Pharmacy Prior Authorization Criteria

BPH Agents

For diagnosis of Benign prostatic hyperplasia (BPH)
Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Cardura XL is NOT indicated for the treatment of hypertension.

For diagnosis of Benign prostatic hyperplasia (BPH)
Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks. Limitations of Use: Entadfi is not recommended for more than 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit beyond 26 weeks is unknown.

Step Therapy

Length of Approval: 12 Month(s)

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

Trial and failure (minimum 30 days supply), contraindication, or intolerance to any TWO of the following generics: [2]

Step Therapy

Length of Approval: 26 weeks [A, 2]

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

Trial and failure (minimum 30 days supply), contraindication, or intolerance to any ONE of the following generics: [B, 3]

AND

Trial and failure, contraindication, or intolerance to any ONE of the following:

2024-01-06, 2023-01-11, 2022-09-19, 2022-01-07, 2021-02-03, 2020-01-22

Cardura XL prescribing information. Pfizer, Inc. New York, New York. June 2021.
Entadfi prescribing information. Veru Inc. Miami, FL. December 2021.
The American Urological Association. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I—Initial Work-up and Medical Management. Guideline 2021. Available at: https://www.auajournals.org/doi/10.1097/JU.0000000000002183. Accessed September 9, 2022.

Limitations of Use: Entadfi is not recommended for more than 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit beyond 26 weeks is unknown. [2]
Attempts to identify subgroups of patients who may respond better to one alpha- blocker or another have not shown differences in efficacy. Given that medication type and patient characteristics do not impact effectiveness, it is not recommended to switch between various options for insufficient response. However, changing from one alpha- blocker to another on the basis of a side effect is worthwhile. [3]