CurrentCignaPolicy IP0519

Finasteride and tadalafil capsule (Entadfi) for Benign Prostatic Hyperplasia

Cigna coverage policy governing medical necessity, authorization, and reauthorization for Entadfi (finasteride 5 mg + tadalafil 5 mg) for treatment of benign prostatic hyperplasia (BPH) in men.

Policy Summary

PayerCigna

PolicyFinasteride and tadalafil capsule (Entadfi) for Benign Prostatic Hyperplasia

Policy CodePolicy IP0519

Change TypeNo material change

Effective Date3/15/2025

Next Review DateNot specified

Key ActionObtain documentation showing inability to take single-agent finasteride 5 mg and tadalafil 5 mg concurrently (may require prior authorization).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 12 monthsinitial authorization

up to 12 monthsreauthorization

26 weekslabel initiation limit

BPHindication covered

ED w/o BPHnot covered

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Entadfi for BPH initial coverage: 1) The prescription is for benign prostatic hyperplasia (BPH). 2) Documented inability to take single agent finasteride 5 mg and tadalafil 5 mg concurrently (may require prior authorization).

Receipt of sample product does not satisfy criteria requirements for coverage.

Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Reauthorization for Entadfi: 1) Initial medical necessity criteria continue to be met. 2) Documentation of beneficial response to therapy is provided.

Any use of Entadfi other than treatment of benign prostatic hyperplasia (BPH) is considered experimental, investigational, or unproven and may be denied. The policy explicitly excludes other indications and notes that uses outside of BPH are not covered.

Policy Summary

PayerCigna

PolicyFinasteride and tadalafil capsule (Entadfi) for Benign Prostatic Hyperplasia

Policy CodePolicy IP0519

Change TypeNo material change

Effective Date3/15/2025

Next Review DateNot specified

Key ActionObtain documentation showing inability to take single-agent finasteride 5 mg and tadalafil 5 mg concurrently (may require prior authorization).

SourceLink

On This Page

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Use of Entadfi for erectile dysfunction without benign prostatic hyperplasia and for alopecia is not indicated and is considered not covered / experimental. Specifically, Entadfi is not indicated for erectile dysfunction in patients who do not have BPH, and it is not indicated for treatment of alopecia.

Provider Actions & Requirements

Prior Authorization

Prior authorization may be required

May require prior authorization for coverage of Entadfi; the patient must have a documented inability to take single agent finasteride 5 mg and tadalafil 5 mg concurrently.

Step Therapy

Trial or inability of component agents required

Coverage is contingent on documentation that the patient cannot take the two component agents separately (finasteride 5 mg and tadalafil 5 mg).

Documentation Required

Required documentation for initial and reauthorization

Documentation must show the patient’s inability to take single agent finasteride 5 mg and tadalafil 5 mg concurrently. For reauthorization, provide documentation of a beneficial response to therapy.

Initial authorization: documented inability to take the two single-agent products concurrently.
Reauthorization: documentation of beneficial response is required.

Denial Risk

Non‑covered indications — ED and alopecia

Use of Entadfi for indications other than benign prostatic hyperplasia (for example, erectile dysfunction without BPH or alopecia) is considered experimental, investigational, or unproven and may be denied.

Erectile dysfunction without benign prostatic hyperplasia is not an indicated use.
Alopecia is not an indicated use for Entadfi.

Background

Entadfi is a fixed-dose combination product composed of finasteride 5 mg and tadalafil 5 mg. It is indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate; labeling limits initiation use and the product should be used for BPH rather than other conditions.

Definitions

Entadfi

Drug compositionFixed‑dose combination capsule containing finasteride 5 mg and tadalafil 5 mg.

IndicationIndicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Limitation of use (initiation)Use for initiation is limited to up to 26 weeks because the incremental benefit of tadalafil beyond 26 weeks is unknown.

Mechanism classesFinasteride: 5‑alpha‑reductase inhibitor; Tadalafil: phosphodiesterase‑5 (PDE5) inhibitor.

Labeling noteLimitation mirrors tadalafil labeling when used with finasteride for BPH initiation.