FINASTERIDE/ TADALAFIL CAP,ORAL
Clinical Criteria Summary
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.)