Coverage Policy Manual
Policy #: 1997210
Category: Surgery
Initiated: July 1994
Last Review: March 2024
  Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy Gamma Knife Surgery, Linear Accelerator, Cyberknife, TomoTherapy

Description:
Stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT) are techniques that use highly focused, conformal radiation beams to treat both neoplastic and non-neoplastic conditions. SRS and SBRT rely on 3-dimensional imaging to localize the therapy target. Because they are more targeted than traditional external radiation therapy, SRS and SRBT are often used for treatment at sites that are difficult to reach via surgery, located close to other vital structures, or subject to movement within the body. SRS primarily refers to such radiotherapy applied to intracranial lesions. SBRT refers to therapy generally applied to other areas of the body. Both techniques differ from conventional external-beam radiotherapy, which involves exposing large areas of tissue to relatively broad fields of radiation over multiple sessions.
 
Although SRS and SBRT may be completed with 1 session (single-fraction), additional sessions (typically no more than 5) over a course of days, referred to as fractionated stereotactic radiotherapy, may be required.
 
SRS and SBRT can be administered by several types of devices that are distinguished by their source of radiation, including particle beams (proton), gamma rays from cobalt-60 sources, or high-energy photons from linear accelerator (LINAC) systems. The use of charged particle (proton beam) radiation therapies is addressed in a separate policy (Policy No. 2008012). The most commonly used gamma ray device is the Gamma Knife® (Elekta, Inc., Stockholm), which is a fixed device used for intracranial lesions, typically for smaller lesions. Several brands of LINAC devices are available, including the Novalis Tx® (Novalis, Westchester, IL), the TrueBeamSTx (Varian Medical Systems, Palo Alto, CA), and the CyberKnife® system (Accuray, Sunnyvale, CA).
 
Non-Neoplastic Conditions Treated with SRS
Arteriovenous malformations consist of a tangled network of vessels in which blood passes from arteries to veins without intervening capillaries. They range in size from small, barely detectable lesions to huge lesions that can occupy an entire hemisphere. SRS incites an inflammatory response in the vessels, which results in ongoing fibrosis with eventual complete obliteration of the lesion over a course of months to years. This latency period is variable, depending on the size of the AVM and the dose distribution of the radiosurgery. During this latency period, there is an ongoing but declining risk of hemorrhage. In contrast, surgical excision provides an immediate effect on the risk of hemorrhage. Total surgical extirpation of the lesion, if possible, is the desired form of therapy to avoid future hemorrhage. However, a small subset of AVMs because of their size or location cannot be excised without serious neurologic sequelae. SRS is an important alternative in these patients.
 
Trigeminal neuralgia is a disorder of the fifth cranial (i.e. trigeminal) nerve that causes episodes of intense, stabbing pain in the face. Although trigeminal neuralgia is initially treated medically, in a substantial number of cases, drug treatment is either ineffective or the adverse effects become intolerable. Neurosurgical options include microvascular decompression, balloon compression, and rhizotomy. SRS has been investigated as an alternative to these neurosurgical treatments.
 
Seizure disorders are initially treated medically. Surgical treatment is only considered in those rare instances when the seizures have proven refractory to all attempts at aggressive medical management, when the seizures are so frequent and severe as to significantly diminish quality of life, and when the seizure focus can be localized to a focal lesion in a region of the brain that is amenable to resection. SRS has been investigated as an alternative to neurosurgical resection.
 
For chronic pain that is refractory to a variety of medical and psychological treatments, there are a variety of surgical alternatives.Neuro-destructive procedures include cordotomy, myelotomy, dorsal root entry zone (DREZ) lesions, and stereotactic radiofrequency thalamotomy. SRS targeting the thalamus has been considered an investigative alternative to these neuro-destructive procedures.
 
SRS for the destruction of the thalamic nuclei (thalamotomy) has been proposed for a treatment of essential tremor and other forms of tremor (ie, secondary to Parkinson’s disease, multiple sclerosis, or other neurologic conditions), as an alternative to medical therapy or surgical therapy in extreme cases.
 
Benign Neoplastic Intracranial Lesions Treated with SRS
SRS is used for primary intracranial tumors and tumors that are relatively inaccessible surgically and that are often near eloquent or radiosensitive areas such as symptomatic acoustic neuroma, pituitary adenoma, craniopharyngioma, and glomus jugulare tumor.
 
Acoustic neuromas, also called vestibular schwannomas, are benign tumors originating on the eighth cranial nerve, sometimes seen in association with neurofibromatosis, which can be associated with significant morbidity and even death if their growth compresses vital structures. The tumors arise from the Schwann cell sheath surrounding the vestibular or cochlear branches of the eighth cranial nerve. Pituitary adenomas are benign tumors with symptoms related to hormone production (ie, functioning adenomas) or neurologic symptoms due to tumor impingement on surrounding neural structures. Craniopharyngiomas are benign tumors that arise from pituitary embryonic tissue at the base of the gland. However, because of their proximity to the optic pathways, pituitary gland, and hypothalamus, these tumors may cause severe and permanent damage to these critical structures and can be life-threatening. A glomus jugulare tumor is a rare, benign tumor arising in the skull temporal bone that involves middle and inner ear structures.
 
For acoustic neuromas, radiosurgery has been used as a primary treatment or as a treatment for recurrence after incomplete surgical resection. For pituitary adenomas, SRS has been used as a primary treatment. For pituitary adenomas, surgical excision is typically offered to patients with functioning adenomas because complete removal of the adenoma leads to more rapid control of autonomous hormone production. In patients with nonfunctioning adenomas, the treatment goal is to control growth; complete removal of the adenoma is not necessary. Conventional radiotherapy has been for nonfunctioning adenomas with an approximate 90% success rate and few complications. For craniopharyngiomas, total surgical resection is often difficult. For glomus jugulare tumors, no consensus exists on optimal management to control tumor burden while minimizing treatment-related morbidity.
 
Malignant Neoplastic Intracranial Lesions Treated with SRS
SRS is used to treat certain primary and metastatic intracranial malignant tumors including gliomas, malignant meningiomas, and primitive neuroectodermal tumors (ie, medulloblastoma, pineoblastoma) that are relatively inaccessible surgically and which are often located in proximity to eloquent or radiosensitive areas. Treatment of primary brain tumors such as gliomas is more challenging, due to their generally larger size and infiltrative borders. Intracranial metastases tend to have a smaller spherical size and noninfiltrative borders. Brain metastases occur frequently, seen in 25% to 30% of all patients with cancer, particularly in those with cancer of the lung, breast, colon , melanoma, and kidney. SRS is typically used as an alternative to open neurosurgical intervention. SRS offers the additional ability to treat tumors with relative sparing of normal brain tissue in a single-fraction.
 
Uveal Melanoma Treated with SRS
Melanoma of the uvea (choroid, ciliary body, and iris) is the most common, primary, malignant, intraocular tumor in adults. The following therapies are established treatment modalities for the treatment of uveal melanoma: enucleation, local resection, brachytherapy, and proton beam radiotherapy. Photodynamic therapy with verteporfin has also been used as a primary treatment for choroidal melanoma. The main objectives of treating the tumor are 2-fold: (1) to reduce the risk of metastatic spread; and (2) to salvage the eye with useful vision (if feasible). Treatment selection depends on tumor size and location, associated ocular findings, the status of the other eye, as well as other individual factors, including age, life expectancy, QOL, concurrent systemic diseases, and patient expectations. SRS may be used as an alternative to enucleation of the eye.
 
Stereotactic Body Radiotherapy
The purpose of SBRT is to use a focused radiotherapy technique to treat certain primary and metastatic extracranial tumors that are relatively inaccessible surgically and that are often located in proximity to radiosensitive organs at risk. SBRT has resulted in improved overall survival, symptoms, and treatment-related morbidity for individuals with the following conditions: stage T1 or T2A non-small cell lung cancer who are not candidates for surgical resection; primary or metastatic tumor of the liver that is considered inoperable; primary prostate carcinoma; pancreatic adenocarcinoma; primary or metastatic renal cell carcinoma who are not good surgical candidates; oligometastases involving lung, adrenal glands, or bone (other than spine or vertebral body; and primary and metastatic spinal or vertebral body tumors who have received prior spinal radiotherapy).
 
Regulatory Status
Several devices that use cobalt 60 radiation (gamma-ray devices) for SRS have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The most commonly used gamma-ray device, approved in 1999, is the Gamma Knife® (Elekta; product code IWB), which is a fixed device used only for intracranial lesions. Gamma-ray emitting devices that use cobalt 60 degradation are also regulated through the U.S. Nuclear Regulatory Commission.
 
A number of LINAC movable platforms that generate high-energy photons have been cleared for marketing by the FDA through the 510(k) process. Examples include the Novalis Tx® (Novalis); the TrueBeam STx (Varian Medical Systems; approved 2012; FDA product code IYE); and the CyberKnife® Robotic Radiosurgery System (Accuray; approved 1998; FDA product code MUJ). LINAC-based devices may be used for intracranial and extracranial lesions.   
 

Policy/
Coverage:
Effective August 1, 2021, for members of plans that utilize a radiation oncology benefits management program, Prior Approval is required for this service and is managed through the radiation oncology benefits management program.
 
Effective October 20, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
 
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Intracranial Lesions
 
Malignant Brain Lesions
        • High-Grade Gliomas (grade 3-4) for EITHER of the following:
                • Recurrent disease; OR
                • For retreatment of a previously irradiated field.
        • Low-Grade Gliomas (grade 1-2) for any ONE of the following:
                • Initial treatment; or
                • Recurrent disease; or
                • For retreatment of a previously irradiated field.
        • Medulloblastoma, supratentorial primitive neuroectodermal tumors (PNET) Ependymoma
                • Only for re-treatment of a previously irradiated field  
        • CNS lymphoma
                • Only for re-treatment of a previously irradiated field
Benign Brain Lesions
        • Treatment of intracranial arteriovenous malformations (AVM);
        • Pituitary adenomas when EITHER of the following conditions is met:
                • When individual is symptomatic; OR
                • For retreatment of a previously irradiated field
        • Meningiomas when ANY of the following conditions are met:  
                • When lesion is unresectable or recurrent, or if there is residual disease following surgery; OR
                • For retreatment of a previously irradiated field.
        • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors.
Ocular Lesions
        • For uveal melanoma when ANY of the following conditions are met:
                • For treatment of melanoma of the choroid; OR
                • For retreatment of a previously irradiated field.
 
Neurologic Indications
 
Trigeminal Neuralgia
        • Refractory to medical management or for retreatment of a previously irradiated field.
Mesial temporal lobe epilepsy
        • Refractory to medical management when standard alternative surgery is not an option.
Sarcoma, Thymoma and Thymic Carcinoma
        • Only for retreatment of a previously irradiated field.
 
 
Stereotactic Body Radiotherapy (SBRT)
 
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Spinal Lesions: Primary Or Metastatic Lesions Of The Spine
 
Spine Lesions
        • When other treatment options are not available, and there is documentation of BOTH of the following:
                • The lesion(s) are not amenable to surgical resection (eg. related to prior surgery, tumor location, or the individual is not a surgical candidate); or surgery alone is not an option; and
                • The lesion(s) are not amenable to 3D conformal techniques;
OR
        • For retreatment of a previously irradiated field.
Colorectal and Anal Cancers
        • Only for retreatment of a previously irradiated field.
Cholangiocarcinoma, Esophageal, Gastric Cancers
        • Only for retreatment of a previously irradiated field.
Liver Cancer
Hepatocellular Carcinoma
        • As palliative treatment for individuals with liver-related symptoms; OR
        • As treatment of new or recurrent HCC unsuitable for surgery, embolization, or TACE, when these therapies either have been done and failed or are contraindicated when BOTH of the following conditions are met:  
                • < 5 HCC lesions with a sum of < 20 cm
                • Patients have a Child-Pugh category A or B OR Barcelona Clinic Liver Cancer Stage A, B or C disease
        • For retreatment of a previously irradiated field
Liver Metastasis
        • As palliative treatment for individuals with liver-related symptoms; OR  
        • For retreatment of a previously irradiated field
Pancreatic Cancer
        • For locally advanced or recurrent disease without evidence of metastasis; OR
        • For retreatment of a previously irradiated field
Genitourinary Cancer (Bladder, Penile, and Testicular)
        • Only for retreatment of a previously irradiated field
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
        • Only for retreatment of a previously irradiated field
Head and Neck or Thyroid Cancer
        • Only for retreatment of a previously irradiated field
Lung Cancer
Small Cell and Non-Small Cell Lung Cancers
        • As an alternative to surgical resection when ALL of the following criteria are met:
                • Treatment is given with curative intent; and
                • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); and
                • There is a single lesion measuring less than or equal to 5 cm; and
                • The lesion is inoperable for any of the following reasons:
                        • Tumor location; or
                        • Individual is not a surgical candidate;
OR
        • For retreatment of a previously irradiated field.
 
Metastatic Lesions in the Lung
        • To treat oligometastatic disease (see below criteria for Extracranial Oligometastases)
OR
        • For retreatment of a previously irradiated field
Prostate cancer
        • *Low or *Intermediate risk of recurrence (EITHER of the following)
                • As primary treatment; or
                • For retreatment of a previously irradiated field
 
        • *High risk of recurrence or Post-Prostatectomy
                • Only for retreatment of a previously irradiated field
 
        • Local recurrence after radiotherapy
                • To treat locally recurrent disease with no evidence of distant metastasis
 
        • *Low-risk of recurrence (ALL must be present to qualify as low risk)
                • Stage T1-T2a; and
                • Gleason score of 6; and
                • Prostate-specific antigen (PSA) below 10 ng/mL.
        • *Intermediate-risk of recurrence (ANY one characteristic)
                • Stage T2b to T2c; or
                • Gleason score of 7; or
                • PSA 10-20 ng/mL.
        • *High-risk of recurrence (ANY one characteristic)
                • Stage T3a; or
                • Gleason score 8-10; or
                • PSA greater than 20 ng/mL.
Extracranial Oligometastases
        • When ALL of the following conditions are met:
                • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; and
                • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; and
                • Primary tumor is controlled; and
                • No prior history of metastatic disease.
Other Malignancies
Only for retreatment of a previously irradiated field.
 
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
 
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Brain
        • Metastatic Brain Lesions when EITHER of the following conditions is met:  
                • Primary treatment of 4 or fewer unresected brain metastases; OR
                • Postoperative treatment of 1-2 brain metastases; OR
                • For retreatment of a previously irradiated field
Breast Cancer
        • For retreatment of a previously irradiated field.
Bone Metastases
        • For retreatment of a previously irradiated field; OR
        • If re-treatment with EBRT would result in significant risk of adjacent organ injury.
Hodgkin and Non-Hodgkin Lymphoma
        • Only for retreatment of a previously irradiated field.
Pediatric (age 20 years or younger) Tumors
        • To treat an intracranial malignancy; OR
        • For retreatment of a previously irradiated field
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.   
 
Effective April 14, 2024 to October 19, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
 
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Intracranial Lesions
 
Malignant Brain Lesions
        • High-Grade Gliomas (grade 3-4) for EITHER of the following:
                • Recurrent disease; OR
                • For retreatment of a previously irradiated field.
        • Low-Grade Gliomas (grade 1-2) for any ONE of the following:
                • Initial treatment; or
                • Recurrent disease; or
                • For retreatment of a previously irradiated field.
        • Medulloblastoma, supratentorial primitive neuroectodermal tumors (PNET) Ependymoma
                • Only for re-treatment of a previously irradiated field  
        • CNS lymphoma
                • Only for re-treatment of a previously irradiated field
Benign Brain Lesions
        • Treatment of intracranial arteriovenous malformations (AVM);
        • Pituitary adenomas when EITHER of the following conditions is met:
                • When individual is symptomatic; OR
                • For retreatment of a previously irradiated field
        • Meningiomas when ANY of the following conditions are met:  
                • When lesion is unresectable or recurrent, or if there is residual disease following surgery; OR
                • For retreatment of a previously irradiated field.
        • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors.
Ocular Lesions
        • For uveal melanoma when ANY of the following conditions are met:
                • For treatment of melanoma of the choroid; OR
                • For retreatment of a previously irradiated field.
 
Neurologic Indications
 
Trigeminal Neuralgia
        • Refractory to medical management or for retreatment of a previously irradiated field.
Mesial temporal lobe epilepsy
        • Refractory to medical management when standard alternative surgery is not an option.
Sarcoma, Thymoma and Thymic Carcinoma
        • Only for retreatment of a previously irradiated field.
 
 
Stereotactic Body Radiotherapy (SBRT)
 
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Spinal Lesions: Primary Or Metastatic Lesions Of The Spine
 
Spine Lesions
        • When other treatment options are not available, and there is documentation of BOTH of the following:
                • The lesion(s) are not amenable to surgical resection (eg. related to prior surgery, tumor location, or the individual is not a surgical candidate); or surgery alone is not an option; and
                • The lesion(s) are not amenable to 3D conformal techniques;
OR
        • For retreatment of a previously irradiated field.
Colorectal and Anal Cancers
        • Only for retreatment of a previously irradiated field.
Cholangiocarcinoma, Esophageal, Gastric Cancers
        • Only for retreatment of a previously irradiated field.
Liver Cancer
Hepatocellular Carcinoma
        • As palliative treatment for individuals with liver-related symptoms; OR
        • As treatment of new or recurrent HCC unsuitable for surgery, embolization, or TACE, when these therapies either have been done and failed or are contraindicated when BOTH of the following conditions are met:  
                • < 5 HCC lesions with a sum of < 20 cm
                • Patients have a Child-Pugh category A or Barcelona Clinic Liver Cancer Stage B or C disease
        • For retreatment of a previously irradiated field
Liver Metastasis
        • As palliative treatment for individuals with liver-related symptoms; OR  
        • For retreatment of a previously irradiated field
Pancreatic Cancer
        • For locally advanced or recurrent disease without evidence of metastasis; OR
        • For retreatment of a previously irradiated field
Genitourinary Cancer (Bladder, Penile, and Testicular)
        • Only for retreatment of a previously irradiated field
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
        • Only for retreatment of a previously irradiated field
Head and Neck or Thyroid Cancer
        • Only for retreatment of a previously irradiated field
Lung Cancer
Small Cell and Non-Small Cell Lung Cancers
        • As an alternative to surgical resection when ALL of the following criteria are met:
                • Treatment is given with curative intent; and
                • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); and
                • There is a single lesion measuring less than or equal to 5 cm; and
                • The lesion is inoperable for any of the following reasons:
                        • Tumor location; or
                        • Individual is not a surgical candidate;
OR
        • For retreatment of a previously irradiated field.
 
Metastatic Lesions in the Lung
        • To treat oligometastatic disease (see below criteria for Extracranial Oligometastases)
OR
        • For retreatment of a previously irradiated field
Prostate cancer
        • *Low or *Intermediate risk of recurrence (EITHER of the following)
                • As primary treatment; or
                • For retreatment of a previously irradiated field
 
        • *High risk of recurrence or Post-Prostatectomy
                • Only for retreatment of a previously irradiated field
 
        • Local recurrence after radiotherapy
                • To treat locally recurrent disease with no evidence of distant metastasis
 
        • *Low-risk of recurrence (ALL must be present to qualify as low risk)
                • Stage T1-T2a; and
                • Gleason score of 6; and
                • Prostate-specific antigen (PSA) below 10 ng/mL.
        • *Intermediate-risk of recurrence (ANY one characteristic)
                • Stage T2b to T2c; or
                • Gleason score of 7; or
                • PSA 10-20 ng/mL.
        • *High-risk of recurrence (ANY one characteristic)
                • Stage T3a; or
                • Gleason score 8-10; or
                • PSA greater than 20 ng/mL.
Extracranial Oligometastases
        • When ALL of the following conditions are met:
                • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; and
                • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; and
                • Primary tumor is controlled; and
                • No prior history of metastatic disease.
Other Malignancies
Only for retreatment of a previously irradiated field.
 
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
 
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Brain
        • Metastatic Brain Lesions when EITHER of the following conditions is met:  
                • Primary treatment of 4 or fewer unresected brain metastases; OR
                • Postoperative treatment of 1-2 brain metastases; OR
                • For retreatment of a previously irradiated field
Breast Cancer
        • For retreatment of a previously irradiated field.
Bone Metastases
        • For retreatment of a previously irradiated field; OR
        • If re-treatment with EBRT would result in significant risk of adjacent organ injury.
Hodgkin and Non-Hodgkin Lymphoma
        • Only for retreatment of a previously irradiated field.
Pediatric (age 20 years or younger) Tumors
        • To treat an intracranial malignancy; OR
        • For retreatment of a previously irradiated field
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.   
 
Effective August 2023 to April 13, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
 
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Intracranial Lesions
 
Malignant Brain Lesions
    • High-Grade Gliomas (grade 3-4) for EITHER of the following:
        • Recurrent disease; OR
        • For retreatment of a previously irradiated field.
    • Low-Grade Gliomas (grade 1-2) for any ONE of the following:
        • Initial treatment; or
        • Recurrent disease; or
        • For retreatment of a previously irradiated field.
    • Medulloblastoma, supratentorial primitive neuroectodermal tumors (PNET) Ependymoma
        • Only for re-treatment of a previously irradiated field  
    • CNS lymphoma
        • Only for re-treatment of a previously irradiated field
 
Benign Brain Lesions
    • Treatment of intracranial arteriovenous malformations (AVM);
    • Pituitary adenomas when EITHER of the following conditions is met:
        • When individual is symptomatic; OR
        • For retreatment of a previously irradiated field
    • Meningiomas when ANY of the following conditions are met:  
        • When lesion is unresectable or recurrent, or if there is residual disease following surgery; OR
        • For retreatment of a previously irradiated field.
    • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors.
 
Ocular Lesions
    • For uveal melanoma when ANY of the following conditions are met:
        • For treatment of melanoma of the choroid; OR
        • For retreatment of a previously irradiated field.
 
Neurologic Indications
 
Trigeminal Neuralgia
    • Refractory to medical management or for retreatment of a previously irradiated field.
 
Mesial temporal lobe epilepsy
    • Refractory to medical management when standard alternative surgery is not an option.
 
Sarcoma, Thymoma and Thymic Carcinoma
    • Only for retreatment of a previously irradiated field.
 
Stereotactic Body Radiotherapy (SBRT)
 
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Spinal Lesions: Primary Or Metastatic Lesions Of The Spine
 
Spine Lesions
    • When other treatment options are not available, and there is documentation of BOTH of the following:
        • The lesion(s) are not amenable to surgical resection (eg. related to prior surgery, tumor location, or the individual is not a surgical candidate); or surgery alone is not an option; and
        • The lesion(s) are not amenable to 3D conformal techniques;
OR
    • For retreatment of a previously irradiated field.
 
COLORECTAL AND ANAL CANCERS
    • Only for retreatment of a previously irradiated field.
 
CHOLANGIOCARCINOMA, ESOPHAGEAL, GASTRIC CANCERS
    • Only for retreatment of a previously irradiated field.
 
Liver Cancer
 
Hepatocellular Carcinoma
    • As palliative treatment for individuals with liver-related symptoms; OR
    • As an option to surgery or embolization when:
        • These therapies either have been done and failed or are contraindicated, and
        • ALL of the following conditions are met:
            • Treatment of up to 3 lesions; and
            • Diameter of each lesion is less than 6 cm; and
            • Patients have a Child-Pugh category A or B; OR
    • For retreatment of a previously irradiated field.
 
Liver Metastasis
    • As palliative treatment for individuals with liver-related symptoms; OR
    • For retreatment of a previously irradiated field
 
Pancreatic Cancer
    • For locally advanced or recurrent disease without evidence of metastasis; OR
    • For retreatment of a previously irradiated field
 
Genitourinary Cancer (Bladder, Penile, and Testicular)
    • Only for retreatment of a previously irradiated field
 
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
    • Only for retreatment of a previously irradiated field
 
Head and Neck or Thyroid Cancer
    • Only for retreatment of a previously irradiated field
 
Lung Cancer
 
Small Cell and Non-Small Cell Lung Cancers
    • As an alternative to surgical resection when ALL of the following criteria are met:
        • Treatment is given with curative intent; and
        • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); and
        • There is a single lesion measuring less than or equal to 5 cm; and
        • The lesion is inoperable for any of the following reasons:
            • Tumor location; or
            • Individual is not a surgical candidate;
OR
    • For retreatment of a previously irradiated field.
 
Metastatic Lesions in the Lung
    • To treat oligometastatic disease (see below criteria for Extracranial Oligometastases)
OR
    • For retreatment of a previously irradiated field
 
Prostate cancer
    • *Low or *Intermediate risk of recurrence (EITHER of the following)
        • As primary treatment; or
        • For retreatment of a previously irradiated field
 
    • *High risk of recurrence or Post-Prostatectomy
        • Only for retreatment of a previously irradiated field
 
    • Local recurrence after radiotherapy
        • To treat locally recurrent disease with no evidence of distant metastasis
 
    • *Low-risk of recurrence (ALL must be present to qualify as low risk)
        • Stage T1-T2a; and
        • Gleason score of 6; and
        • Prostate-specific antigen (PSA) below 10 ng/mL.
    • *Intermediate-risk of recurrence (ANY one characteristic)
        • Stage T2b to T2c; or
        • Gleason score of 7; or
        • PSA 10-20 ng/mL.
    • *High-risk of recurrence (ANY one characteristic)
        • Stage T3a; or
        • Gleason score 8-10; or
        • PSA greater than 20 ng/mL.
 
Extracranial Oligometastases
    • When ALL of the following conditions are met:
        • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; and
        • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; and
        • Primary tumor is controlled; and
        • No prior history of metastatic disease.
 
Other Malignancies
Only for retreatment of a previously irradiated field.
 
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
 
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Brain
    • Metastatic Brain Lesions when EITHER of the following conditions is met:  
        • Primary treatment of 4 or fewer unresected brain metastases; OR
        • Postoperative treatment of 1-2 brain metastases; OR
        • For retreatment of a previously irradiated field
 
Breast Cancer
    • For retreatment of a previously irradiated field.
 
Bone Metastases
    • For retreatment of a previously irradiated field; OR
    • If re-treatment with EBRT would result in significant risk of adjacent organ injury.
 
Hodgkin and Non-Hodgkin Lymphoma
    • Only for retreatment of a previously irradiated field.
 
Pediatric (age 20 years or younger) Tumors
    • To treat an intracranial malignancy; OR
    • For retreatment of a previously irradiated field
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
 
Effective April 09, 2023 through July 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Intracranial Lesions
Malignant Brain Lesions
          • High-Grade Gliomas (grade 3-4) for EITHER of the following:
              • Recurrent disease; or
              • For retreatment of a previously irradiated field
          • Low-Grade Gliomas (grade 1-2) for any ONE of the following:
              • Initial treatment
              • Recurrent disease
              • For retreatment of a previously irradiated field
          • Medulloblastoma, supratentorial primitive neuroectodermal tumors (PNET) Ependymoma
              • Only for re-treatment of a previously irradiated field  
          • CNS lymphoma
              • Only for re-treatment of a previously irradiated field
Benign Brain Lesions
          • Intracranial Arteriovenous malformations;
          • Pituitary adenomas when EITHER of the following conditions is met:
              • When individual is symptomatic
              • For retreatment of a previously irradiated field
          • Meningiomas when ANY of the following conditions are met:  
              • When lesion is unresectable or recurrent, or if there is residual disease following surgery
              • For retreatment of a previously irradiated field
          • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors
 
Ocular Lesions for uveal melanoma when ANY of the following conditions are met:
          • For treatment of melanoma of the choroid
          • For retreatment of a previously irradiated field
 
Neurologic Indications
        • Trigeminal neuralgia refractory to medical management or for retreatment of a previously irradiated field.
        • Mesial temporal lobe epilepsy refractory to medical management when standard alternative surgery is not an option.
 
Sarcoma, Thymoma and Thymic Carcinoma
        • Only for retreatment of a previously irradiated field
 
Stereotactic Body Radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Spinal Lesions: Primary or Metastatic Lesions of the Spine
Spine Lesions
          • When other treatment options are not available, and there is documentation of BOTH of the following:
              • The lesion(s) are not amenable to surgical resection (eg. related to prior surgery, tumor location, or the individual is not a surgical candidate); OR surgery alone is not an option; AND
              • The lesion(s) are not amenable to 3D conformal techniques
OR
          • For retreatment of a previously irradiated field
 
Colorectal and Anal Cancers
        • Only for retreatment of a previously irradiated field.
 
Cholangiocarcinoma, Esophageal, Gastric Cancers
        • Only for retreatment of a previously irradiated field.
 
Liver Cancer
Hepatocellular Carcinoma
          • As palliative treatment for individuals with liver-related symptoms; or
          • As an option to surgery or embolization
              • when these therapies either have been done and failed or are contraindicated,
AND
          • when ALL of the following conditions are met:
              • Treatment of up to 3 lesions,
              • Diameter of each lesion is less than 6 cm
              • Patients have a Child-Pugh category A or B; or
          • For retreatment of a previously irradiated field
Liver Metastasis
          • As palliative treatment for individuals with liver-related symptoms; OR
          • For retreatment of a previously irradiated field
 
Pancreatic Cancer
        • For locally advanced or recurrent disease without evidence of metastasis; OR
        • For retreatment of a previously irradiated field
 
Genitourinary Cancer (Bladder, Penile, and Testicular)
        • Only for retreatment of a previously irradiated field
 
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
        • Only for retreatment of a previously irradiated field
 
Head and Neck or Thyroid Cancer
        • Only for retreatment of a previously irradiated field
 
Lung Cancer
Small Cell and Non-Small Cell Lung Cancers
            • As an alternative to surgical resection when ALL of the following criteria are met:
                • Treatment is given with curative intent; and
                • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); and
                • There is a single lesion measuring less than or equal to 5 cm; and
                • The lesion is inoperable for any of the following reasons:
                    • Tumor location; or
                    • Individual is not a surgical candidate;
OR
            • For retreatment of a previously irradiated field
 
Metastatic Lesions in the Lung
            • To treat oligometastatic disease (see below criteria for Extracranial Oligometastases)
OR
            • For retreatment of a previously irradiated field
 
Prostate cancer
*Low or *Intermediate risk of recurrence (EITHER of the following)
          • As primary treatment; OR
          • For retreatment of a previously irradiated field
 
*High risk of recurrence or Post-Prostatectomy
          • Only for retreatment of a previously irradiated field
 
Local recurrence after radiotherapy
          • To treat locally recurrent disease with no evidence of distant metastasis
 
*Low-risk of recurrence (ALL must be present to qualify as low risk)
              • Stage T1-T2a; AND
              • Gleason score of 6; AND
              • Prostate-specific antigen (PSA) below 10 ng/mL
*Intermediate-risk of recurrence (ANY one characteristic)
              • Stage T2b to T2c; OR
              • Gleason score of 7; OR
              • PSA 10-20 ng/mL
*High-risk of recurrence (ANY one characteristic)
              • Stage T3a; OR
              • Gleason score 8-10; OR
              • PSA greater than 20 ng/mL
 
Extracranial Oligometastases
When ALL of the following conditions are met:
          • Treatment is given with curative intent; and
          • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; and
          • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; and
          • Primary tumor is controlled; and
          • No prior history of metastatic disease; and
 
Other Malignancies
        • Only for retreatment of a previously irradiated field
 
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
 Brain
Metastatic Brain Lesions when EITHER of the following conditions is met:  
        • Primary treatment of 4 or fewer unresected brain metastases; OR
        • Postoperative treatment of 1-2 brain metastases
        • For retreatment of a previously irradiated field
 
Breast Cancer
        • For retreatment of a previously irradiated field
 
Bone Metastases
        • For retreatment of a previously irradiated field; or
        • If re-treatment with EBRT would result in significant risk of adjacent organ injury
 
Hodgkin and Non-Hodgkin Lymphoma
        • Only for retreatment of a previously irradiated field
 
Pediatric (age 20 years or younger) Tumors
        • To treat an intracranial malignancy; OR
        • For retreatment of a previously irradiated field
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
 
 
Effective November 2022 to April 09, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Intracranial Lesions
Primary Malignant Brain Lesions
        • High-Grade Gliomas (grade 3-4) for EITHER of the following:
          • Recurrent disease; OR
          • For retreatment of a previously irradiated field
        • Low-Grade Gliomas (grade 1-2) for any ONE of the following:
          • Initial treatment
          • Recurrent disease
          • For retreatment of a previously irradiated field
        • Medulloblastoma, supratentorial primitive neuroectodermal tumors (PNET) Ependymoma
          • Only for re-treatment of a previously irradiated field  
        • CNS lymphoma
          • Only for re-treatment of a previously irradiated field
        • Metastatic Brain Lesions when EITHER of the following conditions is met:  
          • There are 5 or fewer brain metastases; OR
          • For retreatment of a previously irradiated field
Benign Brain Lesions
        • Intracranial Arteriovenous malformations;
        • Pituitary adenomas when EITHER of the following conditions is met:
          • When individual is symptomatic
          • For retreatment of a previously irradiated field
        • Meningiomas when ANY of the following conditions are met:  
          • When lesion is unresectable or recurrent, or if there is residual disease following surgery
          • For retreatment of a previously irradiated field
        • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors
 
Ocular Lesions for uveal melanoma when ANY of the following conditions are met:
        • For treatment of melanoma of the choroid
        • For retreatment of a previously irradiated field
 
Neurologic Indications
        • Trigeminal neuralgia refractory to medical management or for retreatment of a previously irradiated field.
        • Mesial temporal lobe epilepsy refractory to medical management when standard alternative surgery is not an option.  
Sarcoma, Thymoma and Thymic Carcinoma
        • Only for retreatment of a previously irradiated field
 
Stereotactic Body Radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Spinal Lesions: Primary or Metastatic Lesions of the Spine
Spine Lesions
          • When other treatment options are not available, and there is documentation of BOTH of the following:
            • The lesion(s) are not amenable to surgical resection (eg. related to prior surgery, tumor location, or the individual is not a surgical candidate); OR surgery alone is not an option; AND
            • The lesion(s) are not amenable to 3D conformal techniques
OR
            • For retreatment of a previously irradiated field
 
Colorectal and Anal Cancers
          • Only for retreatment of a previously irradiated field.
 
Cholangiocarcinoma, Esophageal, Gastric Cancers
          • Only for retreatment of a previously irradiated field.
 
Liver Cancer
Hepatocellular Carcinoma
          • As palliative treatment for individuals with liver-related symptoms; OR
          • As an option to surgery or embolization
            • when these therapies either have been done and failed or are contraindicated,
AND
          • when ALL of the following conditions are met:
            • Treatment of up to 3 lesions,
            • Diameter of each lesion is less than 6 cm
            • Patients have a Child-Pugh category A or B; OR
          • For retreatment of a previously irradiated field
Liver Metastasis
          • As palliative treatment for individuals with liver-related symptoms; OR
          • For retreatment of a previously irradiated field  
Pancreatic Cancer
          • For locally advanced or recurrent disease without evidence of metastasis; OR
          • For retreatment of a previously irradiated field  
Genitourinary Cancer (Bladder, Penile, and Testicular)
          • Only for retreatment of a previously irradiated field  
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
          • Only for retreatment of a previously irradiated field  
Head and Neck or Thyroid Cancer
          • Only for retreatment of a previously irradiated field  
Lung Cancer
Small Cell and Non-Small Cell Lung Cancers
          • As an alternative to surgical resection when ALL of the following criteria are met:
            • Treatment is given with curative intent; AND
            • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); AND
            • There is a single lesion measuring less than or equal to 5 cm; AND
            • The lesion is inoperable for any of the following reasons:
              • Tumor location; OR
              • Individual is not a surgical candidate;
OR
          • For retreatment of a previously irradiated field
 
Metastatic Lesions in the Lung
          • To treat a metastatic lesion when ALL of the following criteria are met:
            • Patient with a single metastatic lesion measuring less than 5 cm; AND (oligometastatic disease may be considered on a case-by-case basis)
            • Extrapulmonary disease is stable or volume of disease is low with remaining treatment options; AND
            • Intent is one of the following:
              • Curative
              • Palliative with a current symptom (airway obstruction or severe hemoptysis) or anticipation of a symptom (eg lesion is close to a major vessel and without local treatment is anticipated to lead to hemoptysis or hemorrhage)
OR
          • For retreatment of a previously irradiated field
 
Prostate cancer
*Low or *Intermediate risk of recurrence (EITHER of the following)
          • As primary treatment OR
          • For retreatment of a previously irradiated field  
*High risk of recurrence or Post-Prostatectomy
          • Only for retreatment of a previously irradiated field  
Local recurrence after radiotherapy
          • To treat locally recurrent disease with no evidence of distant metastasis
 
*Low-risk of recurrence (ALL must be present to qualify as low risk)
              • Stage T1-T2a; AND
              • Gleason score of 6; AND
              • Prostate-specific antigen (PSA) below 10 ng/mL
*Intermediate-risk of recurrence (ANY one characteristic)
              • Stage T2b to T2c; OR
              • Gleason score of 7; OR
              • PSA 10-20 ng/mL
*High-risk of recurrence (ANY one characteristic)
              • Stage T3a; OR
              • Gleason score 8-10; OR
              • PSA greater than 20 ng/mL
 
Extracranial Oligometastases
When ALL of the following conditions are met:
          • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; AND
          • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; AND
          • Primary tumor is controlled; AND
          • No prior history of metastatic disease; and
 
Other Malignancies
          • Only for retreatment of a previously irradiated field
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
Breast Cancer
      • For retreatment of a previously irradiated field  
Bone Metastases
      • For retreatment of a previously irradiated field; OR
      • If re-treatment with EBRT would result in significant risk of adjacent organ injury  
Hodgkin and Non-Hodgkin Lymphoma
      • Only for retreatment of a previously irradiated field  
Pediatric (age 20 years or younger) Tumors
      • To treat an intracranial malignancy; OR
      • For retreatment of a previously irradiated field
 
Stereotactic radiosurgery or stereotactic body radiotherapy performed using fractionation for the indications outlined above meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. (Fractionated SRS refers to SRS or SBRT performed more than once on a specific site. SRS is most often single-fraction treatment; however, multiple fractions may be necessary when lesions are near critical structures. SBRT is commonly delivered over 3 to 5 fractions.)
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Stereotactic radiosurgery for any condition or application not listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery for any condition or application not listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
 
Stereotactic body radiotherapy for any condition or application not listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, stereotactic body radiotherapy for any condition or application not listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
 
Effective May 2022 to October 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Intracranial Lesions
Primary Malignant Brain Lesions
          • High-Grade Gliomas (grade 3-4) for EITHER of the following:
              • Recurrent disease; or
              • For retreatment of a previously irradiated field
          • Low-Grade Gliomas (grade 1-2) for any ONE of the following:
              • Initial treatment
              • Recurrent disease
              • For retreatment of a previously irradiated field
          • Medulloblastoma, supratentorial primitive neuroectodermal tumors (PNET) Ependymoma
              • Only for re-treatment of a previously irradiated field  
          • CNS lymphoma
              • Only for re-treatment of a previously irradiated field
          • Metastatic Brain Lesions when EITHER of the following conditions is met:  
              • There are 5 or fewer brain metastases; OR
              • For retreatment of a previously irradiated field
Benign Brain Lesions
          • Intracranial Arteriovenous malformations;
          • Pituitary adenomas when EITHER of the following conditions is met:
              • When individual is symptomatic
              • For retreatment of a previously irradiated field
          • Meningiomas when ANY of the following conditions are met:  
              • When lesion is unresectable or recurrent, or if there is residual disease following surgery
              • For retreatment of a previously irradiated field
          • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors
 
Ocular Lesions for uveal melanoma when ANY of the following conditions are met:
          • For treatment of melanoma of the choroid
          • For retreatment of a previously irradiated field
 
Neurologic Indications
        • Trigeminal neuralgia refractory to medical management or for retreatment of a previously irradiated field.
        • Mesial temporal lobe epilepsy refractory to medical management when standard alternative surgery is not an option.
Sarcoma, Thymoma and Thymic Carcinoma
        • Only for retreatment of a previously irradiated field
 
Stereotactic Body Radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Spinal Lesions: Primary or Metastatic Lesions of the Spine
Spine Lesions
          • When other treatment options are not available, and there is documentation of BOTH of the following:
              • The lesion(s) are not amenable to surgical resection (eg. related to prior surgery, tumor location, or the individual is not a surgical candidate); OR surgery alone is not an option; AND
              • The lesion(s) are not amenable to 3D conformal techniques
OR
          • For retreatment of a previously irradiated field
 
Colorectal and Anal Cancers
        • Only for retreatment of a previously irradiated field.  
Cholangiocarcinoma, Esophageal, Gastric Cancers
        • Only for retreatment of a previously irradiated field.
 
Liver Cancer
Hepatocellular Carcinoma
          • As palliative treatment for individuals with liver-related symptoms; or
          • As an option to surgery or embolization
              • when these therapies either have been done and failed or are contraindicated,
AND
          • when ALL of the following conditions are met:
              • Treatment of up to 3 lesions,
              • Diameter of each lesion is less than 6 cm
              • Patients have a Child-Pugh category A or B; or
          • For retreatment of a previously irradiated field
Liver Metastasis
          • As palliative treatment for individuals with liver-related symptoms; OR
          • For retreatment of a previously irradiated field
 
Pancreatic Cancer
        • For locally advanced or recurrent disease without evidence of metastasis; OR
        • For retreatment of a previously irradiated field
Genitourinary Cancer (Bladder, Penile, and Testicular)
        • Only for retreatment of a previously irradiated field
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
        • Only for retreatment of a previously irradiated field
Head and Neck or Thyroid Cancer
        • Only for retreatment of a previously irradiated field
Lung Cancer
Small Cell and Non-Small Cell Lung Cancers
            • As an alternative to surgical resection when ALL of the following criteria are met:
                • Treatment is given with curative intent; and
                • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); and
                • There is a single lesion measuring less than or equal to 5 cm; and
                • The lesion is inoperable for any of the following reasons:
                    • Tumor location; or
                    • Individual is not a surgical candidate;
OR
            • For retreatment of a previously irradiated field
Metastatic Lesions in the Lung
            • To treat a metastatic lesion when ALL of the following criteria are met:
                • Patient with a single metastatic lesion measuring less than 5 cm; and (oligometastatic disease may be considered on a case-by-case basis)
                • Extrapulmonary disease is stable or volume of disease is low with remaining treatment options; and
                • Intent is one of the following:
                    • Curative
                    • Palliative with a current symptom (airway obstruction or severe hemoptysis) or anticipation of a symptom (eg lesion is close to a major vessel and without local treatment is anticipated to lead to hemoptysis or hemorrhage)
OR
            • For retreatment of a previously irradiated field
 
Prostate cancer
*Low or *Intermediate risk of recurrence (EITHER of the following)
          • As primary treatment or
          • For retreatment of a previously irradiated field
*High risk of recurrence or Post-Prostatectomy
          • Only for retreatment of a previously irradiated field
Local recurrence after radiotherapy
          • To treat locally recurrent disease with no evidence of distant metastasis
 
*Low-risk of recurrence (ALL must be present to qualify as low risk)
              • Stage T1-T2a; AND
              • Gleason score of 6; AND
              • Prostate-specific antigen (PSA) below 10 ng/mL
*Intermediate-risk of recurrence (ANY one characteristic)
              • Stage T2b to T2c; OR
              • Gleason score of 7; OR
              • PSA 10-20 ng/mL
*High-risk of recurrence (ANY one characteristic)
              • Stage T3a; OR
              • Gleason score 8-10; OR
              • PSA greater than 20 ng/mL
 
Extracranial Oligometastases
When ALL of the following conditions are met:
          • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; and
          • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; and
          • Primary tumor is controlled; and
          • No prior history of metastatic disease; and
 
Other Malignancies
        • Only for retreatment of a previously irradiated field  
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Breast Cancer
        • For retreatment of a previously irradiated field
Bone Metastases
        • For retreatment of a previously irradiated field; or
        • If re-treatment with EBRT would result in significant risk of adjacent organ injury
Hodgkin and Non-Hodgkin Lymphoma
        • Only for retreatment of a previously irradiated field
Pediatric (age 20 years or younger) Tumors
        • To treat an intracranial malignancy; OR
        • For retreatment of a previously irradiated field
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
 
 
Effective February 15, 2022 to April 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Stereotactic Radiosurgery (SRS)
Stereotactic radiosurgery (SRS) using a gamma or LINAC unit meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Intracranial Lesions
Primary Malignant Brain Lesions
          • Gliomas
              • For individuals with a good performance status (ECOG 0,1, 2); or
              • For retreatment of a previously irradiated field
          • Medulloblastoma, supratentorial PNET, ependymoma
              • Only for re-treatment of a previously irradiated field  
          • CNS lymphoma
              • Only for re-treatment of a previously irradiated field  
          • Metastatic brain lesions for:
              • Individuals with a good performance status (ECOG 0,1, 2); AND
              • One of the following:
                  • no active systemic disease (extracranial disease that is stable or in remission); OR
                  • newly diagnosed cancer (within past 3 months) and currently undergoing systemic chemotherapy; OR
                  • no rapidly progressive disease (e.g. provider plans to treat brain metastases prior to treating primary site.  Primary site must not be rapidly progressing.)
OR
              • For retreatment of a previously irradiated field
Benign Brain Lesions
          • Arteriovenous malformations;
          • Pituitary adenomas;
          • Meningiomas that are unresectable, residual, or recurrent
          • Other benign brain tumors, including acoustic neuromas, craniopharyngiomas, pineal gland tumors, schwannomas, glomus jugulare tumors  
Ocular Lesions
          • Uveal melanoma
 
Neurologic Indications
        • Trigeminal neuralgia refractory to medical management; or for retreatment of a previously irradiated field.
        • Mesial temporal lobe epilepsy refractory to medical management when standard alternative surgery is not an option.
Sarcoma, Thymoma and Thymic Carcinoma
        • Only for retreatment of a previously irradiated field
 
 
Stereotactic Body Radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:  
Spinal or Vertebral Body Tumors  
Primary Malignant Spine or Vertebral Body Lesions
          • When other treatment options are not available, and there is documentation of BOTH of the following:
              • The lesion(s) are unresectable, the individual is not a surgical candidate, or surgery alone is not an option; and
              • The lesion(s) are not amenable to 3D conformal techniques
OR
          • For retreatment of a previously irradiated field
 
Colorectal and Anal Cancers
        • Only for retreatment of a previously irradiated field.
 
Cholangiocarcinoma, Esophageal, Gastric Cancers
        • Only for retreatment of a previously irradiated field.
 
Liver Cancer
Hepatocellular carcinoma (Primary or Metastatic)
          • As palliative treatment for individuals with liver-related symptoms; or
          • As an option to surgery or embolization
              • when these therapies either have been done and failed or are contraindicated,
AND
              • when ALL of the following conditions are met:
                  • Treatment of up to 3 lesions,
                  • Diameter of each lesion is less than 6 cm
                  • Patients have a Child-Pugh category A or B
                  • Individual has a good performance status (ECOG 0,1, 2); or
          • For retreatment of a previously irradiated field
Liver Metastasis
          • As palliative treatment for individuals with liver-related symptoms; OR
          • For retreatment of a previously irradiated field
 
Pancreatic Cancer
        • For locally advanced or recurrent disease without evidence of metastasis; OR
        • For retreatment of a previously irradiated field
Genitourinary Cancer (Bladder, Penile, and Testicular)
        • Only for retreatment of a previously irradiated field
Gynecologic Cancers: (Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal)
        • Only for retreatment of a previously irradiated field
Head and Neck or Thyroid Cancer
        • Only for retreatment of a previously irradiated field
 
Lung Cancer
Small Cell and Non-Small Cell Lung Cancers
          • As an alternative to surgical resection when ALL of the following criteria are met:
              • Treatment is given with curative intent; and
              • There is no evidence of nodal or distant metastases based on conventional staging techniques (Stage IA, IB, or IIA with negative lymph nodes); and
              • There is a single lesion measuring less than or equal to 5 cm; and
              • The lesion is inoperable for any of the following reasons:
                  • Tumor location; or
                  • Individual is not a surgical candidate; or
OR
          • For retreatment of a previously irradiated field
 
Metastatic Lesions in the Lung
          • To treat a metastatic lesion when ALL of the following criteria are met:
              • Patient with a single metastatic lesion measuring less than 5 cm; and (oligometastatic disease may be considered on a case-by-case basis)
              • Individual has a good performance status (ECOG 0,1, 2); and
              • Extrapulmonary disease is stable or volume of disease is low with remaining treatment options; and
              • Intent is one of the following:
                  • Curative
                  • Palliative with a current symptom (airway obstruction or severe hemoptysis) or anticipation of a symptom (eg lesion is close to a major vessel and without local treatment is anticipated to lead to hemoptysis or hemorrhage)
OR
          • For retreatment of a previously irradiated field
 
Prostate cancer
When ANY of the following conditions is met:
        • There is a low or intermediate risk of recurrence (as defined below) as primary treatment or
        • To treat a previously irradiated field regardless of risk of recurrence; or
        • To treat locally recurrent disease with no evidence of distant metastasis  
 
Low-risk of recurrence (ALL must be present to qualify as low risk)
              • Stage T1-T2a AND
              • Gleason score of 6 AND
              • Prostate-specific antigen (PSA) below 10 ng/mL
Intermediate-risk of recurrence (ANY one characteristic)
              • Stage T2b to T2c OR
              • Gleason score of 7 OR
              • PSA 10-20 ng/mL
High-risk of recurrence (ANY one characteristic)
              • Stage T3a OR
              • Gleason score 8-10 OR
              • PSA greater than 20 ng/mL
 
Extracranial Oligometastases
When ALL of the following conditions are met:
        • One (1) to three (3) metastatic lesions involving the lungs, liver, bone, adrenal glands, or spine; and
        • Primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell, or sarcoma; and
        • Primary tumor is controlled; and
        • No prior history of metastatic disease; and
        • Good performance status (ECOG 0, 1, 2)
 
Other Malignancies
        • Only for retreatment of a previously irradiated field  
 
Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT)
Stereotactic radiosurgery (SRS) using a gamma or LINAC or Stereotactic body radiotherapy (SBRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:  
Breast Cancer
        • For retreatment of a previously irradiated field
Bone Metastases
        • For retreatment of a previously irradiated field; or
        • If re-treatment with EBRT would result in significant risk of adjacent organ injury
Hodgkin and Non-Hodgkin Lymphoma
        • Only for retreatment of a previously irradiated field
Pediatric (age less than 21) Tumors
        • To treat an intracranial malignancy; OR
        • For retreatment of a previously irradiated field
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
 
For members with contracts without primary coverage criteria, stereotactic radiosurgery or stereotactic body radiation therapy for the treatment of functional disorders other than trigeminal neuralgia, including epilepsy and chronic pain, or for any other condition not listed above as covered, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
 
Due to the detail of the policy statement, the document containing the coverage statements for dates prior to February 15,  2022 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
 

Rationale:
Due to the detail of the rationale, the complete document is not online. If you would like a
hardcopy print, please email: specificinquiry@arkbluecross.com
 
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Data on the use of SRS and SBRT consists primarily of case series, registry data and early phase trials, with a limited number of randomized controlled trials (RCTs) and nonrandomized comparative trials.
 
The selection of variables used in the delivery of SRS and SBRT is complex and individualized, requiring selection of the device, radiation dose, and the size and shape of treatment margins, all of which depend on the location, shape, and radiosensitivity of the target tissue and the function and radiosensitivity of the surrounding tissue. Several ongoing questions exist in the evaluation of SRS and SBRT, related to most appropriate choices of:
  • Radiotherapy delivery device based on the size and shape of the target lesion.
  • Dose fractionation.
  • Methods to reduce toxicity.
 
Trials that would allow direct comparison of all of the possible variables involved in selecting specific SRS and SBRT methods do not currently exist. Therefore, the available evidence is inadequate to permit scientific conclusions about specific radiation planning and delivery techniques, including the specific number of fractions and methods of dose escalation or toxicity reduction. Therefore, the following discussion groups together several different techniques for delivering SRS and SBRT and does not attempt to compare specific radiation planning and delivery techniques.
 
Stereotactic Radiosurgery
Non-Neoplastic Conditions
 
Arteriovenous Malformations
In 2014, Mohr et al reported results of the ARUBA trial, a randomized, multicenter trial to compare medical therapy to medical therapy with interventional therapy (including any neurosurgical, endovascular, or stereotactic radiotherapy procedure) in patients with unruptured arteriovenous malformations (AVM) (Mohr, 2014). Two hundred and twenty-six patients were enrolled and randomized, 116 to interventional therapy and 110 to medical management. Among those randomized to interventional therapy, 91 received interventional therapy, 5 with neurosurgery alone, 30 with embolization alone, 31 with radiotherapy alone, 12 with embolization and neurosurgery, 15 with embolization and radiotherapy, and 1 with all three. The trial was stopped early by its data and safety monitoring board after interim analysis demonstrated superiority of medical management, after outcomes were available for 223 patients with mean follow up time of 33.3 months. The risk of death or stroke was lower in the medical management group than in the interventional therapy group (hazard ratio [HR] 0.27, 95% CI 0.14 to 0.54). Patients will continue to be followed to determine whether differences in outcomes persist. Although a high proportion of patients randomized to interventional therapy (40.5%) received at least some radiotherapy, outcomes are not reported by therapy type, making it difficult to assess the comparative effectiveness of SRS in AVM treatment.
 
Paul et al conducted a retrospective cohort study that included 697 SRS treatments in 662 patients treated with SRS for brain AVMs at a single institution (Paul, 2014). The obliteration rate after a single or multiple SRS procedures was 69.3% and 75%, respectively. The obliteration rates were significantly associated with AVMs that were compact (odds ratio [OR] 3.16, 95% CI 1.92 to 5.22), with undilated feeders (OR 0.36, 95% CI 0.23 to 0.57), with smaller volume (OR 0.95, 95% CI 0.92 to 0.99) and that were treated with higher marginal dose (OR 1.16, 95% CI 1.06 to 1.27).
 
Bowden et al reported outcomes from a retrospective cohort study of patients with cerebellar AVM treated with SRS at a single institution (Bowden, 2014). Sixty-four patients were included, 73% of whom had presented with intracranial hemorrhage and 19% of whom had undergone prior embolization. Total obliteration was achieved at 3, 4, and 5-10 years in 52%, 69%, and 75%, respectively, of subjects. Obliteration was more likely in smaller AVMs but less likely in patients who had undergone prior embolization. Symptomatic adverse radiation events, defined by MRI changes and new neurologic deficits in the absence of hemorrhage, occurred in 3 patients.
 
Fokas et al reported long-term follow up of a cohort of patients who underwent SRS for cerebral AVMs at a single institution (Fokas, 2014). One hundred sixty-four patients were identified, with a median follow up of 93 months (range 12-140 months). Thirty-nine percent of subjects had experienced a prior intracranial hemorrhage, and 43.3% and 8.0%, respectively, had undergone prior embolization or neurosurgical procedures. Complete obliteration was seen in 61% of patients at a median time of 29 months. Complete obliteration was achieved at 3 and 5 years in 61% and 88%, respectively. In multivariable models, higher radiation dosage and smaller target volumes were associated with higher rates of complete obliteration. The annual bleeding risk was 1.3% per year during follow up.
 
Matsuo et al reported outcomes from a cohort of 51 patients with intracranial AVMs treated with SRS at a single institution (Matsuo. 2014). Rates of obliteration after a single SRS at 3, 5, 10, and 15 years were 46.9%, 54.%, 64,%, and 68%, respectively; rates of obliteration after multiple SRS sessions at 3, 5, 10, and 15 years were 46.9%, 61.3%, 74.2%, and 90.3%, respectively. The adverse radiation events occurred in 9 cases (17.6%), with 4 cases (3 symptomatic cysts and 1 intracranial hemorrhage) not occurring until 10 years after the SRS treatment.
 
Potts et al summarized outcomes for 80 children treated with SRS for intracranial AVMs, most of whom (56%) had intracranial hemorrhage at the time of presentation (Potts, 2014). Among the 47% of subjects with available angiograms 3 years after treatment, AVM obliteration occurred in 52% of patients treated with higherdose SRS (18-20 Gy) and in 16% treated with lower-dose SRS (<18 Gy).
 
The evidence related to the use of SRS for AVM consists primarily of noncomparative cohort studies, which demonstrate relatively high rates of complete obliteration of AVM after SRS, in the range of approximately 40% in some studies to greater than 70% in others. Isolating the effect of the SRS therapy in and of itself can be challenging, as many patients are treated with more than one therapy, including endovascular treatments and surgery. Recently, an RCT that compared medical therapy to a variety of interventions in the treatment for AVM showed no significant improvement in outcomes with interventional therapy. However, given that the interventional therapies included a variety of therapies, it is difficult to assess whether one particular component of the intervention has benefit or lacks benefit. Longer-term follow up will be forthcoming from this study.
 
Epilepsy
In the most recent literature review (2014), no new comparative studies evaluating SRS for the treatment of epilepsy were identified.
 
The currently-available research related to the use of SRS for epilepsy treatment is preliminary. There is inadequate information to determine the risk: benefit ratio of SRS compared with other therapies for epilepsy treatment.
 
Tremor
SRS has been used to for the treatment of tremor through stereotactic radiofrequency thalamotomy. In 2008, Kondziolka et al reported outcomes for 31 patients who underwent SRS thalamotomy for disabling essential tremor (Kondziolka, 2008). Among 26 patients with follow-up data available, score on the Fahn-Tolosa-Marin tremor score improved compared with baseline from 3.7 (pre-SRS) to 1.7 (post-SRS; P=<0.000015) and score on the Fahn-Tolosa-Marin handwriting score improved compared with baseline from 2.8 (pre-SRS) to 1.7 (post-SRS; P<0.0002). One patient developed transient mild right hemiparesis and dysphagia and one patient developed mild right hemiparesis and speech impairment.
 
Kooshkabadi et al reported outcomes for 86 patients with tremor treated over a 15 year period, including 48 with essential tremor, 27 with Parkinson disease, and 11 with multiple sclerosis (Kondziolka, 2013). Fahn-Tolosa-Marin tremor scores were used to compare symptoms pre- and post-procedure: the mean tremor score improved from 3.28 (pre-SRS) to 1.81 (post-SRS; P<0.0001), the mean handwriting score improved from 2.78 (pre-SRS) to 1.62 (post-SRS; P<0.0001), and the mean drinking score improved from 3.14 (pre- SRS) to 1.8 (post-SRS, P<0.0001). Complications included temporary hemiparesis in 2 patients, dysphagia in 1 patient, and sustained facial sensory loss in 1 patient.
 
Lim et al reported outcomes for a small cohort of 18 patients who underwent SRS treatment for essential tremor (Lim. 2010). For the 14 patients with videotaped evaluations allowing blinded evaluation of tremor severity and at least 6 months of follow up (N=11 with essential tremor and N=3 with Parkinson disease), Fahn-Tolosa-Marin Tremor Rating Scale activities of daily living scores improved significantly after SRS (mean change score 2.7 points; P = .03). However, there was no significant improvement in other Fahn-Tolosa-Marin Tremor Rating Scale items (P=0.53 for resting tremor, P= 0.24 for postural tremor, P=0.62 for action tremor, P=0.40 for drawing, P >.99 for pouring water, P= 0.89 for head tremor). Mild neurologic complications occurred in 2 patients (lip and finger numbness), and severe neurologic complications occurred in 1 patient (edema surrounding thalamic lesion with subsequent hemorrhage at the lesion site, with speech difficulty and hemiparesis.)
 
Ohye et al conducted a prospective study of SRS for tremor that included 72 patients, 59 with Parkinson disease and 13 with essential tremor) (Ohye, 2012). Among 52 patients who had follow up at 24 months, tremor scores measured using the unified Parkinson’s disease rating scale (P<0.001; approximate score decrease extrapolated from graph from 1.5 at baseline to 0.75 at 24 months follow up).
 
Young et al reported outcomes for a cohort of 158 patients with tremor who underwent SRS, including
102 patients with Parkinson’s disease, 52 with essential tremor, and 4 with tremor due to other conditions (Young, 2000). Among patients with a parkinsonian tremor, at latest follow up (mean 47 months), blinded assessments on unified Parkinson’s disease rating scale demonstrated improvements in several specific items, including overall tremor (from 3.3 pre-treatment to 1.2 at last follow-up; P<0.05) and action tremor (from 2.3 pre-treatment to 1.3 at last follow-up; P<0.05. Among patients with Essential tremor, blinded assessments were conducted using the Fahn-Tolosa-Marin Tremor Rating Scale. At 1 year of follow up,
92.1% of patients with essential tremor were completely or nearly tremor-free. Improvements were reported in components of the Fahn-Tolosa-Marin Tremor Rating Scale, but statistical comparisons are not presented. Three patients developed new neurological symptoms attributed to the SRS.
 
The evidence related to the use of SRS for tremor consists of uncontrolled cohort studies, many of which report outcomes from the treatment of tremor of varying etiologies. Most studies report improvements in standardized tremor scores, although few studies used a blinded evaluation of tremor score, allowing for bias in assessment. No studies that compared SRS to alternative methods of treatment or a control group were identified. Limited long-term follow up is available, making the long-term risk: benefit ratio of an invasive therapy uncertain.
 
Central Nervous System Neoplasms
Acoustic Neuromas
SRS is widely used for the treatment of acoustic neuromas (vestibular schwannomas). Case series report generally high rates of local control. For example, Badahshi et al reported a 3-year local tumor control rate of 88.9% in a study of 250 patients with vestibular schwannoma who underwent SRS or fractionated SRS (Badakhshi, 2014). Williams et al reported rates of tumor progression-free survival for patients with large vestibular schwannomas treated with SRS of 95.2% and 81.8% at 3 and 5 years, respectively (Williams, 2013). For patients with small vestibular schwannomas treated with SRS, tumor progression-free survival was 97% and 90% at 3 and 5 years, respectively. In a retrospective case series of 93 patients with vestibular schwannomas treated with SRS, 83 of whom had long-term follow up, Woolf et al. reported an overall control rate of 92% at a median follow up of 5.7 years. A small study from 2006 that compared microsurgical resection (N=36) with SRS (N=46) for the management of small (<3 cm) vestibular schwannomas showed better hearing preservation at last follow up in the SRS group (P<0.01) and no difference in tumor control between the groups (100% vs 96%, P=0.50) (Pollock, 2006).
 
The evidence related to the use of SRS for acoustic neuroma (vestibular schwannoma) consists primarily of case series and cohort studies, which report high rates of freedom from tumor progression. Given that vestibular schwannoma is a slow-growing tumor with symptoms most often related to local compression, demonstration of slowing of progression is a reasonable outcome. A single comparative study was identified that demonstrated comparable tumor control outcomes between SRS and surgical therapy for small vestibular schwannomas.
 
Craniopharyngioma
The evidence related to the use of SRS for craniopharyngioma consists primarily of case series and cohort studies, which report high rates overall survival. There is a lack of comparative studies evaluating the treatment of pituitary adenomas with SRS versus surgery or traditional radiotherapy.
 
Glomus Jugulare Tumors
The evidence review related to the use of SRS for glomus jugulare tumors identified includes a large meta-analysis, which suggested that SRS treatment is associated with improved patient outcomes.
 
Pituitary Adenoma
In 2013, Chen et al reported results from a systematic review and meta-analysis of studies evaluating SRS (specifically gamma-knife surgery) for the treatment of nonfunctioning pituitary adenoma that included a volumetric classification (Chen, 2013). Seventeen studies met the inclusion criteria, including 7 prospective cohort studies and 10 retrospective cohort studies, with 925 patients included in the meta-analysis. Outcomes were reported related to the rate of tumor control, rate of radiosurgery-induced optic neuropathy injury, and the rate of radiosurgery-induced endocrinologic deficits. In patients with tumor volume <2mL, the rate of tumor control was 99% (95% CI 96 to 100%), the rate of radiosurgery-induced optic neuropathy injury was 1% (95% CI 0 to 4%), and the rate of radiosurgery-induced endocrinologic deficits was 1% (95% CI 0 to 4%). In patients with volumes from 2 to 4 mL, the comparable rates were 96% (95% CI 92 to 99%), 0 (95% CI 0 to 2%), and 7% (95% CI 2 to 14%), respectively, and in patients with volumes larger than 4 mL was 91% (95% CI 89 to 94%), 2% (95% 0 to 5%) and 22% (95% CI 14- 31%), respectively. The rates of tumor control and rates of radiosurgery-induced optic neuropathy injury differed significantly across the three groups.
 
In 2014, Lee et al retrospectively reported outcomes for 41 patients treated with SRS in a cohort of 569 patients treated for nonfunctioning pituitary adenomas at three institutions (Lee, 2014). At a median follow up of 48 months, on neuroimaging 34 patients (82.9%) had a decrease in tumor volume, 4 patients had tumor stability (9.8%), and 3 patients had a tumor increase (7.3%). Progression-free survival was 94% at 5 years and 85% at 10 years post-SRS. New onset or worsened pituitary deficiencies were found in 10 patients (24.4%) at a median follow up of 52 months. The authors conclude that initial treatment with SRS for nonfunctioning pituitary adenomas may be appropriate in certain clinical settings, such as in older patients (70 or more years); in patients with multiple comorbidities in whom an operation would involve a high risk; in patients with clear neuroimaging and neuro-endocrine evidence of an NFA, no mass effect on the optic apparatus, and progressive tumor on neuroimaging follow-up; or in patients who wish to avoid resection. Sheehan et al reported results from a multicenter registry of 512 patients who underwent SRS for nonfunctional pituitary adenomas (Sheehan, 2013). Four hundred seventy-nine (93.6%) had undergone prior resection, and 34 (6.6%) had undergone prior external-beam radiotherapy. Median follow up was 36 months. At last follow up, 31 of 469 patients with available follow up (6.6%) had tumor progression, leading to an actuarial progression-free survival of 98%, 95%, 91%, and 85% at 3, 5, 8, and 10 years post-SRS, respectively. Forty-one (9.3%) of 442 patients had worsened or new CNS deficits, more commonly in patients with tumor progression (P=0.038).
 
Noncomparative studies demonstrate high rates of tumor control (85% and better) for pituitary adenomas with SRS treatment, with better tumor control with smaller lesions. There is a lack of comparative studies evaluating the treatment of pituitary adenomas with SRS versus surgery or traditional radiotherapy.
 
Randomized Controlled Trials
Since the publication of the systematic reviews, several RCTs have been published.
 
Nonrandomized, Comparative Studies
Tian et al reported results from a retrospective, single-institution cohort study comparing neurosurgical resection to SRS for solitary brain metastases from NSCLC. Seventy-six patients were included, 38 of whom underwent neurosurgery (Tian, 2013). Median survival was 14.2 months for the SRS group and 10.7 months for the neurosurgery group. In multivariable analysis, treatment mode was not significantly associated with differences in OS.
 
Noncomparative Studies
Noncomparative studies continue to evaluate the use of SRS without WBRT for the management of brain metastases, and the role of SRS for the management of larger numbers of brain metastases. Yamamoto et al conducted a prospective observational study to evaluate primary SRS in patients with 1-10 newly diagnosed brain metastases (Yamamoto, 2014). Inclusion criteria included largest tumor volume less than 10 mL and less than 3 cm in the longest diameter, a total cumulative volume less than or equal to 15 mL, and a Karnofsky performance status score of 70 or higher. Among total 1,194 patients, the median OS after SRS was 13.9 (95% CI 12.0 to 15.6) in the 455 patients with 1 tumor, 10.8 months (95% CI 9.4 to 12.4) in the 531 patients with 2-4 tumors, and 10.8 months (95% CI 9.1 to 12.7) in the 208 patients with 5-10 tumors. Rava et al, in a cohort study including 53 patients with at least 10 brain metastases, described the feasibility of SRS treatment ((Rava, 2013). Median survival was 6.5 months in this cohort. Raldow et al, in a cohort of 103 patients with at least 5 brain metastases who were treated with SRS alone, demonstrated a median OS of 8.3 months, comparable to historical controls.46 OS was similar for patients with 5-9 and with at least 10 metastases (7.6 months and 8.3 months, respectively).
 
Yomo et al reported outcomes for 41 consecutive patients with 10 or fewer brain metastases from NSCLC who received SRS as primary treatment (Yomo, 2014). The study reported 1- and 2-year OS rates of 44% and 17%, respectively, with a median survival time of 8.1 months. Distant brain metastases occurred in 44% by 1 year, with 18 patients requiring repeat SRS, 7 requiring WBRT, and 1 requiring microsurgery.
 
For cases of brain metastases, evidence from RCTs and systematic reviews indicates that the use of
SRS improves outcomes in the treatment of brain metastases. SRS appears to be feasible in the treatment of larger numbers (e.g. >10) of brain metastases, and outcomes after SRS treatment do not appear to be worse for patients with larger numbers of metastases, et least for patients with 10 or fewer metastases.
 
Uveal Melanoma
Since the publication of the 2012 review, several studies have reported outcomes from SRS for intraocular melanoma. Wackernagel et al reported outcomes for 189 patients with choroidal melanoma treated with SRS (Gamma Knife) (Wackernagel, 2014). All patients with choroidal melanoma at the authors’ institution were offered SRS as an alternative to enucleation if they wished to retain their eye, and other globe-preserving treatment options were not feasible because of tumor size or location or the patient’s general health. Sixty-six patients (37.3%), all treated before 2003, received high-dose SRS (35-80 Gy); subsequently, all patients received low-dose SRS (30 Gy in 87 patients and 25 Gy in 24 patients). The median overall follow-up was 39.5 months. During follow-up, local tumor control was achieved in 167 patients (94.4%). Enucleation was required in 25 patients, 7 due to tumor reoccurrence and 18 due to radiation-induced adverse effects. Overall survival and distant metastasis rates are not reported.
 
Furdova et al reported outcomes for a cohort of 96 patients who underwent SRS at a single center in Slovakia for stage T2/T3 uveal melanoma (Furdova, 2014). Local tumor control occurred in 95% of patients at 3 years of follow up and in 85% of patients at 5 years of follow up. Eleven patients (11.5%) required secondary enucleation between 3 and 5 years post-SRS due to radiation neuropathy or secondary glaucoma.
 
The evidence related to SRS for the treatment of uveal melanoma is limited to case series. The published literature is insufficient to demonstrate improved outcomes with the use of stereotactic radiosurgery over other accepted radiation modalities in the treatment of uveal melanoma.
 
Stereotactic Body Radiation Therapy
 
Spinal Tumors
Sahgal et al evaluated rates of vertebral compression fractures after SBRT in 252 patients with 410 spinal segments treated with SBRT (Shagal, 2013). Fifty-seven fractures were observed (13.9% of spinal segments treated), with 27 de novo fractures and 30 cases of existing fracture progression. Most fractures occurred relatively early post-treatment, with a median and mean time to fracture of 2.46 months and 6.33 months, respectively. Radiation dose per fraction, baseline vertebral compression fracture, lytic tumor, and baseline spinal misalignment were predictive of fracture risk.
 
Non-Small-Cell Lung Cancer
 
Systematic Reviews
In 2014, Zheng et al reported results from a systematic review and meta-analysis comparing survival afterSBRT with survival after surgical resection for the treatment of stage I NSCLC (Zheng, 2014). The authors included 40 studies reporting outcomes from SBRT, including 4850 patients, and 23 studies reporting outcomes after surgery published in the same time period, including 7071 patients. For patients treated with SBRT, the mean unadjusted OS rates at 1, 3, and 5 years were 83.4%, 56.6%, and 41.2%, respectively. The mean unadjusted OS rates at 1, 3, and 5 years were 92.5%, 77.9%, and 66.1%, respectively, with lobectomy, and 93.2%, 80.7%, and 71.7% with limited lung resections. After adjustment for surgical eligibility (for the 27 SBRT studies which reported surgical eligibility) and age, in a multivariable regression model, the treatment modality (SBRT vs surgical therapy) was not significantly associated with OS (P=0.36).
 
Nonrandomized, Comparative Studies
In a matched-cohort study design, Crabtree et al retrospectively compared outcomes between SBRT and surgical therapy in patients with stage 1 NSCLC (Crabtree, 2014). Four hundred fifty-eight patients underwent primary surgical resection and 151were treated with SBRT. Surgical and SBRT patients differed significantly on several baseline clinical and demographic characteristics, with SBRT patients having an older mean age, higher comorbidity scores, a greater proportion of peripheral tumors, and worse lung function at baseline. For the surgical group, 3-year OS and disease-free survival were 78% and 72%, respectively. Of note, among the 458 patients with clinical stage I lung cancer, 14.8% (68/458) were upstaged at surgery and found to have occult N1 or N2 disease. For patients with occult nodal disease, 3-year and 5-year OS were 66% and 43%, respectively. For patients without occult nodal disease, 3- and 5-year OS were 80% and 68%, respectively. For the SBRT group, 3-year OS and disease-free survival were 47% and 42%, respectively.
 
In a propensity score-matched analysis, 56 patients were matched based on clinical characteristics, including age, tumor size, ACE comorbidity score, FEV1%, and tumor location (central versus peripheral). In the final matched comparison, 3-year overall survival was 52% versus 68% for SBRT and surgery, respectively (P=0.05), while disease-free survival was 47% versus 65% (P=0.01). Two-, 3-, 4-, and 5-year local recurrence-free survival for SBRT was 91%, 91%, 81%, and 40%, respectively, versus 98%, 92%, 92%, and 92% for surgery (P=0.07).
 
Jepperson et al compared SBRT with conventional radiation therapy for patients with medically inoperable NSCLC (T1-2N0M0) (Jeppesen, 2013). The study included 100 subjects treated with SBRT and 32 treated with conventional radiation therapy. At baseline, the SBRT-treated patients had smaller tumor volume, lower FEV1, and a greater proportion of T1 stage disease. The median overall survival was 36.1 months versus 24.4 months for SBRT and conventional RT, respectively (p =0.015). Local failure-free survival rates at one year were in SBRT group 93% versus 89% in the conventional RT group and at five years 69% versus 66%, SBRT and conventional RT respectively (P =0.99).
 
Port et al compared SBRT with wedge resection for patients with clinical stage IA NSCLC using data from a prospectively maintained database (Port, 2014).  One hundred sixty-four patients were identified, 99 of whom were matched based on age, sex, and tumor histology. Thirty-eight patients underwent a wedge resection only, 38 patients underwent a wedge resection with brachytherapy, and 23 patients had SBRT. SBRT patients were more likely to have local or distant recurrences than surgically-treated patients (9% vs 30%, P=0.016), but there were no differences between the groups in disease-free 3-year survival (77% for wedge resection vs 59% for SBRT, P=0.066).
 
Varlotta et al compared surgical therapy (N=132 with lobectomy and N=48 with sublobar resection) with SBRT (N=137) in the treatment of stage I NSCLC.67 Mortality was 54% in the SBRT group, 27.1% in the sublobar resection group, and 20.4% in the lobar resection group. After matching for pathology, age, sex, tumor diameter, aspirin use, and Charlson comorbidity index, patients with SBRT had lower OS than patients treated with either wedge resection (P=0.003) or lobectomy (P<0.0001).
 
Noncomparative Studies
In a prospective evaluation of 185 medically inoperable patients with early (T1-T2N0M0) NSCL treated with SBRT, Allibhai et al evaluated the influence of tumor size on outcomes (Allibhai, 2013). Over a median follow up of 15.2 months, tumor size (maximum gross tumor diameter) was not associated with local failure but was associated with regional failure (P=0.011) and distant failure (P=0.021). Poorer overall survival (P=0.001), disease-free survival (P=9.001), and cause-specific survival (P=0.005) were also significantly associated with tumor volume more significant than diameter.
 
Noncomparative Studies
 
Yoon et al reported outcomes for 93 patients with primary non-metastatic HCC treated with SBRT at a single institution (Yoon, 2013).  The median follow up was 25.6 months. OS at 1 and 3 years was 86% and 53.8%, respectively. The main cause of treatment failure was intrahepatic (i.e., out-of-field) metastases. At 1 and 3 years, local control rates were 94.8% and 92.1%, respectively, and distant metastasis-free survival rates were 87.9% and 72.2%, respectively. However, intrahepatic recurrence-free survival rates at 1 and 3 years were 51.9% and 32.4%, respectively.
 
Jung et al reported rates of radiation-induced liver disease in patients with HCC treated with SBRT for small (<6 cm), non-metastatic HCC that was not amenable to surgery or percutaneous ablative therapy (Jung, 2014). Ninety-two patients were included, 17 of whom (18.5%) developed grade 2 or worse radiation-induced liver disease within 3 months of SBRT. In multivariable analysis, Child-Pugh class was the only significant predictor of radiation-induced liver injury. The 1- and 3-year survival rates were 86.9% and 54.4% respectively; with the median survival of 53.6 months. The presence of radiation-induced liver disease was not associated with survival.
 
Prostate Cancer
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
China et al published a systematic review examining the efficacy and safety of Gamma knife radiosurgery for cerebral AVMs (China, 2022). A total of 34 cohort studies (N=8673) with a median follow up of 60 months were identified. The studies included were at moderate risk of bias because none of them were randomized and none concealed treatment allocation. The pooled obliteration rate following single-session SRS for cerebral AVMs was 56.7% in 21 cohorts that confirmed obliteration by angiography alone and 67.8% in 29 cohorts that confirmed obliteration by either angiography or magnetic resonance imaging (MRI). For cohorts with a follow up of at least 2 years, the median obliteration rate was 63.5% and 70.85%, respectively, for obliteration confirmed by angiography or a selection of either angiography or MRI. The authors noted there is a risk of over-estimation of the true obliteration rate when MRI is used to confirm obliteration compared to angiography.
 
Savardekar et al published a systematic review comparing SRS with microsurgery with regard to hearing preservation, tumor control, and facial nerve dysfunction in patients undergoing primary treatment for small to medium (<3 cm) sporadic vestibular Schwannomas (Savardekar, 2022). Microsurgery resulted in 56% hearing preservation, 98% tumor control, and 10% facial nerve dysfunction. Stereotactic radiosurgery resulted in 59% hearing preservation, 92% tumor control, and 2% facial nerve dysfunction.
 
Ong et al completed a systematic review evaluating SRS for patients with glomus jugulare tumors; the review did not compare SRS to other treatment modalities (Ong, 2022). 23 studies (N=460) were identified. The average follow-up across studies was 47 months (range, 4 to 268 months). The pooled tumor control rate after SRS was 95% (95% CI, 93 to 97). Rates of tinnitus, hearing loss, and lower cranial nerve improvement after treatment were 54%, 28%, and 22%, respectively.
 
Garsa et al conducted a systematic review of available evidence comparing WBRT and SRS alone or in combination, as initial or postoperative treatment, with or without systemic therapy for adults with brain metastases due to lung cancer, breast cancer, or melanoma (Garsa, 2021). Despite the identification of 97 studies, statistical analyses were limited due to heterogeneity across the available data. Based on pooled data from 4 RCTs, there was no statistically significant difference in OS when comparing SRS plus WBRT to SRS alone or to WBRT alone (HR, 1.09; 95% CI, 0.69 to 1.73). Based on pooled data from 3 RCTs, OS did not differ when comparing postsurgical WBRT to postsurgical SRS (HR, 1.17; 95% CI, 0.61 to 2.25). Lastly, pooled data from 4 RCTs did not show a significant difference in the risk of serious adverse events with WBRT plus SRS versus WBRT or SRS alone (RR, 1.05; 95% CI, 0.12 to 8.89).
 
Hartgerink et al conducted an RCT comparing WBRT to SRS in Dutch patients with 4 to 10 brain metastases (Hartgerink, 2021). The study was prematurely stopped due to poor accrual, but prior to that, 15 patients were randomized to receive SRS and 14 patients to WBRT. The median number of lesions was 6 (range, 4 to 9). Results demonstrated a 1-year actutimes survival rate of 57% with SRS and 31% with WBRT (p=.52). The actutimes 1-year brain salvage-free survival rate was 50% with SRS and 78% with WBRT (p=.22). In a separate publication describing QOL outcomes in 20 patients 3 months post-treatment, SRS demonstrated favorable outcomes compared to WBRT for the following EuroQol- 5 Dimension domains: mobility (p=.041), self-care (p=.028), and alopecia (p=.014) (Hartgerink, 2022).
 
Guleser et al retrospectively evaluated patients with uveal melanoma who were treated with either brachytherapy (n=201) or Gamma knife radiosurgery (n=52) at a single center in Turkey (Guleser, 2022). The median follow-up time was 45 months for the brachytherapy group and 56 months for the SRS group. The OS at 5 years was 88% and 89% for patients in the SRS and brachytherapy groups, respectively. Local recurrence occurred in 13% of patients in the SRS group and in 7% of patients in the brachytherapy group (p=.13). Eye retention was more likely with brachytherapy compared to SRS (95% vs 81%; p<.001) and vision loss was more likely with SRS compared to brachytherapy (60% vs 44%; p=.048).
 
Sahgal et al compared complete response rates for pain after SBRT (n=114) or EBRT (n=115) in patients with painful spinal metastasis enrolled in an open-label, multicenter, RCT performed at 13 hospitals in Canada and 5 in Australia (Sahgal, 2021). Patients were eligible if they had painful (defined as 2 points with the Brief Pain Inventory) MRI-confirmed spinal metastasis, 3 consecutive vertebral segments to be included in the treatment volume, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 2, and no neurologically symptomatic spinal cord or cauda equina compression. The primary endpoint was the proportion of patients with complete response for pain at 3 months after radiotherapy. At baseline, approximately 75% of enrolled patients were radiosensitive and 25% were radioresistant. Results demonstrated that significantly more patients who received SBRT compared to EBRT achieved the primary endpoint (35% vs 14%; risk ratio, 1.33; 95% CI, 1.14 to 1.55; p=.0002).
 
Ito et al reported on the outcomes for 33 patients with metastatic epidural spinal cord compression who underwent separation surgery and SBRT and were followed prospectively for a median duration of 15 months (range, 3 to 35 months) (Ito, 2022). Approximately 25% of enrolled patients were treated with radiotherapy in the past. The 1-year local failure rate was 13% (95% CI, 4 to 27) and the 1-year OS rate was 79%. Complete or partial pain response at 1, 3, 6, 9, and 12 months was 82%, 92%, 80%, 74%, and 83%, respectively.
 
Zhang et al published a systematic review of 87 studies involving SBRT (n=12,811) and 18 studies involving RFA (n=1,535) for patients with inoperable stage I NSCLC (Zhang, 2022). The local control rates with SBRT were 98%, 95%, 92%, and 92%, respectively, at 1, 2, 3, and 5 years; the local control rates for RFA were significantly lower (75%, 31%, 67%, and 41%, respectively, at 1, 2, 3, and 5 years; p<.01 for all comparisons). The OS rates were similar between SBRT and RFA at 1 year (87% vs 89%, respectively; p=.07) and 2 years (71% vs 69%, respectively; p=.42), whereas the OS was significantly improved with SBRT over RFA at 3 years (58% vs 48%; p<.01) and 5 years (39% vs 21%; p<.01). The most common complication of SBRT was radiation pneumonitis (9.1%), whereas pneumothorax was the most common complication of RFA (27.2%).
 
Shanker et al conducted a meta-analysis of 48 cohort studies (mainly retrospective) assessing the rates of OS and local control in 2846 patients with primary HCC (Shanker, 2021). Comparisons to other treatment Modalities were not made. Pooled 1-, 2- and 3-year OS rates were 78.4%, 61.3%, and 48.3%, respectively. Rates of local control rates at 1-, 2- and 3-years were 91.1%, 86.7%, and 84.2%, respectively.
 
Ji et al compared SBRT to RFA in 60 patients with unresectable HCC at a single center in Japan (Ji, 2022). There were 22 cases treated by SBRT and 38 cases by RFA. The complete remission rate at 3 months was similar in both SBRT and RFA groups (81.8% and 89.4%, respectively), as was the local tumor control rate (90.9% and 94.7%, respectively). The 1-year and 2-year rates of OS were 88.2% and 85.7% in the SBRT group and 100% and 75% in the RFA group, respectively; the differences between treatment groups did not reach statistical significance. Extrahepatic recurrence occurred in 6 patients in the SBRT group and no patients in the RFA group (p<.001).
 
Hannan et al assessed the efficacy of SBRT in 20 patients with metastatic RCC who developed growth of 3 or fewer tumors while receiving first- to fourth-line systemic therapy (Hannan, 2022). Results demonstrated a local control rate of 100%; the OS was not reached. At a median follow-up of 10.4 months, SBRT extended the duration of the ongoing systemic therapy by more than 6 months in 14 patients. The median time from SBRT to the onset of new systemic therapy or death was 11.1 months.
 
Cheung et al assessed the efficacy of SBRT in 37 patients with metastatic RCC who developed growth of 5 or fewer tumors while receiving oral TKI therapy for at least 3 months (Cheung, 2021). Results demonstrated a 1-year local control rate of 93% after SBRT, a median PFS of 9.3 months (95% CI, 7.5 to 15.7), and a 1-year OS rate of 92% (95% CI, 82 to 100). The cumulative incidence of changing systemic therapy was 47%, with a median time to change in systemic therapy of 12.6 months.
 
In 2021, the American Society of Clinical Oncology (ASCO), Society for NeuroOncology (SNO), and the American Society for Radiation Oncology (ASTRO) published a guideline that addresses the role of surgery, radiation therapy, and systemic therapy in the treatment of patients with brain metastases secondary to nonhematologic solid tumors (Vogelbaum, 2022). The following recommendations regarding the use of SRS in this population were made in this guideline:
 
    • "SRS alone (as opposed to WBRT [whole brain radiotherapy] or combination of WBRT and SRS) should be offered to patients with one to four unresected brain metastases, excluding small-cell carcinoma."
        • "Qualifying Statement: The inclusion criteria of the randomized trials that underly this recommendation were generally tumors of less than 3 or 4 cm in diameter and did not include radioprotectant strategies of memantine or hippocampal avoidance"
    • "SRS alone should be offered to patients with one to two resected brain metastases if the surgical cavity can be safely treated and considering the extent of remaining intracranial disease."
        • "Qualifying Statement: The randomized trials upon which this recommendation is based were of single-fraction SRS and conventional WBRT (without radioprotectant strategies of memantine or hippocampal avoidance)"
    • "SRS, WBRT, and the combination of SRS plus WBRT are all reasonable options for patients with more than four unresected or more than two resected brain metastases and better performance status (e.g., [Karnofsky Performance Status] KPS 70). SRS may be preferred for patients with better prognosis or where systemic therapy that is known to be active in the CNS [central nervous system] is available."
In 2022, ASTRO published an evidence-based guideline on indications and techniques for external beam radiation therapy (EBRT) in patients with primary liver cancers (Apisarnthanarax, 2022). SBRT (also referred to as ultrahypofractionation delivered in 5 fractions) was among the EBRT techniques discussed for patients with confirmed HCC and intrahepatic cholangiocarcinoma (IHC). The choice of regimen is based on tumor location, underlying liver function, and available technology.
 
International Stereotactic Radiosurgery Society (ISRS) guideline and practice opinions:
Arteriovenous Fistulas: SRS is recommended for patients with "complex dural arteriovenous fistula who are planned for embolization and are at high risk for not achieving complete obliteration with embolization alone; dural arteriovenous fistula who have received previous embolization without complete obliteration and have refractory symptoms; high-risk noncavernous sinus dural arteriovenous fistula or symptomatic cavernous sinus dural arteriovenous fistula who are not candidates for or have refused both embolization or microsurgery" (Singh, 2022).
 
Postoperative spine malignancy: "Postoperative spine SBRT delivers a high 1-year local control with acceptably low toxicity. Patients who may benefit from this include those with oligometastatic disease, radioresistant histology, paraspinal masses, or those with a history of prior irradiation to the affected spinal segment...the ISRT recommends a minimum interval of 8 to 14 days after invasive surgery before simulation for SBRT, with initiation of radiation therapy within 4 weeks of surgery" (Faruqi, 2022).
Secretory pituitary adenomas: "SRS is an effective option to control growth of GH-, ACTH-, & PRL-secreting residual or recurrent pituitary adenomas after prior surgical resection but offers lower rate of endocrine improvement or remission." "SRS could also be used as primary therapy for GH- and ACTH-secreting pituitary adenomas in patients deemed medically unfit for surgical resection, or as an alternative to surgical resection for PRL-secreting pituitary adenomas unresponsive to dopaminergic agonists." "Withdrawal of antisecretory medications is preferred, typically for 4 to 12 weeks prior to radiosurgery, if safely possible considering endocrinologic status of patient" (Mathieu, 2022).

CPT/HCPCS:
32701Thoracic target(s) delineation for stereotactic body radiation therapy (SRS/SBRT), (photon or particle beam), entire course of treatment
61796Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 simple cranial lesion
61797Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, simple (List separately in addition to code for primary procedure)
61798Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 complex cranial lesion
61799Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, complex (List separately in addition to code for primary procedure)
61800Application of stereotactic headframe for stereotactic radiosurgery (List separately in addition to code for primary procedure)
63620Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 spinal lesion
63621Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional spinal lesion (List separately in addition to code for primary procedure)
77261Therapeutic radiology treatment planning; simple
77262Therapeutic radiology treatment planning; intermediate
77263Therapeutic radiology treatment planning; complex
77280Therapeutic radiology simulation aided field setting; simple
77285Therapeutic radiology simulation aided field setting; intermediate
77290Therapeutic radiology simulation aided field setting; complex
772953 dimensional radiotherapy plan, including dose volume histograms
77299Unlisted procedure, therapeutic radiology clinical treatment planning
77300Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician
77301Intensity modulated radiotherapy plan, including dose volume histograms for target and critical structure partial tolerance specifications
77306Teletherapy isodose plan; simple (1 or 2 unmodified ports directed to a single area of interest), includes basic dosimetry calculation(s)
77307Teletherapy isodose plan; complex (multiple treatment areas, tangential ports, the use of wedges, blocking, rotational beam, or special beam considerations), includes basic dosimetry calculation(s)
77316Brachytherapy isodose plan; simple (calculation[s] made from 1 to 4 sources, or remote afterloading brachytherapy, 1 channel), includes basic dosimetry calculation(s)
77317Brachytherapy isodose plan; intermediate (calculation[s] made from 5 to 10 sources, or remote afterloading brachytherapy, 2 12 channels), includes basic dosimetry calculation(s)
77318Brachytherapy isodose plan; complex (calculation[s] made from over 10 sources, or remote afterloading brachytherapy, over 12 channels), includes basic dosimetry calculation(s)
77321Special teletherapy port plan, particles, hemibody, total body
77331Special dosimetry (eg, TLD, microdosimetry) (specify), only when prescribed by the treating physician
77332Treatment devices, design and construction; simple (simple block, simple bolus)
77333Treatment devices, design and construction; intermediate (multiple blocks, stents, bite blocks, special bolus)
77334Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges, molds or casts)
77336Continuing medical physics consultation, including assessment of treatment parameters, quality assurance of dose delivery, and review of patient treatment documentation in support of the radiation oncologist, reported per week of therapy
77338Multi leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan
77370Special medical radiation physics consultation
77371Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; multi source Cobalt 60 based
77372Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based
77373Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions
77432Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of 1 session)
77435Stereotactic body radiation therapy, treatment management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions
G0339Image guided robotic linear accelerator based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment
G0340Image guided robotic linear accelerator based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment

References: 1994 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 38.

1995 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 5.

1995 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 6.

1995 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 7.

1997 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 24.

1998 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 28.

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