Focal Treatments for Prostate Cancer

POLICY NUMBER

A.8.01.61

DESCRIPTION

Prostate cancer is the second most common cancer diagnosis men receive in the United States, and the behavior of localized prostate cancer can prove difficult to predict on a case-by-case basis. Most men with prostate cancer undergo whole-gland treatments, which can often lead to substantial adverse events. To reduce tumor burden and minimize morbidity associated with radical treatment, investigators have developed a therapy known as focal treatment. Focal treatment seeks to ablate either an “index” lesion (defined as the largest cancerous lesion with the highest grade tumor), or alternatively, to ablate nonindex lesions and other areas where cancer has been known to occur. Addressed in this policy are several ablative methods used to remove cancerous lesions in localized prostate cancer (eg, focal laser ablation, high-intensity focused ultrasound, cryoablation, radiofrequency ablation, photodynamic therapy, irreversible electroporation).

Prostate Cancer

Prostate cancer is the second most common cancer diagnosed among men in the United States. According to the National Cancer Institute, nearly 268,490 new cases are estimated to be diagnosed in the United States in 2022, associated with around 34,500 deaths. Prostate cancer is more likely to develop in older men and in non-Hispanic Black men. About 6 in 10 cases are diagnosed in men who are ≥65 years of age, and it is rare in men <40 years of age. Autopsy studies in the pre-prostate-specific antigen (PSA) screening era identified incidental cancerous foci in 30% of men 50 years of age, with incidence reaching 75% at age 80 years. However, the National Cancer Institute Surveillance Epidemiology and End Results Program data have shown that age-adjusted cancer-specific mortality rates for men with prostate cancer declined from 40 per 100,000 in 1992 to 19 per 100,000 in 2018. This decline has been attributed to a combination of earlier detection via PSA screening and improved therapies.

Focal Treatments for Localized Prostate Cancer

Given significant uncertainty in predicting the behavior of individual localized prostate cancers, and the substantial adverse events associated with definitive treatments, investigators have sought a therapeutic middle ground. The latter seeks to minimize morbidity associated with radical treatment in those who may not actually require surgery while reducing tumor burden to an extent that reduces the chances for rapid progression to incurability. This approach is termed focal treatment, in that it seeks to remove, using any of several ablative methods described next, cancerous lesions at high-risk of progression, leaving behind uninvolved glandular parenchyma. The overall goal of any focal treatment is to minimize the risk of early tumor progression and preserve erectile, urinary, and rectal functions by reducing damage to the neurovascular bundles, external sphincter, bladder neck, and rectum.

Modalities Used to Ablate Lesions

Five ablative methods for which clinical evidence is available are considered in this policy: Focal Laser Ablation; High-Intensity Focused Ultrasound; Cryoablation; Radiofrequency Ablation; Photodynamic Therapy and Irreversible Electroporation. Each method requires placement of a needle probe into a tumor volume followed by delivery of some type of energy that destroys the tissue in a controlled manner. All methods except focal laser ablation currently rely on ultrasound guidance to the tumor focus of interest; focal laser ablation uses MRI to guide the probe. This policy does not cover focal brachytherapy (see the Brachytherapy for Clinically Localized Prostate Cancer Using Permanently Implanted Seeds medical policy).

Focal Laser Ablation

In 2010, the Visualase® Thermal Therapy System (Medtronic) and, in 2015, the TRANBERG® CLS|Laser fiber (Clinical Laserthermia Systems) were cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging guidance for multiple indications including urology, at wavelengths from 800 nm to 1064 nm. In 2020, the FDA cleared the Avenda Health focal laser ablation system and in 2021, the FDA granted a breakthrough device designation for the Avenda artificial intelligence (AI)-enabled focal therapy system for the treatment of localized prostate cancer. In 2023, FDA cleared the Elesta Laser Thermal Therapy Kit to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery including urology, at a wavelength of 1064nm. FDA product code: LLZ, GEX, FRN.

High-Intensity Focused Ultrasound

In October 2015, the Sonablate® 450 (SonaCare Medical) was cleared for marketing through the 510(k) process after approval of a de novo request and classification as class II under the generic name “high intensity ultrasound system for prostate tissue ablation.” This device was the first of its kind to be approved in the United States. In November 2015, Ablatherm®-HIFU (EDAP TMS), was cleared for marketing by the FDA through the 510(k) process. In June 2018, EDAP received 510(k) clearance for its Focal-One® HIFU device designed for prostate tissue ablation procedures. This device fuses magnetic resonance and 3D biopsy data with real-time ultrasound imaging, allowing urologists to view detailed images of the prostate on a large monitor and direct high-intensity ultrasound waves to ablate the targeted area.

Cryoablation

Some cryoablation devices cleared for marketing by the FDA through the 510(k) process for cryoablation of the prostate include Visual-ICE® (Galil Medical), Ice Rod CX, CryoCare® (Galil Medical), IceSphere (Galil Medical), and Cryocare® Systems (Endocare®; HealthTronics). FDA product code: GEH.

Radiofrequency Ablation

Radiofrequency ablation devices have been cleared for marketing by the FDA through the 510(k) process for general use for soft tissue cutting and coagulation and ablation by thermal coagulation. Under this general indication, radiofrequency ablation may be used to ablate tumors. FDA product code: GEI.

Photodynamic Therapy

The FDA has granted approval to several photosensitizing drugs and light applicators. porfirmer sodium (Photofrin®; Axcan Pharma) and psoralen are photosensitizer ultraviolet lamps used to treat cancer; they were cleared for marketing by the FDA through the 510(k) process. FDA product code: FTC.

In 2020, an FDA advisory committee voted against recommending approval of padeliporfin di-potassium (Tookad®; Steba Biotech), a minimally invasive photodynamic therapy for localized prostate cancer, citing concerns that men with very low-risk disease would potentially choose this therapy instead of active surveillance, despite the unproven long-term benefits and harms of treatment.

Magnetic Nanoparticles

MagForce® USA, Inc. is conducting a clinical study evaluating NanoTherm® under an FDA Investigational Device Exemption (IDE) (NCT05010759). NanoTherm uses magnetic nanoparticles and an alternating magnetic field to create heat and local ablation in the ablation of prostate cancer.

Irreversible electroporation

The NanoKnife System was cleared through the 510(k) process (K102329) in 2011 for the surgical ablation of soft tissue. NanoKnife has not received clearance for the treatment of any specific disease.

Related medical policies –

• Whole Gland Cryoablation of Prostate Cancer

• Magnetic Resonance-Guided Focused Ultrasound

• Saturation Biopsy for Diagnosis, Staging, and Management of Prostate Cancer

• Brachytherapy for Clinically Localized Prostate Cancer Using Permanently

  Implanted Seeds

POLICY

Use of any focal therapy modality to treat individuals with localized prostate cancer 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

07/16/2015: Approved by Medical Policy Advisory Committee.

11/10/2015: Policy description updated to add section headings. Policy statement unchanged.

05/26/2016: Policy number A.8.01.61 added.

12/30/2016: Policy description updated regarding ablative methods and devices. Policy statement unchanged. Code Reference section updated to add CPT code 55899.

10/20/2017: Policy description updated regarding localized prostate cancer. Policy statement unchanged.

05/24/2018: Medical policy links updated.

11/09/2018: Policy description updated. Policy statement unchanged.

11/05/2019: Policy reviewed; no changes.

10/16/2020: Policy description updated regarding devices. Policy statement unchanged.

12/16/2020: Code Reference section updated to add new CPT code 55880, effective 01/01/2021.

06/18/2021: Code Reference section updated to add new CPT code 0655T, effective 07/01/2021.

01/12/2022: Policy description updated regarding new prostate cancer data and devices. Policy statement unchanged.

12/06/2022: Policy description updated regarding new data for prostate cancer. Policy statement updated to change "patients" to "individuals."

02/15/2024: Policy description updated regarding magnetic nanoparticles and related medical policies. Policy statement unchanged. Code Reference section updated to add CPT code 0739T.

12/18/2024: Code Reference section updated to add new CPT codes 51721, 55881, and 55882 effective 01/01/2025.

03/07/2025: Policy description updated regarding focal laser ablation and modalities used to ablate lesions. Policy statement unchanged. Code Reference section updated to add CPT codes 0600T and 0601T.

07/18/2025: Code Reference section updated to add new CPT code 0950T. Effective 07/01/2025.

01/01/2026: Code Reference section updated to add new CPT code 55877.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 8.01.61

CODE REFERENCE

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

Investigational Codes

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