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Hydrogel Spacer use During Radiotherapy for Prostate Cancer

Policy Number: MP-724

 

DRAFT

Latest Review Date:  February 2019

Category:  Medical

Policy Grade:  B

 

POLICY:

Effective for dates of service on and after November 15, 2019:

Hydrogel spacer use during radiotherapy for prostate cancer is considered medically necessary when the following criteria are met:

  • Prostate cancer that is considered low or favorable intermediate risk
  • Tumor is confined to prostate
  • PSA <20
  • Gleason score ≤7
  • Prostate volume <80cm3
  • No prior hormone therapy or surgery or radiation of the prostate
  • No active bleeding disorder
  • Patient will be treated with a radiation source other than hadron or proton therapy

 

Hydrogel spacers are considered investigational in all other situations.

 

 

Effective for dates of service prior to November 15, 2019:

Hydrogel spacer use during radiotherapy for prostate cancer is considered not medically necessary and investigational.

 

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

 

 

DESCRIPTION OF PROCEDURE OR SERVICE:

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 (e.g., SpaceOAR System) have been evaluated as perirectal spacers.

 

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 cancer in men, with over one in ten 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, and 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 Table 1.

 

Table 1. Prostate Cancer Grading Systems

Grade Group

Gleason Score (Primary and Secondary Pattern)

Cells

1

6 or less

Well differentiated (low grade)

2

7 (3 + 4)

Moderately differentiated (moderate grade)

3

7 (4 + 3)

Poorly differentiated (high grade)

4

8

Undifferentiated (high grade)

5

9-10

Undifferentiated (high grade)

 

Treatment

Early localized disease can usually be treated with surgery and radiotherapy, although active surveillance may be adopted in men whose cancer is unlikely to cause major health problems during their lifespan or for whom the treatment might be dangerous. In patients with inoperable or metastatic disease, treatment consists of hormonal therapy and possibly chemotherapy. Treatment decisions are based on the anatomic extent of the lesion, the histologic grade from biopsy, and serum prostate-specific antigen level. Other factors in treatment decisions are expected outcomes, potential complications, along with medical condition, age, comorbidities, and personal preferences. For patients with clinically localized low-risk cancer (no palpable tumor and prostate-specific antigen of ten or less), active surveillance is an option. Definitive therapy with radical prostatectomy or radiation therapy (RT) with external beam and/or brachytherapy is also an option for low or intermediate risk disease. Dose escalation of RT improves cancer outcomes but also increases the risk of urinary or bowel toxicity. Image-guided RT and intensity-modulated RT may be used to limit margins and reduce toxicity but because the rectum lies in close proximity to the prostate, the risk of rectal toxicity remains high. Hypofractionation, dose escalation, and salvage RT protocols can be particularly prone to rectal toxicity.

 

Perirectal Spacers

One approach to the problem of rectal toxicity is to push the rectum away from the prostate, increasing the space between the two organs and reducing the radiation dose to the anterior rectal wall. A variety of biomaterials, including collagen, polyethylene glycol (PEG) hydrogels, and absorbable balloons have been evaluated as a means to reduce rectal radiation exposure. The SpaceOAR System is the first PEG hydrogel that was cleared by the U.S Food and Drug Administration specifically for use during RT of the prostate. The chemical composition of the SpaceOAR is similar to a PEG-based hydrogel that is Food and Drug Administration approved as a dural sealant. Hydrodissection is achieved with saline between the retroprostatic (Denonvilliers’) fascia and the anterior rectal wall using a transperineal approach. Once the needle placement is confirmed, two solutions in a two-channel syringe are injected into the perirectal space. The hydrogel then polymerizes to form a soft mass. The hydrogel maintains the space for approximately 3 months, the duration of radiotherapy, and is completely absorbed by 12 months. The PEG hydrogel may be injected at the same time as the placement of fiducial markers in the prostate.

 

 

Key Points:

The literature search was conducted through November 15, 2019.

 

Summary of Evidence

For individuals who have prostate cancer and are undergoing radiation therapy who receive a hydrogel spacer, the evidence includes a pivotal RCT with a three year follow-up. The relevant outcomes include symptoms, QOL, and treatment-related morbidity. The pivotal RCT indicates the hydrogel spacer can reduce the radiation dose to the rectum with a statistically significant decrease in Grade 1 or greater late toxicity and an NNT of 14.3. There were few events of greater than Grade 1 toxicity in either group. Patient-reported declines in rectal and urinary QOL at three years were statistically lower in the spacer group and met the threshold for a clinically significant difference, although it is not clear if patients were blinded to treatment at the longer-term follow-up. The NNTs for late improvement in rectal and urinary QOL were 6.3 to 6.7, respectively. The evidence is sufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

The National Comprehensive Cancer Network (V2:2018) provides the following recommendation in principles of radiation therapy:

 

“Perirectal spacer materials may be employed when the previously mentioned techniques [highly conformal RT, photon or proton beam, brachytherapy boost] are insufficient to improve oncologic cure rates and/or reduce side effects due to anatomic geometry or other patient-related factors, such as medication usage and/or comorbid conditions. Patients with obvious rectal invasion or visible T3 and posterior extension should not undergo perirectal spacer implantation.”

 

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2017) published guidance on the biodegradable spacer. The National Institute for Health and Care Excellence concluded that “current evidence on the safety and efficacy of insertion of a biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer is adequate to support the use of this procedure.”

 

American Society of Clinical Oncology, the American Urological Association, and the American Society for Radiation Oncology

The American Society of Clinical Oncology, the American Urological Association, and the American Society for Radiation Oncology (2018) published a joint guideline on hypofractionated radiation therapy for localized prostate cancer. The guideline recommends that men be counseled about the small increased risk of acute gastrointestinal toxicity with hypofractionation.

 

“Moderately fractionated EBRT has a similar risk of acute and late genitourinary and late GI toxicity compared with conventionally fractionated EBRT. However, physicians should discuss the limited follow-up beyond 5 years for most existing RCTs [randomized controlled trials] evaluating moderate hypofractionation.” This was a strong recommendation based on high-quality evidence and 100% consensus.

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

 

 

KEY WORDS:

Bulking agent, Polyethylene glycol hydrogel, PEG, Prostate cancer, radiation therapy, rectal protection, Spacing organs at risk, OAR, hydrogel, SpaceOAR

 

 

APPROVED BY GOVERNING BODIES:

In October 2014, SpaceOAR® (Augmenix, a subsidiary of Boston Scientific) was cleared by the Food and Drug Administration through the De Novo process (DEN140030). “SpaceOAR System is intended 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 SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.”

 

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

 

CURRENT CODING

CPT Codes:

 

 

55874

Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed. 

 

 

REFERENCES:

  1. Fischer-Valuck BW, Chundury A, Gay H, Bosch W, Michalski J. Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: Impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wall. Pract Radiat Oncol. May - Jun 2017;7(3):195-202. 
  2. Gleason DF. Classification of prostatic carcinomas. Cancer chemotherapy reports. Mar 1966;50(3):125-128.
  3. Hamstra DA, Mariados N, Sylvester J, et al. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys. Apr 1 2017;97(5):976-985. 
  4. Karsh LI, Gross ET, Pieczonka CM, et al. Absorbable hydrogel spacer use in prostate radiotherapy: A comprehensive review of phase 3 clinical published data. Urology. 2018 May; 115:39-44.
  5. Mariados N, Sylvester J, Shah D, et al. Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. Aug 1 2015;92(5):971-977.
  6. Morgan SC, Hoffman K, Loblaw DA, et al. Hypofractionated Radiation Therapy for Localized Prostate Cancer: An ASTRO, ASCO, and AUA Evidence-Based Guideline. J Urol. Oct 9 2018.
  7. National Cancer Institute. SEER Database. 2018; https://seer.cancer.gov/seerinquiry/index.php?page=view&id=20170036&type=q. Accessed October 26, 2018.
  8. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer V2:2018. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed December 17, 2018.
  9. National Institute for Health and Care Excellence. Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer. August 2017. Available at: https://www.nice.org.uk/guidance/ipg590/chapter/1-Recommendations
  10. Skolarus TA, Dunn RL, Sanda MG, et al. Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form. Urology. Jan 2015;85(1):101-105.

 

 

POLICY HISTORY:

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (4): Adopted new policy; however, spaceoar has been previously considered investigational.

Medical Policy Administration Committee, February 2019

Available for comment February 8, 2019 – March 25, 2019

Medical Policy Group, November 2019 (4):  Updated policy statements to allow coverage for spaceoar with criteria.

Medical Policy Administration Committee: December 2019

Available for Comment: November 15, 2019 – December 30, 2019

 

______________________________________________________________________________

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.