Coverage Policy Manual
Policy #: 2003015
Category: Radiology
Initiated: June 2003
Last Review: November 2021
  Intensity Modulated Radiation Therapy (IMRT)

Description:
Intensity modulated radiation therapy (IMRT) refers to a technique of conformal radiation planning and delivery that is designed to better target the lesion, thus sparing surrounding normal tissue and ultimately limiting side effects. The reduced morbidity may also permit higher dosing to the target lesions, thus reducing the risk of local recurrence. One distinguishing feature if IMRT is that the radiation fluence varies across the beam, in contrast to conventional radiation therapy in which a homogeneous radiation dose is delivered to the tumor target, minimally modulated by the use of traditional wedges, blocks and compensators. Specifically in IMRT, non-uniform intensities are assigned to tiny subdivisions of beams, called “beamlets,” enabling custom design of optimum dose distributions.
 
The decision process for using IMRT requires an understanding of accepted practices that take into account the risks and benefits for such therapy compared to conventional treatment techniques. While IMRT technology may empirically offer advantages over conventional or 3-Dimensional conformal radiation, a comprehensive understanding of all consequences is required before applying this technology.
 
There is considerable documentation required in the medical record to support the use of IMRT.
 
Related policies:
2009036_Intensity Modulated Radiation Therapy (IMRT)_Breast
2009034_Intensity Modulated Radiation Therapy (IMRT)_Prostate
2011071_Intensity Modulated Radiation Therapy (IMRT)_Anus, Anal Canal
2009035_Intensity Modulated Radiation Therapy (IMRT)_Lung

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 May 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is covered for:
Head and Neck Cancer
Treatment of radiosensitive tumors of the brain; head and neck region regardless of cell type, including but not limited to Hodgkin and Non-Hodgkin Lymphomas; thyroid; spine and paraspinal regions
 
Pleural Mesothelioma
Treatment of pleural mesothelioma if done as a component of a curative treatment regimen
 
Melanoma and Merkel cell carcinoma
        • Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
        • Treatment of cutaneous melanoma
 
Esophageal Cancer
Treatment of Esophageal Cancer if the following criteria are met:
 
        • The treatment is given with curative intent;
 
AND  
        • The risk of radiation exposure to adjacent critical organs would be excessive with 3D conformal treatment based upon submission of BOTH of the following dosimetric plans for comparison:
            • 3D conformal plan that includes appropriate techniques to limit toxicity, but limits to adjacent critical organ(s)-at-risk (OAR) have been exceeded; and
            • IMRT plan demonstrating improvement to tissue exposure to within safe ranges for adjacent critical organ(s) at risk; OR
        • For retreatment of a previously irradiated field
 
Bone Metastases
Treatment of bone metastases when ALL of the following conditions are met:
        • For retreatment of a previously irradiated field; and
        • Retreatment with EBRT would result in significant risk of adjacent organ injury
 
Sarcoma
Treatment of sarcoma when ANY of the following conditions are met:
        • For initial treatment of a primary pelvic soft tissue sarcoma; OR
        • For initial treatment of a primary retroperitoneal sarcoma; OR
        • For treatment of an extremity sarcoma; OR
        • For retreatment of a previously irradiated field
 
Pediatric Tumors
Treatment of pediatric patients when the following condition is met:
        • To treat pediatric individuals, age less than 21, with a radiosensitive tumor
 
Other Malignancies (not listed above or in a specific IMRT policy)
Treatment of Other Malignancies when the following conditions are met:
        • Where risk of radiation exposure to adjacent critical organs would be excessive with 3D conformal treatment based upon submission of BOTH of the following dosimetric plans for comparison:
            • 3D conformal plan that includes appropriate techniques to limit toxicity, but limits to adjacent critical organ(s)-at-risk (OAR) have been exceeded; and
            • IMRT plan demonstrating improvement to tissue exposure to within safe ranges OR
        • For retreatment of a previously irradiated field 
 
Image guidance or image-guided radiation therapy (IGRT), any modality, used with IMRT meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is covered when ANY of the following conditions are met:
    • Use of IGRT will allow significant reduction of radiation dose to sensitive normal structures, for example:
        • Left-sided breast cancer treatment with deep inspiration breath hold technique (DIBH) for cardiac sparing is being utilized
    • Implanted fiducial markers have been placed
    • Bony anatomy fails to accurately delineate a tumor location and fiducial markers or intensity modulated radiation therapy (IMRT) are not indicated (for example, head and neck cancer or prone breast radiotherapy)
    • The treatment field abuts a previously irradiated field
    • There is significant setup variation affecting the treatment target, for example:
        • Individual is morbidly obese (BMI > 35) and receiving treatment of tumors in the mediastinum, abdomen or pelvis
        • There is significant organ movement due to respiration and a 4D planning CT scan was performed with documentation demonstrating that the treatment plan addresses tumor motion that is both accounted for and managed
  
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
 
Effective Prior to May 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is covered for:
 
Head and Neck Cancer
Treatment of radiosensitive tumors of the brain; head and neck region regardless of cell type, including but not limited to Hodgkin and Non-Hodgkin Lymphomas; thyroid; spine and paraspinal regions
 
Pleural Mesothelioma
Treatment of pleural mesothelioma if done as a component of a curative treatment regimen
 
Melanoma and Merkel cell carcinoma
Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
 
Esophageal Cancer
Treatment of Esophageal Cancer if the following criteria are met:
 
        • The treatment is given with curative intent;
 
AND  
 
        • The risk of radiation exposure to adjacent critical organs would be excessive with 3D conformal treatment based upon submission of BOTH of the following dosimetric plans for comparison:
          • 3D conformal plan that includes appropriate techniques to limit toxicity, but limits to adjacent critical organ(s)-at-risk (OAR) have been exceeded; and
          • IMRT plan demonstrating improvement to tissue exposure to within safe ranges for adjacent critical organ(s) at risk; OR
        • For retreatment of a previously irradiated field
 
Bone Metastases
Treatment of bone metastases when ALL of the following conditions are met:
 
        • For retreatment of a previously irradiated field; and
        • Retreatment with EBRT would result in significant risk of adjacent organ injury
 
Sarcoma
Treatment of sarcoma when ANY of the following conditions are met:
 
        • For initial treatment of a primary pelvic soft tissue sarcoma; OR
        • For initial treatment of a primary retroperitoneal sarcoma; OR
        • For treatment of an extremity sarcoma; OR
        • For retreatment of a previously irradiated field
 
Pediatric Tumors
Treatment of pediatric patients when the following condition is met:
 
        • To treat pediatric individuals, age less than 21, with a radiosensitive tumor
 
Other Malignancies
Treatment of Other Malignancies when the following conditions are met:
 
        • Where risk of radiation exposure to adjacent critical organs would be excessive with 3D conformal treatment based upon submission of BOTH of the following dosimetric plans for comparison:
          • 3D conformal plan that includes appropriate techniques to limit toxicity, but limits to adjacent critical organ(s)-at-risk (OAR) have been exceeded; and
          • IMRT plan demonstrating improvement to tissue exposure to within safe ranges OR
        • For retreatment of a previously irradiated field
        • To deliver hippocampal sparing whole brain radiotherapy
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective July 01, 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is covered for:
 
Head and Neck Cancer
Treatment of radiosensitive tumors of the brain; head and neck region regardless of cell type, including but not limited to Hodgkin and Non-Hodgkin Lymphomas; thyroid; spine and paraspinal regions
 
Pleural Mesothelioma
Treatment of pleural mesothelioma if done as a component of a curative treatment regimen
 
Melanoma and Merkel cell carcinoma
Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
 
Esophageal Cancer
Treatment of Esophageal Cancer if the following criteria are met:
 
        • The treatment is given with curative intent;
 
AND  
        • The risk of radiation exposure to adjacent critical organs would be excessive with 3D conformal treatment based upon submission of BOTH of the following dosimetric plans for comparison:
            • 3D conformal plan that includes appropriate techniques to limit toxicity, but limits to adjacent critical organ(s)-at-risk (OAR) have been exceeded; and
            • IMRT plan demonstrating improvement to tissue exposure to within safe ranges for adjacent critical organ(s) at risk; OR
        • For retreatment of a previously irradiated field
 
Bone Metastases
Treatment of bone metastases when ALL of the following conditions are met:
        • For retreatment of a previously irradiated field; and
        • Retreatment with EBRT would result in significant risk of adjacent organ injury
 
Sarcoma
Treatment of sarcoma when ANY of the following conditions are met:
        • For initial treatment of a primary pelvic soft tissue sarcoma; OR
        • For initial treatment of a primary retroperitoneal sarcoma; OR
        • For treatment of an extremity sarcoma; OR
        • For retreatment of a previously irradiated field
 
Pediatric Tumors
Treatment of pediatric patients when the following condition is met:
        • To treat pediatric individuals, age less than 21, with a radiosensitive tumor
 
Other Malignancies
Treatment of Other Malignancies when the following conditions are met:
        • Where risk of radiation exposure to adjacent critical organs would be excessive with 3D conformal treatment based upon submission of BOTH of the following dosimetric plans for comparison:
            • 3D conformal plan that includes appropriate techniques to limit toxicity, but limits to adjacent critical organ(s)-at-risk (OAR) have been exceeded; and
            • IMRT plan demonstrating improvement to tissue exposure to within safe ranges OR
        • For retreatment of a previously irradiated field
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
 
Effective November 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
        • Treatment of radiosensitive tumors of the brain; head and neck region regardless of cell type, including but not limited to Hodgkin and Non-Hodgkin Lymphomas; thyroid; spine and paraspinal regions; or
        • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
        • Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy, and any other circumstance or condition not listed above or addressed in a separate IMRT policy is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective Prior to November 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain; head and neck region regardless of cell type, including but not limited to Hodgkin and Non-Hodgkin Lymphomas; thyroid; spine and paraspinal regions;  or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
    • Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
 
Effective Prior to July 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, thyroid, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
    • Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective Prior to November 2018
 
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, thyroid, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
    • Treatment of inguinal and axillary area for locally advanced malignant melanoma.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective Prior to February 2017
 
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, thyroid, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Codes for IMRT planning and therapy delivery are not to be used for services associated with stereotactic radiosurgery.
 
Effective prior to July 2012
 
IMRT  meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Codes for IMRT planning and therapy delivery are not to be used for services associated with stereotactic radiosurgery.

Rationale:
2012 Update
This policy update focuses on IMRT for thyroid cancer. Studies on the use of IMRT for thyroid cancers are few. In thyroid cancer, radiation therapy is generally used for 2 indications. The first indication is treatment of anaplastic thyroid cancer, and the second indication is potential use for locoregional control in patients with incompletely resected high-risk or recurrent differentiated (papillary, follicular, or mixed papillary-follicular) thyroid cancer. Anaplastic thyroid cancer occurs in a minority (less than 5%) of thyroid cancer. The largest series comparing IMRT to 3D-CRT was published by Bhatia and colleagues (Bhatia, 2010). This study reviewed institutional outcomes for anaplastic thyroid cancer treated with 3D-CRT or IMRT for 53 consecutive patients. Thirty-one (58%) patients were irradiated with curative intent. Median radiation dose was 55 gray (Gy; range, 4-70 Gy). Thirteen (25%) patients received IMRT to a median 60 Gy (range, 39.9-69.0 Gy). The Kaplan-Meier estimate of OS at 1 year for definitively irradiated patients was 29%. Patients without distant metastases receiving 50 Gy or higher had superior survival outcomes; in this series, use of IMRT versus 3D-CRT did not influence toxicity. The authors concluded that outcomes for anaplastic thyroid cancer treated with 3D-CRT or IMRT remain equivalent to historic results and that healthy patients with localized disease who tolerate full-dose irradiation can potentially enjoy prolonged survival. Schwartz and colleagues reviewed institutional outcomes for patients treated for differentiated thyroid cancer with postoperative conformal external beam radiotherapy (Schwartz, 2009).  This was a single-institution retrospective review of 131 consecutive patients with differentiated thyroid cancer who underwent RT between January 1996 and December 2005. Histologic diagnoses included 104 papillary, 21 follicular, and 6 mixed papillary-follicular types. Thirty-four patients (26%) had high-risk histologic types and 76 (58%) had recurrent disease. Extraglandular disease spread was seen in 126 patients (96%), microscopically positive surgical margins were seen in 62 patients (47%), and gross residual disease was seen in 15 patients (11%). Median RT dose was 60 Gy (range, 38-72 Gy). Fifty-seven patients (44%) were treated with IMRT to a median dose of 60 Gy (range, 56-66 Gy). Median follow-up was 38 months (range, 0-134 months). Kaplan-Meier estimates of locoregional relapse-free survival, disease-specific survival, and OS at 4 years were 79%, 76%, and 73%, respectively. On multivariate analysis, high-risk histologic features, M1 (metastatic) disease, and gross residual disease were predictors for inferior disease-specific and OS. IMRT did not impact survival outcomes but was associated with less frequent severe late morbidity (12% vs. 2%, respectively), primarily esophageal stricture. The authors concluded that conformal external beam radiotherapy provides durable locoregional disease control for patients with high-risk differentiated thyroid cancer if disease is reduced to microscopic burden and that IMRT may reduce chronic radiation morbidity, but additional study is required.
 
There are limited data on use of IMRT for thyroid cancer. The published literature consists of small case series with limited comparison among techniques for delivering radiation therapy. Due to the limitations in this evidence, expert opinion was obtained. There was near-uniform consensus that the use of IMRT for thyroid tumors may be appropriate in some circumstances such as for anaplastic thyroid carcinoma or for thyroid tumors that are located near critical structures such as the salivary glands or spinal cord. When possible adverse events could result if nearby critical structures receive toxic radiation doses, the ability to improve dosimetry with IMRT should be accepted as meaningful evidence for its benefit. The expert opinion combined with a strong indirect chain of evidence and the potential to reduce harms, led to the decision that the coverage statement will be change to allow IMRT for thyroid cancer.
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Brain Metastases
A retrospective study published in 2014 was designed to evaluate the feasibility of whole-brain RT (WBRT) plus simultaneous integrated boost (SIB) with intensity-modulated radiotherapy (IMRT) for inoperable brain metastases of NSCLC (Zhou, 2014). Twenty-nine NSCLC patients with 87 inoperable brain metastases were included. All patients received WBRT at a dose of 40 Gy and SIB boost with IMRT at a dose of 20 Gy concurrent with WBRT in the fourth week. Prior to each fraction of IG-IMRT boost, on-line positioning verification and correction were used to ensure that the set-up errors were within 2 mm by cone beam computed tomography in all patients. The one-year intracranial control rate (ICR), local brain failure rate (BFR), and distant BFR were 63%, 14%, and 19%, respectively. The two-year ICR, local BFR, and distant BFR were 42%, 31%, and 36%, respectively. Both median intracranial PFS and median OS were 10 months. Six-month, one-year, and two-year OS rates were 66%, 41%, and 14%. Patients with Score Index for Radiosurgery in Brain Metastases (SIR) >5, number of intracranial lesions <3, and history of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment had better survival. Radiation necrosis was observed in 3 (3.5%) lesions after radiotherapy. Grades 2 and 3 cognitive impairment with grade 2 radiation leukoencephalopathy were observed in 4 (14%) and 4 (14%) patients. No dosimetric parameters were found to be associated with these late toxicities. Patients who received EGFR-TKI treatment had higher incidence of grades 2-3 cognitive impairment with grade leukoencephalopathy. This evidence suggests WBRT plus SIB with IMRT is a tolerable treatment for NSCLC patients with inoperable brain metastases. However, the evidence does not allow conclusions as to its efficacy.
 
A search of ClinicalTrials.gov on January 2016 did not identify any ongoing or unpublished trials that would likely alter this policy.
 
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Radiation therapy targeting axilla and groin lymph nodes improves regional disease control in locally advanced and high-risk skin cancers. However, trials generally used conventional two-dimensional radiotherapy (2D-RT), contributing towards relatively high rates of side effects from treatment. The goal of this study by Mattes and colleagues is to determine if three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), or volumetric-modulated arc therapy (VMAT) may improve radiation delivery to the target while avoiding organs at risk in the clinical context of skin cancer regional nodal irradiation (Mattes, 2016).Twenty patients with locally advanced/high-risk skin cancers underwent computed tomography simulation. The relevant axilla or groin planning target volumes and organs at risk were delineated using standard definitions. Paired t-tests were used to compare the mean values of several dose-volumetric parameters for each of the 4 techniques. In the axilla, the largest improvement for 3D-CRT compared to 2D-RT was for homogeneity index (13.9 vs. 54.3), at the expense of higher lung V20 (28.0% vs. 12.6%). In the groin, the largest improvements for 3D-CRT compared to 2D-RT were for anorectum Dmax (13.6 vs. 38.9 Gy), bowel D200cc (7.3 vs. 23.1 Gy), femur D50 (34.6 vs. 57.2 Gy), and genitalia Dmax (37.6 vs. 51.1 Gy). IMRT had further improvements compared to 3D-CRT for humerus Dmean (16.9 vs. 22.4 Gy), brachial plexus D5 (57.4 vs. 61.3 Gy), bladder D5 (26.8 vs. 36.5 Gy), and femur D50 (18.7 vs. 34.6 Gy). Fewer differences were observed between IMRT and VMAT. Compared to 2D-RT and 3D-CRT, IMRT and VMAT had dosimetric advantages in the treatment of nodal regions of skin cancer patients.
 
Radiotherapy after lymph node dissection is recommended in high-risk melanoma cases. The aim of this study by Adams and colleagues is to assess whether intensity-modulated radiotherapy (IMRT) offers advantages over three-dimensional conformal radiotherapy (3DCRT) in the groin nodal basin (Adams, 2017). Fifteen consecutively treated patients (5 3DCRT and 10 IMRT) were selected. Optimized theoretical plans using the other modality were created - enabling direct comparisons of 3DCRT and IMRT. Target volume and organs at risk constraints were assessed as achieved or as having minor (5%) or major (>5%) deviations. The Wilcoxon signed-rank test was used to compare the dose received from each patient plan (3DCRT vs. IMRT), whereas the Mann-Whitney U-test was used to compare clinical plans with theoretical plans. Fisher's exact test was used to compare categorical data. Target coverage was achievable in most patients (major deviations - 1 IMRT and 3 3DCRT). Conformity index improved with IMRT - median 0.65, range 0.48-0.81, versus median 0.44, range 0.29-0.60 for 3DCRT; P value less than 0.001. All 3DCRT plans had major deviations for femoral head/neck constraints. Twelve and 13 IMRT plans achieved the high (V42<5%) and low (V36<35%) constraints; P value less than 0.001. IMRT delivered statistically significant lower doses to small bowel volumes up to 40 ml. There were no differences in beam numbers used nor dosimetric endpoints measured when clinical plans were compared with theoretical plans. IMRT appears to allow superior conformity of dose to the target volume while relatively sparing the adjacent the bowel and femoral head/neck. This may reduce toxicity while maintaining control rates.
 
2018 Update
A literature search was conducted through January 2018. There was no new information that would prompt a change in the coverage statement.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The goal of the study by Mattes et al was to determine if three-dimensional conformal radiation therapy (3D-DRT), intensity-modulated radiation therapy (IMRT), or volumetric-modulated arc therapy (VMAT) improve radiation delivery to the target while avoiding organs at risk in the clinical context of skin cancer regional nodal irradiation (Mattes, 2016).
 
Twenty patients with locally advanced/high-risk skin cancers received computed tomography simulation. The relevant axilla or groin planning target volumes and organs at risk were delineated using standard definitions. Paired t-tests were used to compare the mean values of several dose-volumetric parameters for each of the 4 techniques (Mattes, 2016).
 
In the axilla, the largest improvement for 3D-CRT compared to 2D-RT was for homogeneity index (13.9 vs. 54.3), at the expense of higher lung V20 (28.0% vs. 12.6%). In the groin, the largest improvements for 3D-CRT compared to 2D-RT were for anorectum Dmax (13.6 vs. 38.9 Gy), bowel D200cc (7.3 vs. 23.1 Gy), femur D50 (34.6 vs. 57.2 Gy), and genitalia Dmax (37.6 vs. 51.1 Gy). IMRT had further improvements compared to 3D-CRT for humerus Dmean (16.9 vs. 22.4 Gy), brachial plexus D5 (57.4 vs. 61.3 Gy), bladder D5 (26.8 vs. 36.5 Gy), and femur D50 (18.7 vs. 34.6 Gy). Fewer differences were observed between IMRT and VMAT (Mattes, 2016).
 
In conclusuion, 3D-CRT, IMRT and VMAT had dosimetric advantages in the treatment of nodal regions of skin cancer patients compared to 2D-RT (Mattes, 2016).
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
There have been three recent systematic reviews evaluating IMRT compared to 2D-RT or 3D-CRT in patients with head and neck cancers. Overall, Du et al and Luo et al reported significantly improved overall survival (OS), loco-regional free survival/control, and progression- or disease-free survival (PFS or DFS) with IMRT versus 2D-RT or 3D-CRT among patients with nasopharyngeal carcinoma (NPC) (Du, 2019; Luo, 2019). Marta et al concluded that IMRT, when compared with 2D-RT or 3D-CRT, had no significant impact on OS or loco-regional control in previously untreated patients with non-metastatic head and neck cancers (Marta, 2014). The incidence of xerostomia was significantly reduced with IMRT as compared to patients undergoing 2D-RT or 3D-CRT (Du, 2019; Marta, 2014).
 
There are inherent limitations to the data within some of these systematic reviews, including the prevalence of retrospective and nonrandomized study designs. Some studies had small sample sizes of 20 to 50 subjects. Studies also varied considerably with regard to tumor stage, length of follow-up, and radiological dose. All of these variations contributed to heterogeneity of the data. Additionally, 1 of the reviews specifically noted the existence of publication bias for the OS outcome (Du, 2019).
 
Qiu et al published a retrospective, single-center study comparing 2D-CRT and IMRT as treatments for NPC in children and adolescents (Qiu, 2017). All 176 patients (74 treated with 2D-CRT, 102 with IMRT) identified for the study were between 7 and 20 years old and treated at a single institution. The OS rate at 5 years was significantly higher for IMRT than 2D-CRT (90.4% vs 76.1%, respectively; HR, 0.30; 95% CI, 0.12 to 0.78; p=0.007), as well as the 5-year DFS rate (85.7% vs 71.2%, respectively; HR, 0.47; 95% CI, 0.23 to 0.94; p=0.029). Grade 2, 3, and 4 xerostomia (52.7% vs 34%, respectively; p=0.015) and hearing loss (40.5% vs 22.5%, respectively; p=0.01) were also significantly lower with IMRT than with 2D-CRT. The duration of follow-up for late-onset radiation-induced toxicity and small sample size are limitations of the report.
 
A large cohort study conducted by Xiang et al that included >450,000 patients with cancer (of which 12,143 had brain or central nervous system cancer) compared the risk of secondary tumors following treatment with IMRT and 3D-CRT across cancer types (Xiang, 2020). After a mean 5-year follow-up, multivariate, matched analysis showed no difference in risk of secondary cancers between IMRT and 3D-CRT (OR 1.00, 95% CI 0.98 to 1.03). These results were consistent when limited to patients who had not received chemotherapy (OR 1.01, 95% CI 0.96 to 1.06) (Xiang, 2020).
 
A more recent case series included 57 patients with new or recurrent meningioma (WHO Grade 2 or 3) treated with 60 Gy high dose and 54 Gy low dose IMRT following resection. Three-year PFS was 58.8% and overall survival at a mean follow-up of 4 years was 78.6%. Serious adverse events were rare (1.9%) (Rogers, 2020).
 
Brown et al reported results from a phase III trial of 518 patients with brain metastases that assessed the comparative effectiveness of hippocampal-avoiding WBRT (HA-WBRT) using IMRT with conventional WBRT; both groups received memantine (Brown, 2020). Study inclusion criteria required that patients have no brain metastases outside a 5-mm margin around either hippocampus. The primary outcome was time to loss of cognitive function, though OS and toxicity were also reported. After a mean 8-month follow-up, HA-WBRT was associated with a reduced loss of cognitive function (adjusted HR 0.74, 95% CI 0.58 to 0.95) without any difference between groups in overall survival (HR, 1.13, 95% CI 0.90 to 1.41). Specifically, at 4-month follow-up, the HA-WBRT showed less loss of executive function (23.3% v 40.4%; P =.01), while at 6 months, there was less decline in learning (11.5% v 24.7%, P = 0.049) and memory (16.4% vs. 33.3%, P=0.02) in the HA-WBRT group. At 6 months, patients in the HA-WBRT plus memantine arm reported less difficulty with remembering things (mean, 0.16 v 1.29; P =.01) and less difficulty speaking (mean,20.20 v 0.45; P =.049) compared with the WBRT plus memantine arm. There was no difference between groups in quality of life at any time point, nor was there a difference between groups in grade 3 or higher toxicity. The study authors noted that the treatment was likely to be most effective in patients with >4 months expected survival, due to cognitive deterioration likely to occur in those with shorter expected survival. This trial indicates evidence of benefit of HA-WBRT versus WBRT on cognitive outcomes (absolute risk difference 10%) and there were no differences in toxicity, intracranial PFS, or OS.
 
The study has some limitations. At 4-month follow up, only about half of the enrolled participants in both groups provided data for the individual cognitive assessments, because a large proportion of the participants had died. This was also the time point at which a clear difference emerged between groups showing a lower risk of cognitive failure in the HA-WBRT group. In addition, a significantly higher proportion of those allocated to HA-WBRT did not receive treatment 10.7% (28/261) compared to 3.1% (8/257) in the WBRT group (p=0.0016).
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The National Comprehensive Cancer Network Clinical Practice Guidelines on Central Nervous System Cancers (v. 5.2020) support the use of highly conformal fractionated radiotherapy (RT) techniques (eg, IMRT) to "spare critical structures and uninvolved tissues" (NCCN, 2021) When RT is given to patients with low-grade gliomas, NCCN states that "every attempt should be made to decrease the RT dose outside the target volume. This can be achieved with 3-dimensional (3D) planning or IMRT, with improved target coverage and normal brain/critical structure sparing often shown with IMRT." The guideline also states that for high-grade gliomas: "conformal RT techniques, which include 3D-CRT and IMRT are recommended for performing focal brain irradiation. IMRT often will provide superior dosimetric target coverage and better sparing of critical structures than 3D-CRT."
 
For patients with brain metastases and a prognosis of 4 months or greater, the guidelines recommend considering hippocampal-sparing WBRT and memantine during and after WBRT for a total of 6 months (NCCN, 2021).
 
The guidelines did not include recommendations for the use of IMRT to treat high-grade tumors as well as limited or extensive metastases to the central nervous system.
 
In 2020, the American Association of Neurological Surgeons and Congress of Neurological Surgeons Joint Section on Tumors sponsored a systematic review and evidence-based clinical practice guideline update on the role of radiation therapy in the treatment of adults with newly diagnosed glioblastoma multiforme (Ziu, 2020). Among the 14 clinical questions that were examined, one question was specific for the use of IMRT: "In adult patients with newly diagnosed supratentorial glioblastoma is image-modulated RT or similar techniques as effective as standard regional RT in providing tumor control and improved survival?" The authors reviewing the clinical data concluded that: "There is no evidence that IMRT is a better RT delivering modality when compared to conventional RT in improving survival in adult patients with newly diagnosed glioblastoma. Hence, IMRT should not be preferred over the conventional RT delivery modality."
 
Head and neck cancers account for about 4% of all cancer cases in the U.S. (ASCO, 2020). The generally accepted definition of head and neck cancers includes those arising from the oral cavity and lip, larynx, hypopharynx, oropharynx, nasopharynx, paranasal sinuses and nasal cavity, salivary glands, and occult primaries in the head and neck region. Cancers generally not considered as head and neck cancers include uveal and choroidal melanoma, cutaneous tumors of the head and neck, esophageal cancer, and tracheal cancer.
 
Qiu et al published a retrospective, single-center study comparing 2D-CRT and IMRT as treatments for NPC in children and adolescents (Qiu, 2017). All 176 patients (74 treated with 2D-CRT, 102 with IMRT) identified for the study were between 7 and 20 years old and treated at a single institution. The OS rate at 5 years was significantly higher for IMRT than 2D-CRT (90.4% vs. 76.1%, respectively; hazard ratio [HR], 0.30; 95% CI, 0.12 to 0.78; p=.007), as well as the 5-year DFS rate (85.7% vs. 71.2%, respectively; HR, 0.47; 95% CI, 0.23 to 0.94; p=.029). Grade 2, 3, and 4 xerostomia (52.7% vs. 34%, respectively; p=.015) and hearing loss (40.5% vs. 22.5%, respectively; p=.01) were also significantly lower with IMRT than with 2D-CRT. The duration of follow-up for late-onset radiation-induced toxicity and small sample size are limitations of the report.
 
2022 Update
A literature review was performed using the MEDLINE databases through March 2022. Following is a summary of the key literature to date.
 
Cutaneous Melanomas
Cutaneous melanomas are much more likely to have lymph node involvement than non-melanoma skin cancers and also have a significant risk of distant metastasis unless detected early. The primary treatment options are surgical excision or definitive radiation therapy. A detailed review of surgical options is beyond the scope of this guideline. Radiation options include superficial and orthovoltage x-rays, electrons, or high energy photons delivered with either 3D conformal or intensity modulated radiation therapy (IMRT) (NCCN, 2021). The vast majority of non-melanoma skin cancer lesions which are not approached surgically are treated with low energy x-rays or electrons where the cure rate approaches 95%. Melanomas or other skin cancers with risk of lymphatic involvement are best treated with 3D conformal and occasionally IMRT techniques.

CPT/HCPCS:
77301Intensity modulated radiotherapy plan, including dose volume histograms for target and critical structure partial tolerance specifications
77338Multi leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan
77385Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple
77386Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex
77387Guidance for localization of target volume for delivery of radiation treatment, includes intrafraction tracking, when performed
G6015Intensity modulated treatment delivery, single or multiple fields/arcs,via narrow spatially and temporally modulated beams, binary, dynamic mlc, per treatment session
G6016Compensator based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session
G6017Intra fraction localization and tracking of target or patient motion during delivery of radiation therapy (eg,3d positional tracking, gating, 3d surface tracking), each fraction of treatment

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