CurrentPremera BluecrossPolicy 5.01.545_PBC

Pharmacologic Treatment of Benign Prostatic Hyperplasia

Defines pharmacy benefit coverage and prior authorization criteria for specified medications used to treat symptoms of benign prostatic hyperplasia (BPH) across all lines of business; documents drugs that require review, clinical criteria, length of approval, documentation requirements, quantity limits and exclusions.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Benign Prostatic Hyperplasia

Policy CodePolicy 5.01.545_PBC

Change TypeCriteria added, revised and removed (interim reviews)

Effective DateJan 1, 2026

Next Review DateJan 1, 2026

Key ActionProvide chart notes/medical records with prior authorization requests including diagnosis, relevant history, physical exam, and medication history.

POLICY UPDATE CHANGES

Added coverage criteria for Avodart (dutasteride), Chewtadzy (tadalafil), Flomax (tamsulosin), and Tezruly (terazosin).

Clarified quantity limit for Cialis (tadalafil) and generic tadalafil to 5 mg once daily and updated Cialis step therapy to require trial of generic tadalafil.

Removed coverage criteria for Cardura (doxazosin), Entadfi (finasteride and tadalafil), and Flomax (tamsulosin).

Clarified that non-formulary exception review authorizations for all drugs listed may be approved up to 12 months.

6Drugs with coverage criteria listed

5 mgTadalafil dose limit (daily)

12 monthsMax approval length

Coverage Summary

Policy Number: 5.01.545_PBC; Subject: Pharmacologic treatment of benign prostatic hyperplasia (BPH) - specific drugs. This policy defines pharmacy benefit coverage and prior authorization criteria for specified medications used to treat symptoms of benign prostatic hyperplasia (BPH) across all lines of business and is managed through the pharmacy benefit.

Covered pharmacologic classes summarized include alpha-adrenergic antagonists and 5-alpha reductase inhibitors. The policy also addresses PDE5 inhibitors (tadalafil) noting that tadalafil improves lower urinary tract symptoms (LUTS) in randomized trials but does not improve objective urodynamic measures such as peak urinary flow or postvoid residual. The scope includes drugs that require review, clinical criteria, length of approval, documentation requirements, quantity limits, and exclusions.

Policy quick facts

Cialis / generic tadalafil daily dose limit5 mg once daily

Tezruly dose limit10 mg once daily

Max approval length12 months

Drugs with coverage criteria listed6

Initial Therapy Criteria

Avodart (dutasteride) - Medical Necessity

Avodart (dutasteride) may be considered medically necessary when ALL the following conditions are met:

ALL of the following

ALL of the following
- The individual has a diagnosis of benign prostatic hyperplasia (BPH)
- Has tried and had an inadequate response or intolerance to a generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)
- Has tried and had an inadequate response or intolerance to generic finasteride, dutasteride, or silodosin

Cardura XL (doxazosin extended-release) - Medical Necessity

Continuation & Alternate Indications

Tezruly (terazosin oral solution) - Medical Necessity for Hypertension

Tezruly (terazosin) may be considered medically necessary for the treatment of hypertension when ALL the following conditions are met:

The individual has a diagnosis of hypertension

Has tried and had an inadequate response or intolerance to ALL of the following

Calcium channel blocker (e.g., amlodipine)
Angiotensin receptor blocker (e.g., losartan) OR angiotensin-converting enzyme inhibitor (e.g., lisinopril)
Diuretic (e.g., hydrochlorothiazide)

Exclusions / Not Covered

Per the policy history entry dated 01/01/26 (approved 12/22/2025), coverage criteria were removed for Cardura (doxazosin), Entadfi (finasteride and tadalafil), and Flomax (tamsulosin).

Implication: As of that history entry there are no policy coverage criteria listed for these agents (Cardura, Entadfi, Flomax) in this document; they were explicitly removed from the policy criteria.

Applicable Codes

Policy applies to pharmacy benefit - drugs listedNDC|mixed

No codes listed

Provider Actions

Prior Authorization

Prior authorization required with documentation

Documentation in the form of chart notes/medical records must be provided with prior authorization review. Records should include office visit notes with the diagnosis, relevant history, physical evaluation, and medication history to support medical necessity for the requested BPH agent.

Office visit notes with diagnosis
Relevant medical history
Physical evaluation findings
Medication history

Step Therapy

Step therapy / failure requirements

For many agents, members must have tried and had an inadequate response or intolerance to a generic alpha blocker. Additional drug-specific trial requirements apply (for example, Avodart requires prior trial and inadequate response or intolerance to generic finasteride, dutasteride, or silodosin).

Clinical Evidence

-1.3Avodart AUA-SI mean difference at 12 months (dutasteride vs placebo)

-2.1Avodart AUA-SI mean difference at 24 months (dutasteride vs placebo)

12-weekTadalafil primary trials duration: 12-week RCTs (with 1-year open-label extension)

Tadalafil 5 mg once daily demonstrated statistically and clinically significant improvement in IPSS in multiple 12-week randomized, double-blind, placebo-controlled trials, and a 1-year open-label extension suggests the effect is maintained longer-term.

For Avodart (dutasteride), pooled results show an AUA-SI (AUA-SI/IPSS) mean difference versus placebo of -1.3 at 12 months and -2.1 at 24 months in the pivotal studies.

Background & Definitions

This policy covers pharmacologic options for BPH consistent with AUA guidance, describing mechanism classes and management through the pharmacy benefit. Mechanism summaries: alpha-adrenergic antagonists block alpha-1 receptors in the prostate, bladder, and urethra to relax smooth muscle and improve urine flow and symptoms (they do not reduce prostate size); 5-alpha reductase inhibitors interfere with testosterone’s effect on prostate enlargement and reduce prostate size.

Management: the policy documents which medications need prior authorization, step therapy/failure requirements, quantity limits (e.g., tadalafil limited to 5 mg once daily for BPH), documentation requirements, and length of approval; the policy is managed through the pharmacy benefit and applies to all lines of business.

Revision History

2024-12-01added

Interim review (approved 11/12/2024) — updated title to 'Pharmacologic Treatment of Benign Prostatic Hyperplasia'; added coverage criteria for Avodart (dutasteride), Chewtadzy (tadalafil), Flomax (tamsulosin), and Tezruly (terazosin); clarified Cialis and generic tadalafil quantity limit to 5 mg once daily; updated Cialis and generic tadalafil step therapy requirements.

2025-03-01clarified

Annual review (approved 02/24/2025) — clarified that non-formulary exception review authorizations for all drugs listed in the policy may be approved up to 12 months and that medications are subject to FDA dosing and administration prescribing information.

2026-01-01removed

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Benign Prostatic Hyperplasia

Policy CodePolicy 5.01.545_PBC

Change TypeCriteria added, revised and removed (interim reviews)

Effective DateJan 1, 2026

Next Review DateJan 1, 2026

Key ActionProvide chart notes/medical records with prior authorization requests including diagnosis, relevant history, physical exam, and medication history.

On This Page

Cardura XL (doxazosin extended-release) may be considered medically necessary when ALL the following conditions are met:

ALL of the following

The individual has a diagnosis of benign prostatic hyperplasia (BPH)
Has tried and had an inadequate response or intolerance to a generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)
Has tried and had an inadequate response or intolerance to generic finasteride, dutasteride, or silodosin

Chewtadzy (tadalafil) / Cialis (tadalafil) - Medical Necessity

Chewtadzy (tadalafil) and Cialis (tadalafil) may be considered medically necessary as second-line treatment when ALL the following are met:

The individual has a diagnosis of benign prostatic hyperplasia (BPH)

Has tried and had an inadequate response or intolerance to a generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)

Has tried and had an inadequate response or intolerance to generic tadalafil

Dose limit: Dose is limited to 5 mg once daily5 mg once daily

Quantity limit clarified to 5 mg once daily; 10 mg and 20 mg formulations are indicated only for erectile dysfunction, not BPH.

Generic tadalafil - Medical Necessity

Generic tadalafil may be considered medically necessary as second-line treatment when ALL the following are met:

The individual has a diagnosis of benign prostatic hyperplasia (BPH)

Has tried and had an inadequate response or intolerance to a generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)

Dose limit: Dose is limited to 5 mg once daily5 mg once daily

10 mg and 20 mg tablets are for as-needed erectile dysfunction only, not BPH.

Tezruly (terazosin oral solution) - Medical Necessity for BPH

Tezruly (terazosin oral solution) may be considered medically necessary for BPH when ALL the following conditions are met:

ALL of the following

ONE of
- One generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)
- Generic finasteride, dutasteride, or silodosin
Documentation is provided that the oral solution is medically necessary (e.g., unable to swallow tablets or capsules)

Dose limit: Dose is limited to 10 mg once daily10 mg once daily

OR documentation is provided that the oral solution is medically necessary (e.g., unable to swallow tablets or capsules)

Re-authorization requires documentation (chart notes/medical records) showing the individual continues to demonstrate a positive clinical response to therapy. Initial and re-authorization approvals for non-formulary exception reviews and other reviews for listed drugs may be approved for up to 12 months.

The brief clarifies that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months, and re-authorization is contingent on meeting drug-specific criteria and documented continued benefit.

Generic alpha blocker trial required (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)
Avodart: prior trial of generic finasteride, dutasteride, or silodosin required

Billing Rule

Length of approval

Initial and re-authorization approvals for non-formulary exception reviews and other reviews for the listed drugs may be approved for up to 12 months. Re-authorization requires that drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response to therapy.

Documentation Required

Medication-specific FDA prescribing adherence

Approvals are constrained to the product's FDA dosing and administration prescribing information. For example, tadalafil 10 mg and 20 mg formulations are indicated only for erectile dysfunction and not for BPH; tadalafil for BPH is limited to 5 mg once daily.

Tadalafil dose limit for BPH: 5 mg once daily
10 mg and 20 mg tadalafil indicated only for erectile dysfunction, not BPH

Interim review (approved 12/22/2025) — removed coverage criteria for Cardura (doxazosin), Entadfi (finasteride and tadalafil), and Flomax (tamsulosin).