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Medical Policy

Policy Num:      07.001.027
Policy Name:    Transurethral destruction Of Prostate Tissue Using Microwave Thermotherapy
Policy ID           [07.001.027]  [Ar / L / M+ / P-]  [0.00.00]

Last Review:    June 23, 2023
Next Review:    Policy Archived
 

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Related Policies: None

Transurethral destruction Of Prostate Tissue Using Microwave Thermotherapy

summary

Transurethral destruction of prostate tissue by microwave therapy is an alternative to transurethral resection of the prostate (TURP) for patients suffering from benign prostatic hyperplasia. The purpose of microwave thermotherapy is the destruction of the prostatic adenoma in the lateral lobes of the prostate, to improve the symptoms and the elimination of urine. This technology involves placing a catheter containing a microwave antenna at the level of the prostate and limiting microwave radiation at this level. Water is circulated in the catheter to cool the urethra. A Foley-type balloon is inflated at the end of the catheter to control the position of the catheter. Fiberoptic sensors monitor the temperature of the rectum and urethra. Electromagnetic waves emit high-energy photons that interact with prostate tissue, producing heat.

Microwave thermotherapy produces coagulation necrosis in the lateral lobes of the prostate up to a distance of 17mm from the urethra, preserving the urethral surface, distal sphincter, urethral mucosa, bladder neck, and prostatic periphery.

Objective

Policy Statement

Transurethral destruction of prostate tissue as a treatment for benign prostatic hyperplasia by microwave therapy is considered for payment in those patients who, based on the severity of their symptoms, would be candidates for a transurethral resection of the prostate.

Policy Guidelines

I. Based upon our criteria and assessment of peer-reviewed literature, transurethral microwave thermotherapy for BPH has been medically proven to be effective and is medically appropriate as a treatment option for patients who would be candidates for transurethral resection based on the severity of their BPH symptoms when the following criteria have been met:

A. prostatic length of 30-55 mm (the prostate size should meet the labeled indications of the specific device used for TUMT); AND

B. patient must have failed medical therapy prior to proceeding with TUMT.

II. Based upon our criteria and assessment of peer-reviewed literature, transurethral microwave thermotherapy, as yet, has not demonstrated a benefit to patient outcomes and is considered not medically necessary for the treatment of other prostatic conditions (e.g., prostate cancer, chronic prostatitis).

III. Contraindications: A. Patients who have large prostate glands (greater than 5.5 cm in length or greater than 70 g in volume), medium lobe enlargement or bladder neck stenosis;

B. Patients with metallic implants (e.g., artificial joints, pacemaker);

C. Patients with bladder or prostate carcinoma;

D. Patients with a history of previous prostate surgery or pelvic radiation therapy;

E. Penile implants;

F. Neurologic disorders that may influence bladder function;

G. Neurogenic bladder;

H. Diabetic neuropathy; or

I. Urethral stricture.

Benefit Application

BlueCard/National Account Issues

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  

Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate gland that is common in men over age 50. The enlarged prostate gland presses against the urethra, the tube that carries urine from the bladder to the outside of the body. BPH can lead to symptoms, like urinary frequency, urgency, and waking up at night to urinate. BPH is treated with watchful waiting, lifestyle changes, medication, and surgery (transurethral resection of the prostate, or TURP). Alternative treatments for BPH are transurethral water vapor thermal therapy and aquablation. Water vapor thermal therapy is a minimally invasive surgery that uses heated water vapor to remove the prostate tissue that is blocking the urethra. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. Transurethral water vapor thermal therapy and aquablation for the treatment of benign prostatic hyperplasia are unproven (investigational). More studies are needed to see if these treatments are as good or better than proven methods of treating BPH.

Rationale

Evidence from clinical trials demonstrates that TUMT provides relief of lower urinary symptoms comparable to TURP without the need for inpatient hospitalization or general/spinal anesthesia. TUMT also provides significantly greater improvement of lower urinary tract symptoms when compared to medication therapy. TUMT produces fewer major  harmful complications (bleeding, impotence, incontinence, TUR syndrome) than TURP. Symptom relief and voiding improvement have proven to be durable up to 3-4 years after TUMT.

The FDA has approved several microwave thermotherapy devices for the treatment of BPH. These include Prostatron (Edap Technomed, Inc), CoreThermTM (ProstaLund), ProlieveTM (Celsion), Targis (Urologix Inc), Urowave System (Dornier Medical Systems) and TherMatrx® (TherMatrx Inc). The FDA recommends that prostate size should meet the label indications of the specific device used for transurethral microwave therapy. Safety and efficacy of this technology for other prostatic conditions (e.g., prostatic carcinoma) have not been established in clinical trials.

Population Reference No. 1 

Based upon our criteria and assessment of peer-reviewed literature, transurethral microwave thermotherapy for BPH has been medically proven to be effective and is medically appropriate as a treatment option for patients who would be candidates for transurethral resection based on the severity of their BPH symptoms when the following criteria have been met: A. prostatic length of 30-55 mm (the prostate size should meet the labeled indications of the specific device used for TUMT); AND B. patient must have failed medical therapy prior to proceeding with TUMT.

Suplemental Information

N/A

References

1. Petrovich Z, Ameye F, Baert L et al. New trends in the treatment of benign prostatic hyperplasia and carcinoma of the prostate. Am J Clin Oncol 1993; 16(3):187-200.

2. Mebust WK, Holtgrewe HL, Cockett AT et al. Transurethral prostatectomy: immediate and postoperative complications. Cooperative study of 13 participating institutions evaluating 3,885 patients. J Urol, 141: 243-247, 1989. J Urol 2002; 167  (1):5-9.

3. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data: ProstaLund® CoreTherm™. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010055b.pdf. Last accessed July, 2013.

4. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data: Prolieve™ Thermodilatation System (Prolieve ™). Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030006b.pdf. Last accessed July, 2013.

5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). TEC Assessment. 1996; (Tab 19).

6. Hoffman RM, Monga M, Elliott SP et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev 2012; 9:CD004135.

7. Biester K, Skipka G, Jahn R et al. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int 2012; 109(5):722-30.

8. Sponsored by Boston Scientific Corporation. Prolieve® Post-Marketing Study: Treatment of Benign Prostatic Hyperplasia (BPH) (NCT00407953). Available online at: www.clinicaltrials.gov. Last accessed June, 2013.

9. American Urological Association. Management of BPH, revised 2010. Available online at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm. Last accessed June, 2013.

10. European Association of Urology. Guidelines on the treatment of non-neurogenic male LUTS. 2011. Available online at: www.guideline.gov. Last accessed June, 2013.

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Policy History