Alpha Blockers for Benign Prostatic Hyperplasia (BPH)

Cigna National Formulary Coverage Policy

Step Therapy Policy Alpha Blockers for Benign Prostatic Hyperplasia (BPH)

Table of Contents Product Identifier(s)

National Formulary Medical Necessity ...... 1 14262 Conditions Not Covered...... 2 Background ...... 2 References ...... 2 References ...... 2

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

National Formulary Medical Necessity

Drugs Affected: • Cardura® (doxazosin mesylate tablets) • Cardura® XL (doxazosin mesylate extended-release tablets) • Flomax (tamsulosin capsules) • Terazosin capsules • Rapaflo™ (silodosin capsules) • Uroxatral (alfuzosin extended-release tablets)

A step therapy program has been developed to encourage use of a generic alpha1-blocker for BPH prior to a brand name alpha1- blocker. If the step therapy rule is not met for a Step 2 agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration.

Step 1: alfuzosin extended-release tablets, doxazosin tablets, silodosin capsules, tamsulosin capsules, terazosin capsules

Page 1 of 2 Cigna National Formulary Coverage Policy: ST Alpha Blockers for Benign Prostatic Hyperplasia (BPH) Step 2: Cardura tablets, Cardura XL extended-release tablets, Flomax capsules, Rapaflo capsules, UroXatral extended-release tablets

Cigna covers Step 2 agents as medically necessary when the following criteria are met:

1. If the individual has tried a Step 1 agent, then authorization for a Step 2 agent may be given.

Conditions Not Covered

Any other exception is considered not medically necessary.

Background

Overview Alpha1-blockers are classified as first-, second-, or third-generation agents based on their specificity for the 1 prostate. The first-generation alpha1-blockers are not indicated for benign prostatic hyperplasia (BPH). 1 Terazosin, doxazosin, and prazosin are second-generation alpha1-blockers. They are considered non- uroselective and have affinity for all three alpha1 receptor subtypes. Doxazosin (immediate-release) and terazosin are indicated for the symptomatic treatment of BPH and for hypertension.2,3 Cardura XL is only indicated for the treatment of signs and symptoms of BPH.4 Tamsulosin, alfuzosin, and Rapaflo are third- 5,6 generation alpha1-blockers because they exhibit selectivity for alpha1A-receptors in the prostate. Alfuzosin is 1 considered functionally and clinically uroselective. Alfuzosin is not selective for a specific alpha1 receptor 7 subtype, but instead exhibits selectivity for alpha1-adrenergic receptors in the lower urinary tract. The clinical significance of selectivity for the alpha1A-receptor continues to be debated. Theoretically, agents with high selectivity for the alpha1A-receptor should have less effect on blood pressure compared to other non-selective alpha1-blockers.

References

1. Lepor H, Lowe FC. Evaluation and nonsurgical management of benign prostatic hyperplasia. In: Campbell’s Urology. 8th Ed. WB Saunders Company. Philadelphia, PA. 2002:1337-1378. 2. Cardura tablets [prescribing information]. New York, NY: Pfizer, Inc; March 2019. 3. Terazosin capsules [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc.; July 2017. 4. Cardura XL extended-release tablets [prescribing information]. New York, NY: Pfizer, Inc; February 2017. 5. Flomax capsules [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; March 2017. 6. Rapaflo™ capsules [prescribing information]. Irvine, CA: Allergan USA, Inc; June 2017. 7. UroXatral® extended-release tablets [prescribing information]. St. Michael, Barbados: Concordia Pharmaceuticals Inc.; May 2020.

References

Type of Summary of Changes Approval Date Revision Annual No criteria changes. 9/30/2020 Revision

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