BlueCross BlueShield of Tennessee Medical Policy Manual

Proton or Helium Ion Beam (Charged Particle) Radiation Therapy

DESCRIPTION

Proton or helium ion beam (charged particle) radiation therapy is a type of particulate radiation therapy that differs from conventional electromagnetic and/or photon radiation therapy. The use of protons (or helium ions) is produced by an accelerator (cyclotron, synchrotron, synchrocyclotron, or linear). This type of radiation is unique because it allows for minimal scattering as particulate beams pass through tissue and disposes ionizing energy at precise depths (i.e., the Bragg peak). This results in minimizing tissue damage around the area. This type of therapy requires accurate localization of tumor and precise, reproducible positioning of the individual. During the procedure, the individual must be completely immobilized.

POLICY

See also:

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

For the treatment of localized prostate cancer, as well as other listed conditions considered investigational, proton beam therapy has not been shown to be superior to conventional radiation therapy at this time. Further randomized controlled studies are needed.

SOURCES

Agency for Healthcare Research and Quality (AHRQ). (2014). Comparative Effectiveness Review Number 146: Therapies for clinically localized prostate cancer: update of a 2008 systematic review. Retrieved October 5, 2016 from https://www.effectivehealthcare.ahrq.gov/ehc/products/521/2023/prostate-cancer-therapies-update-report-141216.pdf.

Allen, A. M., Pawlicki, T., Dong, L., Fourkal, E., Buyyounouski, M., Cengel, K., et al. (2012). An evidence based review of proton beam therapy: The report of ASTRO’s emerging technology committee. Retrieved April 25, 2014 from http://download.journals.elsevierhealth.com/pdfs/journals/0167-8140/PIIS0167814012000588.pdf.

American College of Radiology. (2014). ACR Appropriateness Criteria®. Nonsurgical treatment for non-small-cell lung cancer: Poor performance status or palliative intent. Retrieved April 6, 2016 from http://www.acr.org/~/media/ACR/Documents/AppCriteria/Oncology/NonsurgicalTreatmentForNSCLCPoorPerformanceStatusOrPalliativeIntent.pdf.

American College of Radiology. (2014). ACR Appropriateness Criteria®. Nonsurgical treatment for locally advanced non-small-cell lung cancer: Good performance status/definitive intent.  Retrieved September 28, 2016 from http://www.cancernetwork.com/oncology-journal/acr-appropriateness-criteria-nonsurgical-treatment-locally-advanced-non-small-cell-lung-cancer-good.

American College of Radiology. (2013). ACR Appropriateness Criteria®. Definitive external beam irradiation in stage T1 and T2 prostate cancer. Retrieved April 25, 2014 from http://www.acr.org/~/media/ACR/Documents/AppCriteria/Oncology/DefinitiveExternalBeamIrradiationInStageT1AndT2ProstateCancer.pdf.

American College of Radiology. (2013). ACR Appropriateness Criteria®. Induction and adjuvant therapy for N2 non-small-cell lung cancer. Retrieved April 25, 2014 from http://www.acr.org/~/media/ACR/Documents/AppCriteria/Oncology/InductionAndAdjuvantTherapyForN2NSCLC.pdf.

American College of Radiology. (2016). ACR Appropriateness Criteria®. Locally advanced, high-risk prostate cancer. Retrieved March 27, 2017 from https://acsearch.acr.org/docs/69397/Narrative/.

American Society for Radiation Oncology. (2013). Proton beam therapy for prostate cancer position statement. Retrieved April 25, 2014 from https://www.astro.org/uploadedFiles/Main_Site/Practice_Management/Reimbursement/ProtonProstateStatement.

American Society for Radiation Oncology. (2014). ASTRO model policies. Proton beam therapy (PBT). Retrieved October 5, 2016 from https://www.astro.org/uploadedFiles/Main_Site/Practice_Management/Reimbursement/ASTRO%20PBT%20Model%20Policy%20FINAL.pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Charged-particle (proton or helium ion) radiotherapy for neoplastic conditions (8.01.10). Retrieved September 26, 2017 from BlueWeb. (36 articles and/or guidelines reviewed)

Bush, D.A., Kayali, Z., Grove, R. & Slater, J.D. (2011). The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer 117, 3053-3059. (Level 2 evidence)

Cahaba Government Benefit Administrators, LLC. (2015, October 1). LCD for radiology: Proton beam therapy. (L34282). Retrieved December 17, 2015 from http://www.cms.gov.

Chao, H., Berman, A., Simone, C., Ciunci, C., Gabriel, P., Lin, H., et al. (2016). Multi-institutional prospective study of reirradiation with proton beam radiotherapy for locoregionally non-small cell lung cancer. Journal of Thoracic Oncology, 2016 Nov 4. [Epub ahead of print]. Abstract retrieved November 30, 2016 from PubMed database.

Chi, A., Chen, H., Wen, S., Yan, H., & Liao, Z. (2017). Comparison of particle beam therapy and stereotactic body radiotherapy for early stage non-small cell lung cancer: a systematic review and hypothesis-generating meta-analysis. Radiotherapy and Oncology, 123 (3), 346-354. Abstract retrieved September 28, 2017 from PubMed database.

Chiba, T., Tokuuye, K., Matsuzaki, Y. Sugahara, S., Chuganji, Y., et al. (2005). Proton beam therapy for hepatocellular carcinoma: a retrospective review of 162 patients. Clinical Cancer Research, 11, 3799-3805. (Level 4 evidence)

Dionisi, F., Widescott, L., Lorentini, S. & Amichetti, M. (2014). Is there a role for proton therapy in the treatment of hepatocellular carcinoma? A systematic review. Radiotherapy and Oncology, 111, 1-10. (Level 2 evidence)

Falkson, C., Vella, E., Yu, E., El-Mallah, M., Mackenzie, R., Ellis, P., & Ung, Y. (2017). Radiotherapy with curative intent in patients with early-stage, medically inoperable, non-small-cell lung cancer: a systematic review. Clinical Lung Cancer, 18 (2), 105-121. (Level 1 evidence)

Habl, G., Uhl, M., Katayama, S., Kessel, K., Hatiboglu, G., Hadaschik, B., et al. (2016). Acute toxicity and quality of life in patients with prostate cancer treated with protons or carbon ions in a prospective randomized phase II study - the IPI trial. International Journal of Radiation Oncology, Biology, Physics, 95 (1), 435-443. Abstract retrieved November 30, 2016 from PubMed database.

Hoppe, B., Mamalui-Hunter, M., Mendenhall, N., Li, Z., & Indelicato, D. (2013). Improving the therapeutic ratio by using proton therapy in patients with stage I or II seminoma. American Journal of Clinical Oncology, 36 (1), 31-37. Abstract retrieved December 6, 2016 from PubMed database.

Igaki, H., Mizumoto, M., Okumura, T., Hasegawa, K., Kokudo, N., & Sakurai, H. (2017). A systematic review of publications on charged particle therapy for hepatocellular carcinoma. International Journal of Clinical Oncology, 2017 Sep 4. Doi: 10.1007/s10147-017-1190-2. [Epub ahead of print]. Abstract retrieved September 28, 2017 from PubMed database.

Kalogeridi, M., Zygogianni, A., Kyrgias, G., Kouvaris, J., Chatziioannou, S., Kelekis, N., & Kouloulias, V. (2015). Role of radiotherapy in the management of hepatocellular carcinoma: a systematic review. World Journal of Hepatology, 7 (1), 101-112. (Level 1 evidence)

Kawashima, M., Kohno, R., Nakachi, K., Nishio, T., Mitsunaga, S., et al. (2011). Dose-volume histogram analysis of the safety of proton beam therapy for unresectable hepatocellular carcinoma. International Journal of Radiation Oncology and Biological Physics, 79, 1479-1486. (Level 4 evidence)

Komatsu, S., Fukumoto, T., Demizu, Y., Miyawaki, D., Terashima, K., et al. (2011). Clinical results and risk factors of proton and carbon ion therapy for hepatocellular carcinoma. Cancer, 117, 4890-4904. (Level 4 evidence)

Leroy, R., Benahmed, N., Hulstaert, F., Van Damme, N., & De Ruysscher, D. (2016). Proton therapy in children: a systematic review of clinical effectiveness in 15 pediatric cancers. International Journal of Radiation Oncology and Biological Physics, 95 (1), 267-278. Abstract retrieved November 30, 2016 from PubMed database.

Matloob, S., Nasir, H., & Choi, D. (2016). Proton beam therapy in the management of skull base chordomas: systematic review of indications, outcomes, and implications for neurosurgeons. British Journal of Neurosurgery, 30 (4), 382-387. Abstract retrieved November 30, 2016 from PubMed database.

Nakayama, H., Sugahara, S., Tokita, M., Fukuda, K., Mizumoto, M., et al. (2009). Proton beam therapy for hepatocellular carcinoma: the University of Tsukuba experience. Cancer, 115, 5499-5506. (Level 4 evidence)

National Comprehensive Cancer Network. (2017, February). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 2.2017. Prostate cancer. Retrieved March 24, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, August). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 3.2017. Hepatobiliary cancers. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, February). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 2.2017. Soft tissue sarcoma. Retrieved March 24, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, August). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 1.2018. Bone cancer. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, August). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 1.2017. Central nervous system cancers. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, July). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 8.2017. Non-small cell lung cancer. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, July). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 2.2017. Malignant pleural mesothelioma. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, May). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 2.2017. Head and neck cancers. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 1.2017. Thymomas and thymic carcinomas. Retrieved March 24, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 3.2017. Esophageal and esophagogastric junction cancers. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2017, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 2.2017. Breast cancer. Retrieved September 27, 2017 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2016, December). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Version 2.2017. Testicular cancer. Retrieved March 24, 2017 from the National Comprehensive Cancer Network.

Patel, S., Wang, Z., Wong, W., Murad, M., Buckey, C., Mohammed, K., et al. (2014). Charged particle therapy versus photon therapy for paranasal sinus and nasal cavity malignant diseases: a systematic review and meta-analysis. Lancet Oncology, 15 (9), 1027-1038. Abstract retrieved March 27, 2017 from PubMed database.

Pennicooke, B., Laufer, I., Sahgal, A., Varga, P., Gokaslan, Z., Bilsky, M., & Yamada, Y. (2016). Safety and local control of radiation therapy for chordoma of the spine and sacrum: systematic review. Spine, 2016 Aug 8 [Epub ahead of print]. Abstract retrieved September 28, 2016 from PubMed database.

Qi, W., Fu, S., Zhang, Q., & Guo, X. (2015). Charged particle therapy versus photon therapy for patients with hepatocellular carcinoma: a systematic review and meta-analysis. Radiotherapy and Oncology, 114 (3), 289-295. Abstract retrieved March 27, 2017 from PubMed database.

Verma, V., Lin, S., Simone, C., & Mehta, M. (2016). Clinical outcomes and toxicities of proton radiotherapy for gastrointestinal neoplasms: a systematic review. Journal of Gastrointestinal Oncology, 7 (4), 644-664. (Level 2 evidence)

Verma, V., Simone, C., Wahl, A., Beriwal, S., & Mehta, M. (2016). Proton radiotherapy for gynecologic neoplasms. Acta Oncologica, 55 (11), 1257-1265. Abstract retrieved December 7, 2016 from PubMed database.

Verma, V., Shah, C., & Mehta, M. (2016). Clinical outcomes and toxicity of proton radiotherapy for breast cancer. Clinical Breast Cancer, 16 (3), 145-154. Abstract retrieved November 30, 2016 from PubMed database.

Verma, V., & Mehta, M. (2016). Clinical outcomes of proton radiotherapy for uveal melanoma. Clinical Oncology (Royal College of Radiologists), 28 (8), e17-e27. Abstract retrieved November 30, 2016 from PubMed database.

Verma, V., Rwigema, J., Malyapa, R., Regine, W., & Simone, C. (2017), Systematic assessment of clinical outcomes and toxicities of proton radiotherapy for reirradiation. Radiotherapy and Oncology, 2017 Sep 20. Doi: 10.1016/j.radonc.2017.08.005. [Epub ahead of print]. Abstract retrieved September 28, 2017 from PubMed database.

Wang, X., Shi, Q., Williams, L., Komaki, R., Gomez, D., Lin, S., et al. (2016).  Prospective study of patient-reported symptom burden in patients with non-small cell lung cancer undergoing proton or photon chemoradiation therapy. Journal of Pain and Symptom Management, 51 (5), 832-838. Abstract retrieved November 30, 2016 from PubMed database.

Wang, K., Eblan, M., Deal, A., Lipner, M., Zagar, T., Wang, Y., et al. (2017). Cardiac toxicity after radiotherapy for stage III non-small-cell lung cancer: pooled analysis of dose-escalation trials delivering 70 to 90 Gy. Journal of Clinical Oncology, 35. (Level 4 evidence)

Winifred S. Hayes, Inc. Medical Technology Directory. (2016, June; last update search May 2017). Proton beam therapy for prostate cancer. Retrieved September 29, 2016 from www.Hayesinc.com/subscribers. (61 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, January). Proton beam therapy for non-small cell lung cancer. Retrieved March 24, 2017 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)

Xi, M. & Lin, S. (2017). Recent advances in intensity modulated radiotherapy and proton therapy for esophageal cancer. Expert Review of Anticancer Therapy, 17 (7), 635-646. Abstract retrieved September 28, 2017 from PubMed database.

ORIGINAL EFFECTIVE DATE:  11/19/2014

MOST RECENT REVIEW DATE:  10/26/2017

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