Download Medical Policy Proton Beam Therapy

Medical Policy
Proton Beam Therapy
Effective Date: September 1, 2015
[Reviewed 2/16]
Subject: Proton Beam Therapy
Overview: Proton beam therapy is a type of radiation therapy that uses streams of protons to kill tumor cells.
The proton beam radiation kills tumor cells but does not damage the nearby tissues. Proton beam therapy is used
to treat cancers in the head and neck and in organs such as the brain, eye, lung, spine, and prostate.
Policy and Coverage Criteria:
NOTE: Prior Authorization is NOT required
Harvard Pilgrim considers proton beam therapy medically necessary for the following conditions:
• Medulloblastomas
• Skull-based tumors (Chordomas and Chondrosarcomas), with no evidence of metastasis
• Uveal Melanomas, with no evidence of metastasis
• Prostate cancer when the following criteria are met:
o Initial monotherapy; and
o Cancer is localized
• Malignancies in children (under the age of 21 years)
Exclusions: Harvard Pilgrim does not consider proton beam therapy medically necessary for conditions other
than those listed above.
Supporting Information:
1. Technology Assessment: Proton beam therapy (PBT) is a type of external radiation treatment in which
positively charged subatomic particles (protons) are precisely targeted to a specific tissue mass by using a
sophisticated stereotaxic planning and delivery system. In contrast to conventional photon irradiation, proton
beam radiation may deliver a higher dose to the target tissue while minimizing exposure to surrounding healthy
tissue.
2. Literature Review:
Medulloblastoma – Brodin et al. (2014) investigated how varying the treatment margin and applying hippocampal
sparing and PBT impact the risk of neurocognitive impairment in pediatric medulloblastoma patients compared
with standard 3D CRT. The largest risk reduction was seen when applying hippocampal sparing proton therapy.
The estimated risk of impaired task efficiency was 92%, 81%, and 50% for 3D conformal radiotherapy, intensitymodulated radiotherapy, and proton therapy, respectively, for the smallest boost margin and 98%, 90%, and
70% if boosting the whole posterior fossa. Jimenez et al (2013) reported outcomes in children under the age of
60 months with medulloblastoma or SPNET who were treated with chemotherapy followed by 3D-CPT. The
authors concluded that proton radiation after chemotherapy resulted in good disease outcomes for the small
cohort. Longer follow-up and larger numbers of patients are needed to assess long-term outcomes and late
toxicity. Zhang et al. (2013) evaluated the predictive risk of cardiac toxicities for a 4-year old boy receiving
photon or proton irradiation CSI for medulloblastoma and concluded that PT CSI carried a lower risk of radiogenic
cardiac toxicity compared to photon CSI. St Clair et al. (2004) generated three plans of a patient affected by
medulloblastoma, while comparing conventional x-rays, IMRT and PT. PT resulted to be the best technique to
reduce the dose to structures located beyond the vertebral body and to the cochlea, pituitary, hypothalamus,
temporo-mandibular joint, parotid and pharynx.
Chordomas and Chondrosarcomas – Amichetti et al. (2010) conducted a systematic review of published literature
on the use of proton beam therapy to treat chondrosarcoma. There were no prospective trials but nine
uncontrolled single-arm studies were identified. The reviewers found that the use of proton therapy following
maximal surgical resection shows a very high probability of medium- and long-term cure with a relatively low risk
of significant complications. Amichetti et al. (2009) conducted a similar review on the use of proton therapy to
treat chordoma and reported that the use of protons has shown better results compared to conventional photon
RT, resulting in the best long-term outcome for this tumor with relatively few significant complications considering
the high doses delivered.
Uveal Melanomas – Romanowska-Dixon et al. (2012) published preliminary results for 9 patients with choroidal
melanoma who were treated using proton bean therapy. The preliminary results showed the proton beam
therapy is a highly precise method of uveal melanoma treatment achieving high rates of local control. Vawas et
al. (2010) studied the clinical profile and prognosis of young patients with uveal melanoma treated by proton
beam therapy. Seventeen patients ≤20 years with uveal melanoma were included in the study. No metastatic
deaths were observed at follow up (16 years). The authors reported that the outcome was excellent regarding
metastasis.
Prostate – The American Society for Therapeutic Radiology and Oncology (ASTRO; 2014) states in their medical
policy that the use of proton beam therapy in the treatment of prostate cancer is evolving and efficacy 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 of 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.” Mendenhall et al. (2014)
reported the 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer.
A total of 211 prostate cancer patients were treated and 5-year rates of biochemical and clinical freedom from
disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients. The authors
concluded that the 5-year clinical outcomes with image-guided proton therapy included high efficacy, minimal
physician-assessed toxicity, and excellent patient-reported outcomes, however, further follow-up and a larger
patient experience are necessary to confirm the favorable outcomes. Yu et al. (2013) performed a retrospective
study of 27,647 Medicare patients ≥ 66 years who received proton beam therapy (553) or IMRT (27,094) for
prostate cancer. The main outcome measures were early genitourinary, gastrointestinal, and other toxicity.
Patients receiving proton beam therapy were younger, healthier, and from more affluent areas than patients
receiving IMRT. Although proton beam therapy was associated with a statistically significant reduction in
genitourinary toxicity at 6 months compared with IMRT, at 12 months post-treatment there was no difference in
genitourinary toxicity. There was no statistically significant difference in gastrointestinal or other toxicity at 6
months or 12 months post-treatment. Vargas et al. (2008) reviewed the contrast in dose distribution between
proton radiotherapy and IMRT in 10 patients with prostate cancer. All rectal and rectal wall volumes treated to
10-80 GE were significantly lower with proton therapy. The rectal V(50) was reduced from 31.3% +/- 4.1% with
IMRT to 14.6% +/- 3.0% with proton therapy for a relative improvement of 53.4% and an absolute benefit of
16.7%. The mean rectal dose decreased 59% with proton therapy. The bladder V(30) was reduced with proton
therapy for a relative improvement of 35.3% and an absolute benefit of 15.1%. The mean bladder dose
decreased 35% with proton therapy. The authors concluded that proton therapy reduced the dose to the doselimiting normal structures while maintaining excellent planning volume coverage compared with IMRT. Trofimov
et al. (2007) compared proton therapy and IMRT for the treatment of early-stage prostate cancer. The authors
noted that proton therapy allows for a reduction in the radiation dose to the surrounding normal pelvic tissues in
the low to moderate range of 0 to 50 Gy range compared to IMRT, while maintaining similar volumes of the
organs at risk which receive higher doses. Slater et al. (2004) analyzed results of conformal proton radiation
therapy for localized prostate cancer in 1255 patients. The authors concluded that conformal proton radiation
therapy yielded disease-free survival rates comparable with other forms of local therapy, and with limited
morbidity.
Codes:
77520
77522
77523
77525
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References:
delivery;
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simple, without compensation
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1. Hayes, Inc. Search & Summary. Proton Beam Therapy for Medulloblastoma in Children. Lansdale, PA: Hayes,
Inc. May 27, 2014.
2. Brodin, NP., Munck, AF., Rosenschold, M., Kiil-Berthlesen, A., Hollensen, C., Vogelius, IR., Lannering, B.,
Bentzen, SoM., Bjork-Eriksson, T. Hippocampal sparing radiotherapy for pediatric medulloblastoma: Impact of
treatment margins and treatment technique. Neuro-Oncology. 2014; 16(4):594-602.
3. Jimenez, RB., Sethi, R., Depauw, N., Pulsifer, MB., Adams, J., McBride, SM., Ebb, D., Fullerton, BC., Tarbell,
NJ., Yock, TI., Macdonald, SM. Proton radiation therapy for pediatric medulloblastoma and supratentorial
primitive neuroectodermal tumors: Outcomes for very young children treated with upfront chemotherapy. Int
J Radiat Oncol Biol Phys. 2013; 87(1):120-126.
4. Zhang R, Howell RM, Homann K, Giebeler A, Taddei PJ, Mahajan A, Newhauser WD: Predicted risks of
radiogenic cardiac toxicity in two pediatric patients undergoing photon or proton radiotherapy.
5. Radiat Oncol 2013, 8(1):184.
6. St Clair WH, Adams JA, Bues M, Fullerton BC, La Shell S, Kooy HM, Loeffler JS, Tarbell NJ: Advantage of
protons compared to conventional X-ray or IMRT in the treatment of a pediatric patient with
medulloblastoma. Int J Radiat Oncol Biol Phys. 2004; 58(3):727-734.
7. Amichetti, M., Amelio, D., Cianchetti, M., Enrici, RM., Minniti, G. A systematic review of proton therapy in the
treatment of chondrosarcoma of the skull base. Neurosurg Rev. 2010; 33(2):155-65.
8. Amichetti, M., Cianchetti, M., Amelio, D., Enrici, RM., Minniti, G. Proton therapy in chordoma of the base of
the skull: a systematic review. Neurosurg Rev. 2009; 32(4):403-16.
9. Romanowska-Dixon, B., Pogrzebielski, A., Bogdali, A., Markiewicz, A., Swakon, J., Olko, P., Jezabek, M., SasKorczynska, B., Pluta, E. Proton beam radiotherapy of uveal melanoma—preliminary results. Klin Oczna.
2012; 114(3):173-9.
10. Vawas, D., Kim, I., Lane, AM., Chaglassian, A., Mukai, S., Gragoudas, E. Posterior uveal melanoma in young
patients treated with proton beam therapy. Retina. 2010; 30(8):1267-71.
11. Trofimov, A., Nguyen, PL., Coen, JJ. Radiotherapy treatment of early-stage prostate cancer with IMRT and
protons: a treatment planning comparison. Int J Radiat Oncol Biol Phys. 2007; 69:444.
12. Slater, JD., Rossi, CJ Jr., Yonemoto, LT., Bush, DA., Jabola, BR., Levy, RP., Grove, RI., Preston, W., Slater,
JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol
Phys. 2004; 59(2):348-52.
13. Mendenhall, NP., Hoppe, BS., Nichols, RC., Mendenhall, WM., Morris, CG., Li Z., WWilliams, CR., Costa, J.,
Henderson, RH. Five-year outcomes from 3 prospective trials of image-guided proton therapy for prostate
cancer. Int J Radiat Oncol Biol Phys. 2014; 88(3):596-602.
14. Yu, JB., Soulos, PR., Herrin, J., Cramer, LD., Potosky, AL., Roberts, KB., Gross, CP. Proton versus intensitymodulated radiotherapy for prostate cancer: patterns of care and early toxicity. J Natl Cancer Inst. 2013;
105(1):25-32.
15. Vargas, C., Fryer, A., Mahajan, C., Indelicato, D., Horne, D., Chellini, A., McKenzie, C., Lawwlor, P.,
Henderson, R., Li, Z., Lin, L., Olivier, K., Keole, S. Dose-volume comparison of proton therapy and intensitymodulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008; 79(3):744-51.
American Society for Therapeutic Radiology and Oncology (ASTRO). Model Policies. Proton Beam Therapy (PBT).
May 2014. Available at:
http://www.astro.org/uploadedFiles/Main_Site/Practice_Management/Reimbursement/ASTRO%20PBT%20Model
%20Policy%20FINAL.pdf. Accessed March 12, 2015.
Summary of Changes
Date
Change
4/17
Removed Benchmarks