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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Entadfi (finasteride + tadalafil)
FDA-Approved Indication (BPH)
Covered when ALL of the following are met:
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 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.
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 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
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