ModifiedPremera Blue Cross of WashingtonPolicy N/A

Optilume Drug-Coated Balloon Treatment for Urethral Stricture and BPH

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This policy addresses coverage of the Optilume urethral drug-coated balloon for recurrent bulbar urethral stricture in adult men and classifies other urethral uses and the Optilume BPH Catheter System as investigational.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyOptilume Drug-Coated Balloon Treatment for Urethral Stricture and BPH

Policy CodePolicy N/A

Change TypeNew policy

Effective DateFebruary 5, 2027

Next Review DateN/A

Key ActionSubmit documentation showing recurrent bulbar urethral stricture in an adult man, a stricture length of 3 cm or less, and failure of prior endoscopic treatment.

SourceLink

POLICY UPDATE CHANGES

A new policy was created stating that the Optilume urethral drug-coated balloon may be medically necessary for recurrent anterior bulbar urethral stricture in adult men when criteria are met.

The policy classifies the Optilume urethral drug-coated balloon as investigational for anterior urethral stricture in all other circumstances.

The policy classifies the Optilume BPH Catheter System as investigational for lower urinary tract symptoms secondary to benign prostatic hyperplasia.

≤3 cmMaximum covered stricture length

Adult menCovered patient population

3Investigational urethral circumstances

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ModifiedPremera Blue Cross of WashingtonPolicy N/A

Optilume Drug-Coated Balloon Treatment for Urethral Stricture and BPH

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Sign up for all premerabluecrossofwashington policy alerts

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyOptilume Drug-Coated Balloon Treatment for Urethral Stricture and BPH

Policy CodePolicy N/A

Change TypeNew policy

Effective DateFebruary 5, 2027

Next Review DateN/A

Key ActionSubmit documentation showing recurrent bulbar urethral stricture in an adult man, a stricture length of 3 cm or less, and failure of prior endoscopic treatment.

SourceLink

POLICY UPDATE CHANGES

A new policy was created stating that the Optilume urethral drug-coated balloon may be medically necessary for recurrent anterior bulbar urethral stricture in adult men when criteria are met.

The policy classifies the Optilume urethral drug-coated balloon as investigational for anterior urethral stricture in all other circumstances.

The policy classifies the Optilume BPH Catheter System as investigational for lower urinary tract symptoms secondary to benign prostatic hyperplasia.

≤3 cmMaximum covered stricture length

Adult menCovered patient population

3Investigational urethral circumstances

Medical Necessity and Investigational Criteria

Medical Necessity: Recurrent Bulbar Urethral Stricture

The Optilume urethral drug-coated balloon may be considered medically necessary for treatment of recurrent bulbar urethral stricture in adult men when ALL of the following criteria are met. Medical records submitted for review must document that the criteria are satisfied, including office visit notes with the relevant history and physical examination.

ALL of the following

The patient is an adult man.
The stricture is located in the bulbar urethra.
The stricture is 3 cm or less in length.<= 3 cm
The stricture is recurrent and prior endoscopic treatment has failed to treat the condition.
Documentation should identify the prior treatment that failed to treat the stricture.

Investigational: Other Optilume Urethral Drug-Coated Balloon Uses

The Optilume urethral drug-coated balloon is considered investigational when used for treatment of an anterior urethral stricture outside the covered medical-necessity indication for recurrent bulbar urethral stricture in an adult man with a stricture 3 cm or less in length and failed prior endoscopic treatment.

The use does not meet all medical-necessity criteria for recurrent bulbar urethral stricture.

Investigational: Optilume BPH Catheter System

The Optilume BPH Catheter System is considered investigational for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH).

The Optilume BPH Catheter System is used to treat lower urinary tract symptoms secondary to BPH.

Updated Medically Necessary Indication

The updated covered indication is limited to recurrent anterior (bulbar) urethral stricture in adult men when the medical-necessity criteria are met.

ALL of the following

The patient is an adult man.
The recurrent anterior urethral stricture is located in the bulbar urethra.
The medical-necessity criteria for treatment with the Optilume urethral drug-coated balloon are met.

Updated Investigational Classification: BPH Catheter System

The Optilume BPH Catheter System remains investigational for treatment of lower urinary tract symptoms secondary to BPH.

Use of the Optilume BPH Catheter System to treat lower urinary tract symptoms secondary to BPH is investigational.

Investigational: Other Urethral Stricture Uses

The Optilume urethral drug-coated balloon is considered investigational for treatment of anterior urethral stricture in all circumstances other than the covered recurrent bulbar urethral stricture indication.

ANY of the following circumstances

Treatment of a penile urethral stricture.
First-time or primary treatment of an anterior urethral stricture.
Repeated use of the Optilume urethral drug-coated balloon.
Any other treatment of an anterior urethral stricture that does not meet all covered medical-necessity criteria.

The following uses of the Optilume urethral drug-coated balloon are investigational: treatment of penile urethral stricture, first-time (primary) treatment, and repeated use of the device. These examples are not exhaustive; treatment of an anterior urethral stricture is investigational whenever the covered recurrent bulbar urethral stricture criteria are not met.

Treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia with the Optilume BPH Catheter System is investigational.

Both the Optilume urethral drug-coated balloon and the Optilume BPH Catheter System are contraindicated in patients with known hypersensitivity to paclitaxel or structurally related compounds and in the presence of an active urinary tract infection. Because paclitaxel is detectable in semen for a period after treatment, barrier contraception is advised for men whose partners may become pregnant.

Codes and Clinical Parameters

CPT CodesCPT

52284	Drug delivery using a drug-coated balloon for male treatment of urethral stricture using an endoscope.
52443	Cystourethroscopy with initial transurethral anterior prostate commissurotomy with a nondrug-coated balloon catheter followed by therapeutic drug delivery into the prostate by a drug-coated balloon catheter, including transrectal ultrasound and fluoroscopy, when performed.

HCPCS CodeHCPCS

C1889

Implantable/insertable device, not otherwise classified

Stricture Length

Recurrent bulbar urethral stricture length3 cm or less

AUA Guideline Parameters

Prostate volume20-80 cc

AUA Guideline Parameters

Prostatic urethral length32-55 mm

Documentation and Coverage Actions

Documentation Required

Optilume Urethral Eligibility

Document that the patient is an adult man with a recurrent bulbar urethral stricture and that all medical-necessity criteria are met before submitting Optilume urethral drug-coated balloon for review.

The stricture is located in the bulbar urethra.
The stricture is 3 cm or less in length.
The stricture is recurrent and has failed prior endoscopic treatment.

Documentation Required

Required Clinical Records

Submit office visit notes containing the relevant history and physical documentation to establish that Optilume is being used to treat recurrent bulbar urethral stricture and that the medical-necessity criteria are met.

Document the patient's adult male status and the diagnosis of recurrent bulbar urethral stricture.
Document stricture location and length, including that it is 3 cm or less.

Clinical Background

Urethral stricture disease is a fibrotic narrowing of the urethral lumen caused by scarring and spongiofibrosis. It commonly affects the anterior urethra, including the bulbar urethra, and may obstruct urine flow, resulting in lower urinary tract symptoms.

Key Terms

Anterior Urethral Stricture

DefinitionA fibrotic narrowing of the urethral lumen caused by scarring of the surrounding corpus spongiosum (spongiofibrosis).

Included segmentsMeatus, fossa navicularis, pendulous (penile) urethra, and bulbar urethra.

Optilume Drug-Coated Balloon

Device definitionA dual-lumen, over-the-wire balloon catheter platform with a semi-compliant balloon coated with paclitaxel along its working length.

MechanismCombines mechanical dilation with localized delivery of paclitaxel, an antiproliferative and antifibrotic agent, to inhibit fibroblast proliferation and reduce scar re-formation.

Benign Prostatic Hyperplasia