Charged-Particle (Proton or Helium Ion) Radiation Therapy
© Blue Cross and Blue Shield of Montana
Current Effective Date:
December 27, 2013
Original Effective Date:
March 01, 2010
September 27, 2013
March 7, 2012; January 30, 2013; September 5, 2013
Charged-particle beams consisting of protons or helium ions are a type of particulate radiation therapy. They contrast with conventional electromagnetic (i.e., photon) radiation therapy due to several unique properties, including minimal scatter as particulate beams pass through tissue, and deposition of ionizing energy at precise depths (i.e., the Bragg peak). Thus, radiation exposure of surrounding normal tissues is minimized. The theoretical advantages of proton beam therapy (PBT) are that it may improve outcomes and decrease toxicitywhen the following conditions apply:
- Conventional treatment modalities do not provide adequate local tumor control;
- Evidence shows that local tumor response depends on the dose of radiation delivered; and
- Delivery of adequate radiation doses to the tumor is limited by the proximity of vital radiosensitive tissues or structures.
Participating Providers are required to Prior authorize radiation oncology/therapy for Blue Cross Blue Shield of Montana (BCBSMT) Members eligible for the CareCore Program. To authorize, Utilize CareCore National’s website: http://www.carecorenational.com/ or call 1-866-668-7446, option1. Services that are not prior authorized will be denied. For benefit questions call (BCBSMT) Customer Service at 1-800-447-7828.
For Non-Eligible Members, Out of State Providers, and Non-participating providers Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review is performed if services are not prior authorized.
BCBSMT may consider charged-particle irradiation with proton or helium ion beams medically necessary in the following clinical situations:
- Uveal melanoma when PBT is considered preferential compared to brachytherapy
- Chordomas and Chondrosarcomas of the base of the skull, localized and in the postoperative setting
- Localized unresectable hepatocellular carcinoma when considered preferential to stereotactic body radiation therapy (SBRT) or radiofrequency ablation
- Pediatric CNS and spinal tumors.
National Cancer Institute Clinical Trials
Two phase III trials are comparing photon versus carbon ion radiation therapy in patients with low and intermediate grade chondrosarcoma of the skull base (NCT01182753) and chordoma of the skull base (CT01182779).
A phase III trial is comparing hypofractionated proton radiation versus standard dose for prostate cancer (NCT01230866).
- Studies on the use of charged-particle beam radiation therapy to treat uveal melanomas have shown local control and survival rates considered equivalent to enucleation. Therefore, it is considered medically necessary for this indication.
- Available evidence suggests that charged-particle beam irradiation is at least as effective as, and may be superior to, alternative therapies, including conventional radiation or resection to treat chordomas or chondrosarcoma of the skull base or cervical spine. Therefore, it is considered medically necessary for this indication.
- Results of proton beam studies for clinically localized prostate cancer have shown similar results and outcomes when compared to other radiation treatment modalities. Currently, the evidence does not support any definitive benefit to PBT in the treatment of prostate cancer. Therefore it is considered experimental, investigational, and unproven for treatment of prostate cancer.
- In treating lung cancer, definite evidence showing superior outcomes with proton beam radiation therapy versus stereotactic body radiation therapy (an accepted approach for treating lung cancer with radiation), is lacking. Therefore, this indication is considered investigational. There is insufficient evidence proving efficacy and safety using PBT for locally advanced lung cancer, and therefore PBT is considered investigational for this indication.
Practice Guidelines and Position Statements
2013 March ASTRO Board of Directors
ASTRO does not support the routine use of PBT for prostate cancer. “While proton beam therapy is not a new technology, its use in the treatment of prostate cancer is evolving.“ is the statementreleased by ASTRO’s Board of Directors on March 13, 2013. “The comparative efficacy evidence of proton beam therapy is still being developed,” said Michael L. Steinberg, MD, FASTRO, ASTRO Chairman. “We look forward to new and innovative research that will more clearly define the role of proton beam therapy for localized prostate cancer among the currently available treatment options.
2011 National Comprehensive Cancer Network (NCCN) guidelines
NCCN guidelines for prostate cancer (v 4.2011) state that proton therapy is not recommended for routine use at this time since clinical trials have not yet yielded data that demonstrates superiority to, or equivalence of, proton beam and conventional external beam for the treatment of prostate cancer.
NCCN guidelines for non-small cell lung cancer (v 3.2011) state that under strictly defined protocols, proton therapy may be allowed.
NCCN guidelines for bone cancer (v 2.2011) state that proton beam radiation therapy has been associated with excellent local tumor control and long-term survival in patients with low-grade base of skull chondrosarcomas.
Medicare National Coverage
There is no national coverage determination.
This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.
The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.
When using this policy to determine whether a service, supply, drug or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
92.26, 170.0, 170.2, 170.9, 190.0 – 190.9, 192.2, 198.5
C41.0, C41.2, C41.9, C49.0, C69.00-C69.92, C72.0, D8004ZZ, D0014ZZ, D0064ZZ
77399, 77299, 77520, 77522, 77523, 77525, 77499
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- Damato B, Kacperek A, Chopra M et al. Proton beam radiotherapy of choroidal melanoma: the Liverpool-Clatterbridge experience. Int J Radiat Oncol Biol Phys 2005; 62(5):1405-11.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Charged particle (proton or helium ion) irradiation for uveal melanoma and for chordoma or chondrosarcoma of the skull base or cervical spine. TEC Assessments 1996; Volume 11, Tab 1.
- Shipley WU, Verhey LJ, Munzenrider JE. Advanced prostate cancer: the results of a randomized comparative trail of high dose irradiation boosting with conformal photons compared with conventional dose irradiation using protons alone. Int J Radiat Oncol Biol Phys 1995; 32(1):3-12.
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- Michalski JM, Winter K, Purdy JA et al. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys 2004; 58(3):735-42.
- 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):1233-9.
- Desjardins L, Lumbroso-Le Rouic L, Levy-Gabriel C et al. Combined proton beam radiotherapy and transpupillary thermotherapy for large uveal melanomas: a randomized study of 151 patients. Ophthalmic Res 2006; 38(5):255-60.
- Wilt TJ, Shamliyan T, Taylor B et al. Comparative effectiveness of therapies for clinically localized prostate cancer. Comparative Effectiveness Review No. 13. Agency for Healthcare Research and Quality. February 2008. Available online at: http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=9&DocID=79 . Last accessed February 2008.
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- Terasawa T, Dvorak T, Ip S et al. Systematic review: charged-particle radiation therapy for cancer. Ann Intern Med 2009; 151(8):556-65.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Proton beam therapy for non-small-cell lung cancer. TEC Assessments 2010; Volume 25, Tab 7.
- 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 2010; 95(1):32-40.
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- Efstathiou JA, Trofimov AV, Zietman AL. Life, liberty, and the pursuit of protons: an evidence-based review of the role of particle therapy in the treatment of prostate cancer. Cancer J 2009; 15(4):312-8.
- Pijls-Johannesma M, Grutters J, 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):93-103.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Proton beam therapy for prostate cancer. TEC Assessments 2010; Volume 25, Tab 10.
- ZacharatouJarlskog C, Paganetti H. Risk of developing second cancer from neutron dose in proton therapy as function of field characteristics, organ, and patient age. Int J RadiatOncolBiol Phys. 2008 Sep 1;72(1):228-35.
- Athar BS, Paganetti H. Neutron equivalent doses and associated lifetime cancer incidence risks for head & neck and spinal proton therapy. Phys Med Biol. 2009 Aug 21;54(16):4907-26.
- Moteabbed M, Geyer A, et al. Comparison of whole-body phantom designs to estimate organ equivalent neutron doses for secondary cancer risk assessment in proton therapy. Phys Med Biol. 2012 Jan 21;57(2):499-515.
- Brenner DJ, Hall EJ. Secondary neutrons in clinical proton radiotherapy: a charged issue. RadiotherOncol. 2008 Feb;86(2):165-70.
- Shih HA, Arvold ND Arvold, Niemierko A, et al. Second Tumor Risk and Projected Late Effects after Proton vs. Intensity Modulated Photon Radiotherapy for Benign Meningioma: A Dosimetric Comparison. International Journal of Radiation Oncology * Biology * Physics Vol. 78, Issue 3, Supplement, Page S272.
- Berrington de Gonzalez,A, et al. Second Solid Cancers After Radiation Therapy: A Systematic Review of the Epidemiologic Studies of the Radiation Dose-Response Relationship. International Journal of Radiation Oncology * Biology * Physics Volume 86, Issue 2 , Pages 224-233, 1 June 2013 http://www.redjournal.org/article/S0360-3016(12)03512-2/fulltext.
- Chung CS, Yock TI, et al. Incidence of Second Malignancies Among Patients Treated With Proton Versus Photon Radiation. Int J RadiatOncolBiol Phys. 2013 Sept 1 : 87(1) : 46-52.
- Bekelman JE et al. Subsequent Malignancies After Photon versus Proton Radiation Therapy. Int J RadiatOncolBiol Phys. 2013 Sept 1: 87(1):10-12
- Zelefsky MJ, Pei X, et al. Secondary cancers after intensity-modulated radiotherapy, brachytherapy and radical prostatectomy for the treatment of prostate cancer: incidence and cause-specific survival outcomes according to the initial treatment intervention. BJU Int. 2012 Dec;110(11):1696-701. http://www.ncbi.nlm.nih.gov/pubmed/22889401.
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||Policy updated with literature search, reference numbers 16-27 added, use for NSCLC added as a specific indication to the investigational statement, other policy statements unchanged |
||Removed treatment of localized prostate cancer from the Medically Necessary statement. |
||Simplified wording of medical necessity criteria. Move prostate cancer to be included in the investigational policy statement. Added combination proton and photon therapy to investigational statement. Updated practice guideline statement with ASCO information.|