Charged-Particle (Proton or Helium Ion) Radiotherapy for Neoplastic Conditions

POLICY NUMBER

A.8.01.10

DESCRIPTION

Charged-particle beams consisting of protons or helium ions are a type of particulate radiotherapy. Treatment with charged-particle radiotherapy is proposed for a large number of tumors that would benefit from the delivery of a high dose of radiation with limited scatter, minimizing the radiation dose to surrounding normal tissues and critical structures.

Charged-particle beams consisting of protons or helium ions are a type of particulate radiotherapy. They have several unique properties that distinguish them from conventional electromagnetic (i.e., photon) radiotherapy, including minimal scatter as particulate beams pass through tissue, and deposition of ionizing energy at precise depths (i.e., the Bragg peak). Thus, radiation exposure of surrounding normal tissues and critical structures is minimized. The theoretical advantages of protons and other charged-particle beams may improve outcomes when the following conditions apply:

• Conventional treatment modalities do not provide adequate local tumor control;

• Evidence shows that local tumor response depends on the dose of radiation delivered; and

• Delivery of adequate radiation doses to the tumor is limited by the proximity of vital radiosensitive tissues or structures.

Radiotherapy is a procedure and, therefore, is not subject to U.S. Food and Drug Administration (FDA) regulations. However, the accelerators and other equipment used to generate and deliver charged-particle radiation (including proton beam) are devices that require FDA oversight. The FDA’s Center for Devices and Radiological Health has indicated that the proton beam facilities constructed in the United States prior to enactment of the 1976 Medical Device Amendments were cleared for use in the treatment of human diseases on a “grandfathered” basis, while at least one that was constructed subsequently received a 510(k) marketing clearance. There are 510(k) clearances for devices used for delivery of proton beam therapy and devices considered to be accessory to treatment delivery systems, such as the Proton Therapy Multileaf Collimator (which was cleared in December 2009). Since 2001, several devices classified as medical charged-particle radiation therapy systems have received 510(k) marketing clearance. FDA product code LHN.

Also see the related medical policy, Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) .

POLICY

Charged-particle irradiation with proton or helium ion beams may be considered medically necessary for treatment in the following clinical situations:

• primary therapy for melanoma of the uveal tract (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;

• postoperative therapy (with or without conventional high-energy x-rays) in patients who have undergone biopsy or partial resection of 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;

• pediatric central nervous system tumors.

Charged-particle irradiation with proton or helium ion beams may be considered medically necessary where treatment with conventional or advanced photon-based radiotherapy cannot meet dose-volume constraints for normal tissue radiation tolerance (see Policy Guidelines section) in the following clinical situations:

• in the curative treatment of primary or benign solid pediatric non-central nervous system tumors, including Ewing sarcoma;

• in the curative treatment of nonmetastatic primary non-small cell lung cancer;

• head and neck cancers.

Other applications of charged-particle irradiation with proton or helium ion beams may be considered investigational. This includes, but may not be limited to:

• clinically localized prostate cancer,

• non-curative treatment of primary or benign solid pediatric non-central nervous system tumors, including Ewing sarcoma;

• non-curative treatment of non-small-cell lung cancer.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Evidence is lacking on the definition of age parameters for the use of proton beam therapy in pediatric individuals. Some studies using proton beam therapy in pediatric central nervous system tumors have mostly included individuals younger than 3 years of age. However, experts cite the benefit of proton beam therapy in pediatric patients of all ages (<21 years of age).

Organs at risk are defined as normal tissues whose radiation sensitivity may significantly influence treatment and/or prescribed radiation dose. These organs at risk may be particularly vulnerable to clinically important complications from radiation toxicity. Table 1 outlines radiation doses that are generally considered tolerance thresholds for these normal structures in various organ regions. Clinical documentation based on dosimetry plans may be used to demonstrate that radiation by conventional or advanced photon-based radiotherapy, including intensity-modulated radiotherapy (IMRT), volume-modulated arc therapy (VMAT), stereotactic radiosurgery (SRS), or stereotactic body radiation therapy (SBRT), would exceed tolerance doses to structures at risk. For patients with radiation-sensitizing genetic syndromes such as neurofibromatosis type 1 (NF-1) or retinoblastoma, clinical documentation of the condition may be used to demonstrate increased risk from exposure during treatment.

Radiation Tolerance Doses for Normal Tissues

Compiled from 2 sources: (1) Morgan MA (2011). Radiation Oncology. In DeVita, Lawrence, and Rosenberg, Cancer (p.308). Philadelphia: Lippincott Williams and Wilkins; and (2) Kehwar TS, Sharma SC. Use of normal tissue tolerance doses into linear quadratic equation to estimate normal tissue complication probability. Available online at: http://www.rooj.com/Radiation%20Tissue%20Tolerance.htm .NP: not provided; TD: tolerance dose.^a TD 5/5 is the average dose that results in a 5% complication risk within 5 years.^b TD 50/5 is the average dose that results in a 50% complication risk within 5 years.

For charged-particle radiotherapy (proton or helium ion) therapy to provide outcomes superior to photon-based radiotherapy, there must be a clinically meaningful decrease in the radiation exposure to normal structures. There is no standard definition for a clinically meaningful decrease in radiation dose. In principle, a clinically meaningful decrease would signify a significant reduction in anticipated complications of radiation exposure. To document a clinically meaningful reduction in dose, dosimetry studies should demonstrate a significant decrease in the maximum dose of radiation delivered per unit of tissue, and/or a significant decrease in the volume of normal tissue exposed to potentially toxic radiation doses. While radiation tolerance dose levels for normal tissues are well-established, the decrease in the volume of tissue exposed that is needed to provide a clinically meaningful benefit has not been standardized. Therefore, precise parameters for a clinically meaningful decrease cannot be provided.

IMRT of the lung is addressed in the Intensity-Modulated Radiotherapy of the Breast and Lung medical policy. IMRT of the prostate is addressed in the Intensity-Modulated Radiotherapy (IMRT) of the Prostate medical policy. IMRT of the head or neck is addressed in the Intensity-Modulated Radiotherapy: Cancer of the Head and Neck or Thyroid medical policy.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

7/27/2006: Approved by Medical Policy Advisory Committee (MPAC).

9/28/2006: Policy updated to include coverage of prostate cancer.

8/21/2008: Policy updated to note that coverage of prostate cancer is not medically necessary. ICD-9 diagnosis 185 removed.

04/27/2010: Added “Charged-Particle” to the policy title. Added link to related policy to the description. Made minor wording change in the policy statement: “may be considered” changed to “is considered” in the second statement. Intent of policy statement unchanged. Added the definition of investigative service to the Policy Guidelines section.

12/30/2010: Policy statement revised to add "including but not limited to use of proton beam therapy for non-small-cell lung cancer (NSCLC) at any stage or for recurrence" as a specific indication to the investigational policy statement. Intent of policy statement unchanged.

12/01/2011: Policy reviewed; no changes.

05/07/2013: Policy statement revised to state that charged-particle irradiation with proton or helium ion beams may be considered medically necessary in the treatment of pediatric central nervous system tumors. The following were added as investigational applications: pediatric non-central nervous system tumors and tumors of the head and neck (other than skull-based chordoma or chondrosarcoma).

04/28/2014: Policy reviewed; description updated to include three advances in photon-based radiation therapy that allow improved targeting of conventional therapy. Policy statement unchanged.

08/21/2015: Code Reference section updated to add ICD-10 codes and to update CPT code descriptions.

09/11/2015: Code Reference section updated to add Investigational Codes table and ICD-10 procedure codes.

11/16/2015: Policy title changed from "Charged-Particle (Proton or Helium) Ion Radiation Therapy" to "Charged-Particle (Proton or Helium Ion) Radiotherapy." Policy description updated to change "radiation therapy" to "radiotherapy." Charged-particle irradiation for clinically localized prostate cancer changed from "not medically necessary" to "investigational. Removed not medically necessary policy statement from policy section. Investigative definition updated in policy guidelines.

05/25/2016: Policy number A.8.01.10 added.

08/22/2016: Policy title changed from "Charged-Particle (Proton or Helium Ion) Radiotherapy" to "Charged-Particle (Proton or Helium Ion) Radiotherapy for Neoplastic Conditions." Policy description updated. Investigational statement updated to include helium ion beams for consistency with first policy statement. Policy Guidelines updated regarding the use of proton beam therapy in pediatric patients.

08/08/2017: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to define medically necessary.

08/16/2018: Policy description updated to remove information regarding the use of proton or helium ion radiotherapy in tumors and abnormalities. Policy statements unchanged.

08/01/2023: Policy description updated. Added medically necessary statement that charged-particle irradiation with proton or helium ion beams may be considered medically necessary where treatment planning with conventional or advanced photon-based radiotherapy cannot meet dose-volume constraints for normal tissue radiation tolerance (see Policy Guidelines section) in the listed clinical situations. Revised investigational indications for clarity. Policy Guidelines updated regarding the following: 1) radiation tolerance doses for normal tissues; 2) to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/14/2024: Policy reviewed. Second policy statement and Policy Guidelines updated to change "treatment planning" to "treatment."

07/24/2024: Policy reviewed; no changes.

08/14/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.10

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

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