CurrentCignaPolicy IP0519

Benign Prostatic Hyperplasia - Entadfi

This Cigna coverage policy governs prior authorization and coverage criteria for Entadfi (finasteride 5 mg + tadalafil 5 mg) to initiate treatment of benign prostatic hyperplasia (BPH) in adult men with enlarged prostate, and specifies approved duration and noncovered uses.

Policy Summary

PayerCigna

PolicyBenign Prostatic Hyperplasia - Entadfi

Policy CodePolicy IP0519

Change TypeRevised approval durationupdated prescriber rationale requirement

Effective DateThe policy effective date is in force until updated or retired.

Next Review Date

Key ActionObtain prior authorization and document a prescriber-stated clinical reason the patient cannot take the component drugs separately; approvals are limited to 6 months.

SourceLink

POLICY UPDATE CHANGES

Updated approval duration from 12 months to 6 months.

Updated preferred product table language to require prescriber statement that patient cannot take finasteride 5 mg and tadalafil 5 mg as separate agents.

Updated policy title from 'Entadfi (finasteride and tadalafil)' to 'Benign Prostatic Hyperplasia - Entadfi'.

6 monthsapproval duration for FDA-approved indication

26 weeksmaximum recommended initiation period

1not-covered: ED without BPH

1not-covered: alopecia

IP0519Coverage Policy Number

Coverage and Medical Necessity Criteria

Initial therapy (FDA-approved indication)

Approve Entadfi for treatment of benign prostatic hyperplasia when ALL of the following are met:

FDA-approved indication: Patient has a diagnosis of benign prostatic hyperplasia (BPH) and is initiating treatment for signs and symptoms of BPH in men with an enlarged prostate.

Based on Entadfi labeling and FDA‑Approved Indication.

Duration: Approval limited to 6 months for the FDA‑approved indication.6 months

Policy approval duration; labeling notes initiation limit up to 26 weeks.

Preferred product criteria: For Employer and Individual/Family plans, the prescriber states the patient has a clinical reason they cannot take finasteride 5 mg and tadalafil 5 mg as separate agents.

Policy Summary

PayerCigna

PolicyBenign Prostatic Hyperplasia - Entadfi

Policy CodePolicy IP0519

Change TypeRevised approval durationupdated prescriber rationale requirement

Effective DateThe policy effective date is in force until updated or retired.

Next Review Date

Key ActionObtain prior authorization and document a prescriber-stated clinical reason the patient cannot take the component drugs separately; approvals are limited to 6 months.

SourceLink

On This Page

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Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Entadfi. All approvals are provided for the duration noted in the policy (approve for 6 months if patient meets criteria). In cases where the approval is authorized in months, 1 month is equal to 30 days.

Approval duration: 6 months when criteria are met

Documentation Required

Prescriber Justification for Combination Product — Employer Plans

For Employer Plans, Entadfi will be considered only when the prescriber indicates a clinical reason the patient cannot take finasteride 5 mg and tadalafil 5 mg as separate agents. This prescriber justification may functionally act as a step before approval and may require prior authorization documentation.

Product: Entadfi (finasteride and tadalafil capsules - Veru)
Requirement: Prescriber must state clinical reason patient cannot take component drugs separately

Documentation Required

Prescriber Clinical Rationale Required — Individual and Family Plans

For Individual and Family Plans, prior authorization requires the prescriber to state a clinical reason the patient cannot take the component drugs separately as part of the authorization request.

Product: Entadfi (finasteride and tadalafil capsules - Veru)
Requirement: Prescriber must state clinical reason patient cannot take component drugs separately

Billing Rule

Billing / Code Mismatch Denial Risk

Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of the submission.

Claims lacking covered diagnosis/procedure codes per this Coverage Policy will be denied as not covered
Use most appropriate codes as of date of submission

Key Definitions

Entadfi (finasteride 5 mg + tadalafil 5 mg) — definition and indicated use

Generic compositionCombination capsule containing finasteride 5 mg (a 5‑alpha‑reductase inhibitor) and tadalafil 5 mg (a phosphodiesterase‑5 inhibitor)

Indicated useInitiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate

Label limitation of useUse for initiation limited to up to 26 weeks because incremental benefit of tadalafil decreases after 4–26 weeks and is unknown beyond 26 weeks

Treatment populationAdult men with enlarged prostate experiencing signs and symptoms of BPH

Policy scope summaryThis policy governs prior authorization and coverage criteria for Entadfi (finasteride 5 mg + tadalafil 5 mg) to initiate BPH treatment

OpenPayer

Benign Prostatic Hyperplasia - Entadfi

Coverage and Medical Necessity Criteria

Provider Requirements, Prior Authorization, and Billing

Key Definitions

Background and Drug Information