Medical Policy Title: Stereotactic ARBenefits Approval: 07/25/2012 Radiosurgery Effective Date: 01/01/2012 Document: ARB0321 Revision Date: Code(s): 77371 Radiation treatment delivery, Stereotactic radiosurgery (SRS), complete course of treatment of cerebral lesions(s) consisting of 1 session; multi source cobalt based. 77372 Radiation treatment delivery, Stereotactic radiosurgery (SRS), complete course of treatment of cerebral lesions(s) consisting of 1 session; linear accelerator based. 77373 Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions. Public Statement: Administered by: 1) Stereotactic radiosurgery uses multiple beams of focused radiation to destroy deep tumors that cannot be treated by standard surgery. 2) Stereotactic radiosurgery is covered for patients who meet the specific criteria listed in this policy. Medical Policy Statement: 1. Cranial stereotactic radiosurgery with a gamma knife, Cyberknife, or linear accelerator (LINAC) is considered medically necessary for any of the following indications: A. For treatment of members with symptomatic, small (less than 3 cm) arterio-venous (AV) malformations, aneurysms, and benign tumors such as: acoustic neuromas (vestibular schwannomas), meningiomas, hemangiomas, pituitary adenomas, craniopharyngiomas, and neoplasms of the pineal gland when the lesion is considered unresectable due to its deep intracranial location or if the member is unable to tolerate conventional operative intervention HAYES B; or B. For the palliative treatment of initial or recurrent brain metastases in members with good performance status (Karnofsky 80 or higher) * who Page 1 of 6
have fewer than four MRI-confirmed metastases. The lesions must each be less than 3 cm in greatest dimension and either: A. the member has no demonstrable extracranial tumor or stable extracranial tumor activity at the time of treatment, or B. the member has localized primary disease for which a definitive approach to the primary site is planned, e.g., lobectomy; or C. For treatment of primary brain malignancies either initial or recurrent that are less than 5 cm in diameter and the member is otherwise in relatively good health (Karnofsky status 80 or higher) * ; or D. For treatment of non-operable primary central nervous system (CNS) tumors invading the spine. or E. Localized malignant conditions within the body where highly precise application of high-dose radiotherapy is required. 2. Fractionated cranial stereotactic radiotherapy is considered medically necessary for treatment of intracranial tumors in hard-to-reach locations, tumors with very unusual shapes, or for tumors located in such close proximity to a vital structure (e.g., optic nerve or hypothalamus) that even a very accurate high-dose single fraction of stereotactic radiosurgery could not be tolerated. 3. Stereotactic Proton beam radiotherapy. See proton beam radiotherapy (ARB0302). 4. * The Karnofsky performance status scale is widely used to evaluate the functional status of cancer patients to determine their eligibility for clinical trials and their prognosis. 80 = normal activity with effort, some signs or symptoms of disease 90 = Able to carry on normal activity; minor signs or symptoms of disease 100 = Normal; no complaints; no evidence of disease. 5. Stereotactic body radiation is eligible for coverage for members with the following: A. Stage 1 non-small cell lung cancer (not larger than 5 cm) showing no nodal or distant disease and who are not candidates for surgical resection; B. Primary or metastatic malignant lesions of the spine or paraspinal regions. 6. Stereotactic radiosurgery with a gamma knife or Cyberknife is considered medically necessary for trigeminal neuralgia when: A. Condition has been present for greater than 6 months; and B. Treatment with medication such as Baclofen or Tegretol has failed. Limits: 1. Stereotactic radiosurgery is considered experimental and investigational for treatment of Parkinson's disease and epilepsy (except when associated with treatment of AV malformations or brain tumors) HAYES C. 2. Stereotactic radiosurgery for the treatment of cluster headaches is considered experimental and investigational. 3. Stereotactic body radiosurgery: Stereotactic administration of radiosurgery to extracranial sites (e.g., liver, lung, kidney, and prostate), other than inoperable Page 2 of 6
primary CNS tumors of the spine, is considered as experimental and investigational. Background: With any external beam radiation therapy, the highest dose of radiation develops where multiple beams intersect. Thus, the fewer beams there are, the greater the dose reaching other areas traversed by the beams. For example, if only two beams are used, the highest dose would develop at the site where the beams intersect, but a significant portion of the dose would be distributed to fields anterior and posterior to the intersection. Stereotactic radiosurgery (SRS) uses the above principle to deliver a highly focused ionizing beam so that the desired target is obliterated, leaving adjacent structures nearly unaffected. Guidance is provided by a variety of imaging techniques, including angiography, computerized tomography (CT), and magnetic resonance imaging (MRI). The key to SRS is immobilization of the patient so that targeting can be accurate and precise. SRS has been attempted in extracranial sites; however, it is considered experimental and investigational for extracranial indications because of unresolved difficulties in immobilizing the patient, since merely breathing can move a pulmonary or abdominal tumor by more than 1cm. A body frame has been designed to immobilize patients for such treatment, but there are few reports of its effectiveness. The radioactive particles used in SRS may come from various sources. The Gamma Knife uses Cobalt-60. Over 200 finely focused beams of gamma radiation simultaneously intersect at the precise location of the brain disorder. Proton beam radiosurgery derives its advantage from the so-called "Bragg peak", a term that describes the pattern of deposition of proton beam radiation. Protons decelerate as they travel though tissue, depositing disproportionately more radiation at greater depths. The protons deposit most of their energy at their depth of maximal penetration, resulting in a "peak" of radiation at that tissue depth. The depth of peak radiation can be precisely defined by the energy the cyclotron imparts to the proton beam. References: 1) Hayes, Medical Technology Directory; Stereotactic Radiosurgery for Trigeminal Neuralgia and Movement Disorders, Jul. 25, 2002 2) Hayes, Medical Technology Directory; Stereotactic Radiosurgery for Arteriovenous Malformations and Intracranial Tumors; Aug. 16, 2002. 3) Arkansas Blue Cross Blue Shield, Coverage Policy Manual; Stereotactic Radiosurgery (Gamma Knife Surgery, Linear Accelerator, Proton Beam) at: http://www.arkansasbluecross.com/members/report.aspx?policynumber=1997210 Page 3 of 6
4) Hailey D. Stereotactic radiosurgery: An update. Information Paper. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); July, 2002. 5) Medical Services Advisory Committee (MSAC). Gamma knife radiosurgery. Assessment Report. MSAC Application 1028. Canberra, Australia: MSAC; October 2000. 6) Hassen-Khodja R. Gamma knife and linear accelerator stereotactic radiosurgery. Montreal, QC: Agence d'evaluation des Technologies et des Modes d'intervention en Sante (AETMIS); 2002. 7) Swedish Council on Technology Assessment in Health Care (SBU). Stereotactic radiosurgery in treating arteriovenous malformations of the brain - early assessment briefs (Alert). Stockholm, Sweden: SBU; 2002. 8) Chang SD, Main W, Martin DP, et al. An analysis of the accuracy of the CyberKnife: A robotic frameless stereotactic radiosurgical system. Neurosurgery. 2003;52(1):140-146; discussion 146-147. 9) Stieber VW, Bourland JD, Tome WA, Mehta MP. Gentlemen (and ladies), choose your weapons: Gamma knife vs. linear accelerator radiosurgery. Technol Cancer Res Treat. 2003;2(2):79-86. 10) Gerosa M, Nicolato A, Foroni R. The role of gamma knife radiosurgery in the treatment of primary and metastatic brain tumors. Curr Opin Oncol. 2003;15(3):188-196. 11) Yamakami I, Uchino Y, Kobayashi E, Yamaura A. Conservative management, gamma-knife radiosurgery, and microsurgery for acoustic neurinomas: A systematic review of outcome and risk of three therapeutic options. Neurol Res. 2003;25(7):682-690. 12) National Institute for Clinical Excellence (NICE). Stereotactic radiosurgery for trigeminal neuralgia using the gamma knife. Interventional Procedure Guidance 11. London, UK: NICE; September 2003. Available at: http://guidance.nice.org.uk/ipg85 13) Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat. Gamma knife. Health Technology Scientific Literature Review. Toronto, ON: Ontario Ministry of Health and Long-Term Care; May 2002. Available at: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_gk nife_050102.pdf 14) Regis J, Rey M, Bartolomei F, et al. Gamma knife surgery in mesial temporal lobe epilepsy: A prospective multicenter study. Epilepsia. 2004;45(5):504-515. 15) Beitler JJ, Makara D, Silverman P, Lederman G. Definitive, high-dose-per-fraction, conformal, stereotactic external radiation for renal cell carcinoma. Am J Clin Oncol. 2004; 27(6):646-648. 16) Donnet A, Valade D, Regis J. Gamma knife treatment for refractory cluster headache: Prospective open trial. J Neurol Neurosurg Psychiatry. 2005; 76(2):218-21. 17) Nagata Y, Takayama K, Matsuo Y, et al. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005; 63(5):1427-1431. 18) McGarry RC, Papiez L, Williams M, et al. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: Phase I study. Int J Radiat Oncol Biol Phys. 2005; 63(4):1010-1015. Page 4 of 6
19) Hiraoka M, Nagata Y. Stereotactic body radiation therapy for early-stage non-smallcell lung cancer: The Japanese experience. Int J Clin Oncol. 2004;9(5):352-355. 20) Lee SW, Choi EK, Park HJ, et al. Stereotactic body frame based fractionated radiosurgery on consecutive days for primary or metastatic tumors in the lung. Lung Cancer. 2003; 40(3):309-315. 21) Timmerman R, Papiez L, McGarry R, et al. Extracranial stereotactic radioablation: Results of a Phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003; 124(5):1946-1955. 22) Whyte RI, Crownover R, Murphy MJ, et al. Stereotactic radiosurgery for lung tumors: Preliminary report of a phase I trial. Ann Thorac Surg. 2003; 75(4):1097-1101. 23) Hara R, Itami J, Kondo T, et al. Stereotactic signle high dose irradiation of lung tumors under respiratlry gating. Radiother Oncol. 2002; 63(2):159-163. 24) Uematsu M, Shioda A, Suda A, et al. Computed tomography-guided frameless stereotactic radiotherapy for Stage I non-small cell lung cancer: A 5-year experience. Int J Radiat Oncol Biol Phys. 2001; 51(3):666-670. 25) Schefter TE, Kavanagh BD, Timmerman RD, et al. A phase I trial of stereotactic body radiation therapy (SBRT) for liver metastases. Int J Radiat Oncol Biol Phys. 2005; 62(5):1371-1378. 26) Hoyer M, Roed H, Sengelov L, et al. Phase-II study on stereotactic radiotherapy of locally advanced pancreatic carcinoma. Radiother Oncol. 2005; 76(1):48-53. 27) Wersall PJ, Blomgren H, Lax I, et al. Extracranial stereotactic radiotherapy for primary and metastatic renal cell carcinoma. Radiother Oncol. 2005; 77(1):88-95. 28) McGarry RC, Papiez L, Williams M, et al. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: Phase I study. Int J Radiat Oncol Biol Phys. 2005; 63(4):1010-1015. 29) Hiraoka M, Nagata Y. Stereotactic body radiation therapy for early-stage non-smallcell lung cancer: The Japanese experience. Int J Clin Oncol. 2004; 9(5):352-355. 30) Lee SW, Choi EK, Park HJ, et al. Stereotactic body frame based fractionated radiosurgery on consecutive days for primary or metastatic tumors in the lung. Lung Cancer. 2003; 40(3):309-315. 31) Timmerman R, Papiez L, McGarry R, et al. Extracranial stereotactic radioablation: Results of a Phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003; 124(5):1946-1955. 32) Whyte RI, Crownover R, Murphy MJ, et al. Stereotactic radiosurgery for lung tumors: Preliminary report of a phase I trial. Ann Thorac Surg. 2003; 75(4):1097-1101. 33) Hara R, Itami J, Kondo T, et al. Stereotactic signle high dose irradiation of lung tumors under respiratlry gating. Radiother Oncol. 2002; 63(2):159-163. 34) Uematsu M, Shioda A, Suda A, et al. Computed tomography-guided frameless stereotactic radiotherapy for Stage I non-small cell lung cancer: A 5-year experience. Int J Radiat Oncol Biol Phys. 2001; 51(3):666-670. Page 5 of 6
Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 6 of 6