- Coding & Pricing
ICD-9-CM Diagnosis Codes
Providers should use current ICD-9-CM codes to report a patient’s diagnosis on claim submissions. Correct coding is the responsibility of the provider submitting a claim for the item or service. Please check with the payor to verify coding or special billing requirements. Below is a list of ICD-9-CM diagnosis codes that may be reasonably related to a diagnosis within the product's approved label.
| ICD-9-CM Diagnosis Code1 | Description |
|---|---|
| 174.0 | Malignant neoplasm of nipple and areola of female breast |
| 174.1 | Malignant neoplasm of central portion of female breast |
| 174.2 | Malignant neoplasm of upper-inner quadrant of female breast |
| 174.3 | Malignant neoplasm of lower-inner quadrant of female breast |
| 174.4 | Malignant neoplasm of upper-outer quadrant of female breast |
| 174.5 | Malignant neoplasm of lower-outer quadrant of female breast |
| 174.6 | Malignant neoplasm of axillary tail of female breast |
| 174.8 | Malignant neoplasm of other specified sites of female breast |
| 174.9 | Malignant neoplasm of breast (female) unspecified site |
| 175.0 | Malignant neoplasm of nipple and areola of male breast |
| 175.9 | Malignant neoplasm of other and unspecified sites of male breast |
1 Centers for Medicare and Medicaid Services. ICD-9 Provider Diagnostic Codes. Downloads: Version 27 Full and Abbreviated Code Titles – Effective October 1, 2009. V27LONG_SHORT_DX110909 file. Information available at http://www.cms.gov/ICD9ProviderDiagnosticCodes/06_codes.asp Accessed August 6, 2010.
Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.
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.
