CurrentCignaPolicy N/A

Entadfi (finasteride + tadalafil) prior authorization for BPH

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Defines Cigna's prior authorization and medical necessity criteria for Entadfi for treatment of benign prostatic hyperplasia (BPH) in affected members; applies to prescription benefit coverage decisions.

Policy Summary

PayerCigna

PolicyEntadfi (finasteride + tadalafil) prior authorization for BPH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewDec 3, 2025

Next Review DateDec 3, 2025

Key ActionObtain prior authorization for Entadfi for BPH; approvals are authorized for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration for FDA-approved indication

≤26 weeksmax initiation duration per label

Requiredprior authorization

NCapplicable state

No criteria changes

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CurrentCignaPolicy N/A

Entadfi (finasteride + tadalafil) prior authorization for BPH

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Know when Cigna releases new policies or updates existing guidance.

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Policy Summary

PayerCigna

PolicyEntadfi (finasteride + tadalafil) prior authorization for BPH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewDec 3, 2025

Next Review DateDec 3, 2025

Key ActionObtain prior authorization for Entadfi for BPH; approvals are authorized for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration for FDA-approved indication

≤26 weeksmax initiation duration per label

Requiredprior authorization

NCapplicable state

No criteria changes

Coverage Criteria for Entadfi (finasteride + tadalafil)

FDA-Approved Indication (BPH)

Covered when ALL of the following are met:

FDA-Approved Indication: Diagnosis of benign prostatic hyperplasia (BPH)

Approve for 6 months per policy

Coverage for Entadfi is limited to the FDA-approved indication of benign prostatic hyperplasia (BPH). Prior authorization is required and approvals for the FDA-approved indication are authorized for 6 months. Entadfi is considered not medically necessary for uses outside the approved indication unless supported by clinical evidence; requests for non‑approved uses may be denied.

Entadfi is not medically necessary for use to treat erectile dysfunction in patients without benign prostatic hyperplasia. Entadfi is also not medically necessary for treatment of alopecia. (Finasteride 1 mg tablets remain the indicated therapy for male pattern hair loss.)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for prescription benefit coverage of Entadfi. Approvals for FDA-approved indications are authorized for 6 months (a month = 30 days). Providers must submit prior authorization requests in accordance with the member's benefit plan and Cigna utilization review submission standards.

Product: Entadfi (finasteride and tadalafil capsules)
Approved duration: 6 months (for FDA-approved BPH indication)
Month definition: 1 month = 30 days

Step Therapy

No step therapy sequencing requirements are specified for Entadfi in this policy.

Documentation Required

Required Documentation

Providers must submit requests and supporting documentation in accordance with the member's specific benefit plan and Cigna's utilization review standards. Ensure documentation supports the FDA‑approved indication (benign prostatic hyperplasia) or other uses only when supportive evidence is provided per policy.

Follow the applicable benefit plan document and utilization review submission requirements
Include clinical documentation demonstrating diagnosis of benign prostatic hyperplasia when requesting approval

Denial Risk

Denial Triggers

Authorization may be denied if prior authorization is not obtained when required, if the request is for uses outside the FDA‑approved indication (e.g., erectile dysfunction without BPH, alopecia), or if submitted documentation does not support medical necessity.

Denial triggers: lack of required prior authorization
Denial triggers: use outside FDA‑approved indication (Entadfi is approved for benign prostatic hyperplasia only)
Denial triggers: unsupported or insufficient clinical documentation

Background

Entadfi is a combination capsule containing finasteride 5 mg (a 5‑alpha‑reductase inhibitor) and tadalafil 5 mg (a phosphodiesterase‑5 inhibitor) indicated to initiate treatment of signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate. Product labeling limits initiation use to a maximum duration of ≤26 weeks because the incremental benefit of tadalafil diminishes after 4 to 26 weeks and is unknown beyond 26 weeks. Clinical guidance recognizes 5‑alpha‑reductase inhibitors for preventing BPH progression and lists daily tadalafil 5 mg as a treatment option.

Definitions

inv-09: Entadfi — combination capsule details and indicated use

Active ingredients and strengthsFinasteride 5 mg + Tadalafil 5 mg (combination capsule)

Drug classFinasteride: 5-alpha-reductase inhibitor; Tadalafil: phosphodiesterase 5 inhibitor

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

Recommended initiation duration per labelingUp to 26 weeks (initiation use only)

Limitation of useNot recommended for use beyond 26 weeks because incremental benefit of tadalafil is unknown after 26 weeks