Hydrogel Spacer Use During Radiotherapy for Prostate Cancer

POLICY NUMBER

A.7.01.164

DESCRIPTION

For low- or intermediate-risk prostate cancer, radiation therapy is an option. Because the rectum lies in close proximity to the prostate, the risk of rectal toxicity is high. One approach is to push the rectum away from the prostate, increasing the space between the two and reducing the radiation dose to the rectum. A variety of biomaterials, including polyethylene glycol hydrogels (eg, SpaceOAR System), hyaluronic acid hydrogels (Barrigel Injectable Gel), or absorbable balloon implants (BioProtect Balloon Implant System), have been evaluated as perirectal spacers.

Prostate Cancer

Prostate cancer is a complex, heterogeneous disease, ranging from microscopic tumors unlikely to be life-threatening to aggressive tumors that can metastasize, leading to morbidity or death. It is the second most common cause of cancer death in men, with approximately one in eight men diagnosed with prostate cancer over their lifetime. Cancer is typically suspected due to increased levels of prostate-specific antigen upon screening. A digital rectal exam may detect nodules, induration, or asymmetry, which is then followed by an ultrasound-guided biopsy with evaluation of the number and grade of positive biopsy cores.

Clinical staging is based on the digital rectal exam and biopsy results. T1 lesions are not palpable while T2 lesions are palpable but appear to be confined to the prostate. T3 lesions extend through the prostatic capsule, and T4 lesions are fixed to or invade adjacent structures. The most widely used grading scheme for a prostate biopsy is the Gleason system. It is an architectural grading system ranging from 1 (well differentiated) to 5 (poorly differentiated); the score is the sum of the primary and secondary patterns. A Gleason score of 6 or less is low-grade prostate cancer that usually grows slowly; 7 is an intermediate grade; 8 to 10 is high-grade cancer that grows more quickly. A revised prostate cancer grading system has been adopted by the National Cancer Institute and the World Health Organization. A cross-walk of these grading systems is shown in the table below.

Prostate Cancer Grading Systems

In October 2014, SpaceOAR (Augmenix, a subsidiary of Boston Scientific) was cleared by the U.S. Food and Drug Administration (FDA) through the De Novo process (DEN140030). Barrigel Injectable Gel (Palette Life Sciences) was approved by the FDA via the premarket approval process in March 2022 (K220641; FDA product code: OVB), followed by BioProtect Balloon Implant System (BioProtect, Ltd) in 2023 (K222972; FDA product code: OVB). The intended and approved use of SpaceOAR System, Barrigel, and BioProtect Balloon Implant is to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of these hydrogel spacers to reduce the radiation dose delivered to the anterior rectum.

DuraSeal® Exact (Integra) was approved by the FDA through the premarket approval process as a spine and cranial sealant (dura mater) and has been used off-label as a perirectal spacer.

Related medical policies – 

• Intensity-Modulated Radiotherapy (IMRT) of the Prostate

POLICY

Hydrogel spacer use during radiotherapy for prostate cancer is considered investigational.

Use of a hydrogel spacer for any other indication is investigational.

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.

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

07/18/2019: Approved by Medical Policy Advisory Committee.

02/18/2020: Policy description updated to remove information regarding treatment and perirectal spacers. Policy statements unchanged.

03/02/2021: Policy description updated regarding FDA approvals. Policy statements unchanged.

12/06/2021: Policy description updated regarding devices. Policy statements unchanged.

08/10/2022: Policy reviewed; no changes.

08/09/2023: Policy reviewed; no changes.

08/14/2024: Policy description updated regarding biomaterials and hydrogels. Policy statements unchanged.

09/11/2025: Policy description updated regarding prostate cancer. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.164

CODE REFERENCE

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

Investigational Codes

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