DESCRIPTION
The prostatic urethral lift procedure (e.g., UroLift®) involves the insertion of one or more permanent implants into the prostate, which retract prostatic tissue and maintain an expanded urethral lumen. This procedure can be done with minimal sedation and is often performed in the office setting.
Benign prostatic hyperplasia (BPH) is a common disorder among older men that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. The normal prostate size for an adult male is 15cc to 30cc (one half ounce to one ounce). BPH prevalence increases with age and is present in more than 80% of men aged 70 to 79. The clinical manifestations of BPH include increased urinary frequency, urgency, nocturia, hesitancy, and weak stream. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection.
Evaluation and management of BPH includes evaluation for other causes of lower urinary tract dysfunction (e.g., prostate cancer). Symptom severity determines the therapeutic approach. Therapies available include oral medications, surgical ablative procedures, or transurethral resection of the prostate (TURP).
POLICY
The prostatic urethral lift procedure (e.g. UroLift®) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The prostatic urethral lift procedure (e.g. UroLift®) performed for all other diagnoses and as a repeat procedure is considered investigational.
MEDICAL APPROPRIATENESS
The prostatic urethral lift procedure is considered medically appropriate if ALL of the following criteria are met:
Age 45 years or older
Diagnosis of benign prostatic hyperplasia
Persistent (greater than 6 months) or progressive urinary outflow tract symptoms
Has failed, or is unable to tolerate medical therapy (e.g., α1-adrenergic antagonists, 5α-reductase inhibitors)
Prostate gland volume is less than or equal to 80ml
ABSENCE of ALL of the following:
Urethra conditions that may prevent insertion of delivery system
Urinary tract infection
Urinary incontinence
Current gross hematuria
Individual reports nickel, titanium, or stainless-steel allergy
Prior prostatic urethral lift procedure
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Two scores are widely used to evaluate BPH-related symptoms: the American Urological Association Symptom Index (AUASI); and the International Prostate Symptom Score (IPSS). The AUASI is a self-administered seven-item questionnaire assessing the severity of various urinary symptoms. Total AUASI scores range from 0 to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35). The IPSS incorporates questions from the AUASI and a quality of life question or a “Bother score.”
SOURCES
American Urological Association. (2021). Benign prostatic hyperplasia: management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline. Retrieved November 17, 2021 from https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline.
BlueCross BlueShield Association. Evidence Positioning System. (9:2022). Prostatic urethral lift (7.01.151). Retrieved September 20, 2023 from www.bcbsaoca.com/eps/. (47 articles and/or guidelines reviewed)
Eure, G., Gange, S., Walter, P., Khan, A., Chabert, C., Mueller, T., et al. (2019). Real-world evidence of prostatic urethral lift confirms pivotal clinical study results: 2-year outcomes of a retrospective multicenter study. Journal of Endourology, 33 (7), 576–584. (Level 4 evidence)
European Association of Urology. (2023, March). EAU guidelines on non-neurogenic male lower urinary tract symptoms (LUTS), incl. benign prostatic obstruction (BPO). Retrieved September 20, 2023 from http://uroweb.org/guideline.
Gratzke, C., Barber, N., Speakman, M., Berges, R., Weterauer, U., Greene, D., et al. (2017). Prostatic urethral lift vs transurethral resectin of the prostate: 2-year resuls of the BPH6 prospective, multicentre, randomized study. BJU International, 119 (5), 767-775. (Level 2 evidence)
Jing, J., Wu, Y., Du, M., Zhang, N., Wang, M., Xu, B., et al. (2020). Urethral lift as a safe and effective procedure for prostatic hyplasia population: A systematic review and meta-analysis. Frontiers In Surgery, doi: 10.3389/fsurg.2020.598728. (Level 1 evidence)
Madersbacher, S., Roehrborn, C G., & Oelke, M. (2023). The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia. BJU International, 126 (3), 317-326. Abstract retrieved September 20, 2023, from PubMed database.
McNicholas, T. A. (2016). Benign prostatic hyperplasia and new treatment options – a critical appraisal of the UroLift system. Medical Devices: Evidence and Research, 9, 115-123. (Level 2 evidence)
Miller, L. E., Chughtai, B., Dornbier, R. A., & McVary, K. T. (2020). Surgical reintervention rate after prostatic urethral lift: Systematic review and meta-analysis involving over 2,000 patients. The Journal of Urology, 204 (5), 1019–1026. Abstract retrieved August 10, 2022 from PubMed database.
National Institute for Health and Care Excellence. (2014, January). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. Retrieved July 7, 2017 from http://www.nice.org.uk.
National Institute for Health and Care Excellence. (2021, May). UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia. Retrieved August 5, 2022 from http://www.nice.org.uk.
Neotract. (2020, February). UroLift® Systems UL400 instructions for use. Retrieved July 20, 2021 from https://www.urolift.com.
Page, T., Veeratterapillay, R., Keltie, K., Burn, J., & Sims, A. (2021). Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics. BMC Urology, 21 (1), 55. (Level 4 evidence)
Perera, M., Roberts, M. J., Doi, S. A. & Bolton, D. (2015). Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systemic review and meta-analysis. European Urology, 67 (4), 704-713. Abstract retrieved September 28, 2016 from PubMed database.
Pushkaran, A., Stainer, V., Muir, G., & Shergill, I. (2017). Urolift - minimally invasive surgical BPH management. Expert Review of Medical Devices, 14 (3), 223-228. Abstract retrieved January 5, 2018 from PubMed database.
Roehrborn, C. G., Barkin, J., Gange, S. N., Shore, N. D., Giddens, J. L., Bolton, D.M., et al. (2017). Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Canadian Journal of Urology, 24 (3), 8802-8813. (Level 2 evidence)
Rukstalis, D., Rashid, P., Bogache, W., Tutrone, R., Barkin, J., Chin, P., et al. (2016). 24-month durability after crossover to the prostatic urethral lift from randomized, blinded sham. BJU International, 118 (3), 14-22. (Level 2 evidence)
Sánchez-Gómez, L. M., Polo-deSantos, M., Gómez-Sancha, F., & Luengo-Matos, S. (2015). Efficacy and safety of the UroLift® system for the treatment of benign prostate hyperplasia symptoms: systematic review. Actas Urologicas Espanolas, 39 (5), 311-319. Abstract retrieved September 28, 2016 from PubMed database.
Tanneru, K., Gautam, S., Norez, D., Kumar, J., Alam, M.U., Koocheckpour, S., et al. (2020). Meta-analysis and systematic review of intermediate-term follow-up of prostatic uretheral lift for benign prostatic hyperplasia. International Urology and Nephrology, 52 (6), 999-1008. Abstract retrieved July 21, 2021 from PubMed database.
U. S. Food and Drug Administration. (2017, December). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database. K173087 (UroLift®). Retrieved February 19, 2019 from http://www.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, June, last update search June 2023). Prostatic Urethral Lift (UroLift System) for treatment of symptoms associated with benign prostatic hyperplasia. Retrieved September 20, 2023 from www.Hayesinc.com/subscribers. (33 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/11/2016
MOST RECENT REVIEW DATE: 11/9/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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