CurrentUnitedHealthcarePolicy N/A

Stendra (avanafil) prior authorization for erectile dysfunction

This document governs prior authorization and medical necessity requirements for coverage of Stendra (avanafil) for treatment of erectile dysfunction for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyStendra (avanafil) prior authorization for erectile dysfunction

Policy CodePolicy N/A

Change TypeNo material change

Effective Date11/16/2025

Next Review DateN/A

Key ActionObtain prior authorization and document trials of two alternative PDE5 inhibitors (drug name, date tried, and reason for failure) before coverage of Stendra.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2required alternative PDE5 agents trialed prior to approval

12 moauthorization duration

11/16/2025effective date

NCapplicable state(s)

Coverage Criteria for Stendra (avanafil)

Initial Therapy Criteria

Stendra will be approved based on ALL of the following criteria:

Primary criteria: 1. Patient has an organic cause of erectile dysfunction (see definition).

Supported by list of qualifying conditions in chunk 2

No nitrate therapy: 2. Patient is not receiving nitrate therapy.

Step therapy: 3. History of failure, contraindication, or intolerance to two of: tadalafil, vardenafil, sildenafil; document drug, date tried and reason for failure.2 agents

Provider must document drug name, date tried, and reason for failure/contraindication/intolerance for two alternative PDE5 inhibitors (see chunk 3).

Policy Summary

PayerUnitedHealthcare

PolicyStendra (avanafil) prior authorization for erectile dysfunction

Policy CodePolicy N/A

Change TypeNo material change

Effective Date11/16/2025

Next Review DateN/A

Key ActionObtain prior authorization and document trials of two alternative PDE5 inhibitors (drug name, date tried, and reason for failure) before coverage of Stendra.

SourceLink

On This Page

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No concurrent PDE5: 4. Patient is not concurrently receiving another phosphodiesterase-5 inhibitor (e.g., tadalafil/Cialis, vardenafil/Levitra, Staxyn, or sildenafil/Viagra).

Authorization will be issued for 12 months when criteria are met.

Concurrent use of nitrate therapy or another phosphodiesterase-5 (PDE5) inhibitor excludes approval of Stendra. The policy explicitly states that the patient must not be receiving nitrate therapy and must not be concurrently receiving an alternative PDE5 inhibitor (for example, tadalafil, vardenafil, Staxyn, or sildenafil).

Prior authorization for Stendra requires documented trial and failure, contraindication, or intolerance to two alternative PDE5 inhibitors before approval. Acceptable alternatives listed by the program are tadalafil, vardenafil, and sildenafil. For each agent tried, the provider must document the drug name, date tried, and reason for failure/contraindication/intolerance to support coverage under the step therapy requirement.

Coding

No specific CPT/HCPCS/ICD-10/NDC codes listedmixed

No codes listed

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. When criteria are met, approval will be issued for 12 months.

Authorization duration: 12 months
Prior authorization program: UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Step Therapy

Step therapy requirement

Step therapy: Member must try two alternative erectile dysfunction medications (tadalafil, vardenafil, sildenafil) prior to coverage of Stendra (avanafil). This program is intended to encourage the use of lower cost alternatives.

Required alternatives: tadalafil (generic Cialis), vardenafil (generic Levitra), sildenafil (generic Viagra)
Member must trial two of the listed agents

Documentation Required

Required documentation

Provider must document the drug name, date tried, and reason for failure, contraindication, or intolerance for two alternative PDE5 inhibitors.

Document for each agent: drug name, date tried, reason for failure/contraindication/intolerance

Denial Risk

Triggers for denial

Authorization may be denied if the patient has not tried and failed, or is not intolerant/contraindicated to, two of the listed alternative PDE5 inhibitors. Also at risk for denial if patient is receiving nitrate therapy or is concurrently receiving another PDE5 inhibitor.

Denial triggers: no documentation of trials/failures for two alternative PDE5 inhibitors
Denial triggers: patient on nitrate therapy
Denial triggers: concurrent use of another PDE5 inhibitor (e.g., Cialis, Levitra, Staxyn, Viagra)

Background

Stendra (avanafil) is a phosphodiesterase-5 inhibitor indicated for the treatment of erectile dysfunction. The prior authorization program is designed to encourage use of lower-cost alternatives by requiring trials of two alternative erectile dysfunction medications prior to coverage of Stendra; when criteria are met, authorization will be issued for 12 months.

Definitions

Organic erectile dysfunction — definition and examples

DefinitionOrganic erectile dysfunction: erectile dysfunction attributed to an identifiable medical condition affecting vascular, neurologic, endocrine, renal, or structural genital integrity.

Common examplesDiabetes mellitus; hypertension; atherosclerosis; hypercholesterolemia; renal insufficiency.

Neurologic causesStroke, seizure disorder, demyelinating disease, spinal cord injury, tumor.

Endocrine and hormonal causesEndocrine disorders including hypogonadism.

Anatomic and surgical causesVascular or neurologic disease affecting the genitalia; history of male genital surgery (including prostatectomy, trauma, or irradiation).

Drug-induced causesErectile dysfunction caused by medication exposure (drug-induced).