Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Functional urinary incontinence.
Treatment:  Formulary exception for Estring.
The insurer denied: Formulary exception for Estring.  
The denial is overturned.

The patient is an elderly female. She has history of vaginal atrophy, hepatitis C, and early-stage ovarian cancer. She has been on vaginal estrogen replacement with Estring for 10 years. The request is to continue.

The request has been denied coverage by the health plan, because the patient has not tried and failed the formulary options. This is being appealed.

The health plan should cover the Formulary exception for Estring.

According to Bachmann et al., estrogen is the most effective treatment for moderate to severe symptoms of vaginal atrophy. Use of estrogen therapy is appropriate for women with symptoms of vaginal atrophy in the setting of low estrogen levels, provided that there are no contraindications to this therapy (e.g., certain women with estrogen-dependent tumors). Adequate estrogen therapy leads to restoration of the normal vaginal acidic pH and microflora, thickening of the epithelium, increased vaginal secretions and decreased vaginal dryness. In addition, estrogen therapy is associated with urinary tract benefits. These include a reduction in the incidence of urinary tract infections and overactive bladder symptoms. Urgency incontinence and stress incontinence, however, do not improve with estrogen therapy alone. Bachmann et al. suggests low dose vaginal estrogen therapy (vaginal administration of a low dose) 
rather than systemic estrogen therapy (oral, transdermal, or vaginal administration of a higher dose) for women treated solely for vaginal atrophy symptoms. For women receiving systemic estrogen therapy for other menopausal effects (e.g., vasomotor symptoms), low dose vaginal therapy may be added if relief of atrophic symptoms is insufficient. A preparation containing only 10 micrograms of estradiol (Vagifem) is effective and can be used in place of somewhat higher doses (i.e., > [greater than] 50 micrograms estradiol or > [greater than] 0.5 grams of conjugated estrogen) if there is concern about small amounts of systemic absorption. Of note, some vaginal preparations administer higher doses of estrogen (e.g., higher doses of vaginal creams) and some are intended to deliver systemic doses (e.g., Femring, 50 to 100 mcg micrograms)/day). The preference for low dose vaginal estrogen therapy is based upon efficacy and risk of systemic effects. Vaginal estrogen therapy is evidenced to be more effective than systemic therapy for treatment of vaginal atrophy. The North American Menopause Society has stated that for urogenital atrophy alone, local vaginal estrogen therapy is generally recommended and that women treated with systemic therapy should be asked whether they have persistent atrophy symptoms. 

In review of the literature, there is no evidence that one formulation of estrogen is more effective than another. However, the literature supports that the dose and duration of treatment varies across patients and should be individualized according to the degree of vaginal atrophy symptoms. The patient in this case has been on Estring since 2013 with management of symptoms. The dose of the formulary options is less than what has managed the patient's symptoms. The mode is also different. Therefore, a change to the formulary options is not equivalent to the requested medication. They would not be as effective and would most likely cause worsening symptoms or an adverse effect. Therefore, the formulary exception for Estring should be covered by the health plan.