CurrentCignaPolicy IP0099

Erectile Dysfunction - Vardenafil (Levitra, Staxyn)

Defines medical necessity, step therapy, quantity limits, indications, and authorization durations for vardenafil products (Levitra tablets and Staxyn ODT) for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyErectile Dysfunction - Vardenafil (Levitra, Staxyn)

Policy CodePolicy IP0099

Change TypeMinor/No material change

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization when plan coverage limitations or step therapy apply; initial approvals are up to 12 months and reauthorization requires documented clinical benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 8max quantity (30 days)

12initial auth (months)

12reauthorization (months)

4supported indications

IP0099policy id

Coverage Criteria for Vardenafil (Levitra, Staxyn)

Medical Necessity Criteria

Vardenafil is considered medically necessary for the following indications when ALL specified criteria are met:

Erectile Dysfunction (general): Vardenafil (Levitra, Staxyn) is medically necessary for treatment of erectile dysfunction when coverage is available under the member's benefit plan.Maximum quantity: up to 8 tablets per 30 days when used as-needed for ED

Coverage varies across plans and may require step therapy; refer to the applicable benefit plan document for coverage availability and terms.

Benign Prostatic Hyperplasia (BPH)

BPH - entry criteria
- Option i: Inadequate response to ONE of: a) an alpha1‑blocker; OR b) a 5‑alpha‑reductase inhibitor; OR c) a combination 5‑alpha‑reductase inhibitor/alpha1‑blocker product.

Policy Summary

PayerCigna

PolicyErectile Dysfunction - Vardenafil (Levitra, Staxyn)

Policy CodePolicy IP0099

Change TypeMinor/No material change

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization when plan coverage limitations or step therapy apply; initial approvals are up to 12 months and reauthorization requires documented clinical benefit.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Reauthorization Criteria

Reauthorization (continuation) is considered medically necessary when the initial criteria were met and clinical benefit is demonstrated.

Reauthorization: Continuation of vardenafil (Levitra, Staxyn) is medically necessary for erectile dysfunction, BPH, Raynaud's disease, or prophylaxis after radical prostatectomy when initial criteria were met AND a beneficial clinical response is demonstrated.

Reauthorization durations: up to 12 months for ED, BPH, and Raynaud's disease; continuation beyond the initial 12 months is not applicable for prophylaxis after radical prostatectomy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required when the customer's benefit plan specifies coverage limitations, step therapy, or other utilization management for vardenafil (Levitra, Staxyn). Initial authorizations are granted for up to 12 months. Reauthorization durations vary by indication: erectile dysfunction — up to 12 months; benign prostatic hyperplasia — up to 12 months; Raynaud's disease — up to 12 months; prophylaxis after radical prostatectomy — continuation beyond the initial 12 months is not applicable. Receipt of sample product does not satisfy prior authorization criteria.

Initial approval duration: up to 12 months
Reauthorization: ED = up to 12 months; BPH = up to 12 months; Raynaud's = up to 12 months; Prophylaxis after radical prostatectomy = not applicable for continuation

Denial Risk

Experimental/Unproven Use Denial

Requests for indications or uses not listed in the medical necessity criteria (any other use) are considered experimental, investigational, or unproven and may be denied. Coverage may also be unavailable for sexual dysfunction under some employer or individual/family plans; confirm benefit availability in the customer's benefit plan document prior to authorization.

Any use not listed in policy clinical criteria = experimental/investigational/unproven
Some plans exclude erectile dysfunction — check benefit plan document

Documentation Required

Required Clinical Documentation

Clinical documentation must demonstrate that the patient meets the applicable medical necessity criteria and, when step therapy applies, must show prior trials and/or intolerances to required alternatives. For continuation (reauthorization), documentation must show a beneficial clinical response to therapy.

Documentation of prior trial(s), failure, contraindication, or intolerance to required alternatives per the step therapy / indication-specific criteria (e.g., trials of alpha1‑blocker and/or 5‑alpha reductase inhibitor for BPH where required)
For prophylaxis after radical prostatectomy: documentation of radical prostatectomy within the previous 12 months and prescription by or consultation with a urologist
For reauthorization: documentation of beneficial response to vardenafil

Definitions

Vardenafil (Levitra, Staxyn) — description and studied indications

Drug class and formulationsVardenafil: phosphodiesterase type 5 (PDE5) inhibitor available as Levitra (tablets) and Staxyn (orally disintegrating tablets).

Primary FDA‑approved indicationTreatment of erectile dysfunction.

Studied additional indicationsBenign prostatic hyperplasia (BPH) / LUTS; prophylaxis after bilateral nerve‑sparing radical prostatectomy (early penile rehabilitation); Raynaud's phenomenon.

Evidence and guideline context for BPH/LUTSStudied in BPH; 2022 European Association of Urology notes PDE5 inhibitors can be used in men with moderate‑to‑severe LUTS with or without ED; benefit greater in younger men with lower BMI and more severe LUTS per meta‑analysis.

Evidence and guideline context for Raynaud'sStudied in Raynaud's phenomenon with improved digital blood flow and fewer attacks; EULAR (2023) recommends CCBs first‑line and considers PDE5 inhibitors as an option when appropriate.

OpenPayer

Erectile Dysfunction - Vardenafil (Levitra, Staxyn)

Coverage Criteria for Vardenafil (Levitra, Staxyn)

Provider Actions and Requirements

Definitions

Background