- Coding & Pricing
Medicare Reimbursement Rate
Centers for Medicare & Medicaid Services (CMS) has updated the reported Medicare reimbursement rate for HALAVEN® (eribulin mesylate) Injection - J9179 – Effective April 1, 2012.
2nd Quarter 2012 HALAVEN® Medicare reimbursement in the Physician
Office setting is $91.035 per 0.1 mg.1
This payment rate is in effect from April 1, 2012 through June 30, 2012.1
Medicare payment for most drugs administered in the physician office setting is based on the drug's Average Sales Price (ASP) + 6%.1
ASP rates are recalculated and released on a quarterly basis by CMS but can be updated more frequently. Please visit the CMS website below for the most up to date information.
HALAVEN® is currently separately reimbursed in the skilled nursing facility setting. HALAVEN® is excluded from SNF consolidated billing for claims submitted to Fiscal Intermediaries/A/B MACS for payment. This is effective for claims with dates of service as of January 1, 2012.2
For additional information and assistance with HALAVEN®, please contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-61-34724, Monday through Friday from 8:00 A.M. to 8:00 P.M. (Eastern Time).
Medicare Reimbursement Rate – Physician Office
References
1. Centers for Medicare & Medicaid Services Web Site, Medicare, Medicare Part B Drugs Average Sales Price, 2012 ASP Drug Pricing Files, April 2012 ASP Pricing File – Updated March 15, 2012. Accessed on March 19, 2012 at this address: http://www.cms.gov/McrPartBDrugAvgSalesPrice/01a17_2012ASPFiles.asp#TopOfPage. Rates are subject to change.
2. Centers for Medicare & Medicaid Services Web Site, Overview on Skilled Nursing Facility Consolidated Billing, 2012 Carrier A / B / MAC Update. Accessed on December 19, 2011 at this address: https://www.cms.gov/SNFConsolidatedBilling/70m_2012Update.asp#TopOfPage.
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.
