Coverage Policy
The information displayed below pertains specifically to the Pharmacy setting of care. For information tailored to the Physician Office setting or Hospital Outpatient setting, please select the appropriate tab to the left. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. See below
Medicare
In general, Medicare considers subcutaneous injectable medications to be self-administered and, therefore, covered under Part D. However, Medicare covers HALAVEN™ under Part B when administered under a physician’s supervision and under Part D when dispensed for self-administration by a patient or caregiver. When provided as a Part B benefit, claims for HALAVEN™ are billed to contractors such as Fiscal Intermediaries (hospital outpatient setting), carriers (physician office setting) or the new Part A/B Medicare Administrative Contractors (MACs). Part D benefit claims for HALAVEN™ are billed to Part D plan sponsors. Providers should ensure that they are adhering to appropriate local contractor or Part D plan sponsor claim filing requirements when submitting claims for HALAVEN™.
More information about Medicare Part B
More information about Medicare Part D
Payor Reimbursement
Medicare Part D plan sponsors negotiate payment rates with pharmacies. Therefore, reimbursement for drugs dispensed by pharmacies varies by contract. Payments may or may not include a dispensing fee per fill.
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.
