Electronic Brachytherapy for Nonmelanoma Skin Cancer

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1 MEDICAL POLICY Electronic Brachytherapy for Nonmelanoma Skin Cancer BCBSA Ref. Policy: Effective Date: Sept. 1, 2017 Last Revised: Aug. 22, 2017 Replaces: N/A RELATED MEDICAL POLICIES: None Select a hyperlink below to be directed to that section. POLICY CRITERIA CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Brachytherapy is a type of radiation therapy. Brachy- means short, so brachytherapy is a way of giving radiation that doesn t travel through very much other tissues to reach the cancerous tissue. Electronic brachytherapy is being studied as a treatment for skin cancer other than melanoma. Surgery is usually used to treat nonmelanoma skin cancer. With electronic brachytherapy, a high-dose x-ray is used to deliver radiation directly to the cancerous area. Typically, a mold is made and then placed over the treatment area. A probe the source of radiation is inserted into the mold so that the source touches the skin. The radiation is then activated. Once the radiation is delivered, the source is turned off, and the probe and mold are removed. Several sessions are required to complete the treatment. Electronic brachytherapy for nonmelanoma skin cancer is unproven. More studies are needed to see if this treatment is as good as or better than surgery and other types of radiation treatment. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

2 Treatment Electronic brachytherapy (nonmelanoma skin cancer) Investigational Electronic brachytherapy for the treatment of nonmelanoma skin cancer* is considered investigational. *Note: Nonmelanoma skin cancer refers to squamous cell carcinoma and basal cell carcinoma. There are other less common types of skin cancer, such as T-cell lymphoma or Merkel cell tumor, which may have specific treatment options that are different from basal and squamous cell carcinomas and may need to be considered on an individual basis. Coding Code CPT 0394T 0395T Note: Description High dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, when performed High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS). Related Information Benefit Application Electronic brachytherapy for the treatment of breast cancer is a covered diagnosis. Evidence Review Page 2 of 8

3 Description Electronic brachytherapy is a form of radiotherapy designed to deliver high-dose rate radiation to treat nonmelanoma skin cancer. This technique focuses a uniform dose of x-ray source radiation to the lesion with the aid of a shielded surface application. Background Nonmelanoma Skin Cancer Squamous cell carcinoma and basal cell carcinoma are the most common types of nonmelanoma skin cancer in the United States, affecting between 1 and 3 million people per year 1,2 and increasing at a rate of 3% to 8% per year. 1 Other types (eg, T-cell lymphoma, Merkel cell tumor, basosquamous carcinoma, Kaposi sarcoma) are much less common. The primary risk factor for nonmelanoma skin cancer is sun exposure, with additional risk factors such as toxic exposures, other ionizing radiation exposure, and immunosuppression playing smaller roles. 2 Although these cancers are rarely fatal, they can impact the quality of life, functional status, and physical appearance. Treatment Surgical Treatment of nonmelanoma skin cancer is primarily surgical, 3 and the choice of surgical procedure depends on the histologic type, size and location of the lesion. Patient preferences can also play a factor in surgical decisions due to cosmetic reasons, as well as the consideration of comorbidities and patient risk factors such as anticoagulation. Local excisional procedures, such as electrodesiccation and curettage or cryotherapy, can be used for low-risk lesions, while surgical excision is indicated for lesions that are not low risk. Mohs surgery is an excisional procedure that uses microscopic guidance to achieve greater precision and sparing of normal tissue. In patients who meet criteria for Mohs surgery, 5-year cure rates for basal cell cancer range from 98% to 99%, 4 making Mohs surgery the preferred procedure for those who qualify. Page 3 of 8

4 Radiotherapy Radiotherapy is indicated for certain nonmelanoma skin cancers that are not amenable to surgery. In some cases, this is due to the location of the lesion on the eyelid, nose, or other structures that make surgery more difficult and which may be expected to have a less desirable cosmetic outcome. In other cases, surgery may be relatively contraindicated due to clinical factors such as bleeding risk or advanced age. In elderly patients with a relatively large tumor that would require extensive excision, the benefit/risk ratio for radiotherapy may be considered to be favorable. The 5-year control rates for radiotherapy are in the range of 80% to 92%, which is lower than for surgical excision. 4 A randomized controlled trial published in 1997 reported that radiotherapy for basal cell carcinoma resulted in greater numbers of persistent and recurrent lesions compared with surgical excision. 5 When radiotherapy is used for nonmelanoma skin cancer, the primary modality is external beam radiation. A number of different brachytherapy techniques have also been developed, including low-dose rate systems, Iridium-based systems, and HDR systems. 4 Electronic Brachytherapy Electronic brachytherapy is a form of radiotherapy delivered locally. Available systems for the treatment of nonmelanoma skin cancers are designed to deliver HDR brachytherapy for the treatment of skin surface lesions. This technique is feasible for well-circumscribed, superficial tumors. It focuses a uniform dose of x-ray source radiation to the lesion with the aid of a shielded surface application. A pliable mold is constructed of silicone or polymethyl-methacrylate and fitted to the tumor surface. This mold allows treatment to be delivered to nonflat surfaces such as the nose or ear. A radioactive source is then inserted into the mold to contact the tumor and deliver a uniform radiation dosage. 4 Potential advantages of this treatment modality compared with standard radiotherapy include a shorter treatment schedule and the avoidance of radioisotopes and a dedicated treatment vault. 1 Summary of Evidence For individuals who have nonmelanoma skin cancer who receive electronic brachytherapy, the evidence includes a systematic review and case series. Relevant outcomes are overall survival, Page 4 of 8

5 disease-specific survival, change in disease status, and treatment-related morbidity. No controlled trials were identified that have compared electronic brachytherapy with alternative treatment options. Further, a 2016 systematic review of case series found local control rates ranging from 83% to 100% and recurrence rates ranging from 0% to 17%. In most studies, the recurrence rate was less than 5%. In the absence of controlled studies, conclusions cannot be drawn about the efficacy and safety of electronic brachytherapy compared with other treatments for nonmelanoma skin cancer. Controlled trials are needed in defined populations that compare electronic brachytherapy with alternatives, specifically other forms of radiotherapy or surgical approaches. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this policy are listed in Table 1. Table 1. Summary of Key Ongoing Trials NCT No. Trial Name Planned Completion Enrollment Date Ongoing NCT a Xoft Electronic Brachytherapy Clinical Protocol for the 100 Feb 2016 Primary Treatment of Non-Melanoma Skin Cancer (ongoing) NCT Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma 26 May 2018 NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial. Practice Guidelines and Position Statements National Comprehensive Cancer Network National Comprehensive Cancer Network guidelines on basal cell carcinoma (v ) 13 and squamous cell skin cancer (v ) 14 both contain the following statement on electronic brachytherapy: There is insufficient long-term efficacy and safety data to support the routine use of electronic brachytherapy. Page 5 of 8

6 American Academy of Dermatology Guidelines from the American Academy of Dermatology on nonmelanoma skin cancers are anticipated before the end of Medicare National Coverage There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. Regulatory Status Electronic brachytherapy systems for the treatment of nonmelanoma skin cancers are designed to deliver high-dose rate brachytherapy to treat skin surface lesions. This technique focuses a uniform dose of x-ray source radiation to the lesion with the aid of a shielded surface application. The Esteya Electronic Brachytherapy System (Nucletron BV) and the Xoft Axxent Electronic Brachytherapy System (icad, Nashua, NH) are 2 systems that have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. FDA product code: JAD. References 1. Bhatnagar A. Nonmelanoma skin cancer treated with electronic brachytherapy: results at 1 year. Brachytherapy. Mar-Apr 2013;12(2): PMID Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. Feb ;375(9715): PMID Pons-Llanas O, Ballester-Sanchez R, Celada-Alvarez FJ, et al. Clinical implementation of a new electronic brachytherapy system for skin brachytherapy. J Contemp Brachytherapy. Jan 2015;6(4): PMID Alam M, Nanda S, Mittal BB, et al. The use of brachytherapy in the treatment of nonmelanoma skin cancer: a review. J Am Acad Dermatol. Aug 2011;65(2): PMID Avril MF, Auperin A, Margulis A, et al. Basal cell carcinoma of the face: surgery or radiotherapy? Results of a randomized study. Br J Cancer. 1997;76(1): PMID Delishaj D, Rembielak A, Manfredi B, et al. Non-melanoma skin cancer treated with high-dose-rate brachytherapy: a review of literature. J Contemp Brachytherapy. Dec 2016;8(6): PMID Page 6 of 8

7 7. Paravati AJ, Hawkins PG, Martin AN, et al. Clinical and cosmetic outcomes in patients treated with high-dose-rate electronic brachytherapy for nonmelanoma skin cancer. Pract Radiat Oncol. Nov-Dec 2015;5(6):e PMID Delishaj D, Laliscia C, Manfredi B, et al. Non-melanoma skin cancer treated with high-dose-rate brachytherapy and Valencia applicator in elderly patients: a retrospective case series. J Contemp Brachytherapy. Dec 2015;7(6): PMID Tormo A, Celada F, Rodriguez S, et al. Non-melanoma skin cancer treated with HDR Valencia applicator: clinical outcomes. J Contemp Brachytherapy. Jun 2014;6(2): PMID Bhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non-melanoma skin cancer. Radiat Oncol. Sep ;5:87. PMID Gauden R, Pracy M, Avery AM, et al. HDR brachytherapy for superficial non-melanoma skin cancers. J Med Imaging Radiat Oncol. Apr 2013;57(2): PMID Guix B, Finestres F, Tello J, et al. Treatment of skin carcinomas of the face by high-dose-rate brachytherapy and custom-made surface molds. Int J Radiat Oncol Biol Phys. Apr ;47(1): PMID National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer. Version Accessed August National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Squamous Cell Skin Cancer. Version Accessed August American Academy of Dermatology. Guidelines for Non-Melanoma Skin Cancers, currently in development. Accessed August History Date Comments 07/14/15 New Policy. Policy created with literature review through April 30, Electronic brachytherapy is considered investigational for the treatment of nonmelanoma skin cancer. 01/20/16 Coding update. New CPT codes 0394T-0395T, effective 1/1/16, added to policy. 10/01/16 Annual Review, approved September 13, Policy created with literature review through June 13, 2016; references 9-10 added. Added delete date in coding section. Policy statement unchanged. 09/01/17 Annual Review, approved August 22, Policy created with literature review through June 6, 2017; reference 6 added. Policy statement unchanged. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. Page 7 of 8

8 CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) Premera All Rights Reserved. Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage. Page 8 of 8

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10 日本語 (Japanese): この通知には重要な情報が含まれています この通知には LifeWise Health Plan of Oregon の申請または補償範囲に関する重要な情報が含まれている場合があります この通知に記載されている可能性がある重要な日付をご確認ください 健康保険や有料サポートを維持するには 特定の期日までに行動を取らなければならない場合があります ご希望の言語による情報とサポートが無料で提供されます (TTY: ) までお電話ください 한국어 (Korean): 본통지서에는중요한정보가들어있습니다. 즉이통지서는귀하의신청에관하여그리고 LifeWise Health Plan of Oregon 를통한커버리지에관한정보를포함하고있을수있습니다. 본통지서에는핵심이되는날짜들이있을수있습니다. 귀하는귀하의건강커버리지를계속유지하거나비용을절감하기위해서일정한마감일까지조치를취해야할필요가있을수있습니다. 귀하는이러한정보와도움을귀하의언어로비용부담없이얻을수있는권리가있습니다 (TTY: ) 로전화하십시오. ລາວ (Lao): ແຈ ງການນ ມ ຂ ມ ນສ າຄ ນ. ແຈ ງການນ ອາດຈະມ ຂ ມ ນສ າຄ ນກ ຽວກ ບຄ າຮ ອງສະ ໝ ກ ຫ ຄວາມຄ ມຄອງປະກ ນໄພຂອງທ ານຜ ານ LifeWise Health Plan of Oregon. ອາດຈະມ ວ ນທ ສ າຄ ນໃນແຈ ງການນ. ທ ານອາດຈະຈ າເປ ນຕ ອງດ າເນ ນ ການຕາມກ ານ ດເວລາສະເພາະເພ ອຮ ກສາຄວາມຄ ມຄອງປະກ ນສ ຂະພາບ ຫ ຄວາ ມຊ ວຍເຫ ອເລ ອງຄ າໃຊ ຈ າຍຂອງທ ານໄວ. ທ ານມ ສ ດໄດ ຮ ບຂ ມ ນນ ແລະ ຄວາມ ຊ ວຍເຫ ອເປ ນພາສາຂອງທ ານໂດຍບ ເສຍຄ າ. ໃຫ ໂທຫາ ភ ស ខមរ (Khmer): សចកត ជ នដ ណ ង ន ម នព ត ម នយ ងស ខ ន សចកត ជ នដ ណ ង ន រប ហល ជ ម នព ត ម នយ ងស ខ ន អ ព ទរមង បបបទ ឬក ររ ប រងរបស អនកត មរយ LifeWise Health Plan of Oregon រប ហលជ ម ន ក លបរ ចឆទស ខ ន ន កន ង សចកត ជ នដ ណ ង ន អនករប ហលជ រត វក រប ញច ញសមតថភ ព ដល ក ណត ថង ជ ក ចប ស ន ន ដ មប ន ងរកស ទ កក រធ ន រ ប រងស ខភ ពរបស អនក ឬរប ក ជ ន យ ចញ ថល អនកម នស ទធ ទទ លព ត ម ន ន ន ងជ ន យ ន កន ងភ ស របស អនក ដ យម នអសល យ ឡ យ ស មទ រស ពទ (TTY: ) ਪ ਜ ਬ (Punjabi): ਇਸ ਨ ਟਸ ਵਚ ਖ ਸ ਜ ਣਕ ਰ ਹ. ਇਸ ਨ ਟਸ ਵਚ LifeWise Health Plan of Oregon ਵਲ ਤ ਹ ਡ ਕਵਰ ਜ ਅਤ ਅਰਜ ਬ ਰ ਮਹ ਤਵਪ ਰਨ ਜ ਣਕ ਰ ਹ ਸਕਦ ਹ. ਇਸ ਨ ਜਸ ਜਵਚ ਖ ਸ ਤ ਰ ਖ ਹ ਸਕਦ ਆ ਹਨ. ਜ ਕਰ ਤ ਸ ਜਸਹਤ ਕਵਰ ਜ ਰ ਖਣ ਹ ਵ ਜ ਓਸ ਦ ਲ ਗਤ ਜ ਵ ਚ ਮਦਦ ਦ ਇਛ ਕ ਹ ਤ ਤ ਹ ਨ ਅ ਤਮ ਤ ਰ ਖ਼ ਤ ਪ ਹਲ ਕ ਝ ਖ ਸ ਕਦਮ ਚ ਕਣ ਦ ਲ ੜ ਹ ਸਕਦ ਹ,ਤ ਹ ਨ ਮ ਫ਼ਤ ਵ ਚ ਤ ਆਪਣ ਭ ਸ਼ ਵ ਚ ਜ ਣਕ ਰ ਅਤ ਮਦਦ ਪ ਰ ਪਤ ਕਰਨ ਦ ਅ ਧਕ ਰ ਹ,ਕ ਲ (Farsi): فارسی اين اعالميه حاوی اطالعات مھم ميباشد.اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم تقاضا و يا پوشش بيمه ای شما از طريق LifeWise Health Plan of Oregon باشد. به تاريخ ھای مھم در اين اعالميه توجه نماييد.شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه ھای درمانی تان به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد.شما حق اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد. برای کسب اطالعات با شماره (کاربران TTY تماس باشماره ) تماس برقرار نماييد. 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Tumawag sa ไทย (Thai): ประกาศน ม ข อม ลส าค ญ ประกาศน อาจม ข อม ลท ส าค ญเก ยวก บการการสม ครหร อขอบเขตประก น ส ขภาพของค ณผ าน LifeWise Health Plan of Oregon และอาจม ก าหนดการในประกาศน ค ณ อาจจะต องด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณหร อการ ช วยเหล อท ม ค าใช จ าย ค ณม ส ทธ ท จะได ร บข อม ลและความช วยเหล อน ในภาษาของค ณโดยไม ม ค าใช จ าย โทร (TTY: ) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Oregon. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. 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