Medical Policy: 06.01.15 

Original Effective Date: July 2016 

Reviewed: July 2021 

Revised: July 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Stereotactic radiosurgery (SRS) (also referred to as stereotactic ablative surgery) is a form of radiation therapy in which three-dimensional (3D) images are utilized to specifically direct focused radiation to obliterate abnormal tissues in the head and neck (facilitated by a rigid head frame), while sparing surrounding healthy tissue. This technique differs from conventional radiation therapy, which involves exposing large areas of tissue to relatively broad fields of radiation.

 

Stereotactic body radiation therapy (SBRT) (also referred to as stereotactic ablative radiotherapy [SABR]) is similar in technique to intracranial SRS except the target areas are in the body (utilizing a body frame) and do not include the head or neck (extracranial). SBRT involves a single high-dose radiation delivery, or a series of fractionated radiation deliveries given over several days, which is perceived to decrease the short and long-term side effects of radiation therapy. In some situations, it also purportedly permits a higher total radiation dosage to be given.

 

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. Although SRS and SBRT may be completed with 1 session (single-fraction), SRS typically refers to a single-session procedure to ablate the target lesion. However, either technique may require additional sessions (typically not >5) over a course of days, referred to as fractionated radiotherapy.

 

Delivery systems for SRS and SBRT include, but may not be limited to, the following:

  • CyberKnife is a radiation delivery system that consists of a lightweight linear accelerator device (LINAC) that is mounted to a multi-jointed robotic arm. This device reportedly utilizes a proprietary real-time image-guidance system to deliver stereotactic radiosurgery or radiotherapy. It was designed to enable access hard to reach or complex shaped tumors that may not be accessible by surgery and other radiosurgical technologies.
  • Gamma Knife (e.g., Perfexion SRS system, Target System, Gamma Knife Icon, Leksell, Akesis Galaxy) is s radiosurgery technology, which by design is restricted to treating brain tumors. The device utilizes ionizing radiation (gamma rays) produced by 201 radioactive colbalt-60 sources to ablate intracranial targets via a fixed stereotactic frame.
  • GammaPod is a stereotactic radiotherapy system that is designed to deliver SBRT by purportedly using thousands of individual focused beams from 36 rotating radioactive Cobalt-60 sources. It is intended for use in the noninvasive stereotactic delivery of radiation to a portion of the breast in conjunction with breast conserving treatment. The individual will lie prone on a table with the breast immobilized in a vacuum-assisted cup, which supposedly provides increased accuracy in the delivery of the radiation. 

 

The delivery of stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (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 the 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 possible variables involved in selecting specific SRS and SBRT methods do not currently exist. Therefore, the available evidence is inadequate to permit 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 review groups several different techniques for delivering SRS and SBRT and does not compare specific radiation planning and delivery techniques.

 

Clinical Context and Therapy Purpose

Stereotactic radiosurgery (SRS) (also referred to as stereotactic ablative surgery) is a form of radiation therapy in which three-dimensional (3D) images are utilized to specifically direct focused radiation to obliterate abnormal tissues in the head and neck (facilitated by a rigid head frame), while sparing surrounding healthy tissue.

 

Stereotactic body radiation therapy (SBRT) (also referred to as stereotactic ablative radiotherapy [SABR]) is similar in technique to intracranial SRS except the target areas are in the body (utilizing a body frame) and do not include the head or neck (extracranial).

 

Populations

The relevant population of interest is patients with neoplastic and non-neoplastic conditions.

 

Interventions

The therapy being considered is stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT)

 

Comparators 

Alternatives to SRS and SBRT include, but may not be limited to, the following:

  • Chemotherapy
  • Deep brain stimulation
  • Endovascular embolization
  • Intensity modulated radiation therapy (IMRT)
  • Prescription drug therapy
  • Proton beam radiation
  • Radiotherapy
  • Surgical removal 

 

Outcomes

The outcomes of interest are overall survival (OS), symptom improvement, and treatment-related morbidity.

 

Clinical Input 2018

In 2018, Clinical input was sought by the BCBSA to help determine whether the use of SRS and SBRT for individuals with various neoplasms/conditions would provide a clinically meaningful improvement in the net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 5 respondents, including 2 specialty society-level responses, 1 of which included multiple specialty societies, and 3 physician-level responses either identified by specialty societies or an academic medical center, while this policy was under review.

 

Stereotactic Radiosurgery

For individuals who have uncommon benign neoplastic intracranial lesions (acoustic neuroma, pituitary adenoma, craniopharyngioma, and glomus jugulare tumors) who receive SRS, clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice. Clinical input continues to support an individualized approach to the use of SRS for these tumors with the recognition that outcomes are affected by factors such as the location of the tumor and type of SRS used (hypofractionated, fractionated, or single-session treatment).

 

For individuals who have uveal melanoma, clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice. Clinical input reported that the use of SRS to treat uveal melanoma could provide patients with low-risk disease (based on tumor size using the Collaborative Ocular Melanoma Study definition of small and medium) an option to avoid or postpone enucleation with preservation of some visual acuity and functional abilities.

 

Stereotactic Body Radiotherapy

For individuals who have primary and metastatic spinal or vertebral body tumors who have received prior radiotherapy who are treated with SBRT, clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice. Clinical input reported that SBRT is an important treatment option for patients whose spinal tumors had prior radiotherapy because of the ability to spare the spinal cord and escalate tumor dose.

 

For individuals who have NSCLC, clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients. The following patient selection criteria are based on clinical expert opinion from clinical study populations: patients with NSCLC who are poor surgical candidates or who do not wish to undergo surgery.

 

For individuals who have primary HCC, clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients. Clinical input confirmed the lack of RCTs and reported on nonrandomized observational studies that support the use of SBRT as an alternative locoregional treatment for patients with inoperable primary HCC or metastatic lesions and referred to national guidelines that have rendered the same recommendation. The following patient selection criteria are based on clinical expert opinion from clinical study populations: patients including primary or metastatic tumor of the liver that is considered inoperable.

 

For individuals who have primary prostate carcinoma, limited clinical input reported that the use of SBRT to treat primary prostate cancer provides biochemical control of disease (based on prostate-specific antigen surveillance), preserved quality of life (primarily focused on erectile dysfunction) and acceptable short-term urinary tract toxicity posttreatment. This input did not differentiate candidate patients using guideline-based risk stratification for localized prostate cancer.

 

For individuals who have pancreatic adenocarcinoma, limited clinical input reported that the use of SBRT for inoperable pancreatic adenocarcinoma also referred to guideline-based recommendations for use in localized disease.

 

For individuals who have renal cell carcinoma (RCC), clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients. The following patient selection criteria are based on clinical expert opinion from clinical study populations: patients with primary RCC who are not good surgical candidates, or for relapsed or stage IV disease.

 

For individuals who have oligometastatic disease, clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients. The following patient selection criteria are based on clinical expert opinion from clinical study populations: patients with oligometastatic disease that includes 1 or both adrenal glands in patients who are poor surgical or radiofrequency ablation candidates.

 

In 2013, the American Society for Radiation Oncology (ASTRO) issued a model policy regarding stereotactic body radiation therapy (SBRT). The therapeutic intent of SBRT is to maximize cell-killing effect on the target(s) while minimizing radiation-related injury in adjacent normal tissues. SBRT is indicated for primary malignant tumors of the lung, liver, kidney, adrenal gland, pancreas, bone, and prostate, and primary malignant and benign tumors of the spine and spinal cord. The patient’s general medical condition (namely, the performance status) must justify aggressive, curative treatment to a primary, non-metastatic tumor and be specifically documented in the medical record.

 

SBRT is indicated for treatment of (1) secondary, or metastatic, tumors and (2) recurrent tumors or (3) any tumor arising within or near previously irradiated volumes when at least one of the following criteria is met and specifically documented in the medical record:

  1. The patient’s general medical condition (namely, the performance status) justifies aggressive local therapy to one or more deposits of metastatic cancer in an effort either to achieve total disease clearance in the setting of oligometastatic disease or to reduce the patient’s overall burden of systemic disease for a specifically defined clinical benefit. 
  2. Recurrent disease requiring palliation or any tumor cannot be treated as effectively or safely by other radiotherapy methods due to proximity of previously irradiated volumes and a high level of precision and accuracy is needed to minimize the risk of injury to surrounding normal tissues

 

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

NCCN Recommendations for Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SABR)

 

Cancer Guideline/Cancer Type Recommendation
Acute Lymphoblastic Leukemia version 2.2021 No mention of SRS or SBRT
Acute Myeloid Leukemia version 3.2021 No mention of SRS or SBRT
Anal Carcinoma Version 2.2021 The consensus of the panel is that intensity- modulated RT (IMRT) is preferred over 3D conformal RT in the treatment of nal carcinoma.
  • Image guided RT (IGRT) with kilovoltage (kV) imaging or cone beam CT imaging should be routinely used during the course of treatment with IMRT and stereotactic body RT (SBRT)
  • Consider SBRT for patients with oligometastatic disease
Basal Cell Skin Cancer Version 2.2021 No mention of SRS or SBRT
B-cell Lymphomas Version 4.2021 No mention of SRS or SBRT
Bladder Cancer Version 4.2021 No mention of SRS or SBRT
Bone Cancer Version 1.2020 No mention of SRS or SBRT
Breast Cancer Version 5.2021 No mention of SRS or SBRT
Central Nervous System Cancers Version 1.2021
  • Meningiomas: Stereotactic or image-guided therapy is recommended when using tight margins or when close to critical structures
  • Metastatic Spine Tumors:
    • Stereotactic radiation approaches (SRS/stereotactic body radiotherapy [SBRT]) for spinal cases may be preferred for patients with oligometastatic disease where tumor ablation is a goal of treatment of tumors considered radioresistant (e.g., renal cell, melanoma, sarcoma, hepatocellular, some colorectal and NSCLC cases)
    • Stereotactic radiation approaches may also be preferred in the setting of tumor recurrence after prior radiation as a strategy to limit radiation dose to the spinal cord or other critical structures. Careful adherence to consensus guidelines for radiosurgery planning and delivery recommended. 

Adult Intracranial and Spinal Ependymoma (Excluding Subependymoma)

  • Spine or brain recurrence
    • Resectable → no prior RT → Gross total or subtotal resection; CSF cytology negative → standard RT → treatment for progression or recurrence → consider stereotactic radiosurgery (SRS) if geometrically favorable.
    • Unresectable → evidence of metastasis (brain, spine or CSF) → treatment for progression or recurrence → consider stereotactic radiosurgery (SRS) if geometrically favorable. 

Adult Medulloblastoma

  • Treatment for recurrence: chemotherapy and/or additional radiation such as stereotactic radiosurgery (SRS) after resection or high dose chemotherapy with autologous stem cell reinfusion 

Limited Brain Metastases

  • Disseminated systemic disease with poor systemic treatment options → SRS in select patients
  • Newly diagnosed or stable systemic disease or reasonable systemic treatment options exist → SRS preferred
  • Recurrence
    • Recurrent disease local site → previous surgery only → Surgery followed by SRS or RT to the surgical bed; or single dose or fractionated stereotactic RT; or WBRT for large volumes; or consider systemic therapy
    • Recurrent disease local site → previous WBRT or prior SRS → surgery followed by SRS or RT to the surgical bed; or single dose (category 2B or fractionated stereotactic RT; or consider systemic therapy
    • Recurrent disease distant brain +/- local recurrence → limited brain metastases → surgery followed by SRS or RT to the surgical bed; or single dose or fractionated stereotactic RT; or WBRT for large volumes if not previously administered; or consider systemic therapy
  • Relapse
    • Stable systemic disease or reasonable systemic treatment options → surgery; or SRS; or WBRT; or laser thermal ablation; or systemic therapy
    • Systemic disease progression with limited systemic treatment options and poor PS
      • No prior WBRT → WBRT; or SRS in select patients; or palliative/best supportive care
      • Prior WBRT → Reirradiation if prior positive response to RT; or SRS in select patients; or palliative/best supportive care 

Extensive Brain Metastases  

  • Primary treatment:
    • WBRT; or SRS; or systemic therapy (SRS can be considered for patients with good performance and low overall tumor volume and/or radioresistant tumors such as melanoma)
  • Recurrent disease
    • Stable disease or reasonable systemic treatment options
      • Surgery; or SRS; or WBRT; or systemic therapy 

Leptomeningeal Metastases

  • Good risk (KPS ≥ 60; no major neurologic deficits; minimal systemic disease; reasonable systemic treatment options if needed) SRS or RT (involved-filed and/or whole brain) to bulky disease and neurologically symptomatic (such as cranial neuropathies) or painful sites. 

Radiation oncologists use several different treatment modalities in patients with primary brain tumors, including fractionated stereotactic RT and stereotactic radiosurgery (SRS). RT for patients with primary brain tumors is administered within a limited field (covering tumor or surgical cavity and small margin of adjacent brain tissue), while whole-brain RT (WBRT) and SRS are used primarily for treatment of brain metastases. 

SRS offers an excellent minimally invasive ablative treatment option for brain metastases. Patients undergoing SRS avoid the risk of surgery-related morbidity, and SRS is generally preferred over surgery for patients with small, asymptomatic lesions that do not require surgery and for patients with lesions that are not surgically accessible.

Cervical Cancer Version 1.2021
  • Conformal external beam therapies such as IMRT or stereotactic body radiation therapy (SBRT) should not be used as routine alternative to brachytherapy for treatment of central disease in patients with an intact cervix

Radiation Treatment Planning

CT-based treatment planning with conformal blocking and dosimetry is considered standard of care for EBRT. Brachytherapy is a critical component of definitive therapy in patients with cervical cancer who are not candidates for surgery (i.e. those with intact cervix); it may also be used as adjuvant therapy. Brachytherapy is typically combined with EBRT in an integrated plan. MRI imaging immediately preceding brachytherapy may be helpful in delineating residual tumor geometry. Stereotactic body radiotherapy (SBRT) allows delivery of very high disease of focused external beam radiation and may be applied to isolated metastatic sites.

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Version 4.2021 No mention of SRS or SBRT
Chronic Myeloid Leukemia Version 3.2021 No mention of SRS or SBRT
Colon Cancer Version 2.2021

Principles of Radiation and Chemoradiation Therapy

  • In patients with a limited number of liver or lung metastases, ablative radiotherapy to the metastatic site can be considered in highly selected cases or in the setting of a clinical trial. Radiotherapy should not be used in the place of surgical resection. Radiotherapy should be delivered in a highly conformal manner. The techniques can include 3-D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), or stereotactic body radiation therapy (SBRT) 

Perioperative Chemoradiation

  • If RT is to be used, conformal beam radiation should be the routine choice; intensity-modulated RT (IMRT) which uses computer assisted inverse treatment planning to focus radiation to the tumor site and potentially decrease toxicity to normal tissue, or stereotactic body RT (SBRT; also called stereotactic ablative radiotherapy [SABR] should be considered for unique clinical situations, such as reirradiation of previously treated patients with recurrent disease or anatomical situations where IMRT facilitates the delivery of recommended target volume doses while respective accepted normal issue dose-volume constraints.
Dermatofibrosarcoma Protuberans Version 1.2021 No mention of SRS or SBRT
Esophageal and Esophagogastric Junction Cancers Version 3.2021 No mention of SRS or SBRT
Gastric Cancer Version 3.2021 No mention of SRS or SBRT
Gastrointestinal Stromal Tumors (GIST) Version 1.2021 No mention of SRS or SBRT
Gestational Trophoblastic Neoplasia Version 2.2021
  • High risk GTN confirmed >7 prognostic score or stage IV: Consider brain radiotherapy: stereotactic brain radiotherapy +/- intrathecal methotrexate; or whole brain radiation 

Management of CNS Metastases

The panel recommends that whole-brain radiation or stereotactic brain radiotherapy (SBRT with or without intrathecal methotrexate also be considered for patients with brain metastases. Reported cure rates with brain metastases range from 50% to 80%, depending on the patient’s symptoms as well as number, size, and location of brain lesions. 

Hairy Cell Leukemia Version 2.2021 No mention of SRS or SBRT
Head and Neck Cancers Version 3.2021

Principles of Radiation Techniques

  • Palliative 3D conformal RT, IMRT and Stereotactic Body RT (SBRT) 

Stereotactic Body Radiation Therapy

Stereotactic Body RT (SBRT) is an advanced technique of external beam ET (EBRT) that delivers large ablative doses of radiation in a limited number of fractions. Advantages of SBRT include shorter treatment time, promising local control rates, and higher but acceptable toxicity depending on the specific location treated. There is currently insufficient evidence to recommend SBRT for treatment of H&N cancers, but the NCCN Panel acknowledge that it might be beneficial in the settings of re-irradiation, palliation or for older adults. Careful anticipation of toxicity is especially important in planning the delivery of this modality to a patient.

Hepatobiliary Cancers Version 3.2021

Principles of Radiation Therapy

  • All tumors irrespective of the location may be amendable to radiation therapy (RT) (3D conformal RT (3D-CRT), intensity-modulated RT (IMRT), or stereotactic body RT (SBRT). Image guided RT (IGRT) is strongly recommended when using EBRT, IMRT and SBRT to improve treatment accuracy and reduce treatment-related toxicity

Radiation Therapy

Radiation therapy options for patients with unresectable or inoperable HCC, include EBRT and stereotactic body radiation therapy (SBRT). SBRT is an advanced technique or EBRT that delivers large ablative doses of radiation. There is growing evidence (primarily from non-RCTs) supporting the usefulness of SBRT for patients with unresectable, locally advanced or recurrent HCC.

Histiocytic Neoplasms Version 1.2021 No mention of SRS or SBRT
Hodgkin Lymphoma Version 4.2021 No mention of SRS or SBRT
Kaposi Sarcoma Version 2.2021 No mention of SRS or SBRT
Kidney Cancer Version 1.2022
  • Stereotactic body radiotherapy (SBRT) may be considered for medically inoperable patients with stage I kidney cancer (category 2B), with stage II/III kidney cancer (both category 3)

Patients who have undergone a nephrectomy and years later develop an oligometastatic recurrence also have the option of metastastectomy, stereotactic body radiation therapy (SBRT), or ablative techniques, in addition to the first-line therapy options. 

Supportive care remains a mainstay of therapy for all patients with metastatic RCC. Stereotactic radiotherapy, if available, is an alternative to surgery for limited-volume brain metastasis, and whole brain irradiation is recommended for those patients with multiple brain metastases.
Malignant Pleural Mesothelioma Version 2.2021

Principles of Radiation Therapy

  • Advanced technologies may be used such as image-guided RT (IGRT) for treatment involving IMRT/Stereotactic radiosurgery (SRS)/stereotactic body RT (SBRT)
Melanoma Cutaneous Version 2.2021

Principles of Radiation Therapy for Melanoma

Distant Metastatic Disease

  • Brain metastases
    • Stereotactic radiosurgery (SRS) and fractionated stereotactic RT (SRT) are techniques for delivering a high dose of radiation to a specific target while delivering a minimal dose to surrounding tissues, generally in the brain and spine and in 1 to 5 sessions. IGRT should be used to improve accuracy of radiotherapy delivery, where clinically appropriate.
    • SRS or SRT as primary treatment
    • SRS/SRT as adjuvant treatment 

Ablative Treatment of Intact Extracranial Metastasis

  • Higher doses utilizing conformal techniques such as stereotactic body RT (SBRT) may offer more durable local control
  • SBRT may be considered for selected patients with oligometastasis 

Higher doses utilizing conformal techniques such as stereotactic body radiation therapy (SBRT) may offer more durable local control and freedom from regional or distant progression. SBRT may be used in selected patients with oligometastatis. The potential benefit must be weighed against potential toxicities, and strict adherence to normal tissue constraints is recommended. 

Radiation for Brain Metastases

SRS is gaining importance in the management of CNS metastases from melanoma. With the increasing use of stereotactic radiation, the value of WBRT in patients with melanoma brain metastases is increasingly unclear and controversial.

Melanoma Uveal Version 2.2021

Primary Treatment

  • Tumor Size
    • Largest diameter > 19 mm (any thickness); or
    • Thickness > 10 mm (any diameter); or
    • Thickness > 8 mm with optic nerve involvement (any diameter)
      • Options
        • Radiation therapy: Particle beam radiation or stereotactic radiosurgery (SRS)
        • Enucleation

Principles of Radiation Therapy

Stereotactic Radiosurgery (SRS)

  • SRS is the least often used from of definitive radiotherapy for the treatment of primary or recurrent intraocular tumors

NCCN Recommendations for Stereotactic Radiation

Due to the lack of randomized prospective data (compared with other RT techniques), SRS is the least often used form of definitive RT for the treatment of primary or recurrent intraocular tumors. Like particle beam RT, SRS can be used to treat large choroidal melanomas. The choice between these two options generally depends on the radiation oncology facilities available. In rare cases where both particle beam RT and SRS facilities are available, some NCCP Panel members prefer particle beam RT because there are more supporting data for this approach.
Merkel Cell Carcinoma Version 1.2021 No mention of SRS or SBRT
Multiple Myeloma Version 7.2021 No mention of SRS or SBRT
Myelodysplastic Syndromes Version 3.2021 No mention of SRS or SBRT
Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Fusion Genes Version 4.2021 No mention of SRS or SBRT
Myeloproliferative Neoplasms Version 1.2021 No mention of SRS or SBRT
Neuroendocrine and Adrenal Tumors Version 2.2021

Bronchopulmonary Neuroendocrine Tumors

  • If surgery is contraindicated, thermal ablation or stereotactic body RT (SBRT) is recommended.
Non-Small Cell Lung Cancer Version 5.2021
  • Stage IA (peripheral T1abc, N0) with negative mediastinal nodes → medically inoperable → definitive RT preferably stereotactic ablative therapy (SABR)
  • Stage IVA, M1b → PS 0-2 Limited metastases confirmed → Brain → stereotactic radiosurgery (SRS) alone; or surgical resection if symptomatic or warranted for diagnosis, followed by SRS or whole brain RT (WBRT)
  • Palliative RT for Advanced/Metastatic NSCLC
    • Single-fraction stereotactic RT produced better control of pain response and local control of non-spine bone metastases compared to standard 30 Gy in 10 fractions 

SABR= stereotactic ablative RT also known as stereotactic body RT (SBRT) 

Surgery

Patients with medically inoperable early – stage NSCLC may be candidates for SABR, also known has stereotactic body RT (SBRT). If SBR is considered for patients at high risk, a multidisciplinary evaluation is recommended. 

Radiation Therapy

Whole brain RT and stereotactic radiosurgery (SRS) for brain metastases are also discussed in this section.

Definitive RT, particularly SABR, is recommended for patients with early-stage NSCLC (i.d. stage I-II, N0) who are medically inoperable or those who refuse surgery. 

Stereotactic Ablative Radiotherapy

SABR (also known as SBRT) uses short courses of very high (ablative), highly conformal, and dose-intensive RT precisely delivered to limited-size targets. 

Whole Brain RT and Stereotactic Radiosurgery

SRS alone is recommended for patients with limited volume metastases. 

Stage I, Stage II, Stage IIIA Disease

Definitive RT, including SABR, is recommended for patients with early-stage NSCLS who are medically inoperative or refuse surgery; RT can be considered as an alternative to surgery in patients at high risk of complications. 

Occult Primary (Cancer of Unknown Primary [CUP]) Version 2.2021
  • Localized adenocarcinoma or carcinoma not otherwise specified with lung nodules
    • Management based on workup findings: stereotactic body radiotherapy (SBRT)

Principles of Radiation Therapy

General Principles

  • Localized Disease
    • Consider definitive radiotherapy for patients with localized disease
      • Consider stereotactic ablative radiotherapy (SABR) for limited (1-3) metastases and pulmonary metastases

Treatment Based on Workup Findings

Adenocarcinoma

Chemotherapy, preferably as part of a clinical trial, or stereotactic body RT (SBRT) can be considered for oligometastatic lung nodules with or without resection.

Radiation Therapy

Stereotactic ablative radiotherapy (SABR) may be used for limited (1-3) metastases or pulmonary metastases.

Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer Version 1.2021 No mention of SRS or SBRT
Pancreatic Adenocarcinoma Version 2.2021
  • Locally Advanced Disease with good performance status
    • First-Line Therapy: Induction chemotherapy (preferably 4-6 months) followed by chemoradiation or stereotactic body RT (SBRT) in selected patients (Locally advanced without systemic metastases) 

Radiation and Chemoradiation Approaches

Stereotactic body RT (SBRT) is another technique aimed at increasing does to the gross tumor while sparing radiation to nearby healthy tissue. SBRFT should not be used if direct invasion of the bowel or stomach is observed on imaging, and care should be taken to limit dose to these areas to reduce treatment-related toxicity, particularly in patients with unresectable disease. Since the data regarding appropriateness use of SBRT are evolving, the panel recommends that SBRT should be used preferably in the context of a clinical trial and at an experienced high-volume center.

Pediatric Acute Lymphoblastic Leukemia Version 3.2021 No mention of SRS or SBRT
Pediatric Hodgkin Lymphoma Version 3.2021 No mention of SRS or SBRT
Penile Cancer Version 2.2021 No mention of SRS or SBRT
Primary Cutaneous Lymphomas Version 2.2021 No mention of SRS or SBRT
Prostate Cancer Version 2.2021

Systemic Therapy for Castration – Naïve Prostate Cancer

  • M1: SBRT to metastases can be considered in patients with oligometastatic progression where progression-free survival is a goal

Principles of Radiation Therapy

  • SBRT is acceptable in practices with appropriate technology, physics, and clinical expertise. SBRT for metastases can be considered in the following circumstances:
    • In patient with limited metastatic disease to the vertebra or paravertebral region with ablation is the goal (e.g., concern for impending fracture or tumor encroachment on spinal nerves or vertebra)
    • In a patient with oligometastatic progression where progression free survival is the goal
    • In a symptomatic patient where the lesion occurs in or immediately adjacent to a previously irradiated treatment field. 

Unfavorable Intermediate Risk

  • Prophylactic nodal radiation can be considered if additional risk assessments suggest aggressive tumor behavior. ADT should be used unless additional risk assessments suggest less-aggressive tumor behavior or if medically contraindicated. The duration of ADT can be reduced when combined with EBRT and brachytherapy. Brachytherapy combined with ADT (without EBRT), or SBRT combined with ADT can be considered if delivering longer courses of EBRT would present medical or social hardship. 

High and Very High Risk

  • Prophylactic nodal radiation can be considered. ADT is required unless medically contraindicated. Brachytherapy combined with ADT (without EBRT), or SBRT combined with ADT, can be considered if delivering longer courses of EBRT would present a medical or social hardship.

Stereotactic Body Radiation Therapy

Stereotactic body radiation therapy (SBRT) is a technique that delivers highly conformal, high-dose radiation in five or fewer treatment fractions which are safe to administer only with precise image guided delivery. Single institution series with median follow-up as long as 6 years report excellent biochemical PFS and similar early toxicity (bladder, rectal, and QOL) compared to standard radiation techniques. 

SBRT/extremely hypofractionated image-guided IMRT regimens can be considered as an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics, and clinical expertise. Longer follow-up and prospective multi-institutional data are required to evaluate longer-term results, especially because late toxicity theoretically could be worse in hypofractionated regimens compared to conventional fractionation.

Rectal Cancer Version 1.2021

Principles of Radiation Therapy

General Principles

  • In patients with limited number of liver or lung metastases, ablative radiotherapy to the metastatic site can be considered in highly selected cases or in the setting of a clinical trial. Radiotherapy should not be used in the place of surgical resection. Radiotherapy should be delivered in highly conformal manner. The technique can include 3-D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), or stereotactic body radiation therapy (SBRT)

Treatment Information

  • Consider SBRT for patients with oligometastatic disease 

Technical Aspects of Radiation Therapy

Intensity-modulated RT (IMRT) or stereotactic body RT (SBRT) should only be used in the setting of a clinical trial or in unique clinical situations such as re-irradiation of previously treated recurrent disease, localized oligometastatses, or unique anatomical situations where IMRT/SBRT facilitates the delivery of recommended target volumes while respecting accepted normal tissue dose-volume constraints.  

Local Therapies for Metastases

SBRT (also called stereotactic ablative radiotherapy [SABR]) is a reasonable option for patients who cannot be resected or ablated. Many patients, however, are not surgical candidates and/or have disease that cannot be ablated with clear margins or safely treated by SBRT. 

Liver or Lung Directed Therapies

Local radiation therapies include arterial radioembolization with microspheres and conformal (stereotactic) external beam RT (EBRT).

EBRT to the metastatic site can be considered in highly selected cases in which the patient has a limited number of liver and lung metastases, or the patient is symptomatic or in the setting of a clinical trial. It should be delivered in a high conformal manner and should not be used in place of surgical resection. The possible techniques include three-dimensional conformal RT (CRT), SBRT, IMRT which uses computer assisted inverse treatment planning to focus radiation to the tumor site and potentially decrease toxicity to healthy tissue.

Small Bowel Adenocarcinoma Version 1.2021 No mention of SRS or SBRT

Small Cell Lung Carcinoma Version 3.2021

SABR

Emerging data suggests that SABR (also known as stereotactic body radiation therapy [SABR]) may be useful for patients with clinical stage I or IIA (T1-2, N0) SCLC who are medically inoperable or refuse surgery.

Soft Tissue Sarcoma Version 2.2021

Extremity/Body Wall, Head/Neck

Synchronous Stage IV disease 

  • Single organ (primarily pulmonary) with limited tumor bulk that is amendable to local therapy → Primary Treatment
    • Consider the following options for metastases
      • For lung metastases, resection preferred or SBRT
      • Stereotactic body radiation therapy (SBRT)
  • Disseminated metastasis
    • Palliative treatment options
      • RT/SBRT 

Recurrent Disease

  • Metastatic disease
    • Single organ and limited tumor bulk that are amendable to local therapy → Treatment
      • SBRT +/- systemic therapy
    • Disseminated metastases → palliative options
      • SBRT/RT
    • Isolated regional disease or nodes
      • SBRT

Limited Metastases

Patients with limited metastasis confined to single organ and limited tumor bulk that are amendable to local therapy should receive primary tumor management as described for stage II or III tumors. In addition, patients can also receive stereotactic body RT (SBRT) or chemotherapy as an alternate method for control of metastatic lesions. Several recent revies and case series support the use of SBRT for local control, with potential survival benefits in selected patients.

Squamous Cell Skin Cancer Version 1.2021
  • Palpable regional lymph node(s) or abnormal lymph nodes identified by imaging studies → FNA or core biopsy positive → inoperable or not fully resectable disease RT +/- systemic therapy (Consider palliative RT/surgery for symptomatic sites SBRT may also be considered in select patients)
  • Regional recurrence or distant metastases
    • Consider palliative RT/surgery for symptomatic sites SBRT may also be considered in select patients 

NCCN Recommendations

The NCCN Panel encourages participation in a clinical trial for patients with metastatic cSCC. Unfortunately such trials are scarce. For symptomatic sites palliative RT or surgery should be considered. Stereotactic body RT (SBRT) may be appropriate in select patients.

Systemic Light Chain Amyloidosis Version 1.2022 No mention of SRS or SBRT
Systemic Mastocytosis Version 3.2021 No mention of SRS or SBRT
T-cell Lymphomas Version 1.2021 No mention of SRS or SBRT
Testicular Cancer Version 2.2021 No mention of SRS or SBRT
Thymomas and Thymic Carcinomas Version 1.2021

Thymomas

  • Stereotactic body radiation therapy (SBRT) may be appropriate for limited focal metastases, whereas conventional fractionation is appropriate for larger metastases.
Thyroid Carcinoma Version 1.2021

Papillary, Follicular and Hurthle Cell Carcinomas

  • Locoreginal recurrence
    • Consider preoperative iodine total body scan
      • or select patients with unresectable, non-radioiodine-avid, and progressive disease consider
        • EBRT (IMRT/SBRT) and/or systemic therapies 
  • Treatment of locally recurrent, advanced, and or metastatic disease not amendable to RAI therapy
    • Unresctable locoregional recurrent/persistent disease or soft tissue metastases (e.g., lung, liver, muscle) excluding CNS metastases
      • Consider resection of distant metastases and/or EBRT (SBRT/IMRT)/other local therapies when available to metastatic lesions if progressive and/or symptomatic 
  • Treatment of Metastatic Disease not Amendable RAI Therapy
    • Bone metastases: Consider surgical palliation and/or EBRT/SBRT/other local therapies when available if symptomatic, or asymptomatic in weight-bearing sites

Principles of Radiation and Radioactive Iodine Therapy External Beam Radiation Therapy (EBRT)

    • Bony or soft tissue metastases
      • For patients with oligometastatic disease and good performance status consider higher doses 

External Beam RT and Surgical Excision of Metastases

Surgical excision, EBRT, stereotactic body radiation therapy (SBRT) or other local therapies can be considered for symptomatic isolated skeletal metastases or those that are symptomatic isolated skeletal metastases or those that are asymptomatic in weight bearing sites.

Most recurrent tumors respond well to surgery, I therapy; EBRT, SBRT, or IMRT; or other local therapies such as ethanol ablation, cryoablation, or radiofrequency ablation. 

Metastatic Disease not Amendable to RAI Therapy

For skeletal metastases, consider surgical palliation for symptomatic or asymptomatic tumors in weight-bearing extremities; other therapeutic options are EBRT, SBRT or other local therapies.

Uterine Neoplasms Version 3.2021

Endometrial Cancer

  • Suspected extrauterine disease → Suitable for primary surgery → distant metastases → Primary treatment
    • SBRT- consider ablative radiation therapy 1-5 metastatic lesions if hysterectomy is performed (category 2B)

 

Vulvar Cancers Version 3.2021 No mention of SRS or SBRT
Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma Version 1.2022 No mention of SRS or SBRT
Wilms Tumor Version 2.2021 No mention of SRS or SBRT

 

American College of Radiology

The following is from the Expert Panel on Radiation Oncology-Gynecology/American College of Radiology‘s Appropriateness Criteria on the definitive therapy for early stage cervical cancer which states the following: "Stereotactic body RT (SBRT) has been shown to be a useful treatment option in other tumor sites, especially in early stage lung cancer. There are preliminary data on its use in treating cervical cancer, but, given target definition, tumor motion, and the proven track record of brachytherapy, SBRT should not be considered a substitute for brachytherapy."

 

American Academy of Ophthalmology

In 2015, the American Academy of Ophthalmology updated its evidence-based preferred practice pattern on age-related macular degeneration. For extrafoveal choroidal neovascularization, radiotherapy was not recommended (SIGN grade: III; GRADE assessment: moderate level of evidence, strong recommendation).

 

In their 2019 Preferred Practice Pattern for age-related macular degeneration, they state that current data is insufficient “to demonstrate clinical efficacy” for extrafoveal choroidal neovascularization or 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.

 

Prior Approval:

Not applicable

 

Policy:

Stereotactic Radiosurgery (SRS): Also referred to as stereotactic ablative surgery is a form of radiation therapy in which three-dimensional (3D) images are utilized to specifically direct focused radiation to obliterate abnormal tissues in the head and neck (facilitated by a rigid head frame), while sparing surrounding healthy tissue.

 

Stereotactic Body Radiotherapy (SBRT): Also referred to as stereotactic ablative radiotherapy (SABR) is similar in technique to intracranial SRS except the target areas are in the body (utilizing a body frame) and do not include the head or neck (extracranial).

 

Oligometastatic Extracranial Disease:  Metastasis can occur when one or more cancer cells develop the capacity to enter the bloodstream (hematogenous) and establish secondary tumors in distant organs such as the brain, lungs, liver and bone. While widespread metastatic disease is generally considered incurable, there exists a subset of patients with limited metastatic involvement who can potentially be cured of their disease. This state has been termed “oligometastatic” and is most commonly defined as having 3 or fewer metastatic lesions (sites).

 

Synchronous Oligometastasis: Oligometastatis diseases (hematogenous) found at the time of the diagnosis of the primary tumor .

 

Metachronous Oligometastasis: Oligometastatic disease (hematogenous) found after treatment of the primary tumor.

 

Oligoprogression: Progression of a limited number of metastatic sites (1-3) (hematogenous) while other metastatic disease sites remain controlled.

 

Stereotactic radiosurgery (SRS) (also referred to as stereotactic ablative surgery) of the head and neck or Stereotactic Body Radiotherapy (SBRT) (also referred to as stereotactic ablative radiotherapy [SABR]) of the body (extracranial) may be considered medically necessary for the following indications:

  • Benign Brain Lesions
    • Arteriovenous malformations less than 3 cm in size and individuals who are a poor surgical risk or surgically inaccessible AVM
    • Acoustic neuromas
    • Pituitary adenomas
    • Craniopharyngiomas
    • Pineocytomas
    • Schwannoma
    • Glomus tumors
  • Trigeminal neuralgia refractory to medical management
  • Uveal Melanoma
  • Individuals who have oligometastatic extracranial disease when ALL of the following are met:
    • One to three hematogenous (originated or carried by the blood) metastatic lesions (sites); and
    • The primary tumor is breast, colorectal, melanoma, lung, prostate, renal cell or soft tissue sarcoma; and
    • The primary tumor received curative therapy and is controlled; and
    • No prior evidence of metastatic disease
  • Anal carcinoma for patients with low-volume liver oligometastasis after systemic therapy or for the treatment of primary and nodal recurrence in the setting of low-volume metastatic disease
  • Base of skull chordomas and chondrosarcomas;
  • Cervical cancer in isolated metastatic sites only
  • Colorectal cancer
    • In patients with limited number of liver or lung metastases (1-3 metastatic lesions); or
    • Reirradiation of previously treated patients with recurrent disease
  • Gestational Trophoblastic Neoplasia with brain metastases – High risk GTN confirmed ≥ 7 prognostic score or Stage IV
  • Bronchopulmonary neuroendocrine tumor(s) if surgery is contraindicated
  • Non-small cell lung cancer (NSCLC)
    • For Stage I, Stage II or Stage IIIA disease and the individual is medically inoperable or refuses surgery; or
    • Stage IVA, M1b with limited metastases (1-3 lesions) to the brain confirmed
    • Palliative therapy for advanced or metastatic NSCLC
  • Small cell lung cancer
    • In patients with clinical Stage I or Stage IIA who are medically inoperable or refuse surgery
  • Prostate Cancer for the following indications:
    • Low-risk prostate cancer defined as having ALL of the following:
      • Stage T1 to T2a; and
      • Gleason score < 6; and
      • Prostate specific antigen (PSA) < 10 ng/mL.
    • Intermediate – risk prostate cancer defined as having ALL of the following:
      • Stage T2b or T2c; and
      • Gleason score 7
      • Prostate specific antigen (PSA) 10 to 20 ng/mL; and
      • Favorable intermediate risk is defined as having ALL of the following: 1 intermediate risk factor (IRF), Grade Group 1 or 2, and < 50% biopsy cores positive; OR
      • Unfavorable intermediate-risk defined as having one or more of the following: 2 to 3 intermediate risk factors (IRF), Grade Group 3, and/or ≥ 50% biopsy cores positive.
    • High-risk prostate cancer defined as having ALL of the following:
      • Stage ≥ T3a; and
      • Gleason score ≥ 8; and
      • PSA > 20 ng/mL
    • Metastatic prostate cancer in the following circumstances:
      • In patients with limited metastatic disease to the vertebra or paravertebral region (concern for impending fracture or tumor encroachment on spinal nerves and vertebra); or
      • In a patient with oligometastatic progression; or
      • In a symptomatic patient where the lesion occurs in or immediately adjacent to previously irradiated treatment field
      • Nodal oligometastases for individuals with limited volume metastatic disease
  • Occult Primary (Cancer of Unknown Primary [CUP])
    • Localized adenocarcinoma or carcinoma not otherwise specified with limited (1-3) metastatic lesions and pulmonary metastases
  • Thymomas for limited metastases (1-3 metastatic lesions)
  • Thyroid Carcinoma for the following indications:
    • Locoregional recurrence for patients with unresectable, non-radioiodine – avid and progressive disease; or
    • Unresectable locoregional recurrent/persistent disease or soft tissue metastases (e.g., lung, liver, muscle) excluding CNS metastases if metastatic lesion is progressive and/or symptomatic.
  • Central nervous system (CNS) cancers for the following indications:
    • High-grade gliomas and low- grade gliomas
      • Initial treatment
      • Treatment of recurrence
      • To treat previously irradiated field
    • Meningiomas when using tight margins or close to critical structures
    • Adult medulloblastoma for treatment of recurrence
    • Adult intracranial and spinal ependymoma (excluding subependymoma) with spine or brain recurrence
    • Brain metastases as primary treatment or for recurrent disease
    • Metastatic spinal tumors
  • Head and neck cancers
    • For re-irradiation
    • Palliative radiation should be considered in the advanced cancer setting when curative-intent treatment is not appropriate
  • Hepatocellular Carcinoma (HCC) for the following indications:
    • Unresectable (HCC); or
    • Locally advanced (HCC); or
    • Recurrent HCC
  • Pancreatic Cancer locally advanced without systemic metastasis to include no direct invasion of bowel or stomach observed on imaging
  • Kidney Cancer when ALL of the following criteria are met:
    • Relapse or Stage IV; and
    • Unresectable; and
    • Symptomatic metastases.

 

Required Documentation

The documentation requirements outlined below are used to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the service requested. The medical records submitted should include all of the following:

  • History and physical; and
  • The medical condition requiring treatment; and
  • The physician’s treatment plan.

 

Stereotactic radiosurgery (SRS)/Stereotactic body radiotherapy (SBRT) is considered investigational including, but not limited to the following indications, because the evidence is insufficient to determine the effects of this technology on net health outcomes:

  • The treatment of seizures, including epilepsy
  • Functional disorders (other than trigeminal neuralgia), including chronic pain and headaches
  • Parkinson’s disease and other movement disorders
  • Cardiac arrhythmia (including but not limited to ventricular tachycardia)
  • Cardiac radio-ablation
  • Choroidal neovascularization
  • Mammographic microcalcification
  • Behavior health disorders
  • Acute lymphoblastic leukemia
  • Acute myeloid leukemia
  • Anal carcinoma except as indicated above
  • Basal cell skin cancer
  • B-cell lymphomas
  • Bladder cancer – primary
  • Bone cancer – primary
  • Breast cancer
  • Central nervous system cancers except as indicated above
  • Cervical cancer except as indicated above
  • Chronic lymphocytic leukemia/small lymphocytic leukemia
  • Chronic myeloid leukemia
  • Colorectal cancer except as indicated above
  • Dermatofibrosarcoma protuberans
  • Esophageal and esophagogastric junction cancers
  • Gastric cancer
  • Gastrointestinal stromal tumors (GIST)
  • Gestational trophoblastic neoplasia except as indicated above
  • Hairy cell leukemia
  • Head and neck cancers except as indicated above
  • Hepatobiliary cancers except hepatocellular carcinoma as indicated above
  • Histiocytic neoplasms
  • Hodgkin lymphoma
  • Kaposi sarcoma
  • Kidney cancer except as indicated above
  • Malignant pleural mesothelioma
  • Melanoma cutaneous except for individuals who have oligometastatic extracranial disease indicated above
  • Merkel cell carcinoma
  • Multiple myeloma
  • Myelodysplastic syndromes
  • Myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes
  • Myeloproliferative neoplasms
  • Neuroendocrine and adrenal tumors except as indicated above
  • Non-small cell lung cancer (NSCLC) except as indicated above
  • Oligoprogression disease (hematogenous) – limited number of metastatic sites (1-3) while other metastatic disease sites remain controlled
  • Occult primary (cancer of unknown primary [CUP] except as indicated above
  • Ovarian cancer/fallopian tube cancer and primary peritoneal cancer
  • Pancreatic cancer when invasion of the bowel or stomach is observed on imaging or endoscopy and except as indicated above
  • Penile cancer
  • Primary cutaneous lymphomas
  • Prostate cancer except as indicated above
  • Small bowel adenocarcinoma
  • Small cell lung cancer except as indicated above
  • Soft tissue sarcoma except for individuals who have oligometastatic extracranial disease indicated above
  • Systemic light chain amyloidosis
  • Systemic mastocytosis
  • T-cell lymphomas
  • Testicular cancer
  • Thymomas except as indicated above
  • Thymic carcinoma
  • Thyroid cancer except as indicated above
  • Uterine neoplasms
  • Vulvar cancers
  • Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma

 

Policy Guidelines

Curative Intent: treatment provided with the main intent being to improve or eliminate symptoms that the patient is experiencing and to extend the patient’s overall length of life.

 

Very Low Risk Prostate Cancer

Has all of the following:

  • T1c AND
  • Grade Group 1 AND
  • PSA<10 ng/mL AND
  • Fewer than 3 prostate biopsy fragments/cores positive, ≤ 50% cancer in each fragment/core AND
  • PSA density < 0.15 ng/mL/g

 

International Society of Urological Pathologists
Risk Group ISUP Grade Group Gleason Score
Low Grade Group 1 Gleason Score ≤ 6
Intermediate Favorable Grade Group 2 Gleason Score 7 (3+4)
Intermediate Unfavorable Grade Group 3 Gleason Score 7 (4+3)
High Grade Group 4 Gleason Score 8
Very High Grade Group 5 Gleason Score 9-10

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 32701 Thoracic target(s) delineation for stereotactic body radiation therapy (SRS/SBRT), (photon or particle beam), entire course of treatment
  • 61796 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 simple cranial lesion
  • 61797 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator) each additional cranial lesion, simple (List separately in addition to code for primary procedure)
  • 61798 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 complex cranial lesion
  • 61799 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator) each additional cranial lesion, complex (List separately in addition to code for primary procedure)
  • 61800 Application of stereotactic headframe for stereotactic radiosurgery (List separately in addition to code for primary procedure)
  • 63620 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 spinal lesion
  • 63621 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional spinal lesion (List separately in addition to code for primary procedure)
  • 77371 Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; multi-source Cobalt 60 based
  • 77372 Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based
  • 77373 Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions
  • 77432 Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of 1 session)
  • 77435 Stereotactic body radiation therapy, treatment management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions
  • G0339 Image guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session, or first session of fractionated treatment
  • G0340 Image 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 5 sessions per course of treatment

 

Selected References:

  • Buyyounouski M, Miller R, Schefter T, et al. Stereotactic body radiotherapy (SBRT) for primary management of early-stage, low-intermediate risk prostate cancer. Report of the ASTRO Emerging Technology Committee (ETC). Fairfax, VA: American Society for Therapeutic Radiation Oncology (ASTRO); September 19, 2008.
  • Buyyounouski MK, Balter P, D'Ambrosio DJ, et al. Stereotactic body radiotherapy for early-stage non-small-cell lung cancer: Report of the ASTRO Emerging Technology Committee. Full Report. Fairfax, VA: American Society for Therapeutic Radiation Oncology (ASTRO); January 12, 2010.
  • Yamada Y, Laufer I, Cox BW, et al. Preliminary results of high-dose single-fraction radiotherapy for the management of chordomas of the spine and sacrum. Neurosurgery. 2013;73(4):673-680; discussion 680.
  • Shah A, Hahn SM, Stetson RL, et al. Cost-effectiveness of stereotactic body radiation therapy versus surgical resection for stage I non-small cell lung cancer. Cancer. 2013;119(17):3123-3132.
  • Small W Jr, Strauss JB, Jhingran A, et al, Expert Panel on Radiation Oncology-Gynecology. ACR Appropriateness Criteria® definitive therapy for early stage cervical cancer. [online publication]. Reston (VA): American College of Radiology (ACR); 2012.
  • Howington JA, Blum MG, Chang AC, et al. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e278S-e313S.
  • Zhang B, Zhu F, Ma X, et al. Matched-pair comparisons of stereotactic body radiotherapy (SBRT) versus surgery for the treatment of early stage non-small cell lung cancer: A systematic review and meta-analysis. Radiother Oncol. 2014;112(2):250-255.
  • Chang JY, Senan S, Paul MA, et al. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: A pooled analysis of two randomised trials. Lancet Oncol. 2015;16(6):630-637.
  • Hernandez-Duran S, Hanft S, Komotar RJ, Manzano GR. The role of stereotactic radiosurgery in the treatment of intramedullary spinal cord neoplasms: A systematic literature review. Neurosurg Rev. 2015 Jul 30 [Epub ahead of print].
  • Tipton KN, Sullivan N, Bruening W, et al. Stereotactic body radiation therapy. Effective Healthcare Program Technical Brief.No. 6 Prepared by the ECRI Institute Evidence-Based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) under Contract No. 290-02-0019. AHRQ Publication No. 10(11)-EHC058-EF. Rockville, MD: AHRQ; May 2, 2011.
  • National Comprehensive Cancer Network. Clinical practice guideline: Hepatobiliary Cancers. Version 4.2020 NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network (NCCN). Acute Lymphoblastic Leukemia Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Acute Myeloid Leukemia Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Anal Carcinoma Version 2.2021
  • National Comprehensive Cancer Network (NCCN). B-cell Lymphomas Version 4.2021
  • National Comprehensive Cancer Network (NCCN). Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Version 4.2021
  • National Comprehensive Cancer Network (NCCN). Chronic Myeloid Leukemia Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Dermatofibrosarcoma Protuberans Version 1.2021
  • National Comprehensive Cancer Network (NCCN). Esophageal and Esophagogastric Junction Cancers Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Gastric Cancer Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Gastrointestinal Stromal Tumors (GIST) Version 1.2021
  • National Comprehensive Cancer Network (NCCN). Gestational Trophoblastic Neoplasia Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Hairy Cell Leukemia Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Hepatobiliary Cancers Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Histiocytic Neoplasms Version 1.2021
  • National Comprehensive Cancer Network (NCCN). Hodgkin Lymphoma Version 4.2021
  • National Comprehensive Cancer Network (NCCN). Kaposi Sarcoma Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Malignant Pleural Mesothelioma Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Melanoma Uveal Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Merkel Cell Carcinoma Version 1.2021
  • National Comprehensive Cancer Network (NCCN). Multiple Myeloma Version 7.2021
  • National Comprehensive Cancer Network (NCCN). Myelodysplastic Syndromes Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Fusion Genes Version 4.2021
  • National Comprehensive Cancer Network (NCCN). Myeloproliferative Neoplasms Version 1.2021
  • National Comprehensive Cancer Network (NCCN). Occult Primary (Cancer of Unknown Primary [CUP]) Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer Version 1.2021
  • National Comprehensive Cancer Network (NCCN). Pediatric Acute Lymphoblastic Leukemia Version 3.2021
  • National Comprehensive Cancer Network (NCCN). Pediatric Aggressive Matures B-Cell Lymphomas Version 2.2021
  • National Comprehensive Cancer Network (NCCN). Pediatric Hodgkin Lymphoma Version 3.2021
  • National Comprehensive Cancer Network. Penile Cancer Version 2.2021
  • National Comprehensive Cancer Network. Primary Cutaneous Lymphomas Version 2.2021
  • National Comprehensive Cancer Network. Small Bowel Adenocarcinoma Version 1.2021
  • National Comprehensive Cancer Network. Squamous Cell Skin Cancer Version 1.2021
  • National Comprehensive Cancer Network. Systemic Light Chain Amyloidosis Version 1.2022
  • National Comprehensive Cancer Network. Systemic Mastocytosis Version 3.2021
  • National Comprehensive Cancer Network. T-cell Lymphomas Version 1.2021
  • National Comprehensive Cancer Network. Testicular Cancer Version 2.2021
  • National Comprehensive Cancer Network. Thyroid Carcinoma Version 1.2021
  • National Comprehensive Cancer Network. Uterine Neoplasms Version 3.2021
  • National Comprehensive Cancer Network. Vulvar Cancers Version 3.2021
  • National Comprehensive Cancer Network. Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma Version 1.2022
  • National Comprehensive Cancer Network. Wilms Tumor Version 2.2021
  • National Comprehensive Cancer Network. Clinical practice guideline: Pancreatic Adenocarcinoma. Version 2.2021 NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Kidney Cancer. Version 1.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Cutaneous Melanoma. Version 2.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Breast cancers. Version 5.2020. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Cervical cancers. Version 1.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Bone cancers. Version 1.2020. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Small Cell Lung Cancer. Version 3.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Non-Small Cell Lung Cancer. Version 5.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline Head and Neck Cancers. Version .3.2021.  NCCN: Fort Washington, PA
  • National Comprehensive Cancer Network. Clinical practice guideline: Prostate Cancer. Version 2.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Neuroendocrine and Adrenal Tumors. Version 2.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Central Nervous System Cancers. Version 1.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Anal Carcinoma. Version 2.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Soft Tissue Sarcoma. Version 2.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Colon Cancer. Version 2.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline: Rectal Cancer. Version 1.2021. NCCN: Fort Washington, PA.
  • National Comprehensive Cancer Network. Clinical practice guideline Thyroid Carcinoma. Version 2.2020. NCCN: Fort Washington, PA
  • American College of Radiology (ACR). ACR Appropriateness Criteria. Management of recurrent endometrial cancer.
  • Régis, J., Tuleasca, C., Resseguier, N., Carron, R., Donnet, A., Gaudart, J., & Levivier, M. (2016). Long-term safety and efficacy of gamma knife surgery in classical trigeminal neuralgia: A 497-patient historical cohort study. Journal of Neurosurgery, 124(4), 1079–1087. doi:10.3171/2015.2.jns142144
  • Herman, J., Chang, D., Goodman, K., et. al. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma. Cancer 2015; 121(7):1128-1137. 
  • Wahl, D., Stenmark, M., Tao, Y., et. al. Outcomes after stereotactic body radiotherapy or radiofrequency ablation for hepoatocellular carcinoma. J Clin Oncology 2016; 34:452-9. 
  • ECRI Institute. Technology News. FDA approves GammaPod radiotherapy system for breast cancer. Published February 12, 2018.
  • Nguyen T, Chung LK, Sheppard JP, et al. Surgery versus stereotactic radiosurgery for the treatment of multiple meningiomas in neurofibromatosis type 2: Illustrative case and systematic review. Neurosurg Rev. 2017 Sep 13
  • Bui TT, Lagman C, Chung LK, et al. Systematic analysis of clinical outcomes following stereotactic radiosurgery for central neurocytoma. Brain Tumor Res Treat. 2017;5(1):10-15.
  • Zhong J, Patel K, Switchenko J, et al. Outcomes for patients with locally advanced pancreatic adenocarcinoma treated with stereotactic body radiation therapy versus conventionally fractionated radiation. Cancer. 2017;123(18):3486-3493
  • Hintenlang LL, Miller DH, Kaleem T, et al. Treatment of a glioblastoma multiforme dural metastasis with stereotactic radiosurgery: A case report and select review of the literature. J Clin Neurosci. 2018;48:118-121
  • Pan J, Jabarkheel R, Huang Y, et al. Stereotactic radiosurgery for central nervous system hemangioblastoma: Systematic review and meta-analysis. J Neurooncol. 2018;137(1):11-22.
  • Chen L, Douglass J, Kleinberg L, et al. Concurrent immune checkpoint inhibitors and stereotactic radiosurgery for brain metastases in non-small cell lung cancer, melanoma, and renal cell carcinoma. Int J Radiat Oncol Biol Phys. 2018;100(4):916-925.
  • Kobiela J, Spychalski P, Marvaso G, et al. Ablative stereotactic radiotherapy for oligometastatic colorectal cancer: Systematic review. Crit Rev Oncol Hematol. 2018;129:91-101.
  • Lehrer EJ, Peterson J, Brown PD, et al. Treatment of brain metastases with stereotactic radiosurgery and immune checkpoint inhibitors: An international meta-analysis of individual patient data. Radiother Oncol. 2018 Sep 18 [Epub ahead of print].
  • Lydiard S, Caillet V, Ipsen S, et al. Investigating multi-leaf collimator tracking in stereotactic arrhythmic radioablation (STAR) treatments for atrial fibrillation. Phys Med Biol. 2018;63(19):195008.
  • Zei PC, Wong D, Gardner E, et al. Safety and efficacy of stereotactic radioablation targeting pulmonary vein tissues in an experimental model. Heart Rhythm. 2018;15(9):1420-1427.
  • American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern: Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2019. 
  • Karnofsky DA, Burchenal JH. (1949). “The Clinical Evaluation of Chemotherapeutic Agents in Cancer.” In: MacLeod CM (Ed), Evaluation of Chemotherapeutic Agents. Columbia Univ Press. pp 196.
  • Coverage with Evidence Development Requirements Position Statement. American Society for Radiation Oncology Web site
  • Brand DH, Tree AC, Ostler P, et al. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet, Sept. 17, 2019.

 

Policy History:

  • July 2021- Annual Review, Policy Revised
  • November 2020 - Interim Review, Policy Revised
  • July 2020- Annual Review, Policy Revised
  • October 2019 - Interim Review, Policy Revised
  • July 2019 - Annual Review, Policy Revised
  • November 2018 - Interim Review, Policy Revised
  • July 2018 - Annual Review, Policy Revised
  • July 2017 - Annual Review, Policy Revised
  • July 2016 - New policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.