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Medical Policy: 08.01.05
Original Effective Date: April 2001
Reviewed: January 2012
Revised: January 2011
Benefit Application
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.
Description:
Proton beam therapy is a form of external beam radiation that may be used alone or in combination with traditional photon radiation therapy, surgery, and chemotherapy to treat certain cancers and some noncancerous conditions. Theoretical advantages of protons over photons relate to the way proton energy is delivered. The path of a proton beam is linear allowing the point of energy release to be precisely determined. This reduces collateral tissue damage in that tissue along the beam’s pathway to the target receive only a small radiation dose, while tissues around and behind the target receive even less radiation. In theory, avoidance of collateral tissue damage should result in a decrease of harmful acute side effects of radiation, especially when a tumor is located in or near critical structures.
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Prior Approval:
Not applicable
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Policy:
Proton beam therapy may be considered medically necessary for the following conditions:
- 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 24mm in largest diameter and 14mm in height.
- Post operative therapy (with or without conventional high energy x-ray) in patients who have under gone biopsy or partial resection of the chordoma or low grade (I or II) chondrosarcoma of the basisphenoid region (skull-base chordoma or chondrosarcoma) or cervical spine. Patients eligible for this treatment have residual localized tumor without evidence of metastasis.
Proton beam therapy as a treatment for prostate cancer is considered not medically necessary.
A 2010 technology assessment by the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) addressed the use of proton beam therapy for prostate cancer and concluded that it has not yet been established whether proton beam therapy improves health outcomes in any setting for prostate cancer. A total of 9 studies were included in the review; 4 were comparative and 5 were noncomparative. The following is a summary of the key findings and conclusions:
- There is inadequate evidence from comparative studies to permit conclusions concerning the impact of proton beam therapy compared with other treatments for prostate cancer.
- Of two randomized, controlled trials that have been published, a good quality trial showed significantly improved incidence of biochemical failure, an intermediate outcome, for patients receiving high-dose proton beam boost compared with conventional-dose proton boost. No difference between groups has been observed in overall survival.
- Grade 2 acute gastrointestinal toxicity was significantly more frequent in the group receiving high-dose proton beam boost but acute genitourinary toxicity and late toxicities did not significantly differ.
- A single study with intermediate outcome data of uncertain relation to survival is insufficient to permit conclusions about the comparative effects of x-ray external-beam radiotherapy plus either a conventional-dose proton beam boost or a high-dose proton beam boost.
- The other randomized trial, also rated good in quality, found no significant differences between patients receiving x-ray versus proton beam boost on overall survival or disease-specific survival, but rectal bleeding was significantly more frequent among patients who had a proton beam boost. This trial used x-ray external-beam radiotherapy methods that are no longer relevant to clinical practice, precluding conclusions about the comparative effects of x-ray external-beam radiotherapy plus either an x-ray boost or a proton beam boost.
- The only other comparative study was not randomized, used inadequate statistical methods, and compared quality of life and symptom scale outcomes for x-ray external-beam radiotherapy plus a proton beam boost, watchful waiting, radical prostatectomy, proton beam therapy alone, and x-ray external-beam radiotherapy alone. This study was too small and did not appear to use adequate confounder adjustment procedures, so the observed differences may be distorted by imbalances on important outcome predictors.
- Regarding use of proton beam therapy without x-ray external-beam radiotherapy, evidence is insufficient. The flawed nonrandomized comparative study noted above included a group treated with proton beam therapy alone. Additional noncomparative evidence comes from a case series mixing patients receiving proton beam therapy alone or combined protons and x-rays; reports from 2 other centers provide insufficient evidence.
Proton beam therapy as a treatment for non-small cell lung cancer (NSCLC) is considered investigational.
A 2010 BCSBA TEC Assessment addressed the key question of how health outcomes (overall survival, disease-specific survival, local control, disease-free survival, and adverse events) for NSCLC treated with PBT compared with outcomes observed for stereotactic body radiotherapy (SBRT), which is an accepted radiation therapy approach to treat NSCLC.
- There were no studies, randomized or nonrandomized, directly comparing PBT and SBRT
- Eight PBT case series were identified that included a total of 340 patients. For these studies, 301 (88.5%) of all patients had stage I NSCLC, and 39 patients (11.5%) were in other stages or had recurrent disease.
- Reported adverse events after PBT generally fell into the following categories: rib fracture, cardiac, esophageal, pulmonary, skin, and soft tissue.
- The TEC Assessment concluded that the evidence was insufficient to permit conclusions about the results of PBT for any stage of NSCLC. In the absence of randomized controlled trials, the comparative effectiveness of PBT and SBRT is uncertain. Limitations of the current evidence included the following:
- Adverse events were generally poorly reported and were difficult to interpret due to lack of consistent reporting across studies, detail about observation periods and information about rating criteria and grades.
- There was no mention of use of an independent assessor of patient-reported adverse events.
- Details were lacking on several aspects of PBT treatment regimens.
- Subjects in the PBT studies were similar in age, but there was great variability in percent within stage IA NSCLC, sex ratio, and percent of medically inoperable cancers.
- There was a high degree of treatment heterogeneity among the PBT studies, particularly with respect to planning volume, total dose, number of fractions, and number of beams.
- Survival results were highly variable, ranging from 39% - 98% for reported probability of 2-year overall survival in 7 studies and 25% - 78% for 5-year overall survival in 5 studies. It is unclear whether the heterogeneity of results can be explained by differences in patient and treatment characteristics.
- Indirect comparisons between PBT and SBRT, comparing separate sets of single-arm studies on PBT and SBRT, may be distorted by confounding.
All other uses of proton beam therapy are considered investigational.
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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
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Selected References:
- 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. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
- 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). Available:http://www.ecri.org.
- 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. Available:http://www.ecri.org
- 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.
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Policy History:
Date Reason Action
January 2011 Annual review Policy revised
January 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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