Subject:
Radiation Therapy for Bladder 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. Non-muscle invasive bladder carcinoma (stages Ta, Tis, T1)
A. In the treatment of newly diagnosed non-muscle invasive bladder carcinoma, the use of radiation therapy is not considered medically necessary.
II. Muscle-invasive bladder carcinoma (stages T2-T4)
A. In an individual undergoing bladder preservation, the use of up to 37 fractions of 3D conformal radiation (3DCRT) is considered medically necessary.
B. In the preoperative setting (i.e. prior to planned cystectomy), the use of radiation therapy is considered medically necessary.
C. In the postoperative setting (i.e. following cystectomy), the use of up to 33 fractions of 3DCRT is considered medically necessary in those who have pT3-T4 disease, positive lymph nodes and/or positive surgical margins.
III. Palliation
A. In the palliative treatment of bladder carcinoma, the use of up to 20 fractions of 3DCRT is considered medically necessary.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination for jurisdiction JL on Radiation Therapy for Bladder Cancer 3D conformal radiation (3DCRT). Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). 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: For non-muscle invasive (stages Ta, Tis, T1) bladder carcinoma (NMIBC), treatment includes transurethral resection of bladder tumor (TURBT) often followed by intravesical therapy (Babjuk, 2013; Brausi 2011). In patients with high-risk non-muscle invasive bladder cancer, radiation has been evaluated. However, its use in this group of patients is not well defined. For example, in a retrospective study of 141 patients with high-risk T1 bladder cancer, radiation alone or combined with chemotherapy was found to be a “…reasonable alternative to intravesical treatment or early cystectomy...” (Weiss, 2006). On the other hand, in a randomized control trial of 210 patients with pT1G3 bladder cancer, radiation therapy was found to be equivalent to more conservative treatment (Harland, 2007). Further, NCCN currently does not endorse the use of radiation therapy for non-muscle invasive bladder cancer (NCCN v3.2018). As such, the use of radiation is considered not medically necessary for the treatment of non-muscle invasive bladder cancer.
For an individual with muscle-invasive bladder cancer, treatment options include cystectomy or definitive chemoradiation as part of a bladder preserving approach (Gakis, 2013). An ideal candidate for bladder preservation includes one with tumors < 5 cm, a visibly complete TURBT, absence of associated carcinoma in situ, and no evidence of ureteral obstruction (Milosevic, 2007). NCCN also indicates that “optimal candidates for bladder preservation with chemoradiotherapy include patients with tumors that present without hydronephrosis, are without concurrent extensive or multifocal Tis, and are <6 cm. Ideally, tumors should allow a visually complete or maximally debulking TURBT."
Radiotherapy with concurrent cisplatin is the most common bladder sparing approach used to treat muscle-invasive bladder cancer. Following TURBT, 40 to 45 Gy is given to the whole pelvis using 3DCRT. Afterwards, repeat endoscopy is performed to examine the tumor response. If residual disease is seen, then a cystectomy is recommended. If a complete response is noted, then an additional 20 to 25 Gy is delivered with cisplatin. This approach demonstrated a 5-year survival of 49% when examined prospectively in RTOG 89-03 (Shipley, 1998). In a phase III randomized trial, concurrent chemoradiation improved 5-year disease-free survival (DFS) from 54% to 67% (p = 0.01) (James, 2012). Furthermore, approximately 80% of long-term survivors will maintain an intact bladder with this approach (Mak, 2014; Rodel, 2002). While several phase II prospective studies have examined alternative radiation fractionation schemes, none has demonstrated a clinically meaningful benefit compared to standard once a day fractionation schedules (Hagan, 2003; Kaufman, 2000). Recently, anti-PD-L1 immunotherapy with agents such as atezolizumab (Tecentriq) was approved for the treatment of advanced bladder cancer for patients who are unable to receive cisplatin. However, the use of radiation therapy with these agents is considered investigational, experimental, and unproven (EIU) at this time. Definitive radiotherapy alone is considered for an individual with no evidence of metastatic disease who cannot undergo a cystectomy or concurrent chemoradiation.
In the preoperative setting, there remains insufficient data to determine the benefit of radiation therapy. For example, in an intergroup trial of 140 patients with invasive bladder cancer or recurrent superficial high-grade cancer, preoperative radiation (20 Gy in 5 fractions) was not associated with a survival advantage at five years (Smith, 1997). On the other hand, several publications have suggested a benefit to preoperative radiation in patients with high stage disease (Parsons, 1988; Cole, 1995). Further, recent NCCN GuidelinesTM state, “…for invasive tumors, consider low-dose preoperative radiation therapy prior to segmental cystectomy…” though this is a category 2B recommendation.
In the postoperative setting, the role of radiation is more defined. Data from a retrospective series demonstrate higher local recurrence rates in patients with T3-T4 disease, positive nodes or positive surgical margins (Herr, 2004). The benefit of postoperative radiation and reducing local recurrence and improving disease-free survival has been shown in several studies (Bayoumi, 2014; Zaghloul, 1992; Nasr 2015). Further, recent NCCN GuidelinesTM recommend consideration of postoperative pelvic radiation for patients with pT3/pT4 pN0-2 disease. As a result, the use of radiation in the postoperative setting is considered medically necessary for an individual with pT3-T4 disease, positive lymph nodes and/or positive surgical margins.
In an individual with evidence of metastatic disease, palliative radiation is medically necessary, up to 20 fractions using 3D techniques.]
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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 Bladder Cancer
Radiation Treatment of Bladder Cancer
Bladder Cancer, Radiation Treatment for
References:
1. Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol. 2013 Oct; 64(4):639-653.
2. Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: Update 2013. Eur Urol. 2013 Oct; 64(4):639-653.
3. Bayoumi Y, Heital T, and Darweish H. Survival benefit of adjuvant radiotherapy in stage III and IV bladder cancer: Results of 170 patients. Cancer Manag Res. 2014; 6:459-465.
4. Brausi M, Witjes JA, Lamm D, et al. A review of current guidelines and best practice recommendations for the management of nonmuscle invasive bladder cancer by the International Bladder Cancer Group. J Urol. 2011 Dec; 186(6):2158-2167.
5. Cole CJ, Pollack A, Zagars GK, et al. Local control of muscle-invasive bladder cancer: Preoperative radiotherapy and cystectomy versus cystectomy alone. Int J Radiat Oncol Biol Phys. 1995 May 15; 32(2):331-340.
6. Gakis G, Witjes JA, Compérat E, et al. EAU guidelines on primary urethral carcinoma. Euro Urol. 2013. 2013 Nov; 64(5):823-830.
7. Hagan MP, Winter KA, Kaufman DS, et al. RTOG 97-06: Initial report of a Phase I–II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy. Int J Radiat Oncol Biol Phys. 2003 Nov 1; 57(3):665-672.
8. Herr HW, Faulkner JR, Grossman HB, et al. Surgical factors influence bladder cancer outcomes: a cooperative group report. J Clin Oncol. 2004 Jul 15; 22(14):2781-2789.
9. James ND, Hussain SA, Hall, et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. NEJM. 2012 Apr 19; 366(16):1477-1488.
10. Kaufman DS, Winter KA, Shipley WU, et al. The initial results in muscle-invading bladder cancer of RTOG 95-06: Phase I/II trial of transurethral surgery plus radiation therapy with concurrent cisplatin and 5-fluorouracil followed by selective bladder preservation or cystectomy depending on the initial response. Oncologist. 2000 Dec; 5(6):471-476.
11. Mak RH, Hunt D, Shipley WU, et al. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: A pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014 Dec 1; 32(34):3801-3809.
12. Milosevic M, Gospodarowicz M, Zietman A, et al. Radiotherapy for bladder cancer. Urology. 2007 Jan; 69(1 Suppl):80-92.
13. Rödel C, Gragenbauer, GG, Kühn R, et al. Combined-modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002 Jul 15; 20(14):3061-3071.
14. Nasr AM, El Mongi M, Hagag M, et al. Postoperative radiotherapy in bladder cancer patients: 5-year institutional experience of National Cancer Institute, Cairo University. J Canc Therapy. 2015 Jul 16; 6(7):579-593.
15. National Comprehensive Cancer Network (NCCN) Guidelines® Version 3.2020 – January 17, 2020. Bladder Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer 3.2020. ©2020 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.
16. Parsons JT and Million RR. Planned preoperative irradiation in the management of clinical stage B2-C (T3) bladder carcinoma. Int J Radiat Oncol Biol Phys. 1998 Apr; 14(4):797-810.
17. Shipley WU, Winter KA, Kaufman DS, et al. Phase III trial of neoadjuvant chemotherapy in patients with invasive bladder cancer treated with selective bladder preservation by combined radiation therapy and chemotherapy: Initial results of Radiation Therapy Oncology Group 89-03. J Clin Oncol. 1998 Nov 01; 11:3576-83.
18. Smith JA Jr., Crawford ED, Paradelo JC, et al. Treatment of advanced bladder cancer with combined preoperative irradiation and radical cystectomy versus radical cystectomy alone: a phase III intergroup study. J Urol. 1997 Mar; 157(3):805-807.
19. Weiss C, Wolze C, Engelhausen DG, et al. Radiochemotherapy after transurethral resection for high-risk T1 bladder cancer: an alternative to intravesical therapy or early cystectomy? J Clin Oncol. 2006 May; 24(15):2318-2324.
20. Zabhloul MS, Awwad HK, Akoush HH, et al. Postoperative radiotherapy of carcinoma in bilharzial bladder: improved disease free survival through improving local control. Int J Radiat Oncol Biol Phys. 1992; 23(3):511-517.
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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