ModifiedPremera BluecrossPolicy N/A

Pharmacologic Treatment of Benign Prostatic Hyperplasia

This pharmacy policy defines prior authorization, medical necessity criteria, and coverage limits for tadalafil (brand and generic) and terazosin oral solution (Tezruly) for treatment of BPH, and notes exclusions and investigational uses. It applies to providers submitting pharmacy benefit requests.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Benign Prostatic Hyperplasia

Policy CodePolicy N/A

Change TypeMaterial revisions to title, step therapy, and product inclusions/removals

Effective DateJun 1, 2026

Next Review DateMay 25, 2026

Key ActionSubmit prior authorization with chart notes/medical records documenting diagnosis, prior therapy trials, and medication history to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Updated title from 'Tadalafil Products for Benign Prostatic Hyperplasia' to 'Pharmacologic Treatment of Benign Prostatic Hyperplasia'.

Added coverage criteria for Avodart (dutasteride), Chewtadzy (tadalafil), Flomax (tamsulosin), Tezruly (terazosin), Cardura (doxazosin) and Cardura XL (doxazosin extended-release) at various updates.

Clarified that the quantity limit for Cialis (tadalafil) and generic tadalafil is 5 mg once daily.

Updated step therapy requirements for Cialis (tadalafil) to require prior inadequate response or intolerance to a generic alpha blocker and generic tadalafil; updated generic tadalafil step therapy to require prior trial of a generic alpha blocker.

Removed coverage criteria for Chewtadzy (tadalafil), Avodart (dutasteride), Entadfi (finasteride and tadalafil), Cardura XL (doxazosin extended-release), Flomax (tamsulosin) and references to nonformulary exception reviews in 2026 and earlier updates.

3drugs with specific coverage criteria

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12 monthsmax approval length

5 mgtadalafil dose limit

requireddocumentation

2017-2026updates cited

Coverage and Medical Necessity Criteria

Cialis (tadalafil) — Medical Necessity

Cialis (tadalafil) 5 mg once daily may be considered medically necessary as second-line treatment for BPH when ALL the following are met:

Cialis BPH criteria: 1. Diagnosis of benign prostatic hyperplasia (BPH). 2. Tried and had an inadequate response or intolerance to a generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin). 3. Tried and had an inadequate response or intolerance to generic tadalafil. 4. Dose is limited to 5 mg once daily.dose <= 5 mg once daily

10 mg and 20 mg tablet formulations are indicated for as-needed use for erectile dysfunction only (ED).

Generic tadalafil — Medical Necessity

Generic tadalafil 5 mg once daily may be considered medically necessary as second-line treatment for BPH when ALL the following are met:

Generic tadalafil BPH criteria: 1. Diagnosis of benign prostatic hyperplasia (BPH). 2. Tried and had an inadequate response or intolerance to a generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin). 3. Dose is limited to 5 mg once daily.dose <= 5 mg once daily

10 mg and 20 mg tablet formulations are indicated for as-needed treatment of erectile dysfunction only and may be contract exclusions for ED-only use where applicable.

Tezruly (terazosin oral solution) — Medical Necessity for BPH

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

Tezruly BPH criteria: 1. Diagnosis of benign prostatic hyperplasia (BPH). AND 2. Either: (A) Has tried and had an inadequate response or intolerance to ALL of the following: one generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin) AND generic finasteride, dutasteride, or silodosin; OR (B) Documentation that the oral solution formulation is medically necessary (e.g., unable to swallow tablets or capsules). AND 3. Dose is limited to 10 mg once daily.dose <= 10 mg once daily

Oral solution pathway allows approval when swallowing impairment or other justification for solution formulation is documented.

Tezruly (terazosin) — Medical Necessity for Hypertension

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

Tezruly hypertension criteria: 1. Diagnosis of hypertension. AND 2. Either: (A) Has tried and had an inadequate response or intolerance to ALL of the following antihypertensive classes: a calcium channel blocker (e.g., amlodipine), an angiotensin receptor blocker (e.g., losartan) OR an angiotensin-converting enzyme inhibitor (e.g., lisinopril), and a diuretic (e.g., hydrochlorothiazide); OR (B) Documentation that the oral solution formulation is medically necessary (e.g., unable to swallow tablets or capsules).

When oral solution is justified, prior-trial requirements may be waived with documentation; dose limits for BPH are specified separately.

Extracted coverage statements and constraints

Documented coverage-related statements and constraints present in this portion of the policy include:

Quantity limit for tadalafil products: Cialis (tadalafil) and generic tadalafil quantity limited to 5 mg once daily.5 mg once daily

Clarified/added in 2024 updates.

Entadfi duration limit: Entadfi (finasteride + tadalafil) is not recommended for more than 26 weeks because the incremental benefit of tadalafil decreases after 4 weeks until 26 weeks and is unknown beyond 26 weeks.<= 26 weeks

Added in 2022 review.

Step therapy prior trials for Cialis: Prior inadequate response or intolerance required to a generic alpha blocker and generic tadalafil (per 2024 step therapy update).prior trial required

Use of tadalafil (brand or generic) solely for the treatment of erectile dysfunction in individuals without a diagnosis of benign prostatic hyperplasia is a contract exclusion and may be denied under benefits that exclude ED treatment. Requests for Cialis (tadalafil) or generic tadalafil for ED-only indications should be evaluated against the member's plan benefits and will be processed consistent with the exclusion described in the policy.

This exclusion applies regardless of formulation; note that the policy limits tadalafil for BPH to 5 mg once daily, whereas the 10 mg and 20 mg tablets are indicated for as‑needed ED use and are outside the covered dosing for BPH.

Product-specific coverage criteria that previously appeared in the policy have been removed when the product was discontinued or criteria were rescinded. Examples include removal of criteria for discontinued or rescinded listings such as Chewtadzy (tadalafil), Avodart (dutasteride), Cardura XL (doxazosin extended-release), and other products as reflected in the history of updates.

Providers should rely on the current policy's active product listings and criteria; historic product entries that were removed are no longer applicable for authorization decisions.

Use of Cialis (tadalafil), generic tadalafil, and Tezruly (terazosin) for any indications not supported by the product's US Food and Drug Administration prescribing information is considered investigational / not medically necessary under this policy. Prior authorization determinations will follow the FDA‑approved dosing and administration unless a specific, documented justification for an off‑label use consistent with member benefits is provided.

Documentation submitted for requests must support that the requested indication and dosing align with the product's FDA labeling; absent such support, the request may be denied as investigational.

An example of an unsupported indication is treatment of Duchenne muscular dystrophy. Randomized trial evidence cited in the policy found that tadalafil did not show benefit in reducing rate of ambulatory decline in individuals with Duchenne muscular dystrophy; consequently, use for this indication is not supported by the evidence reviewed and is considered investigational.

Requests for tadalafil for indications such as Duchenne muscular dystrophy should include high‑quality supporting evidence and will be evaluated against the policy statement that non‑FDA indications are investigational.

Coding and Billing

Codingmixed

No codes listed

Provider Requirements, Prior Authorization, and Utilization Management

Prior Authorization

Prior Authorization Required

Prior authorization is required for tadalafil products and Tezruly (terazosin) when used for treatment of benign prostatic hyperplasia (BPH). Approvals may be granted for up to 12 months for initial and re-authorization reviews when drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response.

Applies to Cialis (tadalafil), generic tadalafil, and Tezruly (terazosin)
Approvals up to 12 months for initial and re-authorization reviews

Step Therapy

Step Therapy and Quantity Limits

Step therapy requirements must be met prior to approval. For Cialis (tadalafil): member must have a diagnosis of BPH AND have tried and had an inadequate response or intolerance to a generic alpha blocker AND have tried and had an inadequate response or intolerance to generic tadalafil. For generic tadalafil: member must have a diagnosis of BPH AND have tried and had an inadequate response or intolerance to a generic alpha blocker. Dose for both Cialis and generic tadalafil is limited to 5 mg once daily.

Background and Definitions

Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate resulting from proliferation of epithelial and stromal cells and commonly causes lower urinary tract symptoms (LUTS) such as diminished urinary stream, urgency, nocturia, and incomplete bladder emptying. Medical treatment options typically include alpha blockers, 5‑alpha reductase inhibitors, and phosphodiesterase‑5 inhibitors among others.

Tadalafil 5 mg once daily has demonstrated short‑term improvement in symptom scores (e.g., IPSS) for men with LUTS/BPH but has limited effects on nocturia and urodynamic measures; treatment decisions should consider guideline recommendations, FDA‑approved indications, and individual patient factors.

BPH — definition and concise clinical description

DefinitionBenign prostatic hyperplasia (BPH) — noncancerous enlargement of the prostate due to epithelial and stromal cell proliferation that can cause lower urinary tract symptoms (LUTS) such as weak or slow urinary stream, sense of incomplete emptying, urgency, nocturia, and intermittency.

Clinical impactEnlarging prostate tissue can press on the urethra and bladder, producing obstructive and irritative LUTS; prevalence increases with age and is common in men over age 50.

Recommended medical therapies (AUA-recognized)Alpha-adrenergic antagonists, 5‑alpha reductase inhibitors, anticholinergics, and PDE5 inhibitors (tadalafil 5 mg daily is an AUA‑recognized option for LUTS/BPH).

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Benign Prostatic Hyperplasia

Policy CodePolicy N/A

Change TypeMaterial revisions to title, step therapy, and product inclusions/removals

Effective DateJun 1, 2026

Next Review DateMay 25, 2026

Key ActionSubmit prior authorization with chart notes/medical records documenting diagnosis, prior therapy trials, and medication history to support medical necessity.

SourceLink

On This Page

Step order revised in 2024.

Step therapy prior trials for generic tadalafil: Prior inadequate response or intolerance required to a generic alpha blocker (per 2024 step therapy update).prior trial required

Step order revised in 2024.

Product removals: Coverage criteria for products such as Chewtadzy (tadalafil), Avodart (dutasteride), Cardura XL (doxazosin extended-release), Entadfi, and Flomax (tamsulosin) were removed in subsequent updates.N/A

Products removed in 2025-2026 updates.

Cialis (tadalafil): requires prior trial of a generic alpha blocker and generic tadalafil
Generic tadalafil: requires prior trial of a generic alpha blocker
Quantity limit: 5 mg once daily for Cialis and generic tadalafil

Documentation Required

Required Documentation for Prior Authorization

Documentation in the form of chart notes/medical records must be submitted with prior authorization requests. Records should include diagnosis, relevant history, physical examination, and comprehensive medication history to demonstrate trials and inadequate response or intolerance to prior therapies.

Office visit notes with diagnosis and relevant history
Physical evaluation findings
Medication history documenting prior trials (generic alpha blocker, generic tadalafil, finasteride/dutasteride/silodosin where applicable)
Documentation of intolerance or inadequate response to prior therapies

Denial Risk

Denial Risk and Coverage Exclusions

Requests may be denied for use of tadalafil products for erectile dysfunction in individuals without BPH (contract exclusion), for failure to meet step therapy or documentation requirements, or for requests exceeding the quantity limit.

Use of tadalafil for ED without BPH is a contract exclusion and may be denied
Denial triggers: missing documentation of prior therapy trials or inadequate response/intolerance
Denial triggers: requests exceeding the 5 mg once daily quantity limit

Typical symptoms listedDiminished urine stream, intermittency, straining, polyuria, nocturia, urgency, and inability to empty the bladder.

IPSS — International Prostate Symptom Score as endpoint

DefinitionInternational Prostate Symptom Score (IPSS) — a validated questionnaire measuring severity of BPH‑related lower urinary tract symptoms; used as the primary efficacy endpoint in pivotal tadalafil trials.

Use in trialsPrimary efficacy endpoint in three 12‑week randomized, double‑blind, placebo‑controlled trials of tadalafil 5 mg once daily (change from baseline in total IPSS).

Scope measuredAssesses the spectrum of BPH symptoms; trials showed statistically and clinically significant improvements in IPSS after 12 weeks with tadalafil 5 mg once daily.

Entadfi — combination product and usage considerations

DefinitionEntadfi — fixed‑dose combination product of finasteride (a 5‑alpha‑reductase inhibitor) and tadalafil (a PDE5 inhibitor) for treatment of BPH symptoms.

Duration considerationNot recommended for more than 26 weeks because the incremental benefit of the tadalafil component decreases from 4 weeks until 26 weeks and the benefit beyond 26 weeks is unknown.

Mechanistic noteCombines a prostate‑size–reducing agent (finasteride) with a PDE5 inhibitor (tadalafil) intended to address both prostate growth and LUTS, but long‑term incremental benefit of the PDE5 component is uncertain beyond 26 weeks.