Medical Policy: 08.01.05
Original Effective Date: April 2001
Reviewed: October 2014
Revised: May 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Proton beam therapy (PBT) is a type of radiotherapy using protons rather than photons used in traditional external beam radiation therapy. PBT is used to treat solid tumors and is intended to minimize total radiation dose and side effects, including potential damage to surrounding healthy tissues. PBT can be used in conjunction with standard treatment strategies like surgery, chemotherapy and even conventional photon beam radiotherapy. Proton beam therapy (PBT), is also known as intensity-modulated proton therapy, pencil beam scanning, proton therapy, proton beam radiotherapy, and spot scanning.
A proton beam can be delivered by two methods, passive or active spreading.
- Passive Spreading: uses patient specific beam modifying devices (e.g., compensators, collimators) to scatter the proton beam before it enters the body. Compensators and collimators must be made for each patient to optimize scattering for specific tumor shapes and could require repositioning throughout treatment. When the proton beam passes through a beam modifying device, radioactive neutrons are released, possibly increasing the radioactive dose to patients or staff, and the beam modifying device becomes radioactive. Radioactive compensators and collimators must be stored for a few months after use while the radioactivity decays.
- Active Spreading: also known as spot scanning or pencil beam scanning, offers an alternative to passive spreading and reportedly provides more targeted treatment by sequentially focusing on smaller fields with narrower beams. Active spreading PBT might diffuse more rapidly than passive spreading PBT because active spreading potentially reduces scan time, minimizes radioactive exposure outside the target, and penetrates to deeper tumors.
Beam intensity or scan speed can be varied throughout the course of treatment to deliver different radiation doses to different parts of the target instead of using beam modifying devices.
It is not known whether the higher precision of proton beam therapy actually translates to better clinical outcomes than other types of radiation treatment of many common cancers. There is limited clinical evidence that directly compares proton beam therapy with other types of radiation therapy. Comparative effectiveness studies including randomized controlled trials are needed to document the theoretical incremental advantages of proton beam therapy over other radiotherapies (e.g., IMRT, conventional radiotherapy or stereotactic photon radiosurgery). Additional trials are underway to determine the role of proton therapy in other cancers and for other indications.
Prostate cancer is typically detected based on digital rectal examination and screening with serum prostate specific antigen (PSA). Prostate cancer is diagnosed by biopsy and evaluated (staged) to determine the extent of disease (local, regional or distant metastatic). The most appropriate treatment options may include active surveillance, radical prostatectomy or radiation therapy using x-ray (photon) external beam radiotherapy and brachytherapy.
Proton beam therapy has been proposed for the treatment of prostate cancer. The goal of proton beam therapy is to achieve higher doses to small targets, with possibly greater benefit, and create similar to lower risk of adverse events compared with other treatments. In spite of the theory that protons cause less damage to normal tissue, there is at present no convincing evidence that urinary (bladder problems), gastrointestinal (rectal leakage or bleeding), or sexual (erectile dysfunction), complication rates are lower following proton therapy. A few studies suggest that rates of some side effects might even be higher.
Based on review of medical literature clinical utility has not been determined, this is done best by clinical trials. There are no randomized trials completed that directly compare 3D-CRT or IMRT with proton beam therapy (PBT), and rely mainly on single arm studies. Comparative clinical trials are warranted to determine the effectiveness on health outcomes. There is no evidence that this approach offers any advantages over other radiotherapy modalities when measured by survival, tumor control or toxicity. Therefore, the use of proton beam therapy (PBT) for the treatment of prostate cancer is considered investigational.
Practice Guidelines and Position Statements
American College of Radiology
2014 ACR Appropriateness Criteria Definitive External Beam Irradiation in Stage T1 and T2 Prostate Cancer states:
- “There are only limited data comparing proton-beam therapy to other methods of irradiation or to radical prostatectomy for treating stage T1 and T2 prostate cancer. Further studies are needed to clearly define its role for such treatment.
- There are growing data to suggest that hypofractionation at dose per fraction < 3.0 Gy per fraction is reasonably safe and efficacious, and although the early results from hypofractionation/SBRT studies at dose per fraction > 4.0 Gy seem promising, these approaches should continue to be used with caution until more mature, ongoing Phase II and III randomized controlled studies have been completed.”
American Society for Radiation Oncology (ASTRO)
The Emerging Technolgogy Committee of American Society of Radiation Oncology (ASTRO) published 2012 evidence-based recommendations declaring a lack of evidence for proton beam therapy for malignancies outside of large ocular melanomas and chordomas:
“Current data do not provide sufficient evidence to recommend proton beam therapy (PBT) outside of clinical trials in lung cancer, head and neck cancer, GI (gastrointestinal) malignancies. In hepatocellular carcinoma and prostate cancer, there is evidence for the efficacy of PBT but no suggestion that it is superior to photon based approaches. In pediatric CNS malignancies, there is a suggestion from the literature that PBT is superior to photon approaches, but there is currently insufficient data to support a firm recommendation for PBT. In the setting of craniospinal irradiation for pediatric patients, protons appear to offer a dosimetric benefit over photons, but more clinical data are needed. In large ocular melanomas and chordomas, we believe that there is evidence for a benefit of PBT over photon approaches. In all fields, however, further clinical trials are needed and should be encouraged. “
In September 2013, as part of its national “Choosing Wisely” initiative, ASTRO listed PBT for prostate cancer as one of 5 radiation oncology practices that should not be routinely used because they are not supported by evidence.
In 2014, ASTRO published a model policy on use of PBT. The document state that ASTRO supports proton beam therapy for the following conditions:
- Ocular tumors, including intraocular melanomas
- Tumors that approach or are located at the base of the skull, including but not limited to:
- Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated
- Primary hepatocellular cancer treated in a hypofractionated regimen
- Primary or benign solid tumors in children treated with curative intent and occasional palliative treatment of childhood tumors when at least one of four criteria are met.
- Patients with genetic syndromes making total volume of radiation minimization crucial such as but not limited to NF-1 patients and retinoblastoma patients.
The model policy stated the following regarding PBT for treating prostate cancer: “In the treatment of prostate cancer, the use of PBT is evolving as the comparative efficacy evidence is still being developed. In order for an informed consensus on the role of PBT for prostate cancer to be reached, it is essential to collect further data, especially to understand how the effectiveness or proton therapy compares to other radiation therapy modalities such as IMRT and brachytherapy. There is a need for more well-designed registries and studies with sizable comparator cohorts to help accelerate data collection. Proton beam therapy for primary treatment of prostate cancer should only be performed in the context of a prospective clinical trial or registry.”
National Comprehensive Cancer Network (NCCN)
National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer version 1.2015 refer to ASTRO’s current position which states that “proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial.” The costs associated with proton beam facility construction and proton beam treatment are high compared with the expense of building and using the more common photon linear accelerator based practice. The NCC panel believes there is no clear evidence supporting a benefit or decrement to proton therapy over IMRT for either treatment efficacy or long term toxicity.
Prior approval is required.
Proton beam radiation therapy is considered investigational for the following indications including but not limited to:
- Age related macular degeneration (AMD)
- Bladder cancer
- Gastrointestinal cancers, including esophageal and pancreatic
- Gynecological cancers
- Hepatocellular carcinoma
- Lung cancer
- Non-Hodgkin’s and Hodgkin lymphomas
- Soft tissue sarcomas
- Colon and rectal cancer
- Anal cancer
- Breast cancer
- Thymomas and Thymic carcinomas
- Prostate cancer
It is not known whether the higher precision of proton beam therapy actually translates to better clinical outcomes than other types of radiation treatment of many common cancers or for other indications. There is limited clinical evidence that directly compares proton beam therapy with other types of radiation therapy. Comparative effectiveness studies including randomized controlled trials are needed to document the theoretical incremental advantages of proton beam therapy over other radiotherapies (e.g., IMRT, conventional radiotherapy or stereotactic photon radiosurgery). Current published evidence also does not allow for any definitive conclusions about the safety and efficacy of proton beam therapy for the indications listed above and therefore, proton beam radiation therapy is considered investigational.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 77520 Proton treatment delivery; simple, without compensation
- 77522 Proton treatment delivery; simple, with compensation
- 77523 Proton treatment delivery; intermediate
- 77525 Proton treatment delivery; complex
- Nilsson S, Norlen BJ, Widmark A. A systematic overview of radiation therapy effects in prostate cancer. Acta Oncol. 2004;43(4):316-81.
- Yeboah C Sandison GA. Optimized treatment for prostate cancer comparing IMPT, VHEET and 15 MV IMXT. Phys Med Biol. 2002;47(13):2247-61
- Gardner BG, 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 Jan;167(1)123-6
- Thurman SA et al. Radiation therapy for the treatment of locally advanced and metastatic prostate cancer. Hematol Oncol Clin North Am. 2001 Jun;15(3): 423-43
- Rossi CJ, et al. Particle beam radiation therapy in prostate cancer: is there an advantage? Semin Radiat Oncol. 1998 Apr;8(2): 115-23.
- 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. JAMA 2005; 294(10):1233-9.
- ECRI Institute. Health Technology Information Service. Emerging Technology Report. (May 2007). Proton beam radiation therapy (overview). Retrieved December 18, 2007 from ECRI Institute.
- Trikalinos TA, Terasawa T, Ip S et al. Particle Beam Radiation Therapies for Cancer. Technical Brief No. 1. (Prepared by Tufts Medical Center Evidence-based Practice Center under Contract No. HHSA-290-07-10055.) Rockville, MD: Agency forHealthcare Research and Quality. September 2009.
- Brada M, Pijls-Johannesma M, De Ruysscher D. Proton Therapy in Clinical Practice: Current Clinical Evidence. J Clin Oncol. 2007 Mar 10; 25(8):965-70.
- Wilt TJ, MacDonald R, Rutks I et al. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008; 148:435-48.
- Wilt TJ, Shamliyan T, Taylor B et al. Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer. Comparative Effectiveness Review No. 13. (Prepared by Minnesota Evidence-based Practice Center under Contract No. 290-02-00009.) Rockville, MD: Agency for Healthcare Research and Quality; 2008.
- Schulz-Ertner D, Tsujii H. Particle radiation therapy using proton and heavier ion beams. J Clin Oncol 2007; 25:953-64.
- Goetein M, Cox JD. Should randomized clinical trials be required for proton radiotherapy? J Clin Oncol 2008; 26:175-6.
- 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 meta-analysis. Radiother Oncol. 95(1):32-40.
- Iwata H, Murakami M, Demizu Y et al. High-dose proton therapy and carbon-ion therapy for stage I non-small cell lung cancer. Cancer. 116(10):2476-85.
- Pijls-Johannesma M, Grutters JP et al. Do we have enough evidence to implement particle therapy as standard treatment in lung cancer? A systematic literature review. Oncologist. 1591):93-103.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Proton Beam Therapy for Non-small Cell Lung Cancer. TEC Assessments 2010; 25.
- TARGET [database online]. Plymouth Meeting (PA):ECRI Institute; 2010 Nov 1. Proton beam radiation therapy (overview).
- Kagan AR, Schulz RJ. Proton-beam therapy for prostate cancer. Cancer J 2010; 16(5):405-9.
- Zietman AL, Bae K, Slater JD et al. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/American College of Radiology 95-09. J Clin Oncol. Mar 1 2010; 28(7):1106-11. doi: 10.1200/JCO.2009.25.8475.
- Talcott JA, Rossi C, Shipley WU et al. Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA. Mar 17; 303(11):1046-53.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Proton Beam Therapy for Prostate Cancer. TEC Assessments 2010; Volume 25, Tab 10.
- Emerging Technology Evidence Report. Proton Beam Therapy (overview). Plymouth Meeting (PA): ECRI Institute; 2011 Oct.
- Coen JJ, Zietman AL, Rossi CJ et al. Comparison of high-dose proton radiotherapy and brachytherapy in localized prostate cancer: a case-matched analysis. Int J Radiat Oncol Biol Phys. 2012 Jan 1; 82(1):e25-31. Epub 2011 Apr 4.
- Coen JJ, Paly JJ, Niemierko A et al. Long-term quality of life outcome after proton beam monotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Jan 1; 82(1):213-21. Epub 2010 Nov 17.
- Kahn J, Loeffler JS, Niemierko A et al. Long-term outcomes of patients with spinal cord gliomas treated by modern conformal radiation techniques. Int J radiat Oncol Biol Phys. 2011; 81(1):232-38.
- 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. 2011; 37(3):185-201.
- ECRI Institute. Proton Beam Radiation Therapy (Overview). Plymouth Meeting (PA): ECRI Institute. August 2012. [Emerging Technology Evidence Report].
- Allen AM, Pawlicki T, Dong L, Fourkal E, et al. An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. Radiother Oncol 2012 Apr;103(1):8-11.
- National Comprehensive Cancer Network (NCCN). Soft Tissue Sarcoma Version 1.2013.
- National Comprehensive Cancer Network(NCCN). Bone Cancer Version 1.2014.
- National Comprehensive Cancer Network(NCCN). Prostate Cancer Version 1.2014. National Comprehensive Cancer Network (NCCN). Non Small Cell Lung Cancer Version 2.2014. Also available at: www.nccn.org
- National Comprehensive Cancer Network(NCCN). Central Nervous System Cancers Version 2.2013.
- UpToDate. Radiation Therapy Techniques in Cancer Treatment. Timur Mitin, M.D., PhD. Topic last updated: September 9, 2013.
- ASTRO. Practice Management-Proton Beam Therapy for Prostate Cancer Position Statement.
- ASTRO. News and Medical Releases 2013. Encouraging Outcomes for Pediatric Brain Tumor Patients Treated with Proton Therapy. September 22, 2013.
- American Brain Tumor Association. Pituitary Tumors.
- ECRI Institute. Emerging Technology Evidence Report. Proton Beam Radiation Therapy (Overview). January 2013.
- American Brain Tumor Association: Proton Therapy.
- UpToDate. Local Treatment for Primary Soft Tissue Sarcoma of the Extremities and Chest Wall. Thomas F. DeLaney, M.D., David C. Harmon, M.D., Mark C. Gebhardt, M.D.. Topic last updated: October 2, 2013.
- National Cancer Institute. Childhood Craniopharyngioma Treatment. Last modified August 2013.
- National Cancer Institute. Intraocular (Uveal) Melanoma Treatment. Last modified November 2012.
- Agency for Healthcare Research and Quality (AHRQ). Proton Beam Radiation Therapy. March 2013.
- ECRI Institute. Hotline Response. Proton Beam Radiation Therapy for Cancers of the Brain, Head, Neck and Skull Base. May 2013.
- UpToDate. Brain Arteriovenous Malformation. Robert J. Singer, M.D., Christopher S. Ogilvy, M.D., Guy Rordorf, M.D. Topic last updated: May 3, 2012.
- UpToDate. Chordoma and Chondrosarcoma of the Skull Base. Carol Snyderman, M.D., MBA, Derrick Lin, M.D. Topic last updated July 30, 2013.
- UpToDate. Uveal and Conjunctival Melanoma. Evangelos S. Gragoudas, M.D., Anne Marie Lane, MPH, Helen A. Shih, M.D., Richard D. Carvajal, M.D.. Topic last updated October 29, 2013.
- UpToDate. External Beam Radiation Therapy for Localized Prostate Cancer. Steven J. DiBiase, M.D., Mack Roach, III, M.D.. Topic last updated October 9, 2013.
- American Cancer Society. Radiation Therapy for Pituitary Tumors. Last reviewed January 2013.
- ASTRO Model Policies – Proton Beam Therapy (PBT) June 2014. Also available at www.astro.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Soft Tissue Sarcoma. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Prostate cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 4.2014 Non-Small Cell Lung Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 1.2015 Bone Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 1.2015 Anal Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Bladder Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2015 Colon Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 1.2015 Rectal Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 1.2014 Esophageal and Esophoagogastric Junction Cancers. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Hepatobillary Cancers. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Hodgkin Lymphoma. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Non-Hodgkin’s Lymphoma. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 3.2014 Ovarian Cancer. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 2.2014 Pancreatic Adenocarcinoma. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Version 1.2015 Uterine Neoplasms. Also available at www.nccn.org
- ECRI. Health Technology Forecast. Proton Beam Therapy for Treating Cancer, July 2014. Also available at www.ecri.org
- F. Daniel Armstrong, University of Miami Miller School of Medicine; and Holtz Children’s Hospital, Univerity of Miami/Jackson Memorial Medical Center, Miami, FL. Proton Beam Radiation Therapy and Health Related Quality of Life in Children with CNS Tumors. Journal of Clinical Oncology, Volume 30, Number 17, June 10, 2010.
- National Comprehensive Cancer Network (NCCN). Non-Hodgkin’s Lymphomas Version 1.2015. Also available at www.nccn.org
- National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 1.2015, Also available at www.nccn.org
- American College of Radiology (ACR) Appropriateness Definitive External Beam Irradiation in Stage T1 and T2 Prostate Cancer, Am J Clin Oncol 2014;37:278-288
- American Society for Radiation Oncology (ASTRO) Model Policies: Proton Beam Therapy (PBT) 2014. Also available at http://www.astro.org
- American Society for Radiation Oncology (ASTRO) Recommends Five Radiation Oncology Treatments to Question as Part of Choosing Wisely Campaign, September 2013. Also available at http://gicasym.org/astro-recommends-five-radiation-oncology-treatments
- National Cancer Institute. Health Professional PDQ Prostate Cancer Treatment. Also available at www.cancer.gov
Date Reason Action
January 2011 Annual review Policy revised
January 2012 Annual review Policy renewed
January 2013 Annual review Policy renewed
January 2014 Annual review Policy revised
October 2014 Annual review Policy renewed
January 2015 Policy revised
May 2015 Interim review Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.