PROTON BEAM RADIATION THERAPY
Policy Number:
2013M0022A
Effective Date:
January 1, 2014
Table of Contents:
Page:
Cross Reference Policy:
POLICY DESCRIPTION
2
NOT AVAILABLE
COVERAGE RATIONALE/CLINICAL CONSIDERATIONS
2
BACKGROUND
4
REGULATORY STATUS
6
CLINICAL EVIDENCE
7
APPLICABLE CODES
7
REFERENCES
9
POLICY HISTORY/REVISION INFORMATION
13
INSTRUCTIONS:
“Medical Policy assists in administering UCare benefits when making coverage determinations for members
under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility,
federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific
Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of
a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance
supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the
service, procedure or treatment, or when the member’s EOC document is silent or not specific, medical
policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided
for informational purposes
and does not constitute medical advice.
In addition to medical policies, UCare
also uses tools developed by third parties, such as the InterQual Guidelines®, to assist us in administering
health benefits. The InterQual Guidelines are intended to be used in connection with the independent
professional medical judgment of a qualified health care provider and do not constitute the practice of
medicine or medical advice
.
Other Policies and Coverage Determination Guidelines may also apply. UCare
reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide
benefits otherwise excluded by medical policies when necessitated by operational considerations.”
POLICY DESCRIPTION:
This medical policy describes the use of Proton Beam Therapy (PBT), a form of external radiotherapy in
which positively charged subatomic particles (protons) are precisely targeted to a specific tissue mass using
a sophisticated treatment planning and delivery system. PBT is used to reduce recurrence of a tumor after
surgical excision or as a primary treatment for an inoperable mass. The goal is to deliver higher target doses
to the tissue than is possible with conventional photon irradiation while improving local control of tumors
and reducing acute and late complications.
COVERAGE RATIONALE / CLINICAL CONSIDERATIONS:
A.
Proton Beam Radiation Therapy (PBT) is considered
MEDICALLY NECESSARY
for the treatment of:
1.
Pediatric, adolescent, or adults with radiosensitive tumor sites that may be considered for Proton
Beam Radiotherapy:
a.
Those requiring craniospinal irradiation
b.
Central nervous system tumors or lesions:
1)
Ependymomas
2)
Craniopharyngiomas
3)
Primitive neuroectodermal tumors
4)
Low grade gliomas (astrocytoma, glioblastoma)
5)
Medulloblastomas
6)
Benign and atypical meningiomas
7)
Neuromas
c.
Non-central nervous system tumors:
1)
Chordomas and chondrosarcomas
2)
Rhabdomyosarcomas
3)
Retroperitoneal sarcoma
4)
Malignant lesions of the paranasal sinus and nasal cavity tumors
5)
Advanced staged and unresectable malignant lesions of the head and neck
6)
Solid tumors in children
7)
Ewing’s sarcoma
8)
Pineal tumors
2.
Intracranial arteriovenous malformations (AVMs)
3.
Melanoma of the uveal tract (iris, ciliary body and choroid), not amenable to surgical excision or
other conventional forms of treatment
4.
Spinal cord tumors
B.
Proton Beam Radiation Therapy (PBT) is considered
EXPERIMENTAL/INVESTIGATIONAL
for the
conditions listed below, however it
would
be covered by
CMS
when the therapy is part of a clinical trial,
registry or both.
1.
Unresectable lung cancers and upper abdominal/peri-diaphragmatic cancers
2.
Advanced stage, unresectable pelvic tumors including those with peri-aortic nodes or malignant
lesions of the cervix
3.
Left breast tumors
5.
Skin cancer with macroscopic perineural/cranial nerve invasion of skull base
6.
Unresectable malignant lesions of the liver, biliary tract, anal canal and rectum
7.
Prostate cancer, non-metastatic
Presence of an Institutional Review Board (IRB) review is expected. Physician documentation of patient
selection criteria and patient informed consent are also required.
Note:
There is as yet no good comparative data to determine whether or not Proton Beam Therapy for
these conditions is superior, inferior, or equivalent to external beam radiation, IMRT, or brachytherapy
in terms of safety or efficacy.
Comparative effectiveness studies including randomized controlled trials
are needed to document the theoretical incremental advantages of PBT over other radiotherapies in
many common cancers. It is not known whether the higher precision of PBT actually translates to
better clinical outcomes. Therefore, PBT is considered a form of external beam radiation therapy,
non-preferentially to other forms of external beam radiation.
C.
Proton Beam Radiation Therapy is considered
EXPERIMENTAL/INVESTIGATIONAL
for the treatment of
other indications, including but not limited to:
1.
Age-related macular degeneration (AMD)
2.
Bladder cancer
3.
Carotid body tumor
4.
Cavernous hemangioma
5.
Choroidal hemangioma
6.
Esophageal cancer
7.
Germ cell tumors
8.
Lymphoma
9.
Non-uveal melanoma
10.
Small bowel adenocarcinoma
11.
Tumors of the vestibular system
12.
Thymoma
13.
Intracranial and skull base tumors that have metastasized from another primary site
There is inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical
literature to support the use of PBT on these conditions.
D.
Proton beam radiation therapy used in conjunction with intensity-modulated radiation therapy (IMRT)
is considered
EXPERIMENTAL/INVESTIGATIONAL
.
Clinical evidence is insufficient to support the combined use of these technologies in a single treatment
plan. Comparative effectiveness studies including randomized controlled trials are needed to
Clinical Considerations:
Alternatives to PBT include, but may not be limited to, the following:
Chemotherapy
Electron beam radiation therapy (EBRT)
Endovascular embolization
Surgical excision.
Physician documentation of patient selection criteria is required.
The patient's record demonstrates why proton beam radiotherapy is considered the treatment of
choice for the individual patient.
For the treatment of primary lesions, the intent of treatment must be curative.
There is documented clinical rationale that doses generally thought to be above the level otherwise
attainable with other radiation methods might improve control rates.
There is documented clinical rationale that higher levels of precision associated with proton beam
therapy compared to other radiation treatments are clinically necessary.
For the treatment of metastatic lesions, there must be:
o
The expectation of a long-term benefit (greater than 2 years of life expectancy) that could not
have been attained with conventional therapy.
o
The expectation of a complete eradication of the metastatic lesion that could not have been
safely accomplished with conventional therapy, as evidenced by a dosimetric advantage for
proton beam radiotherapy over other forms of radiation therapy (IMRT or 3-D radiation
therapy).
BACKGROUND:
Unlike other types of radiation therapy that use x-rays or photons to destroy cancer cells, proton beam
therapy (PBT) uses a beam of special particles (protons) that carry a positive charge. There is no significant
difference in the biological effects of protons versus photons; however, protons can deliver a dose of
radiation in a more confined way to the tumor tissue than photons. After they enter the body, protons
release most of their energy within the tumor region and, unlike photons, deliver only a minimal dose
beyond the tumor boundaries (American College of Radiology website, 2012).
The greatest energy release with conventional radiation (photons) is at the surface of the tissue and
decreases exponentially the farther it travels. In contrast, the energy of a proton beam is released at the
end of its path, a region called the Bragg peak. Since the energy release of the proton beam is confined to
the narrow Bragg peak, collateral damage to the surrounding tissues should be reduced, while an increased
dose of radiation can be delivered to the tumor.
Because of these physical properties, it has been theorized that PBT may be especially useful for cancers
located in areas of the body that are highly sensitive to radiation and/or where damage to healthy tissue
would be an unacceptable risk to the patient. In addition, PBT may also benefit patients with tumors that
are not amenable to surgery. Theoretically, the use of protons and other charged-particle beams may
improve outcomes when the following conditions apply:
1.
Conventional treatment modalities do not provide adequate local tumor control;
2.
Evidence shows that local tumor response depends on the dose of radiation delivered; and
3.
Delivery of adequate radiation doses to the tumor is limited by the proximity of vital radiosensitive
issues or structures.
PBT has been used in stereotactic radiosurgery of intracranial lesions. The gamma knife and linear
accelerator have also been used in stereotactic radiosurgery. Proton beam radiotherapy has been shown
to be particularly useful in treating radiosensitive tumors that are located next to vital structures, where
complete surgical excision or administration of adequate doses of conventional radiation is difficult or
impossible. Examples include uveal melanomas, chordomas and chondrosarcomas at the base of the skull,
and inoperable arterio-venous malformations.
To date, there are no published, controlled, comparative studies describing outcomes from patients treated
with proton beam radiotherapy versus other therapies; thus the advantage of protons over conventional
photon therapy is based on the dosimetric advantage of protons over photons for tumors that are in
immediate proximity to critical structures. The majority of the published literature is in the form of
prospective or retrospective case series and cohort studies; there is also significant variation in the types
and stages of cancer for which treatment with proton beam radiotherapy has been reported, as well as the
reported doses and fractionation schedules. Published reports focus mainly on toxicity, and include
pediatric, adolescent, and adult patients treated with proton beam radiotherapy primarily for ocular
cancers, spine or skull base chordomas and chondrosarcomas, spinal and paraspinal bone and soft tissue
sarcomas, head and neck cancers, and brain tumors. In addition, there is some literature reporting the use
of proton beam radiotherapy for patients with lymphoma, non-small cell lung cancer, prostate cancer, and
some gastrointestinal cancers.
As of April 2013, there are 41 facilities worldwide that offer treatment with proton beam radiotherapy. In
North America, there are currently 12 facilities in operation, and 8 more are under development or being
constructed.
Device:
The proton beam facility involves an accelerator-synchrotron system, a beam transport system, a
beam delivery system, and a patient alignment and imaging system (treatment planning system), all under
the operation of a facility control system. Protons are generated by an ion source and then accelerated by a
linear accelerator up to approximately 2 million electron volts (MeV). The beam then enters the
synchrotron; as the protons complete each trip around the synchrotron, their energy is increased to the
desired level by the addition of radiofrequency energy. The desired energy level would be that required to
position the Bragg peak into the cancerous tissue. The beam transport system consists of additional
magnets that focus and direct the beam from the synchrotron to the delivery system, which is located in
one of several treatment rooms. The beam delivery system that is used for treatment of tumors in
locations other than the head and neck or the eye is mounted on very large steel gantries. These gantries
can rotate 360° around the patient, thus providing great flexibility in exact delivery of the proton beam.
Several components serve to spread and shape the beam so that it fits the target irradiation volume.
Computed tomography (CT) scans, magnetic resonance imaging (MRI), and positron emission tomography
(PET), along with conventional x-rays, can be utilized to construct a digital three-dimensional model of the
cancerous tissue for treatment planning (MacDonald et al., 2006; Optivus, 2006).
Treatment:
Precise targeting of the Bragg peak is of utmost importance in PBT because there is a sudden
release of energy within the Bragg peak, but minimal energy release proximal to it and virtually none distal
to it. Additional margins are added to the gross tumor volume to define a clinical target volume and a
planning target volume, thus allowing a small margin of noncancerous tissue to be irradiated. Multiple
tumors are encompassed within a single target volume. Penetration depth is controlled by the initial energy
selected for the beam. Proton dose is measured in cobalt gray equivalents (CGE), which are calculated by
multiplying the amount of energy delivered, measured in grays (Gy), times a relative biological
effectiveness (RBE) ratio. The RBE expresses the relative effect of a test radiation compared with the same
energy delivered as photon radiation. For proton beams, the RBE is usually considered to be 1.1. As with
conventional radiation therapy, PBT usually uses fractionation of dose and multiport beam entry to limit
exposure to the skin and other non-target tissue. The patient’s positioning must be consistent for
consecutive treatment sessions. Patient immobilization is also an essential component of precise targeting
and is often accomplished by placing the patient in a polyvinyl mold. A technique referred to as respiration
gating may be used to help avoid irradiation beyond the planned volume because of organ motion that
occurs during breathing. In some patients, conformal photon irradiation may be administered in
conjunction with PBT (Bush et al., 2004a; Chiba et al., 2005; Levin et al., 2005; Hata et al., 2006a;
MacDonald et al., 2006; Nihei et al., 2006).
REGULATORY STATUS:
1.
U.S. FOOD AND DRUG ADMINISTRATION (FDA):
Radiation therapy is a procedure and, therefore, is not subject to FDA regulation. However, the
accelerators and other equipment used to generate and deliver proton beam radiation therapy are
regulated by the FDA.
Proton beam therapy systems are approved by the FDA 510(k) process as a “medical device designed to
produce and deliver a proton beam for the treatment of patients with localized tumors and other
conditions susceptible to treatment by radiation” (FDA, 2006).
Examples of such systems are the Optivus Proton Beam Therapy System (Optivus Technology Inc., Loma
Linda, CA) and the Probeat (Hitachi, Ltd., Power Systems Group, Tokyo, Japan) (FDA, 2006; FDA, 2000).
The following devices have received 510(k) clearance for PBT of tumors and other medical conditions
susceptible to proton radiation therapy:
The Harvard University Cyclotron Laboratory Beam Therapy system is a pre-amendment (pre-1976)
device (FDA, 2001a; FDA, 2001b).
The Loma Linda University Proton Beam Therapy system received 510(k) clearance on February 22,
1988 (FDA, 1998).
The Optivus Proton Beam Therapy System (Optivus Technology, Inc, Loma Linda, CA) received
510(k) clearance on July 21, 2000 (FDA, 2000).
The Proton Therapy System (Ion Beam Applications S.A., Louvain-la-Neuve, Belgium; distributed in
the U.S. by Ion Beam Applications, Philadelphia, PA) received 510(k) clearance on July 12, 2001
(FDA, 2001a).
The Northeast Proton Therapy Center (Massachusetts General Hospital, Boston, MA) received FDA
510(k) clearance on July 20, 2001 (FDA, 2001b).
Hitachi Probeat (Hitachi, Ltd., Power Systems Group, Tokyo, Japan) received FDA 510(k) clearance
(FDA, 2006b).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
. Accessed April 19, 2013.
2.
CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS):
Medicare does not have a National Coverage Determination (NCD) for Proton Beam Therapy
(PBT).
A Local Coverage Determinations (LCDs) exist for Proton Beam Therapy (PBT) and compliance with the
policy is required. LCD ID Number: L31617. Primary Geographic Jurisdiction: Minnesota. Accessed April
19, 2013.
3.
MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS):
Minnesota DHS does not have a policy statement regarding PBT in its Provider Manual or other specific
provider references.
CLINICAL EVIDENCE:
The Agency for Healthcare Research and Quality (AHRQ) published a report on particle beam therapy for
treating a variety of cancers. More than half of the publications the AHRQ identified described treatment of
ocular cancers (uveal melanoma in particular), and cancers of the head and neck (brain tumors, and tumors
arising from skull base, cervical spine and nearby structures). In order of decreasing number of studies, the
following types of malignancies were also described: gastrointestinal (esophageal cancer, hepatocellular
carcinomas of the liver, pancreatic cancer), prostate, lung, spine and sacrum, bone and soft tissue, uterine
(cervix and corpus), bladder, and miscellaneous (skin cancer or a compilation of a center’s experience with
a variety of cancers treated there).
According to the AHRQ report, there are many publications on particle (mainly proton) beam therapy for
the treatment of cancer. However, they typically do not use a concurrent control, focus on heterogeneous
populations and they employ different definitions for outcomes and harms. These studies do not document
the circumstances in contemporary treatment strategies in which radiotherapy with charged particles is
superior to other modalities. Comparative effectiveness studies including randomized controlled trials are
needed to document the theoretical advantages of charged particle radiotherapy to specific clinical
situations. At present, there is very limited evidence comparing the safety and effectiveness of PBRT with
other types of radiation therapies for cancer. Therefore, it is not possible to draw conclusions about the
comparative safety and effectiveness of PBRT at this time (AHRQ, 2009).
Several systematic reviews (Terasawa, 2009; Brada, 2009; Lodge, 2007; Olsen, 2007) previously reported
the lack of evidence supporting proton beam therapy and the need for well-designed prospective studies
comparing proton beam therapy to other forms of radiation therapy.
APPLICABLE CODES:
The Current Procedural Terminology (CPT®) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply.
CPT® Codes
Description
0073T Compensator-based beam modulation treatment delivery of inverse planned treatment
using 3 or more high resolution (milled or cast) compensator convergent beam modulated fields, per treatment session
0197T Intra-fraction localization and tracking of target or patient motion
during delivery of radiation therapy (e.g., 3D positional tracking, gating, 3D surface tracking), each fraction of treatment
77301 Intensity modulated radiotherapy plan, including dose-volume
histograms for target and critical structure partial tolerance specifications
77338 Multi-leaf collimator (MLC) device(s) for intensity modulated radiation
therapy (IMRT), design and construction per IMRT plan
77418 Intensity modulated treatment delivery, single or multiple fields/arcs,
via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session
77520 Proton treatment delivery; simple, without compensation
77522 Proton treatment delivery; simple, with compensation
77523 Proton treatment delivery; intermediate
77525 Proton treatment delivery; complex
ICD-9 Codes
Description
140.0 - 209.30, 230.0 - 234.9
Malignant neoplasm [radiosensitive]
158.0 Malignant neoplasm of retroperitoneum [soft tissue sarcomas not amenable to other
radiotherapy]
170.0 Malignant neoplasm of bones of skull and face, except mandible
170.2 Malignant neoplasm of vertebral column, excluding sacrum and coccyx
185 Malignant neoplasm of prostate
190.0 Malignant neoplasm of eyeball, except conjunctiva, cornea, retina, and choroid (e.g., uveal
tract) [confined to globe - not distant metastases]
190.6 Malignant neoplasm of choroid
191.0 - 191.9 Malignant neoplasm of brain
192.0 Malignant neoplasm of cranial nerves
192.1 Malignant neoplasm of cerebral meninges
192.2 Malignant neoplasm of spinal cord
192.3 Malignant neoplasm of spinal meninges
192.8 - 192.9 Malignant neoplasm of other and unspecified parts of nervous system
194.3 Malignant neoplasm of pituitary gland and craniopharyngeal duct
198.3 Secondary malignant neoplasm of brain and spinal cord
198.4 Secondary malignant neoplasm of other parts of nervous system
225.0 Benign neoplasm of brain
225.1 Benign neoplasm of cranial nerves [not covered for vestibular schwannoma]
225.2 Benign neoplasm of cerebral meninges
225.3 Benign neoplasm of spinal cord
227.3 Benign neoplasm of pituitary gland and craniopharyngeal duct (pouch)
237.0 Neoplasm of uncertain behavior of pituitary gland and craniopharyngeal duct
237.5 Neoplasm of uncertain behavior of brain and spinal cord
747.82 Spinal vessel anomaly [arterio-venous malformations]
ICD-10 Codes
Description
C69.30 Malignant neoplasm of unspecified choroid
C69.31 Malignant neoplasm of right choroid
C69.32 Malignant neoplasm of left choroid
C69.40 Malignant neoplasm of unspecified ciliary body
C69.41 Malignant neoplasm of right ciliary body
C69.42 Malignant neoplasm of left ciliary body
C70.1 Malignant neoplasm of spinal meninges
C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles
C71.1 Malignant neoplasm of frontal lobe
C71.2 Malignant neoplasm of temporal lobe
C71.3 Malignant neoplasm of parietal lobe
C71.4 Malignant neoplasm of occipital lobe
C71.5 Malignant neoplasm of cerebral ventricle
C71.6 Malignant neoplasm of cerebellum
C71.7 Malignant neoplasm of brain stem
C71.8 Malignant neoplasm of overlapping sites of brain
C71.9 Malignant neoplasm of brain, unspecified
C72.0 Malignant neoplasm of spinal cord
C72.1 Malignant neoplasm of cauda equina
C79.31 Secondary malignant neoplasm of brain
C79.32 Secondary malignant neoplasm of cerebral meninges
C79.40 Secondary malignant neoplasm of unspecified part of nervous system
C79.49 Secondary malignant neoplasm of other parts of nervous system
D07.5 Carcinoma in situ of prostate
D33.0 Benign neoplasm of brain, supratentorial
D33.1 Benign neoplasm of brain, infratentorial
D33.2 Benign neoplasm of brain, unspecified
D42.0 Neoplasm of uncertain behavior of cerebral meninges
D42.1 Neoplasm of uncertain behavior of spinal meninges
D42.9 Neoplasm of uncertain behavior of meninges, unspecified
D43.0 Neoplasm of uncertain behavior of brain, supratentorial
D43.1 Neoplasm of uncertain behavior of brain, infratentorial
D43.2 Neoplasm of uncertain behavior of brain, unspecified
D43.4 Neoplasm of uncertain behavior of spinal cord
D49.6 Neoplasm of unspecified behavior of brain
Q28.3 Other malformations of cerebral vessels
Q28.2 Arteriovenous malformation of cerebral vessels
HCPCS Codes
Description
S8030 Scleral application of tantalum ring(s) for localization of lesions for proton beam therapy
CPT® is a registered trademark of the American Medical Association.
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