1. Technique
   1. Electron beam and/or superficial photon radiation is considered medically necessary in the treatment of localized malignant melanoma for any of the following:
      1. Definitive treatment
         1. When the member is inoperable or declines surgical resection
         2. When surgery would result i cosmetic or functional compromise
      2. Postoperative treatment in the setting of
         1. A primary deep desmoplastic melanoma with close margins
         2. Presence of extensive neurotropism
      3. Locally recurrent disease
   2. The use of 3D conformal radiation is considered medically necessary when treating regional adenopathy when any of the following risk factors for recurrence are present (as defined by the NCCN®):
      1. Extranodal extension
      2. One or more involved parotid lymph nodes of any size
      3. Two or more involved cervical or axially lymph nodes and/or tumor within a node is 3 cm or larger and/or tumor within a node is 4 cm or larger
   3. Electron beam and/or superficial photon radiation is considered medically necessary to palliate unresectable nodal, satellite, or in-transit disease
   4. 3D conformal radiation is considered medically necessary to palliate symptomatic visceral metastatic lesions. For treatment of bone or brain metastases from melanoma, please refer to the respective policy.
      1. The use of SBRT to induce the abscopal effect is considered investigational

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: Melanoma can arise outside of the skin, wherever melanocytes exist. Mucosal melanoma represents a spectrum of clinical entities depending on site of origin, and most commonly arises in the head and neck sinuses, the oral cavity the anorectum, vagina, and mucosa of the GI and GU tracts. There are specific genetic alterations in distinct clinical subtypes of melanoma, often correlated with degree of sun damage. BRAF mutation is seen in roughly half of the non-CSD (non-chronic sun damaged) skin melanomas, whereas KIT gene aberrations are rare in that group. Non-mucosal, non-cutaneous melanomas also occur, such as in the uveal tract, and represent distinct presentations. Non-cutaneous melanoma cases (i.e., mucosal melanomas and those of the eye) are addressed in other sections of this clinical guideline, such as the Head and Neck clinical guideline for melanomas of the sinuses, or the Proton Beam Therapy clinical guideline on proton beam therapy for uveal melanomas.

The natural history of cutaneous melanoma is one of local invasion, lymphatic metastases, and hematologic dissemination. The risk of all three may be greater than that of a non-melanoma skin cancer in the same location. Surgery is the primary therapy for cutaneous melanoma. A preoperative evaluation should include a careful physical examination of the primary site, the regional lymphatics, and the entire skin surface. Equivocal findings on physical examination of the regional lymphatics may trigger an ultrasound exam of the area. If symptomatic, cross-sectional imaging is indicated, otherwise not routinely to be performed for early state (0, I, II) cases. Sentinel lymph node evaluation is recommended for thicker lesions, but rarely needed with lesions less than 0.75 mm thick. As stage advances higher, baseline imaging is appropriate, or if there is clinical evidence of adenopathy or symptoms are present that suggest nerve or bone invasion. Clinically positive nodes should be confirmed with fine needle aspiration (FNA) or core biopsy. If there is clinical or radiographic evidence of distant metastases, confirmation by FNA or core biopsy is recommended, as is imaging of the brain. Patients with minimal signs or symptoms of CNS involvement should undergo a brain magnetic resonance imaging (MRI) scan due to the high risk of brain metastases.

The optimal degree of clear margin necessary to minimize the risk of local is dependent on tumor thickness. For thin (<2 mm) lesions it appears a margin of 1 cm is adequate. For thicker lesions, a 2 cm margin is currently recommended. Lentigo maligna and melanoma in situ present unique features because of possible lateral subclinical extension, for which imiquimod is an option. Radiation therapy has been also used in such cases, with complete clearance rates in the 85% to 90% range. For a melanoma that has undergone adequate wide local excision and there is no adenopathy on clinical and/or sentinel node examination, adjuvant radiation therapy is rarely indicated, the possible exception being desmoplastic neurotropic melanoma. If regional adenopathy is clinically present, a complete therapeutic node dissection should be included with wide excision of the primary tumor. If melanoma is found in sentinel nodes but was not clinically suspicious, current recommendations include offering a complete node dissection, though its impact on disease control and survival is not well established and is the focus of current study. Following wide excision and nodal dissection, radiation therapy to the nodal basin is to be considered in high risk cases, based on location, size and number of positive nodes, and the presence or absence of extranodal extension of melanoma. Radiation therapy is one option for the treatment of in-transit disease (metastases within lymphatics or satellite locations without metastatic nodes for which resection is not feasible. Alternatives include intralesional injections, local ablation therapy, and topical imiquimod.

The radiation prescription is to be made by a qualified radiation oncologist who is familiar with the nuances of the dose deposition that accompany the physical characteristics of the radiation beams and techniques. Dose prescription for electrons is at the 90% isodose line and for superficial or orthovoltage radiation at the Dmax. When sophisticated Complex photon, 3D or IMRT treatments are used, attention is to be paid to the skin dose, and may require the use of bolus.]
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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 Skin Cancer - Melanoma
Malignant Melanoma, Radiation Therapy
Cancers of the Skin, Radiation Therapy for Melanoma
Skin Cancer, Radiation Therapy for Melanoma

References:

1. Agrawal S, Kane III JM, Guadagnolo BA, et al. The benefits of adjuvant radiation therapy after therapeutic lymphadenectomy for clinically advanced, high-risk, lymph node-metastatic melanoma. Cancer. 2009 Dec 15; 115(24):5836-5844.

2. Burmeister BN, Henderson MA, Ainslie J, et al. Adjuvant radiotherapy versus observation alone for patients at risk of lymph-node field relapse after therapeutic lymphadenectomy for melanoma: a randomised trial. Lancet Oncol. 2012 Jun; 13(6):589-597.

3. Chang DT, Amdur RJ, Morris CG, et al. Adjuvant radiotherapy for cutaneous melanoma: comparing hypofractionation to conventional fractionation. Int J Radiat Oncol Biol Phys. 2006 Nov 15; 66(4):1051-1055.

4. Devlin PM, Gaspar LE, Buzurovic I, et al. American College of Radiology - American Brachytherapy Society practice Parameter for electronically generated low-energy radiation sources. Brachytherapy. 2017 Nov-Dec; 16(6):1083-1090.

5. Eggermont AM, Chiarion-Sileni V, Grob, JJ, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma. (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 May; 16(5):522-30.

6. Guadagnolo BA, Prieto V, Weber R, et al. The role of adjuvant radiotherapy in the local management of desmoplastic melanoma. Cancer. 2014 May 1; 120(9):1361-1368.

7. Lee RJ, Gibbs JF, Proulx GM, et al. Nodal basin recurrence following lymph node dissection for melanoma: implications for adjuvant radiotherapy. Int J Radiat Oncol Biol Phys. 2000 Jan 15; 46(2):467-474.

8. Olivier KR, Schild SE, Morris CG, et al. A higher radiotherapy dose is associated with more durable palliation and longer survival in patients with metastatic melanoma. Cancer. 2007 Oct 15; 110(8):1791-1795.

9. Mendenhall WM, Mancuso AA, Kiorwan JM, et al. Skin: principles and practice of radiation oncology. In: Halperin EC, Wazer DE, Perez CA, Brady LW, eds. Perez and Brady's Principles and Practice of Radiation Oncology. 6^th ed. Philadelphia, PA: Lippincott Williams & Wilkins, a Wolters Kluwer business. 2013:626-637.

10. Miller AJ and Mihm MC. Melanoma. NJEM. 2006 Jul 6; 355(1):51-65.

11. National Comprehensive Cancer Network NCCN Radiation Therapy Compendium™.

12. National Comprehensive Cancer Network (NCCN) Guidelines^©. Version 1.2020 - December 19, 2019. Cutaneous Melanoma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^©) for Cutaneous Melanoma Version 1.2020. ^©2019 National Comprehensive Cancer Network, Inc. All right 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.

13. Sause WT, Cooper JS, Rush S, et a. Fraction size in external beam radiation therapy in the treatment of melanoma. Int J Radiat Oncol Biol Phys. 1991 Mar; 20(3):429-432.

14. Strom T, Caudell JJ, Han D, et al. Radiotherapy influences local control in patients with desmoplastic melanoma. Cancer. 2014 May 1; 120(9):1369-1378.

15. Tom MC, Hepel JT et al. Ther American Brachytherapy Society consensus statement for electronic brachytherapy. Brachytherapy. 19(2019) 292-298.