Description

Intensity modulated radiation therapy (IMRT) is an advanced form of external beam radiotherapy that uses computer-controlled linear accelerators to deliver precise radiation doses to specific areas within a tumor. This therapy allows for increased precision by conforming radiation to the planned target site while significantly reducing the amount of radiation to surrounding healthy tissues. Image-guidance in the form of computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US) or X-rays may be utilized to direct delivery of the radiation beams.

Different techniques are utilized to control the radiation amount given during IMRT. The most common approach is the use of multileaf collimators (MLCs). These devices are attached to the linear accelerator. The MLCs are composed of computer- controlled tungsten leaves or panels that move while the radiation beam is directed toward the target. The leaves function as filters that block out certain areas. This modifies the beam’s intensity so that the radiation is distributed according to the treatment plan.

Another delivery approach is compensator based IMRT. This approach utilizes custom made (based on three dimensional (3D) images and the treatment plan) high-density blocks to control the administration of the radiation. The blocks are placed into position according to the treatment plan and the radiation is delivered.

Tomotherapy and volumetric modulated arc therapy (VMAT) are types of IMRT. In these forms of treatment, the machines combine the linear accelerator with MLCs and CT scanners in an effort to provide IMRT with increased precision to select tumors. The frame that houses the treatment and scanning devices rotates in a 360-degree fashion around the individual to deliver a focused beam of radiation to the tumor. Tomotherapy involves obtaining a CT scan prior to each treatment session to identify any changes to tumor shape or position so that adjustments can be made. The radiation is delivered in smaller beams (beamlets) which deliver varying doses of radiation to the target. In VMAT, one or more beams of radiation are delivered in an uninterrupted arc delivered as the housing rotates. The radiation beams may be modified according to the shape of the tumor.

The placement of a transperineal biodegradable spacer (e.g., SpaceOAR, SpaceOAR Vue) positions the anterior (frontal) section of the rectal wall away from the prostate during external beam radiotherapy treatments for prostate cancer with the goal of limiting the radiation exposure to the anterior rectum. Because this material is biodegradable, it is absorbed over time by the individual’s body. SpaceOAR is comprised of a synthetic, absorbable polyethylene glycol-based hydrogel. SpaceOAR Vue contains PEGylated Iodine, which is designed to enhance visibility via CT scan. Barrigel injectable gel is similar to the SpaceOAR product; however, it is made of stabilized hyaluronic acid.

For information regarding coverage determination/limitations not addressed in this medical coverage policy, please refer to the following:

• Brachytherapy
• Transperineal biodegradable spacers
• Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy

Intensity Modulated Radiation Therapy Effective Date: 10/10/2023 Revision Date: 10/10/2023 Review Date: 07/27/2023 Policy Number: HUM-0322-024 Page: 3 of 24

Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Fiducial markers are small metal (typically gold) spheres, coils or cylinders that are implanted in and/or around a tumor prior to radiation treatment, especially within soft tissue tumors in organs that move. The markers are located via imaging each time the individual receives a treatment. This facilitates radiation to the tumor site with precision and accuracy with the goal of decreasing injury to surrounding tissues. Fiducial markers are most commonly utilized in the liver, lung and prostate and may be placed using CT, endoscopic or surgical guidance.

Three-dimensional (3D) bioabsorbable tissue markers (eg, BioZorb) are inserted and sutured in the surgical cavity during a lumpectomy. The bioabsorbable device is imbedded with radiopaque markers that indicate the surgical boundaries in each direction and reportedly offer visualization of targeting for radiation therapy. The device has an open framework that purportedly will keep the lumpectomy cavity from collapsing during the healing period. All but the titanium clips are absorbed by the body in approximately one year. (Refer to Coverage Limitations section)

Coverage Determination

Humana members may be eligible under the Plan for IMRT for the following indications when the lesions are in close proximity to critical structures and there is documented concern about damage to the surrounding tissues with the use of external beam radiation therapy (EBRT) or 3D-conformal radiation therapy (3D- CRT):

• Anal cancer; OR
• Breast cancer; OR
• Central nervous system cancers – including the brain, brainstem and spinal cord; OR
• Cervical cancer in individuals who have had a hysterectomy; OR
• Colorectal cancer ONLY for reirradiation of previously treated individuals with recurrent disease or unique anatomical situations (eg, cecal volvulus, sigmoid volvulus)93,101; OR
• Esophageal cancer; OR
• Gallbladder cancer where dose exceeds 50 Gray (Gy); OR
• Head and neck cancer (esophageal, laryngeal, oral cavity, pharyngeal, sinus cavities, thyroid); OR
• Lung cancer; OR
• Pancreatic cancer where dose exceeds 50 Gy; OR
• Postoperative radiation to pelvis for endometrial cancer; OR
• Prostate cancer; OR
• Squamous cell vulvar cancer

Humana members may be eligible under the Plan for placement of a transperineal biodegradable spacer (eg, Barrigel, SpaceOAR, SpaceOAR Vue) for an individual receiving EBRT, which includes IMRT, for prostate cancer in the absence of contraindications.

Humana members may be eligible under the Plan for placement of fiducial markers for the following indications:

• Bony anatomy is not sufficient for adequate target alignment; AND
• Soft tissue radiation target is not clearly visible on imaging

Coverage Limitations

Humana members may NOT be eligible under the Plan for IMRT for any indications other than those listed above.

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the placement of a transperineal biodegradable spacer (eg, Barrigel, SpaceOAR, SpaceOAR Vue) utilized during Intensity Modulated Radiation Therapy. Effective Date: 10/10/2023 Revision Date: 10/10/2023 Review Date: 07/27/2023 Policy Number: HUM-0322-024 Page: 5 of 24

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

EBRT for any indications other than those listed above or for the following contraindications:

• Active inflammatory or infectious disease in the perineum or injection area58,62; OR
• Bleeding (eg, platelet abnormalities) or coagulation (eg, thrombocytopenia) disorders58,62; OR
• Prior treatment of the prostate with a high risk of adhesions62; OR
• Rectal invasion; OR
• T3 category tumor or greater and posterior extension100

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for 3D bioabsorbable tissue markers (eg, BioZorb) which are utilized to indicate the surgical boundaries after lumpectomy for radiation therapy.

Background

Additional information about cancer may be found from the following websites:

• American Cancer Society
• National Comprehensive Cancer Network
• National Library of Medicine

Medical Alternatives

Alternatives to IMRT include, but may not be limited to, the following:

• 3D conformal radiation therapy
• Brachytherapy (please refer to Brachytherapy Medical Coverage Policy)
• Proton or neutron beam radiation therapy (please refer to Proton Beam, Neutron Beam and Carbon Ion Radiation Therapy Medical Coverage Policy)
• Standard radiation therapy
• Stereotactic radiosurgery (please refer to Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy Medical Coverage Policy)

Physician consultation is advised to make an informed decision based on an individual’s health needs.