Original Date: June 2013 PROTON BEAM RADIATION THERAPY Page 1 of 11 CPT codes: 77520,77522,77523,77525 Last Review Date: August 2015

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1 National Imaging Associates, Inc. Clinical guidelines: Original Date: June 2013 PROTON BEAM RADIATION THERAPY Page 1 of 11 CPT codes: 77520,77522,77523,77525 Last Review Date: August 2015 Guideline Number: NIA_CG_221 Last Revised Date: Responsible Department: Implementation Date : January 2016 Clinical Operations INTRODUCTION: Proton beam therapy (PBT) is a type of external beam radiotherapy that uses charged particles. These particles have unique characteristics, including limited lateral slide, scatter and tissue in a defined range, going for maximum dose delivery over the last few millimeters of the particles range. The maximum is called the Bragg peak. Proton beam irradiation, when applied to treating cancer, uses different proton energy with Bragg peaks at various steps, enabling dose escalation to the tumor, minimizing excess dose to normal surrounding tissue. Over the years, proton beam irradiation has been applied to treating tumors that require dose escalation to achieve a higher probability of care, as well as tumors requiring increased precision in dose deposition while protecting normal surrounding tissue. Proton therapy has an over 40-year history in treating cancer, yet to date, there have been few studies that show superiority to conventional photon beam irradiation, especially with modern techniques. MEDICALLY NECESSARY INDICATIONS FOR PROTON BEAM THERAPY: Uveal Melanoma Proton beam therapy is considered an effective treatment for uveal melanoma, dependent on size, location and extension. Local control rates, eye preservation, and vision retention have been well documented with this treatment. However, other forms of irradiation, including brachytherapy and stereotactic radiosurgery (SRS) are also established treatment options. To date, there is insignificant evidence to support one form of treatment over the other. However, given the published excellent data on proton therapy, PBT is considered an appropriate use of this technology when confined to the globe (no evidence of metastasis or extrascleral extension). Chordomas or Chondrasarcomas Arising at the Base of the Skull As postoperative therapy, evidence suggests that proton beam therapy is at least as effective, and may be superior to, conventional radiation therapy in the treatment of chordomas or chondrasarcomas of the skull. There is no data that shows proton beam therapy as clinically superior to conventional radiotherapy, including intensity modulated radiation therapy, 3-dimensional radiation therapy, or stereotactic radiation therapy. However, based on these tumors being located adjacent to critical CNS structures and the documented efficacy PBT treatment would be considered medically necessary. Arterial Venous Malformation (AVM) 1 Proton Beam Proprietary

2 An AVM is an abnormal vascular structure that usually develops as a congenital defect. Multiple treatment options exist for AVM s, including microsurgery, embolization, or radiosurgery. Surgery is generally considered a treatment of choice, with the majority patients undergoing this procedure. Those considered poor candidates for surgery are typically treated with embolization or radiosurgery. Proton beam therapy is an option for patients not amenable to surgery or stereotactic radiosurgery. Treatment of pediatric central nervous system tumors (less than 21 years of age) TREATMENT OPTIONS REQUIRING ADDITIONAL CLINICAL REVIEW: Central nervous system lesions adjacent to the brain stem, spinal cord, or optic nerve. A treatment plan with a comparison to conventional IMRT/SRS may be required. NOT MEDICALLY NECESSARY INDICATIONS FOR PROTON BEAM THERAPY: Proton beam therapy has not been proven to be superior to conventional radiation therapy for all other indications including, but not limited to: Prostate cancer Breast cancer Lung cancer Colorectal cancer Cervical cancer Metastasis Gliomas Soft tissue sarcoma 2 Proton Beam Proprietary

3 REFERENCES Aetna Clinical Policy Bulletin: Proton Beam and Neutron Beam Radiotherapy. June 12, Agency for Healthcare Research and Quality (AHRQ). Trikalinos TA, Terasawa T, Ip S, Raman G, Lau J. Particle Beam Radiation Therapies for Cancer. Technical Brief No. 1. (Prepared by Tufts Medical Center Evidence-based Practice Center under Contract No. HHSA ) Al-Mefty O, Borba LAB. Skull base chordomas: a management challenge. J Neurosurg. 1997;86: Al-Shahi R, Warlow CP. Interventions for treating brain arteriovenous malformations in adults. Cochrane Database Syst Rev. 2006;(1):CD Allen A, Pawlicki T, Bonilla L, et al; Evaluation Subcommittee of ASTRO s Emerging Technologies Committee. An evaluation of proton beam therapy. Fairfax, VA: American Society for Radiation Oncology (ASTRO); October Allen AM, Pawlicki T, Dong L, et al. An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. Radiother Oncol Apr;103(1):8-11. Almefty K, Pravdenkova S, Colli BO, et al. Chordoma and chondrosarcoma: Similar, but quite different, skull base tumors. Cancer. 2007;110(11): Barker FG II, Butler WE, Lyons S, et al. Dose-volume prediction of radiation-related complications after proton beam radiosurgery for cerebral arteriovenous malformations. J Neurosurgery. 2003;99(2): Bassim MK, Berliner KI, Fisher LM, et al. Radiation therapy for the treatment of vestibular schwannoma: A critical evaluation of the state of the literature. Otol Neurotol. 2010;31(4): Bekkering GE, Rutjes AW, Vlassov VV, et al. The effectiveness and safety of proton radiation therapy for indications of the eye: a systematic review. Strahlenther Onkol Apr;185(4): BlueCross BlueShield Association. Proton Beam Radiation Therapy Medical Policy. December Bonnet RB, Bush D, Cheek GA, et al. Effects of proton and combined proton/photon beam radiation on pulmonary function in patients with resectable but medically inoperable nonsmall cell lung cancer. Chest. 2001;120(6): Brada M, Pijls-Johannesma M, De Ruysscher D. Current clinical evidence for proton therapy. Cancer J Jul-Aug;15(4): Proton Beam Proprietary

4 Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: Preliminary results of a phase II trial. Gastroenterology. 2004;127(5 Suppl 1):S189-S193. Bush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer Jul 1;117(13): Bush DA, McAllister CJ, Loredo LN, et al. Fractionated proton beam radiotherapy for acoustic neuroma. Neurosurgery. 2002;50(2): Bush DA, Slater JD, Bonnet R, et al. Proton-beam radiotherapy for early-stage lung cancer. Chest.1999;116(5): Bush DA, Slater JD, Garberoglio C, et al. A technique of partial breast irradiation utilizing proton beam radiotherapy: Comparison with conformal x-ray therapy. Cancer J. 2007;13(2): Castelluci L. Proton therapy faces high hurdles to general use. J Natl Cancer Inst. 1998;90(23): Chan RV, Yonekawa Y, Lane AM, et al. Proton beam irradiation using a light-field technique for the treatment of choroidal hemangiomas. Ophthalmologica. 2010;224(4): Chang JY, Komaki R, Lu C, et al. Phase 2 study of high-dose proton therapy with concurrent chemotherapy for unresectable stage III nonsmall cell lung cancer. Cancer Mar 22. Cigna Medical Policy for Proton Beam Therapy for Central Nervous Tumors. October 15, Cigna Medical Policy for Proton Beam Therapy for Ocular Melanoma, Ocular Hemangiomas and Macular Degeneration. December 15, Cigna Medical Policy for Proton Beam Therapy for Prostate Cancer. December 15, Ciulla TA, Danis RP, Klein SB, et al. Proton therapy for exudative age-related macular degeneration: a randomized, sham-controlled clinical trial. Am J Ophthalmol. 2002;134(6): Coen JJ, Zietman AL. Proton radiation for localized prostate cancer. Nat Rev Urol. 2009;6(6): Duttenhaver JR, Shipley WU, Perrone T, et al. Protons or megavoltage x-rays as boost therapy for patients irradiated for localized prostatic carcinoma: an early phase I/II comparison. Cancer. 1983;51(9): Efstathiou JA, Trofimov AV, Zietman AL. Life, liberty, and the pursuit of protons: An evidencebased review of the role of particle therapy in the treatment of prostate cancer. Cancer J. 2009;15(4): Proton Beam Proprietary

5 Egger E, Zografos L, Schalenbourg A, et al. Eye retention after proton beam radiotherapy for uveal melanoma. Int J Radiat Oncol Biol Phys. 2003;55(4): Fitzek MM, Linggood RM, Adams J, Munzenrider JE. Combined proton and photon irradiation for craniopharyngioma: Long-term results of the early cohort of patients treated at Harvard Cyclotron Laboratory and Massachusetts General Hospital. Int J Radiat Oncol Biol Phys. 2006;64(5): Fleurette F. Charvet-Protat S. Proton and neutron radiation in cancer treatment: Clinical and economic outcomes. French National Agency for Medical Evaluation (ANDEM). Bull Cancer Radiother. 1996;83(Suppl):223s-227s. Flynn K. Brief overview: Reviews of proton beam therapy for cancer. Boston, MA: Veterans Health Administration Technology Assessment Program (VATAP); August Frau E, Rumen F, Noel G, et al. Low-dose proton beam therapy for circumscribed choroidal hemangiomas. Arch Ophthalmol Oct;122(10): Gardner BG, Zietman AL, Shipley WU, et al. Late normal tissue sequelae in the second decade after high dose radiation therapy with combined photons and conformal protons for locally advanced prostate cancer. J Urol. 2002;167(1): Grutters JP, Kessels AG, Pijls-Johannesma M, et al. Comparison of the effectiveness of radiotherapy with photons, protons and carbon-ions for non-small cell lung cancer: a metaanalysis. Radiother Oncol Apr;95(1): Gudjonsson O, Blomquist E, Nyberg G, et al. Stereotactic irradiation of skull base meningiomas with high energy protons. Acta Neurochir (Wien). 1999;141(9): Habrand JL, Mammar H, Ferrand R, et al. Proton beam therapy (PT) in the management of CNS tumors in childhood. Strahlenther Onkol. 1999;175 Suppl 2: Habrand JL, Schlienger P, Schwartz L, et al. Clinical applications of proton therapy. Experiences and ongoing studies. Radiat Environ Biophys. 1995;34(1): Hall EJ. Intensity-modulated radiation therapy, protons, and the risk of second cancers. Int J Radiat Oncol Biol Phys. 2006;65(1):1-7. Harsh GR, Thornton AF, Chapman PH, et al. Proton beam stereotactic radiosurgery of vestibular schwannomas. Int J Radiat Oncol Biol Phys. 2002;54(1): Hata M, Tokuuye K, Kagei K, et al. Hypofractionated high-dose proton beam therapy for stage I non-small-cell lung cancer: Preliminary results of a phase I/II clinical study. Int J Radiat Oncol Biol Phys. 2007;68(3): Hocht S, Wachtlin J, Bechrakis NE, et al. Proton or photon irradiation for hemangiomas of the choroid? A retrospective comparison. Int J Radiat Oncol Biol Phys Oct 1;66(2): Proton Beam Proprietary

6 Hong TS, Ryan DP, Blaszkowsky LS, et al. Phase I study of preoperative short-course chemoradiation with proton beam therapy and capecitabine for resectable pancreatic ductal adenocarcinoma of the head. Int J Radiat Oncol Biol Phys. 2011;79(1): Hug EB, Fitzek MM, Liebsch NJ, et al. Locally challenging osteo- and chondrogenic tumors of the axial skeleton: results of combined proton and photon radiation therapy using threedimensional treatment planning. Int J Radiat Oncol Biol Phys. 1995;31(3): Hug EB, Slater JD. Proton radiation therapy for chordomas and chondrosarcomas of the skull base. Neurosurg Clin N Am. 2000;11(4): Institute for Clinical and Economic Review (ICER). Brachytherapy and proton beam therapy for treatment of clinically localized, low-risk prostate cancer. Final Appraisal Document. Boston, MA: ICER; December 22, Kagei K, Tokuuye K, Okumura T, et al. Long-term results of proton beam therapy for carcinoma of the uterine cervix. Int J Radiat Oncol Biol Phys. 2003;55(5): Kawashima M, Furuse J, Nishio T, et al. Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma. J Clin Oncol. 2005;23(9): Kjellberg RN, Hanamura T, Davis KR, et al. Bragg-peak proton-beam therapy for arteriovenous malformations of the brain. N Engl J Med. 1983;309: Kjellberg RN, Shintani A, Frantz AG, et al. Proton-beam therapy in acromegaly. N Engl J Med. 1968;278: Konski A, Speier W, Hanlon A, et al. Is proton beam therapy cost effective in the treatment of adenocarcinoma of the prostate? J Clin Oncol. 2007;25: Konski A, Speier W, Hanlon A, et al. Is proton beam therapy cost effective in the treatment of adenocarcinoma of the prostate? J Clin Oncol. 2007;25(24): Koyama S, Tsujii H. Proton beam therapy with high-dose irradiation for superficial and advanced esophageal carcinomas. Clin Cancer Res. 2003;9: Kozak KR, Smith BL, Adams J, et al. Accelerated partial-breast irradiation using proton beams: Initial clinical experience. Int J Radiat Oncol Biol Phys. 2006;66(3): Levy-Gabriel C, Rouic LL, Plancher C, et al. Long-term results of low-dose proton beam therapy for circumscribed choroidal hemangiomas. Retina Feb;29(2): Li W, Gragoudas ES, Egan KM. Tumor basal area and metastatic death after proton beam irradiation for choroidal melanoma. Arch Ophthalmol. 2003;121(1): Lodge M, Pijls-Johannesma M, Stirk L, et al. A systematic literature review of the clinical and cost-effectiveness of hadron therapy in cancer. Radiother Oncol. 2007;83(2): Proton Beam Proprietary

7 Matsuzaki Y, Osuga T, Saito Y, et al. A new, effective, and safe therapeutic option using proton irradiation for hepatocellular carcinoma. Gastroenterology. 1994;106(4): McAllister B, Archambeau JO, Nguyen MC, et al. Proton therapy for pediatric cranial tumors: preliminary report on treatment and disease-related morbidities. Int J Radiat Oncol Biol Phys. 1997;39: Macdonald OK, Kruse JJ, Miller JM, et al. Proton beam radiotherapy versus three-dimensional conformal stereotactic body radiotherapy in primary peripheral, early-stage non-small-cell lung carcinoma: A comparative dosimetric analysis. Int J Radiat Oncol Biol Phys. 2009;75(3): Mehdorn HM, Grote W. Non-invasive follow-up of patients with intracranial arteriovenous malformations after proton-beam radiation therapy. Acta Neurochir. 1988;42: Merchant TE. Proton beam therapy in pediatric oncology. Cancer J. 2009;15(4): Mizumoto M, Sugahara S, Nakayama H, et al. Clinical results of proton-beam therapy for locoregionally advanced esophageal cancer. Strahlenther Onkol. 2010;186(9): Munzenrider JE. Uveal Melanomas. Conservation treatment. Hematol Oncol Clin North Am. 2001;15(2): Nahum AE, Dearnaley DP, Steel GG. Prospects for proton beam radiotherapy. Eur J Canc. 1994;30A: NCCN Clinical Practice Guidelines in Oncology. Nguyen PL, Trofimov A, Zietman AL. et al. Proton-beam vs intensity-modulated radiation therapy. Which is best for treating prostate cancer? Oncology (Williston Park). 2008;22(7): ; discussion 754, 757. Nihei K, Ogino T, Ishikura S, et al. Phase II feasibility study of high-dose radiotherapy for prostate cancer using proton boost therapy: First clinical trial of proton beam therapy for prostate cancer in Japan. Jpn J Clin Oncol. 2005;35(12): Nihei K, Ogino T, Ishikura S, Nishimura H. High-dose proton beam therapy for Stage I nonsmall-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006;65(1): Nishimura H, Ogino T, Kawashima M, et al. Proton-beam therapy for olfactory neuroblastoma. Int J Radiat Oncol Biol Phys. 2007;68(3): Noel G, Habrand JL, Helfre S, et al. Proton beam therapy in the management of central nervous system tumors in childhood: The preliminary experience of the Centre de Protontherapie d'orsay. Med Pediatr Oncol. 2003;40(5): Noel G, Habrand JL, Jauffret E, et al. Radiation therapy for chordoma and chondrosarcoma of the skull base and the cervical spine. Prognostic factors and patterns of failure. Strahlenther Onkol. 2003;179(4): Proton Beam Proprietary

8 Noel G, Habrand JL, Mammar H, Haie-Meder C, et al.. Highly conformal therapy using proton component in the management of meningiomas. Preliminary experience of the Centre de Protontherapie d'orsay. Strahlenther Onkol Sep;178(9): Ollendorf DA, Hayes J, McMahon P, et al. Brachytherapy/proton beam therapy for clinically localized, low-risk prostate cancer. Boston, MA: Institute for Clinical and Economic Review (ICER); Olsen DR, Bruland OS, Frykholm G, Norderhaug IN. Proton therapy - a systematic review of clinical effectiveness. Radiother Oncol May;83(2): Pijls-Johannesma M, Grutters JP, Verhaegen F, et al. Do we have enough evidence to implement particle therapy as standard treatment in lung cancer? A systematic literature review. Oncologist. 2010;15(1): Raju MR. Proton radiobiology, radiosurgery and radiotherapy. Int J Radiat Biol. 1995;67: Ramaekers BL, Pijls-Johannesma M, Joore MA, et al. Systematic review and meta-analysis of radiotherapy in various head and neck cancers: comparing photons, carbon-ions and protons. Cancer Treat Rev May;37(3): Robertson DM. Changing concepts in the management of choroidal melanoma. Am J Ophthalmol. 2003;136(1): Rossi CJ. Conformal proton beam therapy of prostate cancer update on the Loma Linda University medical center experience. Strahlenther Onkol. 1999;175(Suppl 2): Rossi CJ Jr, Slater JD, Reyes-Molyneux N, et al. Particle beam radiation therapy in prostate cancer: Is there an advantage? Semin Radiat Oncol. 1998;8(2): Rossi Jr CJ, Slater JD, Yonemoto LT, et al. Influence of patient age on biochemical freedom from disease in patients undergoing conformal proton radiotherapy of organ-confined prostate cancer. Urology. 2004;64(4): Schulte RW, Slater JD, Rossi CJ Jr, et al. Value and perspectives of proton radiation therapy for limited stage prostate cancer. Strahlenther Onkol. 2000;176:3-8. Schulz RJ, Kagan AR. Should proton-beam therapy be widely adopted? Int J Radiat Oncol Biol Phys (5): Seifert V. Stolke D. Mehdorn HM. Et al. Clinical and radiological evaluation of long-term results of stereotactic proton beam radiosurgery in patients with cerebral arteriovenous malformations. J Neurosurg. 1994;81: Sejpal S, Komaki R, Tsao A, et al. Early findings on toxicity of proton beam therapy with concurrent chemotherapy for non-small cell lung cancer. Cancer Jul 1;117(13): Proton Beam Proprietary

9 Sheets NC, Goldin GH, Meyer AM, et al. Intensity-modulated radiation therapy, proton therapy, or conformal radiation therapy and morbidity and disease control in localized prostate cancer. JAMA Apr 18;307(15): Shipley WU, Verhey LJ, Munzenrider JE, et al. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone. Int J Radiat Oncol Biol Phys. 1995;32(1):3-12. Silander H, Pellettieri L, Enblad P, et al. Fractionated, stereotactic proton beam treatment of cerebral arteriovenous malformations. Acta Neurol Scand. 2004;109(2): Sivagnanavel V, Evans JR, Ockrim Z, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2004;(3):CD Slater JD, Rossi CJ, Jr., Yonemoto LT, et al. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004;59(2): Slater JD, Yonemoto LT, Rossi CJ Jr, et al. Conformal proton therapy for prostate carcinoma. Int J Radiat Oncol Bio Phys. 1998;42(2): Spatola C, Privitera G, Raffaele L, et al. Clinical application of proton beams in the treatment of uveal melanoma: The first therapies carried out in Italy and preliminary results (CATANA Project). Tumori. 2003;89(5): Suit H, Urie M. Proton beams in radiation therapy. J Natl Cancer Inst. 1992;84: Suit HD, Goitein M, Munzenrider JE, et al. Definitive radiation therapy for chordoma and chondrosarcoma of base of skull and cervical spine. J Neurosurg. 1982;56: Terasawa T, Dvorak T, Ip S, et al. Systematic review: Charged-particle radiation therapy for cancer. Ann Intern Med. 2009;151(8): Tsuji H, Inada T, Maruhashi A, et al. Clinical results of fractionated proton therapy. Int J Radiat Oncol Bio Phys. 1993;25(1): UnitedHealthCare Proton Beam Radiation Therapy Medical Policy. December 1, Vargas C, Fryer A, Mahajan C, et al. Dose-volume comparison of proton therapy and intensity modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys Mar 1;70(3): Epub 2007 Sep 27. van de Water TA, Bijl HP, Schilstra C, et al. The potential benefit of radiotherapy with protons in head and neck cancer with respect to normal tissue sparing: a systematic review of literature. Oncologist. 2011;16(3): Vernimmen FJ. Stereotactic proton beam therapy for intracranial arteriovenous malformations. Int J Radiat Oncol Biol Phys. May 1, 2005; 62(1): Proton Beam Proprietary

10 Vernimmen FJ, Harris JK, Wilson JA, et al. Stereotactic proton beam therapy of skull base meningiomas. Int J Radiat Oncol Biol Phys. 2001;49(1): Weber DC, Rutz HP, Pedroni ES, et al. Results of spot-scanning proton radiation therapy for chordoma and chondrosarcoma of the skull base: the Paul Scherrer Institut experience. Int J RAug 9, Oncol Biol Phys Oct 1;63(2): Wenkel E, Thornton AF, Finkelstein D, et al. Benign meningioma: partially resected, biopsied, and recurrent intracranial tumors treated with combined proton and photon radiotherapy. Int J Radiat Oncol Biol Phys. 2000;48(5):1363. Widesott L, Amichetti M, Schwarz M. Proton therapy in lung cancer: clinical outcomes and technical issues. A systematic review. Radiother Oncol Feb;86(2): Wilson VC, McDonough J, Tochner Z. Proton beam irradiation in pediatric oncology: An overview. J Pediatr Hematol Oncol. 2005;27(8): Wilt TJ, MacDonald R, Rutks I, et al. Systematic review: Comparative effectiveness of therapies for clinically localized prostate cancer. Ann Intern Med. 2008;148: Wilt TJ, Shamliyan T, Taylor B, et al. Comparative effectiveness of therapies for clinically localized prostate cancer. Comparative Effectiveness Review No. 13. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); Yock TI, Tarbell NJ. Technology insight: Proton beam radiotherapy for treatment in pediatric brain tumors. Nat Clin Pract Oncol. 2004;1(2): Yonemoto LT, Slater JD, Rossi CJ Jr, et al. Combined proton and photon conformal radiation therapy for local advanced carcinoma of the prostate: Preliminary results of a phase I/II study. Int J Radiat Oncol Bio Phys. 1997;37(1): Zambarakji, H. J., Lane, A. M., Ezra, et al.proton beam irradiation for neovascular age-related macular degeneration. Ophthalmology. 2006;113(11): Zietman AL, Bae K, Slater JD, et al. Randomized trial comparing conventional-dose with highdose conformal radiation therapy in early-stage adenocarcinoma of the prostate: longterm results from Proton Radiation Oncology Group/American College of Radiology J Clin Oncol Mar 1;28(7): Zietman AL, DeSilvio ML, Slater JD, et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: A randomized controlled trial. JAMA. 2005;294(10): Zografos L, Egger E, Bercher L, Chamot L, Munkel G. Proton beam irradiation of choroidal hemangiomas. Am J Ophthalmol Proton Beam Proprietary

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