VARDENAFIL TAB

Criteria for Erectile Dysfunction (ED)

• Applies to: Sildenafil, Tadalafil, and other PDE5 inhibitors
• Prescriber Requirement: VA prescribers only; requires appropriate clinical evaluation before prescription is honored
• Clinician Responsibility: Ensure patient has no contraindications to sildenafil, tadalafil, or the prescribed PDE5 inhibitor; ensure patient understands treatment choices, risks, and benefits
• Quantity Limit: Limited to 6 doses per month. Quantities less than 6 dispensed only at request of patient or prescriber. Greater quantities approved on a case-by-case basis (e.g., couples trying to conceive, inconsistent response)

Criteria for Pulmonary Hypertension

• Applies to: Sildenafil and other PDE5 inhibitors
• Quantity Limit Exception: The 6-dose monthly limit does not apply to patients taking sildenafil or another PDE5 inhibitor for pulmonary hypertension management

Formulary Status

• Sildenafil and Tadalafil: PA-F (available in VHA and VA National Formulary)
• Avanafil and Vardenafil: Non-formulary

Dispensing and Safety Monitoring

• Applies to: All PDE5 inhibitors (Sildenafil, Tadalafil, and others)
• Lost Prescriptions: Not replaced during the intended time period; refills available at next scheduled refill date
• Adverse Events: Must be reported in VA ADERS

Criteria for PDE5 Inhibitors (BPH/LUTS Indication)

General & Indication Criteria

• All phosphodiesterase type 5 inhibitors (PDE5I) have an FDA label indication for erectile dysfunction (ED); tadalafil has a label indication for benign prostatic hyperplasia (BPH) and ED/BPH.
• PDE5 inhibitors should not be used routinely for the management of LUTS-BPH either as monotherapy or in combination with other drugs to treat BPH.
• A formulary PDE5 inhibitor should be considered when more established pharmacotherapies are not an option or have not demonstrated benefit.

Monotherapy vs. Combination Therapy Criteria

• As monotherapy, PDE5 inhibitors result in a significantly greater absolute difference in mean change in IPSS score compared to placebo; only sildenafil achieved the minimal detectable difference of 3 points for IPSS. Maximum urinary flow rate (Qmax) was not significantly changed by any PDE5 inhibitor.
• Tadalafil shows no significant difference compared to tamsulosin monotherapy in reducing IPSS, voiding/storage sub scores, quality of life, postvoid residual, or Qmax.
• Combination therapy with an alpha blocker and a PDE5 inhibitor generally demonstrates better improvement in LUTS than either agent alone per systematic reviews/meta-analyses.
• However, the American Urological Association (AUA) guideline states that combination of low-dose daily 5mg tadalafil with an alpha blocker offers no symptom improvement advantage over either agent alone and recommends against their combined use.

Sequential & Alternative Therapy Criteria

• Initiate a formulary alpha blocker (doxazosin, terazosin, tamsulosin, alfuzosin) using shared decision making and patient-specific factors.
• If ED is present, may consider initiating a formulary PDE5 inhibitor (with quantity limits) in addition to an alpha blocker. (If the patient is already taking a PDE5I, initiate alpha-blocker therapy at the lowest dose to help prevent hypotension).
• If unable to tolerate or lack of response to an adequate trial (12 weeks) of a formulary alpha blocker titrated to maximum therapeutic dose, consider substituting or adding a formulary PDE5 inhibitor. If adding, ensure the patient is on a stable alpha-blocker dose prior to initiating the PDE5I at the lowest recommended dose.
• Consider formulary PDE5 inhibitor monotherapy in place of an alpha blocker if cataract surgery is planned or likely (due to risk of intraoperative floppy iris syndrome up to 9 months after discontinuing an alpha blocker).
• Consider formulary PDE5 inhibitor monotherapy if an alpha blocker is contraindicated or not tolerated AND an antimuscarinic is not appropriate due to post void residual >250 mL, contraindication, intolerance/ineffectiveness, or substantial contribution to existing anticholinergic burden.

Drug-Specific Application Notes

• Sildenafil: May be offered when tadalafil is not available and alpha blockers are not tolerated. Achieved the minimal detectable difference (3 points) for IPSS in monotherapy meta-analysis.
• Tadalafil: 5mg daily should be discussed as a treatment option for LUTS/BPH irrespective of ED. Combination with low-dose daily 5mg tadalafil and an alpha blocker is recommended against per AUA guidelines.
• Vardenafil: Network meta-analysis indicated that combination with an alpha blocker most improved IPSS among PDE5 inhibitors.
• Avanafil: Mentioned only in literature search terms; no specific efficacy, dosing, or utilization criteria detailed in the document text.