Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Atrophic Vulvovaginitis
Treatment: Estring

The health plan should not cover the proposed treatment with Estring 2MF VA RING.

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 (eg, vasomotor symptoms), low dose vaginal therapy may be added if relief of atrophic symptoms is insufficient.  We define low dose vaginal estrogen as less than or equal to  50 micrograms (mcg) estradiol or less than or equal to 0.3 milligrams (mg) conjugated estrogens/less than or equal to 0.5 grams (g) cream. A preparation containing only 10 micrograms of estradiol (Vagifem) is effective and can be used in place of somewhat higher doses (ie, greater than [>] 50 microgram estradiol or > 0.5 g of conjugated estrogen) if there is concern about small amounts of systemic absorption. Of note, some vaginal preparations administer higher doses of estrogen (eg, higher doses of vaginal creams) and some are intended to deliver systemic doses (eg, Femring, 50 to 100 mcg/day).  The preference for low dose vaginal estrogen therapy is based upon efficacy and risk of systemic effects. Vaginal estrogen therapy may be more effective than systemic therapy for treatment of vaginal atrophy. A meta-analysis of 58 comparative studies of women with urogenital atrophy found that patient report of symptom relief was significantly higher for vaginal versus oral estrogen therapy. The reported efficacy rate is approximately 80 to 90 percent for vaginal therapy and 75 percent for systemic therapy, based upon observational data.
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A systematic review of 19 randomized trials including over 4000 women that investigated local estrogen treatment found that creams, tablets, and rings were all similarly effective in relieving symptoms of vaginal atrophy. Systemic absorption, patient preference, convenience, and cost should guide the choice of preparation.  The use of the vaginal estrogen creams are recommended for women who have symptomatic vulvar atrophy (eg, fissures). 

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 use of the Estring is effective and can be used in place of higher doses (ie, >50 microgram estradiol (Estrace) or >0.5 g of conjugated estrogen [Premarin]).   This patient has been on the low dose of the Estring for two years with relief of symptoms.  The patient has failed one formulary option, Premarin cream.  The formulary options of Enjuvia tablet; estradiol patch; estradiol tablet; Menest tablet; and Premarin tablet are systemic formulations and not equivalent to the Estring request which is a local estrogen.  These formulations would be a much higher dose than needed to manage this member's local vulvar/vaginal symptoms.   The use of the lowest dose of estrogen that controls the symptoms is the goal of any hormonal treatment.  It would however be reasonable to try Yuvafem as it is a low dose vaginal estrogen that could be comparable to the Estring for this patient.  Therefore because there is an option on formulary that the patient has not tried, the request for the Estring is not needed at this time and the plan should not cover the proposed treatment.