- Coding & Pricing
Healthcare Common Procedure Coding System (HCPCS) Level II Code
HCPCS codes are 5-digit alphanumeric codes that are assigned to drugs by the Centers for Medicare and Medicaid Services (CMS). Effective for use beginning January 1, 2012, HALAVEN® has been assigned the following unique HCPCS code in the "J" series (known as J codes):
| HALAVEN® HCPCS Code | Description |
|---|---|
| J9179 | Injection, eribulin mesylate, 0.1 mg |
When billing for a drug, payors require physicians to indicate on the claim form the quantity of product administered to the patient expressed in the number of units described by the HCPCS code. Because the HCPCS code for HALAVEN® is expressed as 0.1 mg, the amount of HALAVEN® administered to a patient is expressed in multiples of 0.1 mg on the claim form.
| Example Number of Units to Report for HALAVEN® | |
|---|---|
| 2 mg | Report 20 units of J9179 |
| 3 mg | Report 30 units of J9179 |
In some instances, the number of billing units may be payor or plan specific. To verify the number of billing units to complete the claim form, call the Eisai Assistance Program. For questions regarding the billing and coding of HALAVEN® for dates of service prior to January 1, 2012 contact the Eisai Assistance Program at 1-866-61-EISAI (1-866-613-4724). Available Monday – Friday, 8 am to 8 pm ET.
1 See the Medicare Processing Claims Manual, Chapter 17, Section 40 for further information on Medicare's Wastage Policy
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.
