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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:

  1. The patient will NOT be using the requested agent in combination with another phosphodiesterase type 5 (PDE5) inhibitor for the requested indication AND
  2. The requested agent has been prescribed for preservation of erectile function following radical retropubic prostatectomy AND
  3. 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

ALBP _  Commercial _ CS _ ED_Phosphodiesterase_Type_5_Inhibitors_Topical_Prostaglandin_QL _ProgSum_ 07-01-2024  _ © Copyright Prime Therapeutics LLC. May 2024 All Rights Reserved