Medical Policy: 07.01.69
Original Effective Date: July 2015
Reviewed: February 2018
Revised: February 2018
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Benign prostatic hyperplasia, or BPH, develops from excessive cell proliferation in the prostate. The enlarged gland has been proposed to contribute to the overall lower urinary tract symptoms (LUTS) complex via at least two routes: (1) direct bladder outlet obstruction from enlarged tissue and (2) from increased smooth muscle tone and resistance within the enlarged gland. The associated chronic bladder-outlet obstruction often leads to signs and symptoms. The frequent symptoms of BPH include: urinary retention, urinary frequency, incomplete bladder emptying, gross hematuria (visible blood in the urine), and renal insufficiency.
A questionnaire is often used to evaluate the severity of the condition. Several scoring systems have been developed to assess the subjective symptoms of BPH, including the American Urological Association (AUA) symptom index (SI). The AUA-SI test contains seven questions, and the resulting symptom score is from mild to severe. Each question is answered with a score ranging from 0 for none to 5 for severe. The symptom score (i.e., sum of the answers) is ranked as follows:
Lower urinary tract symptoms (LUTS) secondary to BPH (LUTS/BPH) is not often a life-threatening condition, the impact of LUTS/BPH on quality of life can be significant. The prevalence of LUTS increases with age, the burden and number of men complaining of LUTS will rise with the increasing life expectancy and growth of our elderly population. The treatment options include watchful waiting, medical, surgical, or minimally invasive surgical treatments.
If the patient has no polyuria and medical treatment is considered, the physician can proceed with therapy by focusing initially on modifiable factors such as concomitant drugs, regulation of fluid intake (especially in the evening), lifestyle (increasing activity) and diet (avoiding excess of alcohol and highly seasoned or irritating foods).
If pharmacological treatment is necessary, it is recommended that the patient be followed to assess treatment success and possible adverse events. The time from initiation of therapy to treatment assessment varies according to the pharmacological agent prescribed. This time frame can be as short as 3 weeks and as long as 3 months.
There are guidelines for the overall treatment of BPH from both the American Urological Society and The European Association of Urology, the key recommendations are noted below.
Per the American Urological Association guideline (2014):
In 2017, the European Association of Urology updated its guidelines. The recommendations with grades A from the guideline include:
|Can have surgery under anesthesia||Cannot have surgery under anesthesia|
|Can stop anticoagulations/antipalatelet therapy||Cannot stop anticoagulations/antipalatelet therapy||
|Qualifies as Low Risk Patient||Laser Vaporisation (Current standard/first choice. The alternative treatments are presented in alphabetic order.)|
|Prostate Volume < 30 ml||Prostate Volume 30-80 ml||Prostate Volume >80 ml|
(1) Current standard/first choice. The alternative treatments are presented in alphabetical order.
Notice: Readers are strongly recommended to read the full text that highlights the current position of each treatment in detail.
According to the Agency for Health Care Policy and Research guidelines for the diagnosis and treatment of BPH and the recommendations of the Second International Consultation on Benign Prostatic Hypertrophy, the absolute indications for primary surgical management of BPH are as follows:
The National Institute for Health and Care Excellence (NICE) published a technical guidance on prostatic lift procedures in 2016. NICE performed a literature search and data synthesis to support the development of the guidance. Studies selected were the same studies included in Perera et al (2015), except for the exclusion of Hoffman et al (2012) and the inclusion of Garrido Abad et al (2013) in the analysis. Comparators for the review were transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). When the literature search was performed, there were no studies directly comparing PUL with either TURP or HoLEP. Therefore NICE extracted data from a TURP vs HoLEP systematic review to perform a “pragmatic indirect comparison” of these comparators with prostatic lift procedures. Reviewers concluded that while PUL provided a significant improvement in IPSS, BPH-II, and quality of life, those improvements were smaller than those seen with TURP or HoLEP; however, it should be noted that the PUL procedure was associated with a slight improvement in erectile or ejaculatory function.
BPH/LUTS needs to be treated only if:
An enlarged prostate alone is not reason enough to get treatment. Your prostate may not get bigger than it is now, and your symptoms may not get worse. Watchful waiting is not an active treatment like taking medicine or having surgery. It means getting regular exams to see if your BPH is getting worse or causing problems. Without treatment, BPH symptoms may get better, stay the same, or get worse.
Many men with LUTS are not troubled enough by their symptoms to need drug treatment or surgical intervention. All men with LUTS should be formally assessed prior to any allocation of treatment in order to establish symptom severity and to differentiate between men with uncomplicated (the majority) and complicated LUTS. Watchful waiting is a viable option for many men with non-bothersome LUTS as few will progress to AUR and complications (e.g. renal insufficiency or stones), whilst others can remain stable for years. In one study, approximately 85% of men with mild LUTS were stable on WW at one year.
Medications for management of BPH should be the first line treatment in those that have bothersome symptoms but lack indications for immediate surgical intervention.
α1-blockers aim to inhibit the effect of endogenously released noradrenaline on smooth muscle cells in the prostate and thereby reduce prostate tone and bladder outlet obstruction. α1-adrenoceptors located outside the prostate (e.g. urinary bladder and/or spinal cord) and α1-adrenoceptor subtypes (α1B- or α1D-adrenoceptors) may play a role as mediators of effects. α1-adrenoceptors in blood vessels, other non-prostatic smooth muscle cells, and the central nervous system may mediate adverse events.
α1-blockers currently available are: alfuzosin hydrochloride (alfuzosin); doxazosin mesylate (doxazosin); silodosin; tamsulosin hydrochloride (tamsulosin); terazosin hydrochloride (terazosin).
5-Alpha-reductase Inhibitors (5-ARIs) may be used to prevent progression of LUTS secondary to BPH and to reduce the risk of urinary retention and future prostate-related surgery. There is evidence that prostate size can decrease by 20% at this stage and the risk for acute urinary retention is decreased by 50% after 4 years of therapy.
By itself, an enlarged prostate does not mean you need surgery. An enlarged prostate may not become larger. Also, no operation for BPH lowers the chance of getting prostate cancer in the future. Surgery may be indicated when medications fail to halt or improve bothersome symptoms of LUTS.
Surgery is generally recommended, as a first line treatment, for men with certain problems. These include:
Surgery without these indications is considered a second-line treatment after medication use.
TURP remains the gold standard for surgical correction of BPH. The studies have shown that although other surgeries are less invasive, the TURP and HoLEP laser have the best outcomes for relieving symptoms of BPH.
Transurethral resection of the prostate (TURP) is the gold standard for moderate to severe BPH, which does not respond to medical treatment. TURP involves an endoscopically guided surgical excision of prostate tissue using a cystoscope and electrodissection. The cystoscope is inserted up the urethra to remove prostate tissue that is blocking urine flow.
Transurethral microwave thermotherapy (TUMT) is a minimally invasive BPH treatment that uses heat to ablate obstructive prostatic tissue and reduce symptoms of the condition. This treatment often is used in patients who no longer respond to medication. During treatment, microwaves, which are radio waves varying from 1 mm to 30 cm in length, are delivered to the prostate via a probe inserted into the gland through the urethra. Intraprostatic temperature is monitored during microwave thermotherapy to reduce the risk for damage to surrounding structures. Following the procedure, patients usually require catheterization to prevent urinary retention.
TUNA is performed by placing interstitial radiofrequency (RF) needles through the urethra and into the lateral lobes of the prostate, causing heat-induced coagulation necrosis. The tissue is heated to 110°C at an RF power of 456 kHz for approximately 3 minutes per lesion. The ideal patient for TUNA is thought to be a man with obstructive symptoms and a prostate of 60 g or less with predominantly lateral lobes. TUNA results report a high retreatment rate at 20 months follow-up.
The manufacturer lists the following contraindications to TUNA therapy:
TUEP is a surgical procedure a spatula attached to a tungsten wire loop is used to dissect between the surgical capsule and adenoma by enucleation.
TUIP is a surgical procedure where a resectoscope is inserted through the tip of the penis into the urethra. One or two grooves are cut into the bladder 1neck to open the urinary channel, allowing urine to pass more easily.
TUVP is a surgical procedure which utilizes a loop electrode or grooved roller electrode which is attached to a resectoscope that applies heat from high-voltage electric current ablating obstructive prostatic tissue and sealing the surrounding blood vessels.
Laser prostatectomy and laser based procedures including contact laser ablation of the prostate (CLAP), holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP), photoselective laser vaporization (PVP), transurethral ultrasound-guided laser induced prostatectomy (TULIP), and visually-guided laser ablation of the prostate (VLAP) are minimally invasive techniques for management of BPH, when medications fail to improve symptoms. The current higher powered lasers—holmium laser, thulium laser, green light laser and diode laser—are able to ablate prostatic tissue rapidly. Holmium laser is optimized for incision, and green light laser is optimized for vaporization.
There is currently insufficient high-quality, comparative evidence to support the routine adoption of laser therapies in high-risk patients, that is those who:
The Prostatic UroLift (PUL), also known as the UroLift system or the transprostatic implant system has been researched for a less invasive procedure to manage BPH. The UroLift System received FDA authorization for marketing through a de novo classification approval on September 13, 2013 (K130651), as a Class II device. It is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above, with contraindications noted.
The PUL procedure consists of small permanent transprostatic implants, made with common implantable materials, (i.e., nitinol, stainless steel, and PET suture), placed cystoscopically to compress the prostate tissue, therefore increasing the urethral lumen and reducing obstruction to urine flow. Subsequently, 4 or 5 implants are delivered into the prostatic urethra to maintain urethral patency. A final cystoscopy confirms that the implants were appropriately positioned. The bladder is filled at the end of the procedure and the patient voids. This technique is proposed as an option for geno typical men who are poor candidates for more invasive procedures.
A medical technology guidance was completed (2015) and includes the following conclusions:
The Committee concluded that the UroLift system is effective in relieving symptoms of benign prostatic hyperplasia. It noted that the degree of symptom relief outcomes is slightly less than that after transurethral resection of the prostate (TURP) or holmium laser enucleation (HoLEP), but it is sufficient and clinically important. The Committee recognised that the duration of symptom relief after using the UroLift system is uncertain. It concluded that it is similar in the medium term (up to 3 years) to the comparators but that further evidence on durability and the need for subsequent procedures would be useful.
The Committee considered the evidence that the UroLift system does not damage sexual function to be convincing. This contrasts with a substantial risk to erectile and ejaculatory function after TURP or HoLEP and represents a significant advantage for men who wish to preserve their sexual function.
The Committee noted that evidence for avoiding catheterisation after the UroLift system was sparse, but accepted expert advice that catheterisation time would be reduced and in many cases catheterisation would be avoided, especially as surgeons gain experience with the procedure. It also concluded that it was reasonable and likely that the UroLift system would be used as a dayâ€‘surgery procedure, often under local anaesthetic.
Based on the day–surgery scenario in the cost model, and assuming a maximum of 4 implants are used, the Committee concluded that using the UroLift system is likely to be cost saving compared with TURP. However, the Committee also concluded that at the current costs of implants, using the system in an inpatient setting was likely to be more costly than either TURP or HoLEP.
The prostatic UroLift is a less invasive option to existing BPH treatments. The short term outcomes at 2 years note improvement in urinary symptoms and flow, with preserved sexual function. However, there are no long-term studies, which are necessary to determine the safety and efficacy of these implants, as well as the duration of benefits and the need for further procedures. There are a few ongoing Clinical Trials and studies that will continue to evaluate the Prostatic UroLift (PUL) procedure past 5 years.
The use of temporary prostatic stents has been proposed as treatment of urinary obstruction due to BPH, following surgical treatment of BPH or prostate cancer, or following radiation therapy. Intraprostatic stenting has been investigated as a short-term treatment option permitting voluntary urination as an alternative to an indwelling bladder catheter with an external collection system.
A temporary prostatic stent, The Spanner™ (SRS Medical, North Billerica, MA), received premarket approval (PMA) from the FDA based on a multicenter, prospective, randomized clinical trial designed to evaluate the safety and effectiveness of The Spanner to manage LUTS and bladder emptying following TUMT treatment after an initial period of catheterization. Based on the study results, the FDA indicates "The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization."
According to the guidelines by the American Urological Association "because prostatic stents are associated with significant complications, such as encrustation, infection and chronic pain, their placement should be considered only in high-risk patients, especially those with urinary retention".
Endoscopic balloon dilation for treatment of BPH involves the insertion of a balloon catheter tip through the urethra into the prostatic channel where it is inflated to stretch the urethra narrowed by the prostate. Based on the research, endoscopic balloon dilation has been inadequately studied with limited controlled trials, few long-term studies, and "a fallout in enthusiasm" for this treatment. The 4th International Consultation on BPH has rated balloon dilation as an unacceptable treatment option since 1995. The Guideline states “Balloon dilation is not recommended as a treatment option for patients with symptoms of BPH.”
In this procedure, the interventional radiologist will thread a tiny catheter through the artery in the groin to the arteries supplying blood to the prostate gland. The RIA Endovascular physician will then embolize, or cut off the blood flow to the prostate gland. The decreased blood flow causes the prostate gland to shrink, which helps to decrease the size of the prostate gland.
A National Institute for Health and Care Excellence interventional procedure guidance for prostatic arterial embolization for BPH states: Current evidence on the safety and efficacy of prostate artery embolization for benign prostatic hyperplasia is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.
Cryosurgical ablation (cryoablation or cryosurgery) involves exposing tissues to extreme cold in order to produce well-demarcated areas of cell injury and destruction. The tissue is usually cooled below -20 degrees C. The cold is usually produced by use of a probe containing liquid nitrogen. Cryosurgical ablation may be performed as an open surgical technique, percutaneously, or laparoscopically with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.
Cryosurgical ablation, although the gold standard for prostate cancer, does not have proven efficacy in the treatment of benign prostatic hyperplasia.
Plasma Kinetic Vaporization (i.e.The PlasmaKinetic™ Tissue Management System, PlasmaButton™, also called 'button TURP') uses plasma energy to vaporize tissue with minimal thermal spread.
The Aquablation System delivers a high-velocity saline stream (the AquaBeam®) under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. Using the real-time transrectal ultrasound image and an integrated planning station, the target region for excision is registered within the prostate and the target tissue contour and depth are programmed by the surgeon.
Transurethral ultrasound guided laser induced prostatectomy (TULIP) is similar to transurethral incision of the prostate (TUIP) except that cuts are made with a laser. Laser energy is delivered under ultrasound guidance, producing tissue necrosis.
Water-induced thermotherapy (i.e RezÅ«m System) delivers sterile water vapor (steam) transurethrally directly into hyperplastic tissue. Heat is released as the vapor condenses, causing cell death. The tissue is then either excreted through urine or reabsorbed in the body. The ongoing trials are not assessing how well the RezÅ«m System compares to other minimally invasive treatments for BPH, so no data are forthcoming to address the key question of comparative effectiveness.
Laser treatment has become an alternative to open prostatectomy for the treatment of benign prostatic hyperplasia (BPH). Laser-based procedures that have received U.S. Food and Drug Administration (FDA) approval include, but are not limited to, any of the following:
For treatment of BPH with High Intensity Focused Ultrasound (HIFU) see medical policy 02.01.53
For any interventional procedures to be considered medically necessary for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) there must be moderate or severe symptoms (AUA-SI score ≥8).
For any interventional procedures to be considered medically necessary for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) there must be either 1.) Indications for first line treatment as noted below or 2.) Failure of medication management for 6 months.
Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (eg, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (eg, finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (eg, darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (eg, tadalafil).
Medication would be considered first line treatment for all individuals that do not have the indications for immediate surgery as mentioned below.
Laser therapies and surgical procedures noted below are considered medically necessary as a first line treatment only when one of the following symptoms are present:
Surgical procedures below may be medically necessary as a second line treatment when patients have had insufficient relief in LUTS or post-void residual after consistent pharmacological therapy of 6 months:
Several minimally invasive prostate ablation procedures have been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, prostatic lift, and photoselective vaporization of the prostate. The minimally invasive procedures were individually compared with transurethral resection of the prostate at the time they were developed, which provided a general benchmark for evaluating those procedures.
Use of prostatic urethral lift in individuals with moderate-to-severe (AUA-SI score ≥8) lower urinary tract obstruction due to benign prostatic hyperplasia may be considered medically necessary when all of the following criteria are met:
Use of prostatic urethral lift in other situations is considered investigational.
Use of prostatic urethral lift outside of the above criteria is considered investigational because the population has not been sufficiently studied.
While the UroLift system has demonstrated clear strengths, specifically maintaining sexual function, it has limitations such as: the exclusion of patients with obstructive median lobes, the elimination of patients with larger prostate volumes and a history of urinary retention that eliminates a large proportion of patients. The conclusion of review is that the evidence is very low due to a small number of patients included in studies and that larger trials are needed to answer the question on comparative efficacy for PUL with other minimally invasive therapies. The long term cost effectiveness of PUL can be shown at this time up to five years when 4 or less implants are used per NICE cost-comparison. ECRI found the overall evidence of literature to be low or very low quality for all current trials comparing prosthetic urethral lift to transurethral resection of the prostate. The literature overall as a body of evidence maintain TURP and HoLEP laser as the gold standards for interventional treatment. That noted, prostatic urethral lift may be a minimally invasive solution for those concerned about sexual function side effects and the recovery time of other procedures.
The following laser procedures are considered medically necessary for BPH/LUTS after a 6 month trial of medication management for those with moderate to severe symptoms (AUA-SI score ≥8):
These therapies are considered investigational for all other genitourinary conditions.
Placement of temporary prostatic stents (53855)is considered investigational for all indications including, but not limited to, treatment of BPH/LUTS, following surgical treatment of BPH, prostate cancer, or radiation therapy.
The following procedures are considered investigational:
The American Urology Association’s updated Guideline on the Management of Benign Prostatic Hyperplasia (BPH) excludes a number of procedures from consideration in their treatment outcome analysis as there is insufficient and inadequate evidence available to make a recommendation for these procedures as a treatment alternative for an individual with moderate to severe symptoms of BPH. “The level of evidence regarding the safety and utility of endoscopic balloon dilation, cryosurgical ablation, HIFU ablation, and the placement of stents, including a lack of treatment outcome analysis for temporary prostatic stents, is insufficient to draw any conclusions.” Further studies are needed before determining the role of these treatments in the routine management of men with BPH.
Trials comparing minimally invasive treatments, including Prostatic arterial embolization (PAE), aquablation of the prostate, cryosurgical ablation, water-induced thermotherapy, plasma kinetic vaporization, high-intensity focused ultrasound, transrectal balloon dilation, thermal therapy, interstitial laser coagulation, and temporary prostatic stents, are needed to determine their long-term efficacy and superiority compared to standard treatments for BPH/LUTS.
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