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
The use of proton/helium ion beam (charged particle) radiation therapy for the treatment of cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of proton/helium ion beam (charged particle) radiation therapy for the treatment of macular degeneration is considered investigational.
The use of proton/helium ion beam (charged particle) radiation therapy for the treatment of prostate cancer is considered investigational.
MEDICAL APPROPRIATENESS
The use of proton/helium ion beam (charged particle) radiation therapy is considered medically appropriate if any of the following criteria are met:
Primary therapy for melanoma of the uveal tract (i. e., iris, choroid, or ciliary body), with no evidence of metastasis or extrascleral extension and with tumors up to 24 mm in largest diameter and 14 mm in height; or
Postoperatively in individuals who have undergone either biopsy or partial resection of the chordoma or low-grade (I or II) chondrosarcoma of the basisphenoid region (skull base) or cervical spine, without metastasis and with localized tumor; and
When all of the following apply:
Conventional treatment modalities have failed to provide adequate tumor control; and
Likelihood of metastasis prior to radiotherapy is small to non-existent; and
Evidence exists that local tumor response depends on the exact dose of radiation delivered; and
Limitations exist for delivery of adequate radiation dose due to proximity of tumor to vital radiosensitive tissue or structures.
ADDITIONAL INFORMATION
Proton or helium ion beam (charged particle) radiation therapy is a specialized procedure only performed in six centers in the United States.
For the treatment of localized prostate cancer, proton beam therapy has not been shown to be superior to conventional radiation therapy at this time. Further randomized controlled studies are needed.
SOURCES
Archambeau, J. O., Maco, X. W., Yonemoto, L. T., Slater, J. D., Freidrichsen, E., Teichman, S., et al. (1998). What is the role of radiation in the treatment of subfoveal membranes; review of radiobiologic, pathologic, and other considerations to initiate a multimodality discussion. International Journal of Radiation Oncology, Biology and Physics, 40 (5), 1125-1136. Abstract retrieved July 1, 1999 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2006). Charged-particle (proton or helium ion) radiation therapy (8.01.10). Retrieved September 25, 2007 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2006). Stereotactic radiosurgery and stereotactic radiotherapy (6.01.10). Retrieved September 25, 2007 from BlueWeb.
Donati, G., Soubrane, D., Quaranta, M., Coscas, C., & Soubrane, G. (1999). Radiotherapy for isolated occult subfoveal neovascularisation in age related macular degeneration; a pilot study. The British Journal of Ophthalmology, 83 (6), 646-651. Abstract retrieved July 1, 1999 from PubMed database.
ECRI Institute. Health Technology Information Service. Emerging Technology Report. (2007, May). Proton beam radiation therapy (overview). Retrieved September 25, 2007 from ECRI Institute. (32 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (1998, November). Proton beam radiation therapy for prostate cancer. Retrieved January 23, 2003 from ECRI Institute. (55 articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2004, July). Proton beam therapy for ocular tumors, hemangiomas, and macular degeneration. Retrieved October 25, 2005 from www.Hayesinc.com/subscribers. (44 articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2004, May). Proton beam therapy. Retrieved October 25, 2005 from www.Hayesinc.com/subscribers. (48 articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2006, August). Simultaneous irradiation (ProstRcision®) for localized prostate cancer. Retrieved September 24, 2007 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2006, November). Neutron beam therapy for head and neck (excluding brain) cancer. Retrieved September 24, 2007 from www.hayesinc.com/subscribers. (57articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2006, November). Neutron beam therapy for lung cancer. Retrieved September 24, 2007 from www.Hayesinc.com/subscribers. (41 articles and/or guidelines reviewed)
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Hayes Medical Technology Directory. (2006, October). Neutron beam therapy for pelvic cancers. Retrieved September 24, 2007 from www.Hayesinc.com/subscribers. (46 articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2006, October). Proton beam therapy for prostate cancer. Retrieved September 24, 2007 from www.Hayesinc.com/subscribers. (56 articles and/or guidelines reviewed)
Hayes Medical Technology Directory. (2006, October). Proton beam therapy for thoracic and abdominal organs. Retrieved September 24, 2007 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)
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Mazal, A., Schwartz, L., Lacroix, F., Mammar, H., Delacroix, S., Ferrand, R., et al. (1998). A preliminary comparative treatment planning study for radiotherapy of age-related maculopathy. Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology, 47 (1), 91-98. Abstract retrieved July 1, 1999 from PubMed database.
McAllister, B., Archambeau, J. O., Nguyen, M. C., Slater, J. D., Loredo, L., Schulte, R., et al. (1997). Proton therapy for pediatric cranial tumors; preliminary report on treatment and disease-related morbidities. International Journal of Radiation Oncology, Biology and Physics, 39 (2), 455-460. Abstract retrieved June 17, 1999 from PubMed database.
Miralbell, R., Lomax, A., & Russo, M. (1997). Potential role of proton therapy in the treatment of pediatric medulloblastoma/primitive neuro-ectodermal tumors; spinal theca irradiation. International Journal of Radiation Oncology, Biology and Physics, 38 (4), 805-811. Abstract retrieved May 5, 1999 from PubMed database.
Moyers, M. F., Galindo, R. A., Yonemoto, L. T., Loredo, L. Friedrichsen, E. J., Kirby, J. A., et al. (1999). Treatment of macular degeneration with proton beams. Medical Physics, 26 (5), 777-782. Abstract retrieved July 1, 1999 from PubMed database.
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Rossi, C. J., Jr., Slater, J. D., Reyes-Molyneux, N., Yonemoto, L. T., Archambeau, J. O., Coutrakon, G., et al. (1998). Particle beam radiation therapy in prostate cancer; is there an advantage? Seminars in Radiation Oncology, 8 (2), 115-123. Abstract retrieved June 24, 1999 from PubMed database.
Shipley, W. U., Verhey, L. J., Munzenrider, J. E., Suit, H. D., Urie, M. M., McManus, P. L., et al. (1995). 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. International Journal of Radiation Oncology, Biology and Physics, 2 (1), 3-12. Abstract retrieved June 4, 1999 from PubMed database.
The Technology Evaluation Center [Computer software]. (1996, June). Charged particle (proton or helium ion) irradiation for uveal melanoma and for chordoma or chondrosarcoma of the skull base or cervical spine (Vol. 11, No. 1). Washington, DC: BlueCross BlueShield Association.
U. S. Food and Drug Administration. (2000, July). Center for Devices and Radiological Health. Final Decisions Rendered for July 2000. Retrieved January 31, 2003 from http://www.fda.gov/cdrh/510k/sumjul00.html.
Zietman, A. L., DeSilvio, M. L., Slater, J. D., Rossi, C, J. Jr., Miller, D. W., Adams, J. A., et al. (2005). Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. Journal of the American Medical Association, 294 (10), 1274-1276. Abstract retrieved September 25, 2007 from PubMed database.
ORIGINAL EFFECTIVE DATE: 3/1/2000
MOST RECENT REVIEW DATE: 11/8/2007
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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