Asset Publisher

ph-1089

Erectile Dysfunction -Phosphodiesterase Type 5 Inhibitors, Quantity Limit Program Summary

Policy Number: PH-1089

This program applies to Blue Partner, Commercial, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.

Self-funded groups may exclude this class of medications from coverage or have varying age and/or quantity limitations. Group specific policies will supersede this general policy when applicable. Refer to member’s benefit plan for further details regarding erectile dysfunction medications (may be referred to as Impotence Drugs).

POLICY REVIEW CYCLE

Effective Date	Date of Origin
07-01-2024

FDA LABELED INDICATIONS AND DOSAGE

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

	vardenafil hcl orally disintegrating tab	10 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
	Vardenafil HCl Orally Disintegrating Tab 10 MG	10 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Cialis	Tadalafil Tab 10 MG	10 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Cialis	Tadalafil Tab 2.5 MG	2.5 MG	30	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 6 doses per month. The quantity of 6 doses per month is cumulative.
Cialis	Tadalafil Tab 20 MG	20 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Cialis	Tadalafil Tab 5 MG	5 MG	30	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 6 doses per month. The quantity of 6 doses per month is cumulative.
Levitra	vardenafil hcl tab	10 MG ; 2.5 MG ; 20 MG ; 5 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Stendra	avanafil tab	100 MG ; 200 MG ; 50 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Viagra	sildenafil citrate tab	100 ; 100 MG ; 25 MG ; 50 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Viagra	Sildenafil Citrate Tab 100 MG	100 ; 100 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Viagra	Sildenafil Citrate Tab 25 MG	25 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.
Viagra	Sildenafil Citrate Tab 50 MG	50 MG	8	Tablets	30	DAYS		Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg. All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	vardenafil hcl orally disintegrating tab	10 MG
	Vardenafil HCl Orally Disintegrating Tab 10 MG	10 MG
Cialis	Tadalafil Tab 10 MG	10 MG
Cialis	Tadalafil Tab 2.5 MG	2.5 MG
Cialis	Tadalafil Tab 20 MG	20 MG
Cialis	Tadalafil Tab 5 MG	5 MG
Levitra	vardenafil hcl tab	10 MG ; 2.5 MG ; 20 MG ; 5 MG
Stendra	avanafil tab	100 MG ; 200 MG ; 50 MG
Viagra	sildenafil citrate tab	100 ; 100 MG ; 25 MG ; 50 MG
Viagra	Sildenafil Citrate Tab 100 MG	100 ; 100 MG
Viagra	Sildenafil Citrate Tab 25 MG	25 MG
Viagra	Sildenafil Citrate Tab 50 MG	50 MG

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL	Quantity Limit for the Target Agent(s) will be approved when ALL of the following are met: The patient will NOT be using the requested agent in combination with another phosphodiesterase type 5 (PDE5) inhibitor for the requested indication AND The requested agent has been prescribed for preservation of erectile function following radical retropubic prostatectomy AND The quantity requested is less than or equal to 30 tablets per month Length of Approval: Preservation of erectile function following a radical retropubic prostatectomy: 30 tablets per month for 12 months

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ALL of the following are met:

The patient will NOT be using the requested agent in combination with another phosphodiesterase type 5 (PDE5) inhibitor for the requested indication AND
The requested agent has been prescribed for preservation of erectile function following radical retropubic prostatectomy AND
The quantity requested is less than or equal to 30 tablets per month

Length of Approval: Preservation of erectile function following a radical retropubic prostatectomy: 30 tablets per month for 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment