MA: Accelerated Irradiation Therapy, Brachytherapy

Description 

There are several methods of delivering irradiation including: brachytherapy, balloon intracavitary brachytherapy, intraoperative radiation therapy and external beam therapy.

Accelerated irradiation therapy is a shortened course of high dose radiation therapy that  targets areas where the cancer is likely to recur. By reducing the area irradiated, fewer treatments are needed and the treatment duration is decreased. Accelerated (also called hypofractionated) whole-breast irradiation (AWBI) reduces the number of fractions and the duration of treatment to about 3 weeks. This approach has been commonly used in Canada and Europe. Accelerated partial-breast irradiation (APBI) irradiates a limited part of the breast in and close to the tumor cavity. By reducing the area irradiated, fewer treatments are needed, and the total treatment takes about 1 week. Several approaches can be used to deliver APBI,
including interstitial brachytherapy, balloon brachytherapy, external beam radiotherapy, or intraoperative radiotherapy (which occurs on only 1 day).

Brachytherapy is a form of radiation treatment used to stop the growth of cancer cells and involves placing radioactive material directly into or near a tumor. This allows the tumor to receive a dose of radiation while reducing the exposure to surrounding tissue. Treatment time varies, depending upon the method of treatment, the type of radioactive material, and the cancer site.

Intraoperative radiation therapy (IORT) is designed to increase the intensity of radiation directly delivered to tumors. The tumor and associated tissues at risk for micrometastatic spread are directly visualized at operation. IORT is designed to deliver radiation only to tumor cells while protecting normal/uninvolved tissue.

Accuboost^® for image-guided breast irradiation, also called noninvasive breast brachytherapy, has also been used for local boost around the tumor bed. The Accuboost system provides image-guided radiotherapy with imaging before each treatment to ensure that the radiation is directed at the treatment target.

Policy

Brain Tumors

Balloon Brachytherapy in the treatment of primary or recurrent malignant brain tumors or metastasis/es to the brain from primary solid tumors outside the brain is investigative. 

Breast Cancer

Accelerated whole breast radiation therapy in the treatment of breast cancer is scientifically validated in patients meeting all of the following criteria:

• Invasive carcinoma of the breast (excluding invasive disease or ductal carcinoma in situ involving the margins of excision); AND
• Tumor < 5 cm in diameter; AND
• Breast width < 25 cm at posterior border of medial and lateral breast tangential beams; AND
• Negative lymph nodes; AND
• Negative surgical margins.

Accelerated partial breast irradiation (APBI), including interstitial APBI, balloon APBI (including Mammosite), or external beam APBI, is Scientifically Validated for the treatment of breast cancer in patients meeting all the following criteria:

• Tumor site is less than or equal to 2cm; AND
• Stage is T1; AND
• Margins are negative (greater or equal to 2mm); AND
• Histology is invasive ductal, invasive lobular or other favorable subtypes; AND
• Pure DCIS is not extensive; AND
• Positive ER receptor.

All uses of accelerated partial breast irradiation using any electronic radiotherapy device to treat breast cancer are investigative.

Accelerated partial-breast irradiation (APBI), including interstitial APBI, balloon APBI, intraoperative APBI, external-beam APBI, and noninvasive brachytherapy using AccuBoost is considered investigational. 

All uses of Non Invasive brachytherapy (AccuBoost) are investigative.

Balloon breast brachytherapy without external beam radiation is investigative: 

• When used in patients with stage I or II disease as the sole form of radiotherapy (i.e., 
  accelerated partial breast irradiation) after surgical excision, or
• Local boost irradiation when combined with whole breast radiotherapy but without 
  surgical excision.

All other uses of interstitial or balloon breast brachytherapy are investigative.

Intraoperative Radiation Therapy (IORT) for the treatment of breast cancer is scientifically validated when the following criteria are met:

• Tumor cannot be completely removed; OR
•  Tumor has a high risk of recurring in surrounding tissues.

All other uses of IORT in the treatment of Breast Cancer are investigative.
 
Colon Cancer

Intraoperative Radiation Therapy (IORT) for the treatment of colon cancer is scientifically validated when the following criteria are met:

• Tumor cannot be completely removed; OR
• Tumor has a high risk of recurring in surrounding tissues.

All other uses of IORT in the treatment of colon cancer is investigational. 
 
Endobronchial Tumors

Endobronchial brachytherapy is scientifically validated in the following clinical situations:

• In patients with primary endobronchial tumors who are not otherwise candidates for surgical resection or external beam radiation therapy due to comorbidities or location of the tumor.
• As palliative therapy in patients with obstructing endobronchial primary or metastatic tumors.

Other applications of endobronchial brachytherapy are investigative including, but not limited to, its use as a radiation "boost" to external beam radiotherapy.

The use of IORT in the treatment of Endobronchial tumors is investigative. 
 
Gynecologic Cancers (Uterine, Cervical, Endometrial)

Brachytherapy is scientifically validated in patients with uterine, cervical or endometrial cancer.

Intraoperative Radiation Therapy (IORT) for the treatment of endometrial cancer is scientifically validated when the following criteria are met:

• Tumor cannot be completely removed; OR
• Tumor has a high risk of recurring in surrounding tissues

All other uses of IORT in the treatment of Gynecologic Cancers are investigative.
 
Choroid Melanoma

Brachytherapy is Medically Necessary for the indication of Choroid Melanoma.
 
Nonmelanoma Skin Cancer

Electronic brachytherapy for treatment of nonmelanoma skin cancer is considered investigational.

Prostate Cancer

Radioactive seed implantation alone or as an adjunct to external beam radiation therapy for the treatment of localized non-metastatic (stages AC) prostate cancer is scientifically validated.

All other uses of radioactive seed implantation for prostatic cancer are investigative

The use of IORT in the treatment of Prostate Cancer is investigative.
 
Rectal Cancer

Use of intraoperative radiation therapy (IORT) in the treatment of rectal cancer is scientifically validated in patient who meet one of the following criteria:

• Positive or close margins with T4 lesions; OR
• Recurrent disease

All other uses of IORT are investigative.
 
Pancreatic Cancer

Intraoperative Radiation Therapy (IORT) for the treatment of pancreatic cancer is scientifically validated when the following criteria are met:

• Tumor cannot be completely removed; OR
• Tumor has a high risk or recurring in surrounding tissues. 

All other uses of IORT in the treatment of Pancreatic Cancers are investigative.
 
Soft Tissue Sarcoma

Intraoperative Radiation Therapy (IORT) for the treatment of soft tissue sarcoma is considered scientifically validated when the following criteria are met:

• Tumor cannot be completely removed; OR
• Tumor has a high risk of recurring in surrounding tissues

All other uses of IORT in the treatment of soft tissue sarcoma are investigational. 

Practice Guidelines and Position Statements

Breast

Current National Comprehensive Cancer Network (NCCN) guidelines ( v.2.2024)⁸, on breast cancer state that "APBI/PBI [accelerated partial breast irradiation / partial breast irradiation] offers comparable local control to WBRT [whole breast radiotherapy] in selected low-risk patients with early-stage breast cancer. However, the optimal external beam-APBI/PBI technique/fractionation for minimizing long-term cosmesis effects has not been determined. Patients are encouraged to participate in clinical trials. The NCCN Panel recommends APBI/PBI for any patient who is BRCA negative and meets the 2016 ASTRO criteria" (see Table 10 below)." The NCCN guideline has not been updated to reflect the 2023 ASTRO criteria.

For whole-breast radiotherapy, the NCCN recommends a hypofractionated dose of 40 to 42.5 Gy in 15 to 16 fractions, and in selected cases, 46 to 50 Gy in 23 to 25 fractions. Ultra-hypofractionated whole-breast radiotherapy of 28.5 Gy delivered as 5 once-weekly fractions may be considered in select patients aged >50 years following breast-conserving surgery with pTis/T1/T2/N0 based on data from the FAST-Forward trial. A boost to the tumor bed is recommended in patients at higher risk of recurrence, typically delivered as 10 to 16 Gy in 4 to 8 fractions.

Prostate

National Comprehensive Cancer Network ( v.4.2024) guidelines for prostate cancer note that LDR brachytherapy as monotherapy is indicated for patients with very low-, low-, or favorable intermediate-risk prostate cancer. ¹⁴, Additionally, "LDR or HDR brachytherapy can be added as a boost to EBRT plus ADT in patients with unfavorable intermediate-, high-, or very high-risk prostate cancer being treated with curative intent. Combining EBRT and brachytherapy allows dose escalation while minimizing acute or late toxicity in patients with high-risk localized or locally advanced cancer. This combination has demonstrated improved biochemical control over EBRT plus ADT alone in randomized trials, but with higher toxicity."

The guidelines further state that patients with very large or very small prostates (size cutoffs were not discussed), symptoms of bladder outlet obstruction, or previous transurethral resection of the prostate are more difficult to implant and may suffer an increased risk of adverse events. In cases of an enlarged prostate, neoadjuvant ADT may be used to shrink the prostate. However, increased toxicity would be expected, and prostate size may not shrink.

The National Comprehensive Cancer Network guidelines (v.1.2023) on the treatment of prostate cancer state that brachytherapy monotherapy is indicated for patients with "very low, low, or favorable intermediate-risk prostate cancer, depending on life expectancy.".¹⁸, For unfavorable intermediate-, high- and very high-risk cancers, combination brachytherapy, including HDR brachytherapy, with external-beam radiotherapy is indicated. Permanent low-dose radiotherapy or temporary HDR is indicated for local recurrence following external-beam radiotherapy or primary brachytherapy.

CNS

The National Comprehensive Cancer Network guidelines ( v.1.2024) for central nervous system cancers does not mention brachytherapy as 1 of several treatment options used by radiation oncologists.22 

Non Melanoma Skin Cancer

The National Comprehensive Cancer Network guidelines on basal cell carcinoma (v.3.2024)²⁴, and squamous cell skin cancer (v.1.2024)²⁵, both contain the following statement on brachytherapy: "There is insufficient long-term efficacy and safety data to support the routine use of electronic surface brachytherapy."

Endobronchial

The National Comprehensive Cancer Network Guidelines (v.5.2024 ) for non-small cell lung cancer include EBRT and brachytherapy as treatment options for severe hemoptysis or endobronchial obstruction in locoregional recurrent disease or symptomatic local disease (category 2A). ²⁸,

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers. 

Codes

77316	77317	77318	77424
77425	77761	77762	77763
77767	777768	77770	77771
77772	77778	77790	77799