Coverage Policy
The information displayed below pertains specifically to the Hospital Outpatient setting of care. For information tailored to the Physician Office 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
Physician-administered drugs are generally covered under Medicare Part B if (1) they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; (2) they are not usually self-administered; and (3) they meet the requirements for coverage of items as incident to a physician’s service. The general requirements for coverage under the “incident to” provision are that the drug be of a form that is not usually self-administered and that the drug be furnished and administered by a physician1. Based on these criteria, HALAVEN® is eligible for Medicare coverage and payment.
Medicare has not issued a National Coverage Determination (NCD) for HALAVEN®. Local Medicare contractors (Fiscal Intermediary, Carrier or Part A/B Medicare Administrative Contractor (MAC)) may make local coverage decisions (LCDs) for HALAVEN®. Some local contractors may publish LCDs or other coverage instruction through articles and bulletins that relate to HALAVEN®. However, the absence of a published coverage policy does not mean that there is no coverage for HALAVEN®2.
For more information on Medicare coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI.
Payor Reimbursement
Services paid under the Medicare Hospital Outpatient Prospective Payment System (OPPS) are assigned to an Ambulatory Payment Classification (APC) code. Each APC is linked to a payment amount that represents the total payment to the hospital. In addition, separate payments are made for some drugs, biologicals, and devices. HALAVEN® now has pass-through status. With pass-through status, it is separately reimbursed by Medicare at Average Sales Price (ASP) plus 6 percent, adjusted quarterly3. Once pass-through status expires, the reimbursement rate for HALAVEN® may change.
Administration Services
Drug administration CPT codes are assigned to APCs according to their clinical and resource requirements. Several drug administration codes may map to a single APC. APCs for drug administration services are updated yearly by CMS.
For more information on Medicare reimbursement for HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-61-34724.
1 See the Medicare Benefits Policy Manual, Chapter 15, section 50 for further information.
2 Medicare Benefits Policy Manual, Chapter 15, Section 50. Information available at http://www.cms.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=1&sortOrder=ascending&itemID=CMS012673&intNumPerPage=10. Accessed August 6, 2010.
3 See Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements. Information available at http://www.ofr.gov/%28X%281%29S%28001vnfheati55xaqg24a15ga%29%29/OFRUpload/OFRData/2011-28612_PI.pdf. Accessed November 2, 2011.
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.
