Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Erectile Dysfunction
Treatment Cialis 5 mg
The insurer denied Cialis 5 mg
The determination is upheld.

This patient with erectile dysfunction (ED) has requested coverage for Cialis 5 milligrams (mg) daily for continued use. He has tried tadalafil 5 mg daily, sildenafil 100 mg, and Viagra 100 mg without sufficient efficacy according to the attending physician's (AP's)appeal documents. Per the records, he had started to try Levitra. At issue is whether the formulary drug Vardenafil will be or has been ineffective, would not be as effective as the nonformulary drug, Cialis or would have adverse effects.

The Vardenafil has not been shown to be ineffective. There is no documentation to show that it would not be as effective as the Cialis or would have adverse effects. Per the records, the patient has tried brand Levitra, but not vardenafil.
The American Urological Association (AUA) Guidelines note that: "Men with ED should be informed regarding the treatment option of an Food and Drug Administration (FDA -approved oral phosphodiesterase type 5 inhibitor (PDE5i), including discussion of benefits and risks/burdens, unless contraindicated. (Strong Recommendation; Evidence Level: Grade B)"
"The FDA-approved oral PDE5i available for management of ED in the U.S. include sildenafil, tadalafil, vardenafil, and avanafil. Several other PDE5i have been approved for use in other countries. The mechanism of action for all commercially available PDE5i is similar. PDE5i inhibit the phosphodiesterase type 5 enzyme from breaking down cyclic guanasine monophosphate (cGMP). This inhibition results in an increase in the concentration of penile cavernosal cGMP that then causes smooth muscle relaxation in the corpus cavernosum vasculature resulting in increased erection hardness and duration in men with ED who have sufficient intact vasculature."
"Efficacy: The PDE5i medications have been extensively studied; nearly a quarter of a million men have been evaluated from the general ED population and approximately 25,000 men evaluated from various special populations (e.g., diabetes, benign prostatic hyperplasia (BPH)/ lower urinary tract symptoms (LUTS), post-prostatectomy, post-spinal cord injury). Most studies of men from the general ED population involved on-demand use of medications (approximately 90%). Of the four FDA-approved PDE5i drugs, most men were administered sildenafil or vardenafil with relatively fewer men administered tadalafil and limited data available on avanafil (fewer than 2,000 men). The general ED population: Data from individual studies and trials, including analyses that pooled data across multiple trials and reports of published systematic reviews suggest the following major findings:
i.) The PDE5i medications, particularly sildenafil, tadalafil, and vardenafil, appear to have similar efficacy in the general ED population. Relative efficacy is less clear for avanafil because the published literature is limited. In general, the literature lacks trials in which medications were compared to each other. However, given the large number of trials and participants overall, it is likely that any differences across the most frequently studied medications would be evident. The pattern of similar efficacy across medications is consistent across various measures of erectile function. The most frequently used measure across trials was the erectile function subscale of the International Index of Erectile Function (IIEF). Table 2 presents changes (minimum, maximum, mean) in International Index of Erectile Function - Erectile Function (IIEF-EF) scores by medication from the pre-treatment baseline to post-treatment for trials that provided extractable information; the magnitude of change across medications is similar."
The records indicate that the patient had started to try Levitra (generic equivalent is vardenafil). Results were not provided. The efficacy of vardenafil is similar to Cialis, as both have the same mechanism of action.