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Medical Policy | ||
| Subject: Brachytherapy | |||
| Policy #: RAD.00014 | Current Effective Date: | 07/02/2007 | |
| Status: Revised | Last Review Date: | 05/17/2007 | |
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Description/Scope
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.
Policy Statement
Breast Cancer:
Medically Necessary:
Breast brachytherapy is considered medically necessary as an adjunctive “boost” to the tumor bed in patients who have received whole breast radiation therapy after prior breast conserving surgery (i.e., lumpectomy).
Breast brachytherapy is considered medically necessary as a technique of partial breast irradiation as an alternative to whole breast irradiation in patients who meet ALL of the following criteria:
Investigational/Not Medically Necessary:
Breast brachytherapy is considered investigational/not medically necessary in patients not meeting the above criteria.
The use of high dose rate electronic brachytherapy is considered investigational/not medically necessary for all indications, including but not limited to the treatment of breast cancer.
Prostate Cancer:
Medically Necessary:
Permanent radioactive seed implantation for prostate cancer with or without external beam radiation therapy (EBRT) is considered medically necessary.
High dose rate (HDR) brachytherapy, a temporary seed implantation, is considered medically necessary for locally advanced prostate cancer (T1C, PSA > 10, or T2/T3).
Endobronchial Tumors:
Medically Necessary:
Endobronchial brachytherapy is considered medically necessary for primary tumors that cannot be excised surgically or cannot be treated by EBRT or as palliative treatment for obstructing primary or metastatic endobronchial tumors.
Investigational/Not Medically Necessary:
Endobronchial brachytherapy is considered investigational/not medically necessary as a 'boost' for EBRT.
Uterine, Cervical, Endometrial Cancer:
Medically Necessary:
Brachytherapy is considered medically necessary in patients with uterine, cervical or endometrial cancer.
Investigational/Not Medically Necessary:
Brachytherapy is considered investigational/not medically necessary in tumors not listed above.
For all diagnoses:
Rationale
Breast Cancer
Breast brachytherapy as a “boost” to whole breast irradiation is an accepted technique for women who have undergone breast conserving surgery. Partial breast irradiation using breast brachytherapy after breast conserving surgery is now emerging as an alternative to whole breast irradiation. This option is based on the observation that for appropriately selected patients, irradiation of the whole breast is not necessary. For example, randomized trials comparing lumpectomy alone vs. lumpectomy followed by whole breast irradiation do not show a significant difference in the rate of tumor recurrence outside of the tumor bed. These findings suggest that the benefit of irradiation in general is related to the decreased risk of tumor recurrence in the tumor bed alone, the tissue at highest risk of a local recurrence. A number of clinical studies of partial breast irradiation in conjunction with lumpectomy demonstrate five year local recurrence rates of 0.0%-4.4%, which is comparable to external beam radiation. (Benitez, 2004; Keisch, 2003; King, 2000; Polgar, 2002; Vicini, 2003)) Partial breast irradiation using brachytherapy is also associated with good to excellent cosmetic outcomes with minimal treatment times, compared to the 6-7 week course of whole breast irradiation.
Currently, there are ongoing randomized studies of partial breast irradiation with brachytherapy to confirm the results of initial phase II studies suggesting that the local control rates of partial and whole breast irradiation are equivalent. (University of Wisconsin, 2005) However, at the same time, the American Brachytherapy Society and the American Society of Breast Surgeons have published recommendations regarding patient selection criteria for breast brachytherapy, indicating the general acceptance of brachytherapy as an alternative to whole breast irradiation. (American Society of Breast Surgeons, 2005; Arthur, 2003) This policy indicating that partial breast irradiation with breast brachytherapy is considered medical necessary in certain patients reflects the general acceptance of these techniques among the medical community. The patient selection criteria in this policy are similar to the patient selection criteria included in the large randomized study of breast brachytherapy sponsored by the National Cancer Institute. (University of Wisconsin, 2005).
Prostate Cancer
Treatment options for clinically localized prostate cancer include surgery, brachytherapy and watchful waiting. Randomized studies of these options have been very difficult to conduct due to prolonged natural history of prostate cancer and the many variables of individual prostate cancer, such as levels of prostate specific antigen (PSA), tumor size and tumor grade (i.e., Gleason score). However, brachytherapy using permanently implanted seeds is a well accepted treatment option for clinically localized prostate cancer. High dose rate or temporary brachytherapy is a relatively newer treatment option which has primarily investigated as an adjunct to external beam radiation therapy in patients with poor prognostic factors. Several large case series have been reported. Martinez and colleagues reported on the outcomes of a series of 207 patients treated between 1991 and 2000. (Martinez, 2003) All patients had poor prognostic factors, which included tumor stage T2B, a Gleason score of 7 or a PSA greater than 10 nl/mL. External beam radiation therapy was alternated with high-dose rate radiation therapy as a boost. At a mean follow-up of 4.7 years, overall biochemical control rate (as indicated by PSA monitoring) was 74%, but was 85% if one poor prognostic factor was present, 75% if 2 were present, and 50% if all 3 were present. Late toxicity was minimal. The authors suggest that these results are similar or better to other treatment alternatives for prostate cancer with poor prognostic features. In another analysis, the authors performed a matched-pair analysis of high-dose rate brachytherapy boost versus external beam radiation therapy alone. (Kestin, 2000) A total of 161 patients received a high-dose rate boost; they were randomly matched with a unique patient who received EBRT alone. Patients were matched according to PSA level, Gleason score, T stage, and follow-up of duration. Those who received the HDR boost reported a 5-year biochemical control rate of 67% compared to 44% in those receiving EBRT alone. In a review article, Vicini and colleagues summarized the experience reported in 8 other case series of locally advanced prostate cancer totaling just over 1,000 patients. (Vicini, 2003) The biochemical control rate ranged from 74% to 97% with median follow-ups ranging from 11 to 74 months. Finally, an international group of investigators reported on the use of HDR as an adjunct to EBRT with or without androgen-deprivation therapy in a case series of 611 patients. (Galale, 2004) A total of 209 patients were treated at William Beaumont Hospital, and thus it is likely that there are overlapping patients with the studies reviewed above. The authors reported that adjunctive HDR was associated with excellent long-term outcomes in terms of biochemical control, disease-free survival and cause-specific survival.
Endobronchial Tumors
There are 2 general categories of patients who may be considered candidates for endobronchial brachytherapy.
Primary treatment
Brachytherapy has also been investigated as a technique to deliver a “boost” to patients undergoing primary external beam radiation therapy. External beam radiation therapy is typically the primary treatment for the majority of patients with non-small cell carcinoma of the lung (NSCCL) due to the fact that patients usually present with surgically unresectable disease and that NSCCL is unresponsive to chemotherapy. Huber and colleagues reported on the results of a trial that randomized 98 patients with inoperable lung cancer to receive either external beam radiotherapy or endobronchial brachytherapy. (Huber, 1997) While the brachytherapy group experienced a longer period of local control, there was no significant difference in survival between the 2 groups.
Palliative treatment
For either palliative or primary treatment, no trials have directly compared different methods of local control (i.e., endobronchial brachytherapy, photodynamic therapy, laser therapy, and cryotherapy) to determine if any one method is superior to another in different subsets of patients or if combinations of therapy provide improved results. The choice of modality may depend on local availability and expertise.
Uterine, Cervical and Endometrial Tumors
Brachytherapy is considered the standard of care in patients with gynecologic malignancies, specifically uterine, cervical and endometrial tumors.
Electronic Brachytherapy
In December 2005, Xoft, Inc. (Fremont, CA) received U.S. Food and Drug Administration (FDA) 510K approval for the Axxent™ Electronic Brachytherapy System. The FDA approved the Xoft Axxent™ electronic system as similar to predicate devices such as Mammosite®. Mammosite® utilizes 192IR seeds as the source of radiation, and is used for high dose rate breast irradiation. The Axxent™ system is a proprietary form of providing accelerated partial breast irradiation for early stage breast cancer. Electronic brachytherapy is a non-radioactive, isotope-free treatment requiring minimal shielding, provided via a miniaturized X-ray tube. The system utilizes disposable micro-miniature X-ray radiation sources. This will allow radiation services to be provided in a variety of settings and not limited to heavily shielded settings. Axxent™ electronic brachytherapy is approved to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer. Axxent™ is not approved to provide whole breast irradiation. Although the device received FDA approval, due to the paucity of comparative clinical trials of high dose rate electronic brachytherapy and standard brachytherapy methods, the safety and efficacy of the high dose rate electronic brachytherapy procedure has not been determined.
Background/Overview
Breast Brachytherapy as a Boost to Whole Breast Irradiation Breast conservation surgery (BCS) and radiotherapy (RT) of the conserved breast became widely accepted in the last decade as an alternative to mastectomy for the treatment of early invasive breast cancer. The external beam radiation treatment may be preceded, or followed by, a supplemental or "boost" dose administered to the primary tumor site. When brachytherapy is used as a boost, the radiation is delivered either as a low dose or high dose rate and the radioactive material is left in place until the dose is delivered. For low-dose-rate this usually is 2 to 3 days and for high dose it is a matter of minutes (but may be repeated 1 or 2 times a day for 1 or 2 days). Breast Brachytherapy as an Alternative to Whole Breast Irradiation In contrast to whole breast irradiation, brachytherapy can be completed in a much shortened treatment course. Because of this shortened time frame, there has been interest in breast brachytherapy as a sole modality after lumpectomy. The recent application of brachytherapy is based partly on the observation that most ipsilateral breast recurrences after breast-conserving surgery and radiation therapy occur at or near the tumor bed, with only a minority of recurrences located elsewhere in the breast. In addition, in trials of breast-conserving surgery with versus without radiation therapy, most recurrences also occurred at or near the tumor bed, suggesting that undetected multicentric disease may not be common. Together these findings suggested that tumor bed irradiation may provide the major benefit from external beam radiation therapy. Also, external beam radiation therapy typically is delivered in fractionated doses over a course of 5 to 7 weeks. This extended treatment course may be difficult for some patients, for example those living in remote locations, or the elderly or disabled. Brachytherapy usually is delivered over a week. This shortened treatment course, which has been termed accelerated partial-breast irradiation, may increase the proportion of patients choosing breast-conserving surgery. Various brachytherapy techniques have been investigated. They differ in the timing of implantation relative to other components of breast-conserving therapy, the radiation dose rate, the loading technique, the number and volumetric distribution of radioactive sources, and the radioisotopes used. Most older studies of local boost brachytherapy temporarily implanted needles, wires, or seeds after patients recovered from surgery and completed whole-breast radiation therapy. More recently, investigators have perioperatively implanted hollow needles or catheters that guide placement of the radioactive material. This can be done during the initial lumpectomy if the decision to use brachytherapy has already been made or at the time of a re-excision if the lumpectomy specimen has positive surgical margins. Intraoperative implantation avoids the need for a separate surgical procedure with anesthesia for brachytherapy. Whether intra- or postoperative, these methods are collectively termed interstitial brachytherapy and use multiple radioactive sources placed to deliver a prescribed radiation dose to a defined target volume. Both low-dose rate and high-dose rate interstitial techniques have been used, with high-dose rate techniques increasing in popularity. In the low-dose rate technique, temporarily implanted radioactive seeds deliver radiation therapy continuously over a course of 4 days and then are removed. This treatment is generally an inpatient procedure. In the high-dose rate technique, a computer-controlled device pushes a highly radioactive isotope into a catheter that has been placed into the tumor bed. The patient is exposed to the radiation therapy for a brief period—to 15 minutes—and then the radioactive source is withdrawn. High-dose rate brachytherapy is typically administered on an outpatient basis in 8 fractions given twice daily over 4 days. In addition, phase II studies have suggested that in patients with small, well defined tumors, partial breast irradiation using brachytherapy may provide the same levels of local tumor control compared to whole breast irradiation. The vast majority of patients who receive partial breast irradiation are treated with either interstitial irradiation or more recently balloon brachytherapy, a balloon catheter system, the Mammosite®RTS device; (Proxima Therapeutics, Alpharetta, GA). The device is implanted in the lumpectomy cavity during or shortly after breast-conserving surgery. The balloon is inflated with sterile solution of contrast media in saline, and its position is confirmed radiographically using computed tomography. A high-dose rate source of iridium-192 is then centrally positioned within the applicator by a remote afterloader. This system is used to deliver 34 Gy in 10 fractions over 5 days. Thus, balloon brachytherapy uses a single radioactive source that delivers radiation to a spherical or elliptical target volume. Like interstitial brachytherapy, it can be used to deliver local boost or accelerated partial-breast radiation therapy. Prostate Brachytherapy Brachytherapy is a common treatment option of the treatment of clinically localized prostate cancer. The most common application involves the permanent implantation of low-dose-rate radioactive isotopes, in the form of seeds, into the prostate gland. This is done under general anesthesia as an outpatient surgery procedure. The seeds are inserted into the prostate using preloaded needles and ultrasonic guidance to assist with correct placement. The number of seeds depends on the size of the prostate but typically requires between 60 to 120 seeds. A computerized tomography scan is usually performed at some time after the procedure to determine the quality of seed placement. More may be added if placement is inadequate. The choice of radioactive source, iodine or palladium is usually based on physician preference. Iodine has a half-life of 60 days while palladium has a shorter half-life of 17 days with a slightly higher dose rate. Locally advanced cancers may be undertreated by permanent brachytherapy alone and these patients are usually treated by brachytherapy in combination with external beam radiation therapy. Another form of brachytherapy that has been used to treat prostate cancer is high-dose-rate (HDR) brachytherapy. This technique uses a high activity radioisotope, such as iridium-192, which delivers radiation at a high dose rate through needle catheters inserted into the prostate. The isotope is left in place for a predetermined time, known as the 'dwell' time, which typically falls in the range of 8 to 10 minutes. The dwell time can be altered to control dose distribution to the tumor and surrounding tissue. This type of treatment is commonly referred to as 'temporary brachytherapy' since the radioactive source is removed from the patient at the end of each HDR treatment session. The radiation may be delivered in one or two sessions each day over the course of one to two days. Theoretically, HDR brachytherapy achieves greater dose accuracy and control as it permits more precise delivery of radiation compared to permanent seed implantation in which the dose cannot be altered after seed implantation. In addition, when using permanent seed implantation, swelling (edema) of the prostate and other factors may cause the permanent seed to “migrate” and thus become less effective in delivering the dose to the precise target. HDR brachytherapy is proposed as an adjunct to EBRT to provide local boost radiation in patients with locally advanced prostate cancer. There exists some risk of urethral strictures with HDR treatment (4% – 8% of patients) and a slightly increased incidence of rectal fistula. Otherwise the treatment is generally well-tolerated. Overall, late toxicity is comparable to local dose-escalated external radiation treatment. Endobronchial Brachytherapy Endobronchial brachytherapy describes the delivery of radiation therapy directly to endobronchial lesions, using either permanent interstitial implantation of radioactive seeds or a temporary afterloading implant. The technique permits targeted radiation while minimizing exposure to surrounding radiosensitive structures, such as normal lung, heart, and spinal cord. Endobronchial brachytherapy has been most thoroughly investigated as a treatment of non-small cell lung cancer, specifically for early-stage nonresectable tumors without extraluminal extension, or as a palliative treatment of obstructing primary or metastatic tumors. The technique can be performed in the inpatient setting (30 to 72 hours) using low-dose rate radiotherapy, or more commonly as an outpatient procedure using multiple sessions of high-dose rate radiotherapy. Iridium-192 has become the radioisotope of choice for high-dose therapy. Two to 5 fractions delivered weekly is a typical schedule, although some patients may receive hyperfractionated radiotherapy, i.e., twice daily treatments for 2 consecutive days. However, doses vary among institutions, and there is no clear consensus as to the optimal dose and frequency of fractionation for brachytherapy. In the outpatient setting, the patient receives local anesthesia and monitored sedation. A flexible bronchoscope is passed transnasally; a separate port on the bronchoscope allows passage of the afterloading catheter to the target lesion. Once the catheter is placed, the radioisotope can be administered by the high-dose radiotherapy afterloading machine. Patients with potential airway compromise due to bleeding may require treatment with a rigid bronchoscope, which requires general anesthesia and frequently an overnight hospitalization. Endobronchial brachytherapy represents one approach to the local treatment of endobronchial lesions. Other technologies include electrocoagulation, cryosurgery, laser resection, and endobronchial stent placement. In some instances, the therapies may be used together, such as using laser therapy for initial debulking followed by brachytherapy. In addition, brachytherapy has been investigated as a “boost” to curative external beam radiation therapy. Uterine, Cervical and Endometrial Tumors Radioactive material is placed directly into the cervix for cervical cancer. Placing the radiation in this manner allows a high radiation dose to be delivered directly to the cancer, while reducing radiation to surrounding normal organs, such as the rectum and bladder. During a procedure in the operating room, a small device is placed into the cervix and vagina. This device is later "loaded" with the radiation capsules while the patient is in a lead-shielded hospital room. The radioactive material is left in place for 1-3 days. This procedure may be performed once or twice during the course of treatment. The patient is discharged from the hospital once the device is removed from the cervix. Definitions
Boost: an additional dose of radiation to a reduced size radiation field Breast-conserving surgery: a treatment alternative to mastectomy for early stage breast cancer that consists of tumor removal (lumpectomy) followed by external radiation to the whole breast Brachytherapy (also known as internal radiation): a type of radiation treatment used to stop the growth of cancer cells by implanting radioactive material directly into the tumor or into the surrounding tissues External beam radiation therapy (EBRT) (also known as teletherapy): a form of therapy using radiation to stop the growth of cancer cells; a linear accelerator directs a photon or electron beam from outside the body through normal body tissue to reach the cancer; the radiation is given 5 days a week for a period of 3 to 8 weeks High dose rate (HDR) brachytherapy (temporary): involves implantation of high intensity radiation for a short time period of 3 to 10 minutes and then removing the radiation source; the most commonly used source is Iridium Interstitial implant: a procedure in which radioactive material is placed directly into a tumor site Low dose rate (LDR) brachytherapy (temporary): a low dose of radiation is delivered over the course of several days, after which the radiation source is removed; this requires an in-patient hospital stay; the most commonly used sources are Cesium and Radium Low dose rate (LDR) brachytherapy (permanent): permanently implanted radioactive material (most commonly iodine-125 and palladium-103 radioisotopes) Partial breast irradiation: radiation focused at the tumor bed of the breast, after prior breast conserving surgery; an alternative to whole breast irradiation; breast brachytherapy is one technique of delivering partial breast irradiation Coding
The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. Breast cancer, specific procedures
CPT
ICD-9 Diagnosis
Services are Investigational/Not Medically Necessary for the treatment of breast cancer: For the procedure codes listed above, when criteria are not met, for all other diagnoses, and when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.
When services are also Investigational/Not Medically Necessary:
CPT
ICD-9 Diagnosis
Prostate cancer, specific procedures
CPT
ICD-9 Diagnosis
Services are Investigational/Not Medically Necessary:
Endobronchial tumors, specific procedure
CPT
ICD-9 Diagnosis
Services are Investigational/Not Medically Necessary: For the procedure code listed above when criteria are not met, for all other diagnoses, and when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.
Uterine, cervical and endometrial tumors, specific procedures CPT
ICD-9 Diagnosis
Services are Investigational/Not Medically Necessary:
Radiation Oncology brachytherapy procedures, not specific
CPT
HCPCS
ICD-9 Procedure
ICD-9 Diagnosis
When services may be Medically Necessary when criteria are met: For the procedure codes listed above, for the following diagnosis codes
ICD-9 Diagnosis
When services are Investigational/Not Medically Necessary: For the procedure codes listed above, for all other tumor diagnoses, and when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.
References
Web Sites for Additional Information
Index
Axxent™ Electronic Brachytherapy System
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
Policy History
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Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. ©CPT Only - American Medical Association |