VARDENAFIL TAB
Clinical Criteria Summary
Document 259
Formulary Status
- Avanafil is non-formulary.
- Sildenafil and tadalafil are available on the VA National Formulary (PA-F).
Prescribing & Clinical Evaluation Requirements
- Prescriptions for erectile dysfunction must be written by a VA prescriber following an appropriate clinical evaluation.
- Prescribing clinician is responsible for ensuring no contraindications exist for the prescribed PDE5 inhibitor.
- Patient must understand treatment choices, associated risks, and benefits.
Quantity & Dispensing Limits
- Limited to 6 doses per month for management of erectile dysfunction.
- Quantities less than 6 doses per month dispensed only at request of patient or prescriber.
- Greater quantities may be approved on a case-by-case basis (e.g., couples trying to conceive, veterans with inconsistent response).
- Quantity limit does not apply for management of pulmonary hypertension.
Adverse Event Reporting
- All adverse events must be reported in the VA Adverse Drug Event Reporting System (VA ADERS/VA MedSafe).
Lost Prescription Management
- Lost prescriptions will not be replaced during the intended time period; authorized refills become available at the next scheduled refill date.
Document 287
Clinical Category: Monotherapy & Combination Therapy Restrictions
- A PDE5I should not be used routinely for the management of LUTS-BPH as monotherapy.
- A PDE5I should not be used in combination with alpha blockers for BPH/LUTS, as it offers no symptom improvement advantage over either agent alone per American Urological Association (AUA) guidelines.
Clinical Category: Formulary PDE5I Initiation & Substitution Criteria
- Consider when more established pharmacotherapies are not an option or have not demonstrated benefit.
- Initiate a formulary alpha blocker first using shared decision making and patient-specific factors. If ED is present, may consider adding a formulary PDE5I (with quantity limits) to an alpha blocker.
- Consider substituting or adding a formulary PDE5I if unable to tolerate or lack of response to an adequate trial (12 weeks) of a formulary alpha blocker titrated to maximum therapeutic dose.
- If adding a PDE5I, the patient must be on a stable dose of the alpha-blocker prior to initiation; the PDE5I should then be started at the lowest recommended dose.
Clinical Category: Clinical Scenarios for Formulary PDE5I Monotherapy Consideration
- In place of an alpha blocker in the interim if cataract surgery is planned or likely (due to risk of intraoperative floppy iris syndrome).
- When an alpha blocker is contraindicated or not tolerated and an antimuscarinic is not appropriate due to post-void residual >250 mL, contraindication, ineffective trial, or substantial contribution to existing anticholinergic burden.
- (Note: The document explicitly states that only sildenafil, tadalafil, and vardenafil have been studied for BPH/LUTS; avanafil-specific criteria are not provided in the text.)