported adverse events (≥5%) were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. The most commonly reported adverse reaction was injection site pain (4%).
Refer to Product Monograph for complete warnings, precautions, adverse events, dosing information and patient selection criteria.
Aranesp® Product Monograph
A full list of indications for Aranesp® is contained in the Product Monograph
Resources for Healthcare Professionals and Your Patients
The following websites are external links. DrugCoverage assumes no responsibility for the content of these sites.
Amgen Canada's VICTORY Program provides reimbursement information and assistance 24 hours a day, 7 days per week to patients with a prescription for Aranesp®. Some individuals may qualify for financial assistance. Call 1-888-706-4717 to enrol.
VICTORY Program Patient Enrollment Form
National Comprehensive Cancer Network (NCCN) Website (requires password / login)
Once logged in, click on NCCN Clinical Practice Guidelines in OncologyTM
Scroll down to "Guidelines for Supportive Care" to find:
 Cancer- and Chemotherapy-Induced Anemia V.1.2012
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