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
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
Medicare Part B reimbursement for HALAVEN® in the physician office setting is based on Average Sales Price (ASP). For most physician-administered products eligible for Medicare coverage, Medicare sets an allowable payment amount, updated quarterly, at ASP plus 6 percent. Medicare reimbursement is based on the lesser of this allowable amount or actual charges, as follows: physician offices are reimbursed for 80 percent of the allowable amount and the patient or patient's secondary insurer is responsible for the remaining 20 percent coinsurance3.
Administration Services
Medicare reimbursement for HALAVEN® drug administration services provided in the physician office setting is based on the national fee schedule that is adjusted for geographic variations and updated annually. Medicare reimbursement is based on the lesser of the adjusted fee schedule amount or actual charges, as follows: physicians are reimbursed for 80 percent of the allowable amount and the patient or patient’s secondary insurer is responsible for the remaining 20 percent coinsurance4.
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 Medicare Claims Processing Manual Chapter 17, Section 20.1.2. Accessed August 6, 2010.
4 Federal Register Vol. 74, No. 223, November 20, 2009: Changes to the Hospital Outpatient Prospective Payment System Final Rule, Section XV. Updates to the Ambulatory Surgical Center (ASC) Payment System, Subsection A.3. Page 60597, Middle column, second paragraph. Information available at http://www.cms.gov/HospitalOutpatientPPS/HORD/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=3&sortOrder=descending&itemID=CMS1230047&intNumPerPage=10. Accessed August 6, 2010.
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.
