Coverage for HALAVEN® (eribulin mesylate) is available primarily through a patient’s medical benefit and may vary significantly by payer, specific health insurance plan, and patient. Payers can base coverage decisions on formal policies or make decisions on a case-by-case basis.
Coverage for HALAVEN varies among plans offered by commercial payers. Most third-party payers, including health maintenance organization (HMO) plans, managed care organizations, and others, may provide coverage for HALAVEN. However, specific coverage requirements and restrictions vary based on plan type. The lack of a formal published policy from a particular payer does not necessarily mean that HALAVEN is not covered by that payer.
MANY COMMERCIAL PRESCRIPTION PLANS HAVE DEVELOPED A FORMULARY, OR LIST OF BRAND-NAME PRESCRIPTION DRUGS THAT THE COMPANY PREFERS
Payer formularies are often organized into tiers. If a plan's medical benefit involves tiers, members typically pay the smallest co-payments for drugs/services in the lowest tier and the highest co-payments for drugs/services in the highest tier. Some commercial plans may apply coverage and utilization restrictions such as prior authorization or step therapy requirements for HALAVEN.
WHEN HALAVEN IS NOT COVERED BY A HEALTH PLAN, AN EXCEPTION MAY BE REQUESTED
Coverage of HALAVEN is determined by the member's medical benefit. Providers or patients should contact the health plan directly to determine whether HALAVEN is included on the formulary. If HALAVEN is not covered by the plan, an exception may be requested by the patient and prescriber. Determinations are made on a case-by-case basis and subject to all of the terms, conditions, limitations, and exclusions of the member's contract including medical necessity requirements.
To provide additional information to a payer about why your patient needs to take HALAVEN, download the HALAVEN Sample Letter of Medical Necessity.
“PRIOR AUTHORIZATION REQUIRED” CATEGORIZATION
Prior authorization is a requirement for the physician to obtain approval from the health insurance plan prior to prescribing HALAVEN.
An appeal is a request to change a denial made by a health plan. A representative/prescriber or patient may appeal the denial of coverage. The prescriber will need to provide a reason why he or she believes the coverage decision was incorrect and what the expected outcome should be. Along with the request form, the health plan may require supporting documentation such as previous medical necessity-related denials, the patient's medical records, and documentation from the healthcare professional or facility.
The payer may ask if the patient has tried and failed another cancer therapy before trying HALAVEN. In this case, it is important to include documentation of any previous treatments in the appeal letter.
MEDICARE PART B
The Medicare Part B drug benefit covers prescription drugs administered in a pharmacy, doctor’s office, or hospital outpatient setting. The Part B benefit is federally run. The federal government sets a monthly premium, and beneficiaries must pay a deductible and co-insurance. Patients typically pay 20% of the Medicare-Approved Amount for doctors’ services and outpatient care. Health care providers are reimbursed for 80% of the amount. If a hospital is participating in the 340B Drug Discount Program, a patient’s co-insurance is 20% of the lower amount, with some exceptions.
For more information, visit the CMS website.
Medicaid is a government insurance program that covers low-income parents and children, people who are elderly, and people with disabilities. State Medicaid programs and the federal government share the costs of covering most medical expenses for Medicaid beneficiaries.
Coverage and reimbursement for HALAVEN through Medicaid vary from state to state, as each state Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of offerings covered.
Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers 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.
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/mm3) 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.
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.