CurrentCignaPolicy IP0099

Erectile Dysfunction - Vardenafil (Levitra, Staxyn)

Defines medical necessity and coverage rules for vardenafil (Levitra and Staxyn) across Cigna-administered health benefit plans, including indications, step therapy, quantity limits, and plan-specific exclusions.

Policy Summary

PayerCigna

PolicyErectile Dysfunction - Vardenafil (Levitra, Staxyn)

Policy CodePolicy IP0099

Change TypeNo material changes

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain prior authorization and document required step-therapy trials or intolerance when coverage varies by the member's benefit plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 8/30dmax quantity (ED)

12 monthsinitial auth

12 monthscontinuation

IP0099policy #

Coverage Criteria for Vardenafil

Medical necessity criteria by indication

Vardenafil is considered medically necessary for specified indications when ALL listing criteria for that indication are met.

Erectile Dysfunction (general): Vardenafil (Levitra, Staxyn) is considered medically necessary for the treatment of erectile dysfunction when coverage is available per the customer's benefit plan.up to 8 tablets per 30 days where covered

Erectile dysfunction therapy may be excluded under some benefit plans; refer to the applicable benefit plan document for coverage and quantity limits.

Benign Prostatic Hyperplasia: Individual meets ALL of the following: A. Documentation of ONE of: i. Inadequate response to ONE of: a. alpha1-blocker, b. 5-alpha-reductase inhibitor, c. 5-alpha-reductase inhibitor/alpha1-blocker combination product; OR ii. Failure, contraindication, or intolerance to BOTH alpha1-blockers and 5-alpha-reductase inhibitors.

When step therapy is required by the plan, documentation of prior trials/intolerance may be required.

Policy Summary

PayerCigna

PolicyErectile Dysfunction - Vardenafil (Levitra, Staxyn)

Policy CodePolicy IP0099

Change TypeNo material changes

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain prior authorization and document required step-therapy trials or intolerance when coverage varies by the member's benefit plan.

SourceLink

On This Page

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Vardenafil (Levitra, Staxyn) is recognized as a treatment option for erectile dysfunction; however, erectile dysfunction therapy may be excluded under many benefit plans (including Employer Groups and Individual and Family Plans). Providers must consult the member's specific benefit plan document to confirm whether sexual dysfunction coverage is included and to determine any plan-specific quantity limits or other conditions of coverage.

Coverage for vardenafil varies by plan and may require Step Therapy or medical necessity review per the customer's benefit plan. Where covered for as-needed erectile dysfunction, the policy allows a maximum of up to 8 tablets per 30 days. For plans that do not cover sexual dysfunction, medical necessity review may still be required for non-sexual dysfunction indications — review the applicable benefit plan for details.

Provider Actions and Requirements

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for vardenafil (Levitra, Staxyn) depending on the member's benefit plan. Check the customer's benefit plan document for plan-specific PA requirements and any quantity limits (for example, maximum of 8 tablets per 30 days where covered).

Check member's benefit plan document for PA requirements
Verify quantity limits (e.g., up to 8 tablets/30 days where covered)

Step Therapy

Step Therapy Requirement

Step therapy applies for some employer plans: a trial of the bioequivalent generic vardenafil is required before coverage of Levitra or Staxyn, unless the patient cannot take the generic due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction.

Trial of bioequivalent generic vardenafil required prior to brand coverage
Exception: documented significant allergy or serious adverse reaction to generic's inactive ingredients

Documentation Required

Documentation Required for Step Therapy

When step therapy is required, include documentation demonstrating prior trials and/or intolerance. Provide clear clinical notes showing medication tried, duration, and reason for discontinuation (e.g., inadequate response, contraindication, or adverse reaction). For intolerance related to formulation differences, document the specific inactive ingredient and the clinical reaction.

Clinical note with dates and duration of prior trial(s) of generic vardenafil
Reason for discontinuation (inadequate response, contraindication, intolerance, or allergy)
If claiming formulation-related intolerance, identify the inactive ingredient and clinical evidence of reaction
Prescribe by or in consultation with specialist when applicable (e.g., urologist for post‑prostatectomy rehabilitation)

Denial Risk

Denial Risk for Unlisted Uses

Use of vardenafil for any indication not listed in the policy (including sexual dysfunction when the member's plan excludes coverage, or other off‑label uses) is considered experimental, investigational, or unproven and is not covered. Denials may occur for requests outside the specified medically necessary indications.

Requests for uses not listed in the policy are at high risk for denial
For plans that exclude sexual dysfunction coverage, medical necessity review alone may not allow coverage — confirm benefit availability first

Indication-Specific Definitions

Prophylaxis after radical prostatectomy (Early Penile Rehabilitation)

DefinitionUse of vardenafil in men after bilateral nerve-sparing radical prostatectomy to aid recovery of erectile function.

Required documentationDocumentation of radical prostatectomy within the previous 12 months.

Prescriber requirementMedication must be prescribed by or in consultation with a urologist.

Evidence contextVardenafil was studied in men following bilateral nerve-sparing radical prostatectomy.

Benign Prostatic Hyperplasia (BPH) indication

DefinitionUse of vardenafil for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) as studied in clinical trials and guideline discussions.

Prior-therapy requirementDocumentation of inadequate response to ONE of: an alpha1-blocker, a 5-alpha-reductase inhibitor, or a combination product (5-alpha-reductase inhibitor/alpha1-blocker).

Alternative pathwayOR documentation of failure, contraindication, or intolerance to BOTH alpha1-blockers and 5-alpha-reductase inhibitors.

Guideline contextEAU guidance notes PDE5 inhibitors can be used in men with moderate-to-severe LUTS with or without erectile dysfunction.

Raynaud's phenomenon indication

DefinitionUse of vardenafil to improve digital blood flow and reduce frequency of Raynaud's phenomenon attacks as studied in clinical settings.

Prior-therapy requirementDocumentation of failure, contraindication, or intolerance to ONE calcium channel blocker.

Guideline contextEULAR recommends dihydropyridine calcium channel blockers (eg, oral nifedipine) as first-line therapy; PDE5 inhibitors should be considered in selected patients.

Background

Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor marketed as Levitra (tablets) and Staxyn (orally disintegrating tablets). It is primarily indicated for the treatment of erectile dysfunction and has been studied in other clinical contexts including lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH), prophylaxis after bilateral nerve-sparing radical prostatectomy (early penile rehabilitation), and Raynaud's phenomenon.

Clinical use and coverage of vardenafil depend on plan terms. Where covered, Step Therapy requirements and medical necessity review may apply; providers should document prior trials or intolerances to alternative therapies when required by the benefit plan. For as-needed erectile dysfunction use, the policy sets a maximum quantity limit of up to 8 tablets per 30 days where coverage exists.