- 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 July 1, 2014.
3rd Quarter 2014 HALAVEN® Medicare reimbursement in the Physician
Office setting is $97.632 per 0.1 mg, and in the Hospital Outpatient setting is
$97.63 per 0.1 mg.1
These payment rates are currently in effect from July 1, 2014 through September 30, 2014 and are subject to change without notice.1
Please note that rules and regulations applicable to ASP, coding and all other aspects of Medicare reimbursement are subject to change; please check with CMS websites listed below for the most up-to-date information.
Medicare payment for most drugs administered in the physician office setting is based on the drug's Average Sales Price (ASP) + 4.3%.2
Pass through status for HALAVEN® expired on December 31, 2013.3
Medicare payment for non pass through, separately payable drugs administered in the hospital outpatient setting is based on the drug's Average Sales Price (ASP) + 4.3%.2
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, 2014.4
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).
1. Centers for Medicare & Medicaid Services Web Site, Medicare Claims Processing Manual, Publication 100-04 Chapter 17. Accessed on June 20, 2014 at this address: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf
2. Centers for Medicare & Medicaid Services Web Site, Medicare FFS Provider e-News. Accessed on June 20, 2014 at this address: http://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Downloads/2013-03-08-standalone.pdf
3. Centers for Medicare & Medicaid Services Web Site, Hospital Outpatient Prospective Payment- Final Rule with Comment, 2014. Regulation No. CMS-1601-FC. Accessed on June 20, 2014 at this address: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1601-FC-.html.
4. Centers for Medicare & Medicaid Services Web Site, Overview on Skilled Nursing Facility Consolidated Billing, 2014 Carrier A / B / MAC Update. Accessed on June 20, 2014 at this address: https://www.cms.gov/Medicare/Billing/SNFConsolidatedBilling/2014-Part-B-MAC-Update.html.
5. Centers for Medicare & Medicaid Services Web Site, Medicare, Medicare Part B Drug Pricing Files, July 2014 ASP Pricing File – Updated July 11, 2014. Accessed on June 20, 2014 at this address: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2014ASPFiles.html. Rates are subject to change.
6. Centers for Medicare & Medicaid Services Web Site, Medicare, Hospital Outpatient PPS, 2014 July Addendum B - Updated June 17, 2014. Accessed on June 20, 2014 at this address: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates-Items/2014-July-Addendum-B.html.
- HALAVEN® is a microtubule inhibitor 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
- 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 than patients with normal levels.
- Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received HALAVEN®. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications.
- 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 1 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.
- In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, 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.
Hepatic and Renal Impairment
- For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (CrCl 30-50 mL/min) renal impairment, a reduction in starting dose is recommended.
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.