Subject:
Radiation Therapy for Testicular 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.)
- External beam photon radiation therapy is medically necessary for the following:
- Stage IA, IB, IIA, and IIB testicular seminoma.
- Fractionation
- For seminoma stages IA-IB in the adjuvant setting, regimens of 20 Gy in 10 fractions or 25.5 Gy in 17 fractions are medically necessary.
- For seminoma stages IIA-IIB in the adjuvant setting, up to 18 fractions is medically necessary.
- Technique
- External beam photon radiation therapy with three-dimensional conformal radiation therapy (3DCRT) is medically necessary in the treatment of seminoma.
- In stages IA-IB, the treatment prescription is to the para-aortic nodes to a dose of 20 Gy in 10 fractions delivered with an AP-PA field arrangement.
- In stages IIA-IIB, the initial treatment prescription is to a modified dog-leg field to 20 Gy in 10 fractions followed by a boost of 10 to 16 Gy in 5 to 8 fractions with an AP-PA field arrangement, in two phases.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Therapy for Testicular Cancer.
[RATIONALE Key Clinical Points
I. Seminoma
In an individual with stage I seminoma, radical orchiectomy serves as the initial treatment for testicular malignancies (Groll et al, 2007). Following orchiectomy, the management of the individual is dependent on the histologic type and whether residual disease is present.
Treatment options for those who have a pure seminoma with no sign of residual disease (stage I) include active surveillance, radiation therapy to the para-aortic lymph nodes or single agent carboplatin (Bernard et al., 2015). Cure rates with orchiectomy alone approach 85% (Mortensen, et al., 2014). Furthermore, salvage therapies for seminoma are very effective and administered with curative intent. Therefore, active surveillance is the recommended treatment option in an individual with stage I seminoma because it avoids unnecessary treatment and the treatment-related side effects that are associated with radiation and chemotherapy (Kollmannsberger et al., 2015).
For an individual who refuses active surveillance, chemotherapy or radiation therapy is a treatment option. A phase III trial studied both treatment approaches in 1,477 patients with stage I seminoma and found similar relapse free rates with one cycle of carboplatin vs. radiation (94.7% vs. 96%, respectively) (Oliver et al., 2011). Radiation therapy may be associated with worse long term complications including an increased risk of secondary malignancies and increased risk for cardiovascular disease. In an individual who refuses active surveillance and chemotherapy, radiation can be administered to a dose of 20 Gy to the para-aortic lymph nodes (Jones et al., 2005).
For an individual with stage II seminoma, radiation therapy can be effective in the treatment of stage IIA and non-bulky IIB disease (nodes < 3 cm) (Classen et al., 2003). Chemotherapy is recommended for an individual with bulky nodal disease. Studies in patients with IIA and non-bulky IIB seminoma show 5-year disease free results of greater than 90%. Treatment with radiation consists of 20 Gy in 10 fractions to the para-aortic and superior ipsilateral pelvis followed by a boost of 10 to 16 Gy in 5 to 8 fractions to the involved nodal areas, in two phases (Schmoll et al., 2004).
An individual receiving radiation therapy for seminoma should be treated with a scrotal shield and with an AP-PA technique to limit dose the kidneys, liver and small bowel. Intensity-modulated radiation therapy is not medically necessary because it increases the amount of tissue receiving a low dose of radiation which may increase the risk of second cancers relative to an AP-PA beam arrangement.
II. Nonseminoma
Nonseminomatous germ cell tumors are primarily managed with surgery and chemotherapy (Kollmannsberger et al., 2010). Men at low risk of relapse can be managed with an orchiectomy alone. Those with a higher risk of relapse are managed with chemotherapy. In general, there is no established role for the routine use of radiation therapy in the management of nonseminomatous germ cell tumors.
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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 Testicular Cancer
Radiation Treatment of Testicular Cancer
Testicular Cancer, Radiation Treatment of
References:
1. Bernard B, Sweeney CJ. Diagnosis and treatment of testicular cancer: A clinician's perspective. Surg Pathol Clin. 2015 Dec; 8(4):717-723.
2. Classen J, Schmidberger H, Meisner C, et al. Radiotherapy for stages IIA/B testicular seminoma: final report of a prospective multicenter clinical trial. J Clin Oncol. 2003 Mar 15; 21(6):1101-1106.
3. Groll RJ, Warde P, Jewett MAS. A comprehensive systematic review of testicular germ cell tumor surveillance. Crit Rev Oncol Hematol. 2007 Dec; 64(3):182-197.
4. Jones WG, Fossa SD, Mead GM, et al. Randomized trial of 30 versus 20 Gy in the adjuvant treatment of stage I testicular seminoma: A report on medical research council trial TE18, European Organisation for the Research and Treatment of Cancer trial 30942 (ISRCTN18525328). J Clin Oncol. 2005 Feb 20; 23(6):1200-1208.
5. Kollmannsberger C, Moore C, Chi KN, et al. Non-risk-adapted surveillance for patients with stage I nonseminomatous testicular germ-cell tumors: Diminishing treatment-related morbidity while maintaining efficacy. Ann Oncol. 2010 Jun; 21(6):1296-1301.
6. Kollmannsberger C, Tandstad T, Bedard PL, et al. Patterns of relapse in patients with clinical stage I testicular cancer managed with active surveillance. J Clin Oncol. 2015 Jan 1; 33(1):51-57.
7. Mortensen MS, Lauritsen J, Gundgaard MG, et al. A nationwide cohort study of stage I seminoma patients followed on a surveillance program. Eur Urol. 2014 Dec; 66(6):1172-1178.
8. National Comprehensive Cancer Network (NCCN) Guidelines® Version 2.2020 – November 20, 2019 Testicular Cancer. https://www.nccn.org/professionals/physician_gls/pdf/testicular.pdf. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Testicular Cancer 2.2020. 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.
9. Oliver RT, Mead GM, Rustin GJ, et al. Randomized trial of carboplatin versus radiotherapy for stage I seminoma: Mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214). J Clin Oncol. 2011 Mar 10; 29(8):957-962.
10. Schmoll HJ, Souchon R, Krege S, et al. European consensus on diagnosis and treatment of germ cell cancer: A report of the European Germ Cell Cancer Consensus Group (EGCCCG). Ann Oncol. 2004 Sep; 15(9):1377-1399.
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.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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