1-866-61-EISAI (1-866-613-4724)

Monday – Friday, 8am to 8pm ET

Coverage Policies

Please select the appropriate setting of care to ensure that you obtain the appropriate coverage information.

OFFICE TYPE:

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® (eribulin mesylate) injection 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 or 1-866-613-4724.

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%, adjusted quarterly, however due to recent legislation, Medicare provider payment has been cut under sequestration to ASP plus 4.3%.2 Medicare reimbursement is based on the lesser of this allowable amount or actual charges, as follows: physician offices are reimbursed for 80% of the allowable amount and the patient or patient's secondary insurer is responsible for the remaining 20% coinsurance.1

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% of the allowable amount and the patient or patient's secondary insurer is responsible for the remaining 20% coinsurance.

For more information on Medicare reimbursement for HALAVEN®, contact the Eisai Assistance Program at 1-866-61-EISAI or 1-866-61-34724.

References

1. Centers for Medicare & Medicaid Services Website. Medicare Benefits Policy Manual, Chapter 15, Section 50. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf. Accessed March 1, 2016.

2. MLN Connects Provider eNews. Mandatory Payment Reduction of 2% Continues until Further Notice for the Medicare FFS Program - "Sequestration" https://www.cms.gov/OutreachandEducation/Outreach/FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2016-03-03 Enews.html#_Toc444672557. Accessed March 1, 2016.

HALAVEN® (eribulin mesylate) injection is eligible for coverage under most state Medicaid programs. However, coverage and reimbursement will vary from state to state as each Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of services. Reimbursement rates for services will also vary from state to state. Some Medicaid programs may cover HALAVEN® as a medical benefit, pharmacy benefit or both. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization.

For more information on Medicaid-specific coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Medicaid reimbursement for HALAVEN® in the physician office setting varies by state Medicaid program. Some Medicaid programs may base reimbursement on Average Sales Price (ASP) plus 4%. Others may base reimbursement on a % mark-up or mark-down of ASP, Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC). Drug reimbursement rates may be updated by state Medicaid programs on a monthly, quarterly or yearly basis.

Administration Services

Medicaid reimbursement for HALAVEN® drug administration services performed in the physician office setting varies by state Medicaid program. Many states base reimbursement on a statewide fee schedule that may be updated on a quarterly or annual basis.

Most third-party payors, including Health Maintenance Organization (HMO) plans, managed care organizations, indemnity plans and others provide coverage for HALAVEN® (eribulin mesylate) injection. However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors establish formal published policies, but the lack of a published policy from a particular payor does not mean that HALAVEN® is not covered by that payor. In addition, commercial payors may cover physician-administered drugs as a medical benefit, a pharmacy benefit, or both. Each benefit is administered separately and may have different deductible, copayment and/or coinsurance structures.

For more information on Commercial Payor-specific coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Commercial payor reimbursement for HALAVEN® may be based on a % mark-up of Average Sales Price (ASP) similar to Medicare reimbursement methodologies. Payment may also be based on a % mark-up or mark-down of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC).

Administration Services

Commercial payor reimbursement for HALAVEN® drug administration services provided in the physician office setting may be based on a common fee schedule similar to the Medicare reimbursement methodology such as physician fee scale, for physician services or other contracted rates.

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® (eribulin mesylate) injection 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®1.
For more information on Medicare coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI or 1-866-613-4724.

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%, adjusted quarterly, however due to recent legislation, Medicare provider payment has been cut under sequestration to ASP plus 4.3% and may be subject to change.2 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 1-866-613-4724.

References

1. Centers for Medicare & Medicaid Services Website. Medicare Benefits Policy Manual, Chapter 15, Section 50. Information available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf. Accessed March 1, 2016.

2. Medicare Program: Hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; short inpatient hospital stays; transition for certain Medicare-dependent, small rural hospitals under the hospital inpatient prospective payment system; provider administrative appeals and judicial review 80 Fed. Reg. 70298. http://www.federalregister.com/Browse/AuxData/24117125-F4F6-46BF-A926-6591D341F6A8. Accessed March 3, 2016.

HALAVEN® (eribulin mesylate) injection is eligible for coverage under most state Medicaid programs. However, coverage and reimbursement will vary from state to state as each Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of services. Reimbursement rates for services will also vary from state to state. Some Medicaid programs may cover HALAVEN® as a medical benefit, pharmacy benefit or both. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization.
For more information on Medicaid-specific coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Reimbursement for HALAVEN® administered in Hospital Outpatient settings varies by state Medicaid program. For instance, payment may be based on a percentage of Average Sales Price (ASP), Average Wholesale Price (AWP), Wholesale Acquisition Cost (WAC) or facility-specific cost-to-charge ratios.

Administration Services

Medicaid reimbursement for HALAVEN® drug administration services provided in the hospital outpatient setting varies by state Medicaid program. For instance, payment rates may be based on a fee schedule, contracted rates, cost-to-charge ratios or facility-specific per diem methodologies.

Most third-party payors, including Health Maintenance Organization (HMO) plans, managed care organizations, indemnity plans and others provide coverage for HALAVEN® (eribulin mesylate) injection. However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors establish formal published policies, but the lack of a published policy from a particular payor does not mean that HALAVEN® is not covered by that payor. In addition, commercial payors may cover physician-administered drugs as a medical benefit, a pharmacy benefit, or both. Each benefit is administered separately and may have different deductible, copayment and/or coinsurance structures.

For more information on Commercial Payor-specific coverage of HALAVEN®, contact the Eisai Assistance Program at: 1-866-61-EISAI or 1-866-613-4724.

Payor Reimbursement

Commercial payor reimbursement for HALAVEN® may be based on a % mark-up of Average Sales Price (ASP) similar to Medicare reimbursement methodologies. Payment may also be based on a % mark-up or mark-down of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC).

Administration Services

Commercial payor reimbursement for HALAVEN® drug administration services provided in the physician office setting may be based on a common fee schedule similar to the Medicare reimbursement methodology such as physician fee scale, for physician services or other contracted rates.

Need Help with HCPCS Codes?

HCPCS codes that have been assigned to identify HALAVEN® for billing and coding purposes

HALAVEN® Stands for Survival

For patients who stand up to their cancer. For healthcare teams that stand up for their patients.

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

+ Expand - Collapse

Indication

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.
  • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

HALAVEN® Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC 500 m3) lasting > 1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5 % of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell 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 >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4 %) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN® and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN® in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN® and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN® and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions

In patients with mBC receiving HALAVEN®, the most common adverse reactions (25%) were neutropenia (82%), anemia (58 %), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN®, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN® were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN® and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

For more information about HALAVEN®, please see full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries. This site is published by Eisai Inc.

HALAVEN® is a registered trademark used by Eisai under license from Eisai R & D Management Co., Ltd.
CORP-US106j