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Documents & Resources

Downloadable forms and documents to assist you with reimbursement processes for HALAVEN® 


DOWNLOADABLE FORMS

HALAVEN® Annotated CMS-1500 Form

The CMS-1500 form is the standard paper claim form to bill the Medicare Administrative Contractor when a paper claim is allowed. This form has been annotated to include specific billing and coding information as it relates to HALAVEN®.


HALAVEN® Annotated CMS-1450 Form

The CMS-1450 form (aka UB-04 at present) can be used by an institutional provider to bill a Medicare Administrative Contractor. This form has been annotated to include specific billing and coding information as it relates to HALAVEN®.


HALAVEN® $0 Co-Pay Enrollment Form

The HALAVEN $0 Co-Pay Program assists commercially insured HALAVEN patients with their HALAVEN cost-share (copayments and coinsurances).


HALAVEN® Insurance Verification Form

This form is used to verify coverage for HALAVEN®.


HALAVEN® Patient Assistance Program Enrollment Form

This form is used to determine eligibility for the Halaven Patient Assistance Program.


HALAVEN® Sample Letter of Medical Necessity

The Sample Letter of Medical Necessity is a template of a letter that could be used to provide a payor additional information about the need for a patient to use HALAVEN®.


CHECKLISTS

Eisai Checklist for Claims Submission

To facilitate timely and appropriate reimbursement, physicians and their staff should ensure that coding and documentation is complete and accurate.


PATIENT RESOURCES

These foundations offer financial and other assistance (education, counseling, support groups, etc.) to patients.

Patient Advocate Foundation (PAF)

www.patientadvocate.org >

Assistance Fund (TAF)

www.theassistancefund.org >

Patient Access Network (PAN) Foundation

www.panfoundation.org >

HealthWell Foundations

www.healthwellfoundation.org >

Good Days at Chronic Disease Fund

www.gooddaysfromcdf.org >

Patients Living with Metastatic Breast Cancer

www.halaven.com/metastatic-breast-cancer-info >

Patients Living with Advanced Liposarcoma

www.halaven.com/advanced-liposarcoma-info >

Need Coding Information for HALAVEN®?

Find coverage information for HALAVEN® as determined by payor and setting of care

What Should You Monitor in Patients on HALAVEN®?

Guidelines for patient care prior to and throughout HALAVEN® therapy

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

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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.
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