Coverage Policy
The information displayed below pertains specifically to the Physician Office setting of care. For information tailored to the Hospital Outpatient setting, please select the appropriate tab to the right. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. See below
Third-party payors, including HMO plans, managed care organizations, indemnity plans and others may provide coverage for HALAVEN®. However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors establish formal published policies, but the lack of a published policy from a particular payor does not mean that HALAVEN® is not covered by that payor. In addition, commercial payors may cover physician-administered drugs as a medical benefit, a pharmacy benefit, or both. Each benefit is administered separately and may have different deductible, copayment and/or coinsurance structures.
For more information on Commercial Payor-specific coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI.
Payor Reimbursement
Commercial payor reimbursement for HALAVEN® may be based on a percent mark-up of ASP similar to Medicare reimbursement methodologies. Payment may also be based on a percent mark-up or mark-down of AWP or WAC.
Administration Services
Commercial payor reimbursement for HALAVEN® drug administration services provided in the physician office setting may be based on a common fee schedule similar to the Medicare reimbursement methodology such as physician fee scale, for physician services or other contracted rates.
Indication
- HALAVEN® is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Important Safety Information
Neutropenia
- Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days.
- Severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes > 3 x ULN and bilirubin > 1.5 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Two patients died from complications of febrile neutropenia.
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral motor and sensory neuropathy.
- Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received HALAVEN®. Delay administration of HALAVEN® until resolution to Grade 2 or less.
- Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation.
Pregnancy Category D
- HALAVEN® is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks.
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation was observed on day 8, with no prolongation on day 1. ECG monitoring is recommended for patients with congestive heart failure, bradyarrhythmias, concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics and electrolyte abnormalities.
- Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
Most Common Adverse Reactions
- Most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%).
- The most common serious adverse reactions reported were febrile neutropenia (4%) and neutropenia (2%).
Please see the HALAVEN® full prescribing information.
