Subject:
Radiation Therapy for Anal Canal Cancer
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Over the past several decades, methods to plan and deliver radiation therapy have evolved in ways that permit more precise targeting of tumors with complex geometries. Earlier methods involved two-dimensional treatment planning based on flat images, and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. These methods were collectively termed conventional external beam radiation therapy (EBRT).
Subsequent enhancement evolved using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the tumor, its boundaries with adjacent normal tissue, and organs at risk for radiation damage. Radiation oncologists used these images, displayed from a "beam's-eye-view", to shape each of several beams (e.g., with compensators, blocks, or wedges) to conform to the patient's tumor geometry perpendicular to the beam's axis. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. Methods also were developed to position the patient and the radiation portal reproducibly for each fraction, and immobilize the patient, thus maintaining consistent beam axes across treatment sessions. However, "forward" planning used a trial and error process to select treatment parameters (the number of beams and the intensity, shape, and incident axis of each beam). The planner/radiotherapist modified one or more parameters and recalculated dose distributions, if analysis predicted underdosing for part of the tumor or overdosing of nearby normal tissue. Furthermore, since beams had uniform cross-sectional intensity wherever they bypassed shaping devices, it was difficult to match certain geometries (e.g., concave surfaces). Collectively, these methods are termed 3-dimensional conformal radiation therapy (3D-CRT).
Other methods were subsequently developed to permit beam delivery with non-uniform cross-sectional intensity. This often relies on a device (multi-leaf collimator, MLC) situated between the beam source and patient that moves along an arc around the patient. As it moves, a computer varies aperture size independently and continuously for each leaf. Thus, MLCs divide beams into narrow "beamlets", with intensities that range from zero to 100% of the incident beam. Beams may remain on as MLCs move around the patient (dynamic MLC), or they may be off during movement and turned on once the MLC reaches prespecified positions ("step and shoot" technique). Another method of delivering radiation beam uses a small radiation portal emitting a single narrow beam that moves spirally around the patient, with intensity varying as it moved. This method, also known as tomotherapy or helical tomotherapy, is described as the use of a linear accelerator inside a large "donut" that spirals around the body while the patient laid on the table during treatment. Each method (MLC-based or tomotherapy) is coupled to a computer algorithm for "inverse" treatment planning. The planner/radiotherapist delineates the target on each slice of a CT scan, and specifies that target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally-reconstructed radiographic image of the tumor and surrounding tissues and organs at risk, computer software optimizes the location and shape of beam ports, and beam and beamlet intensities, to achieve the treatment plan's goals. Collectively, these methods are termed intensity-modulated radiation therapy (IMRT).
According to ECRI Institute, there are two different approaches to image-guided radiation therapy that are in current use: pre-treatment imaging and real-time guidance. IMRT is an example of a method that uses pre-treatment imaging to prepare a treatment plan. In contrast, real-time guidance utilizes real-time imaging (at the time of treatment) to guide treatment. It provides real-time, online images of the radiation target area from a computed tomography (CT) scanner before, during, and after therapy. Patient positioning, radiation field alignment, and collimator positioning can be verified and adjusted before and during irradiation. This approach should, in theory, provide more accurate radiation delivery than conventional IMRT. Organ motion, day-to-day variations in tumor position, and differences in patient positioning in each treatment session could be taken into account with real-time imaging.
Policy:
(NOTE: This policy only applies to adult members. It does not apply to pediatric members.
For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. Definitive Treatment
A. External beam photon radiation therapy using Three-Dimensional Conformal Radiation Therapy (3DCRT) or Intensity-Modulated Radiation Therapy (IMRT) is considered medically necessary for the definitive treatment of anal canal cancer.
B. A dose of 45 Gy to 59.4 Gy in 25 to 33 fractions delivered in up to 3 phases is considered medically necessary.
II. Palliation
- Up to 10 fractions of 3DCRT is considered medically necessary.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for External beam photon radiation therapy (EBRT) or 3DCRT. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Treatment of Anal Canal Cancer.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). Medicare Advantage Products will follow LCD L36711 for Intensity Modulated Radiation Therapy (IMRT). Per LCD L36711, IMRT is covered for anal carcinoma when LCD L36711 criteria is met. For additional information and eligibility, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36711&ver=18&name=314*1&UpdatePeriod=749&bc=AAAAEAAAAAAAAA%3d%3d&.
[INFORMATIONAL NOTE: Anal canal cancer is a rare cancer with an annual incidence of approximately 8,500 new cases (American Cancer Society, 2018). However, the incidence of new cases has been increasing over the last 3 decades (American Cancer Society, 2018). Historically, surgery with an abdominoperineal resection (APR) was the mainstay of treatment for patients with anal cancer but was associated with a 40 to 70% 5-year overall survival (OS) rate (Ghosn et al, 2015). In 1974, Nigro and colleagues from Wayne State reported their experience of 3 patients with anal carcinoma who received neoadjuvant chemoradiation therapy and were found to have a complete response at the time of surgery. Following this initial data, multiple studies have demonstrated the effectiveness of chemoradiation therapy in anal cancer with local response rates of 80 to 90% (Glynne-Jones et al., 2014). While there is no prospective randomized data comparing chemoradiation versus APR, chemoradiation therapy is considered the standard of care for initial definitive treatment of anal cancer (Glynne-Jones et al, 2014).
Several studies have evaluated various treatment regimens for the definitive care of patients with nonmetastatic squamous cell anal cancer. Randomized trials have reported on radiation therapy alone versus combined chemoradiation therapy for treatment of patients with anal cancer (Bartelink et al, 1997; Northover et al, 2010). These studies typically utilized doses of 45 Gy to the pelvis followed by a 15 to 20 Gy boost. The data from the UKCCR ACT I trial and the EORTC trial demonstrated improved locoregional control and decreased risk of requiring a colostomy with combined chemoradiation therapy compared to radiation therapy alone (Bartelink et al, 1997; Northover et al, 2010). Locoregional control with radiation therapy alone ranged from 40 to 50% vs. 60 to 70% with chemotherapy and radiation therapy (Bartelink et al, 1997; Northover et al, 2010).
In RTOG 0529, Kachnic and colleagues (2013) performed a Phase II prospective trial to evaluate IMRT as definitive therapy for patients with anal cancer treated with radiation therapy and chemotherapy with 5-FU and mitomycin-C. The radiation therapy dose ranged from 50.4 Gy in 28 fractions to 54 Gy in 30 fractions, depending on tumor or nodal stage. The primary endpoint of this study was to evaluate if IMRT is able to reduce the rate of gastrointestinal (GI) and genitourinary (GU) acute toxicity of chemoradiation by 15% in a multiinstitutional cooperative group setting, when compared to anal cancer patients treated with conventional radiation techniques in RTOG 9811. When the rate of acute GI/GU toxicity was analyzed, the primary endpoint was not met. The rate of grade 2+ GI/GU acute adverse was exactly equivalent in RTOG 9811 and RTOG 0529 (77% vs. 77%, p = 0.5). They found that IMRT was associated with a significant reduction in Grade 2 hematologic toxicity and Grade 3 dermatologic and GI toxicity. An additional primary endpoint of this trial was to determine if dose-painting IMRT is feasible to be performed in accordance with prescribed radiation planning guidelines. In an analysis of radiation planning quality, 81% of submitted cases required revision of planning following the initial submission secondary to incorrect contouring, noncompliance of normal tissue constraints, or incorrect target dosing. Forty-six percent of cases required multiple plan revisions and re-submissions. This trial did not meet the primary endpoint of a reduction in Grade 2 GI/GU toxicity, and there was a high rate of required treatment planning revisions. The authors concluded that dose-painting IMRT is associated with a significant decrease in Grade 2 hematologic, grade 3 gastrointestinal, and grade III dermatologic toxicity.
There is limited data on radiation therapy in the palliative treatment of anal cancer. Anal cancer is a radiosensitive tumor with studies of radiation alone associated with 60 to 90% local control rates depending on the size of the tumor (Newman G et al, 1992; Touboul et al, 1994). The initial studies demonstrating the effectiveness of chemoradiation employed doses of 30 Gy in 15 fractions with concurrent chemotherapy and demonstrated greater than 80 to 90% response rates. NCCN Guidelines™ recommend 20 to 25 Gy in 5 fractions to 30 Gy in 10 fractions in the clinical setting of palliation of disease symptoms. Therefore, up to 10 fractions is recommended in the palliative treatment of anal cancer.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Radiation Therapy for Anal Canal Cancer
Radiation Treatment of Anal Canal Cancer
Anal Canal Cancer, Radiation Treatment
References:
1. American Cancer Society. Cancer Facts & Figures 2018. Atlanta, GA:American Cancer Society; 2018.
2. Bartelink H, Roelofsen F, Rougier P, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol. 1997 May 1; 15(5):2040-2049.
3. Ghosn M, Kourie HR, Abdayen P, et al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol. 2015 Feb 28;21(8):2294-2302.
4. Glynne-Jones R, Nilsson PJ, Aschele C, et al. Anal cancer: ESMO-ESSO=ESTRO clinical practice guidelines for diagnosis, treatment, and follow-up. Radiother Oncol. 2014 Jun;111(3):330-339.
5. Hong TS, Pretz JL, Suh WW, et al. ACR Appropriateness Criteria® Anal Cancer. Date of origin: 1998. Last review date: 2013.
6. Kachnic LA, Winter K, Myerson RJ, et al. RTOG 0529: a phase 2 evaluation of dose-painted intensity modulated radiation therapy in combination with 5-Fluorouracil and Mitomycin-C for the reduction of acute morbidity in carcinoma of the anal canal. Int J Radiat Oncol Biol Phys. 2013 May 1;86(1):27-33.
7. National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2020 – November 19, 2019. Anal Carcinoma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Anal Carcinoma 1.2020. ©2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN®. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org.
8. Newman g, Calverley DC, Acker BD, et al. The management of carcinoma of the anal canal by external beam radiotherapy, experience in Vancouver 1971-1988. Radiother Oncol. 1992 Nov;25(3):196-202.
9. Nigro ND, Vaitevicius VK, Considine Jr. B, et al. Combined therapy for cancer of the anal canal: a preliminary report. Dis Colon Rectum. 1974 May-Jun;17(3):354-356.
10. Northover J, Glynne-Jones R, Sebag-Montefiore D, et al. Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer. 2010 Mar 30:102(7):1123-1128.
11. Touboul E, Schlienger M, Buffat L, et al. Epidermoid carcinoma of the anal canal. Results of curative-intent radiation therapy in a series of 270 patients. Cancer. 1994 Mar 15;73(6):1569-1579.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
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