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Coverage Policy

Gliadel® Wafer (polifeprosan 20 with carmustine implant) is administered in an in-patient setting. The information displayed below pertains specifically to Medicare. For information tailored to Medicaid or commercial payors, please select the appropriate tab to the right. Coding, coverage, and reimbursement may vary significantly by payor, plan, and patient. See below

Medicare Part A

Medicare does not cover Gliadel® Wafer or most other drugs separately in the hospital inpatient setting. Medicare recognizes MS-DRG 023 for coverage when medically reasonable and necessary according to accepted standards of medical practice. The Centers for Medicare and Medicaid Services (CMS) has not issued a National Coverage Determination (NCD) describing the medically reasonable and necessary use of Gliadel® Wafer. Local Medicare contractors (Fiscal Intermediaries, Carriers or Part A/B Medicare Administrative Contractors (MACs)) may make jurisdiction-specific coverage decisions that relate to Gliadel® Wafer; however, contractors have not published local coverage determinations (LCDs) or other coverage instructions through articles and bulletins as of publication of this guide.

Medicare Part B

Physician services are generally covered under Medicare Part B if they are medically reasonable and necessary for the diagnosis or treatment of an illness or injury according to accepted standards of medical practice. CMS has not issued an NCD describing physician services as they may relate to the implantation of Gliadel® Wafers. Local Medicare contractors may make jurisdiction-specific coverage decisions that relate to Gliadel® Wafer; however, contractors have not published LCDs or other coverage instructions through articles and bulletins as of publication of this guide.

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

Payor Reimbursement

MS-DRG 023

Medicare payment for MS-DRG 023 varies by hospital due to differences in area wages, indirect medical education, disproportionate share status, cost of living adjustments, outliers and other factors. DRG payments to hospitals are made under a prospective payment system and are intended to cover all facility costs associated with an inpatient hospital stay including costs for hospital outpatient services performed within 72 hours of admission. Payment to hospitals excludes payments for physician services.

Gliadel® Wafer Physician Services

Medicare reimbursement for physician services associated with Gliadel® Wafer implantation 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.

Indications

Gliadel® Wafer (polifeprosan 20 with carmustine implant) is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel® Wafer is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

Important Safety Information

Gliadel® Wafer should not be given to patients who have demonstrated a previous hypersensitivity to carmustine or any of the components of Gliadel® Wafer.

Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with Gliadel® Wafer, including 1 case leading to brain herniation.

Carmustine, the active component of Gliadel® Wafer, can cause fetal harm when administered to a pregnant women. It is recommended that patients receiving Gliadel® Wafer discontinue nursing.

Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation.

CT and MRI of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of Gliadel® Wafer. This enhancement may represent edema and inflammation caused by Gliadel® Wafer or tumor progression.

The short-term and long-term toxicity profiles of Gliadel® Wafer when given in conjunction with chemotherapy have not been fully explored.

The following 4 categories of adverse events are possibly related to treatment with Gliadel® Wafer:

Seizures: : In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving Gliadel® Wafer and 37.5% in patients receiving placebo. Grand mal seizures occurred in 5% of Gliadel® Wafer-treated patients and 4.2% of placebo-treated patients. The incidence of seizures within the first 5 days after wafer implantation was 2.5% in the Gliadel® Wafer group and 4.2% in the placebo group.

In the surgery for recurrent disease trial, the incidence of post-operative seizures was 19% in both patients receiving Gliadel® Wafer and placebo. In this study, 12/22 (54%) of patients treated with Gliadel® Wafer and 2/22 (9%) of placebo patients experienced the first new or worsened seizure within the first 5 post-operative days.

The median time to onset of the first new or worsened post-operative seizure was 3.5 days in patients treated with Gliadel® Wafer and 61 days in placebo patients.

Brain Edema: In the initial surgery trial, brain edema was noted in 22.5% of patients treated with Gliadel® Wafer and in 19.2% of patients treated with placebo. Development of brain edema with mass effect (due to tumor recurrences, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of Gliadel® Wafer or its remnants.

Healing Abnormalities: The following healing abnormalities have been reported in clinical trials of Gliadel® Wafer clinical trials: wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid leak. In the initial surgery trial, healing abnormalities occurred in 15.8% of Gliadel® Wafer-treated patients and in 11.7% of placebo recipients. Cerebrospinal fluid leaks occurred in 5% of Gliadel® Wafer recipients and 0.8% of those given placebo.

During surgery, a water-tight dural closure should be obtained to minimize the risk of cerebrospinal fluid leak. In the surgery for recurrent disease trial, the incidence of healing abnormalities was the 14% of Gliadel® Wafer treated patients and 5% in patients receiving placebo wafers.

Intracranial Infection: In the initial surgery trial, the incidence of brain abscess or meningitis was 5% in patients treated with Gliadel® Wafer and 6% in patients receiving placebo. In the recurrent setting, the incidence of brain abscess or meningitis was 4% in patients treated with Gliadel® Wafer and 1% in patients receiving placebo.

For more information about Gliadel® Wafer please see full Prescribing Information.



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.

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.

GLIADEL® Wafer is a registered trademark of Eisai Inc.

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This site was last modified on : December 22, 2011 at 12:30pm ET