Intracavitary Balloon Catheter Brain Brachytherapy for Malignant Gliomas or Metastasis to the Brain

POLICY NUMBER

L.8.01.418

DESCRIPTION

Intracavitary balloon catheter brain brachytherapy is an approach to localized radiotherapy using liquid I-125 delivered with an inflatable balloon catheter to treat malignant brain lesions.

Brain Tumors

Malignant GliomasDiffuse fibrillary astrocytoma is the most common glial brain tumor in adults. It is classified histologically into 3 grades: grade II astrocytoma, grade III anaplastic astrocytoma, and grade IV glioblastoma multiforme. Oligodendrogliomas are diffuse neoplasms closely related to diffuse fibrillary astrocytomas clinically and biologically. However, these tumors generally have better prognoses than diffuse astrocytomas, with mean survival times of 10 years versus 2 to 3 years. Also, oligodendrogliomas apparently are more chemosensitive than astrocytomas. The most aggressive and chemoresistant astrocytoma, glioblastoma multiforme has survival times of less than 2 years for most patients.

TreatmentTreatment of primary brain tumors begins with surgery with curative intent or optimal tumor debulking, usually followed by radiotherapy and/or chemotherapy. Survival after chemoradiotherapy largely depends on the extent of residual tumor after surgery. Therefore, tumors arising in the midline, basal ganglia, or corpus callosum or those arising in the eloquent speech or motor areas of the cortex have a particularly poor outcome because they typically cannot be extensively resected. Recurrence is common after surgery for malignant gliomas, even if followed by chemoradiotherapy because the tumors are usually diffusely infiltrating and develop resistance to chemotherapy; also, neurotoxicity limits cumulative doses of whole-brain radiation. Chemotherapy regimens for gliomas usually rely on nitrosourea alkylating agents (carmustine or lomustine), temozolamide, procarbazine, vincristine, and platinum-based agents. The most common regimen combines procarbazine, lomustine, vincristine, and single or multiagent therapy with temozolomide. A biodegradable polymer wafer impregnated with carmustine (Gliadel® Wafer; Guilford Pharmaceuticals) also can be implanted into the surgical cavity as an adjunct to surgery and radiation. It is indicated for newly diagnosed high-grade malignant glioma and for recurrent gliobastoma multiforme.

Brain Metastasis From Other Primary MalignanciesIntracranial metastases are a frequent occurrence seen at autopsy in 10% to 30% of deaths from cancer. Lung cancer is the most common source of brain metastasis (relative prevalence, 48%), followed by breast cancer (15%), unknown primary (12%), melanoma (9%), and colon cancer (5%).

TreatmentTreatment goals in these patients include local control of existing metastases, regional control to prevent the growth of undetected metastases, extending the duration of overall survival, and maintaining quality of life. Surgical resection followed by whole-brain radiotherapy (WBRT) is the mainstay of treatment for patients with 1 to 3 operable brain metastases and with adequate performance status and control of extracranial disease. Resection plus WBRT extends the duration of survival compared with biopsy plus WBRT. Although adding WBRT to resection does not increase the duration of overall survival, it reduces local and distant recurrence of brain metastases. Thus, WBRT decreases the incidence of death from neurologic causes and may help maintain an adequate quality of life, if the cumulative dose does not cause unacceptable neurotoxicity.

Intracavitary Balloon Catheter Brain Brachytherapy

Intracavitary balloon catheter brain brachytherapy is localized temporary high-dose radiotherapy in the brain that requires placement of an inflatable balloon catheter in the surgical cavity, before closing the craniotomy of a resection to remove or debulk a malignant brain mass. A radiation source is then placed in the balloon to expose surrounding brain tissue to radiation, either continuously or in a series of brief treatments. After the patient completes therapy, the radiation source is permanently removed, and the balloon catheter is surgically explanted.

Safety ConsiderationsOverall, adverse events with GliaSite do not differ greatly from those observed with other brain brachytherapy techniques; however, Adkison and colleagues (2008) reported a case in which linens of a patient with the GliaSite implant were contaminated with radiation. Recovery studies confirmed that systemic absorption is greater than anticipated. Adkison and colleagues concluded that precaution with a Foley catheter should be taken in patients with urinary incontinence. Gerber and colleagues (2007) reported cases of brain hemorrhage, suggesting the need for careful coagulation control.

In 2001, the GliaSite® Radiation Therapy System (GliaSite® RTS; IsoRay Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K003206). The FDA determined that this device was substantially equivalent to separately marketed ventricular reservoirs and catheters, manual radionuclide applicator systems, and radionuclide sources.

In 2011, a modified GliaSite® RTS was cleared for marketing by the FDA through the 510(k) process (K111931). GliaSite® RTS includes a catheter tray with a double balloon catheter and accessories used for implantation of an aqueous saline solution of molecularly bound radioactive iodine (sodium 3 [I-125] iodo-4-hydroxybenzenesulfonate; lotrex™) as the radiation source; and an access tray with items used for afterloading and retrieving the radioactive material. One to three weeks after resection and balloon implantation, the lotrex™ solution is loaded through a subcutaneous port and left in for 3 to 6 days. Prescribed radiation doses are usually 40 to 60 gray measured at 0.5 to 1.0 cm from the balloon surface. This procedure has been performed on an inpatient basis.

In December 2013, CESITRX (Liquid Cesium131 solution) was cleared for marketing by the FDA through the 510(k) process (K132996) for use with GliaSite RTS.

In April 2016, IsoRay Medical terminated the supply, manufacture, and distribution of the GliaSite RTS due to poor sales. Other intracavitary balloon brachytherapy systems have also been cleared for marketing by the FDA through the 510(k) process, such as the MammoSite (2004) and Contura (2008) Systems manufactured by Hologic for the treatment of breast cancer.

FDA product code: KXK.

POLICY

Intracavitary balloon catheter brain brachytherapy is considered investigational, alone or as part of a multimodality treatment regimen, for primary or recurrent malignant brain tumors.

Intracavitary balloon catheter brain brachytherapy is considered investigational, alone or as part of a multimodality treatment regimen, for metastasis to the brain from primary solid tumors outside the brain.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

6/8/2007: Policy added.

7/25/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC).

12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions.

1/06/2009: Policy reviewed. No changes.

04/27/2010: Policy statement updated to make minor wording changes. In the first statement, "gliomas" was changed to "tumors."  In the second statement, "malignancies" was changed to "solid tumors." Intent of the statements unchanged. FEP verbiage added to the Policy Exceptions section.

06/22/2011: Policy reviewed; no changes.

05/09/2012: Policy reviewed; no changes.

08/09/2013: Policy reviewed; no changes.

07/08/2014: Policy reviewed; description updated. Policy statement unchanged. Removed deleted CPT codes 77781, 77782, 77783, and 77784 from the Code Reference section.

12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77316, 77317, and 77318.

08/28/2015: Code Reference section updated for ICD-10.

09/16/2015: Policy description updated regarding devices. Policy statements unchanged. Investigative definition updated in Policy Guidelines section.

12/31/2015: Code Reference section updated to removed deleted CPT codes 77326, 77327, and 77328. Added new 2016 CPT codes 77770, 77771, and 77772. Code description for CPT code 77778 revised with an effective date of 01/01/2016.

05/26/2016: Policy number A.8.01.45 added.

09/30/2016: Code Reference section updated to add new ICD-10 procedure code 3E0Q004.

09/20/2017: Policy description updated regarding devices. Policy statements unchanged. Code Reference section updated to remove deleted CPT codes 77776, 77777, 77785, 77786, and 77787.

08/14/2018: Policy description updated regarding safety considerations. First policy statement updated to change "malignant tumors" to "malignant brain tumors."

09/16/2019: Policy description updated regarding devices. Policy statements unchanged.

09/21/2020: Policy reviewed; no changes.

12/02/2021: Policy reviewed; no changes.

08/24/2022: Policy reviewed; no changes.

08/14/2023: Policy reviewed; no changes.

08/14/2024: Policy reviewed; no changes.

10/09/2025: Policy number changed from "A.8.01.45" to "L.8.01.418." Policy reviewed. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 8.01.45

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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