Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Erectile dysfunction
Treatment: Viagra
The insurer denied Viagra.
The denial is upheld.

The patient is an adult male with erectile dysfunction (ED). He has tried generic Viagra multiple times, but has found that the brand name Viagra seems to be the only medication that works for him. Also, the patient notes lower urinary tract symptoms. The request for Viagra was denied as not medically necessary as it does not meet the requirements of the plan (see below).

The health plan should not cover the proposed treatment with Viagra.

This patient's request for Viagra was denied as not meeting the plan criteria, and thus it was deemed not medically necessary. The health plan requires that the patient try the two formulary alternatives which include generic Viagra and generic Cialis (sildenafil and tadalafil, respectively), or provide reason(s) for not trying these alternatives such as adverse effects or contraindication. The patient is reported to have tried and failed one formulary drug, sildenafil. There is lack of clinical trials comparing generic formulations to brand formulations. There is lack of scientific data to support a superior efficacy of one phosphodiesterase 5 (PDE-5) inhibitor compared to others, as noted in a recent review. "Overall, in the available studies, the strength of evidence for most pairwise comparisons between different dosages and formulations of PDE5 inhibitors was considered low or very low due to the lack of high-quality RCTs [randomized controlled clinical trials] comparing different types of PDE5 inhibitors." "Combining the outcomes of all available dosages, Yuan, et al (2013) suggested that tadalafil may be considered the most effective compound in the general population, followed by vardenafil. Hence, based on the network meta-analysis by Chen, et al (2015), sildenafil 50 mg [milligrams] (SMD [standardized mean difference]: 0.47, 95% CI [confidence interval]: 0.340.59) followed by sildenafil 100 mg (SMD: 0.46, 95% CI: 0.350.56) were considered the treatments of choice when compared to placebo." (1)

One report noted, "Tadalafil has a longer duration of action than sildenafil and vardenafil. Tadalafil is similarly effective as sildenafil in the treatment of ED. In comparison studies, tadalafil is preferred to sildenafil (50/100mg) by men with ED, possibly because of its longer duration of action." (4)

Another systematic review and meta-analysis concluded, "Tadalafil shares a similar efficacy and safety with sildenafil and significantly improves patients' sexual confidence." (5)

The literature does not provide sufficient scientific evidence to support a decrease in efficacy or increase in adverse effects with generic formulations compared to brand formulations. The literature reports at least a similar efficacy between sildenafil and tadalafil and a longer duration of action of tadalafil which may be preferable. Thus, there is lack of evidence to support that the nonformulary request will be more beneficial than the formulary alternative that the patient has not tried, tadalafil. The adverse effects amongst phosphodiesterase 5 (PDE-5) inhibitors are comparable and there is lack of comparisons available between generic and brand formulations in terms of efficacy and adverse effects.