Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Menopausal Atrophic Vagnitis.
Treatment: Formulary exception for Intrarosa 6.5mg Insert.
The insurer denied the formulary exception for Intrarosa 6.5mg Insert.
The denial is upheld. 

The patient is a female with atrophic vaginitis. She has had recurrent infections and discomfort with dryness. According to her letter, she has tried and failed Estrace, premarin, estradiol creams, and the vaginal ring. She has been on Intrarosa with improvement in symptoms. The request is for continuance.

No, the health plan should not cover the Formulary exception for Intrarosa 6.5mg Insert.

According to the health plan's formulary preferences, for Intrarosa, it states that the patient must have had serious side effects or drug failure with all formulary alternatives (both brand and generic) within this drug class. Formulary alternatives include estradiol cream, Vagifem insert, Estring vaginal ring, Premarin cream.

The patient has tried and failed Estring, estradiol cream, and premarin cream. Therefore, because she has not tried and failed Vagifem, the patient has not met the formulary requirements.

Vaginal DHEA (dehydroepiandrosterone), also referred to as prasterone, is a treatment option for dyspareunia associated with genitourinary syndrome of menopause (GSM). The FDA (United State Food and Drugs Administration) approved the use of prasterone 6.5 mg (milligrams) (0.5% formulation) as a daily vaginal suppository for the treatment of dyspareunia in the setting of vulvar or vaginal atrophy due to menopause.

The mechanism of action of prasterone on the vagina is likely due to the aromatization of androstenedione and testosterone locally to estrone and estradiol through a process referred to by some investigators as intracrinology. In one study, weeks of vaginal DHEA (6.5 mg [milligrams]) caused estrone to rise from 15 to 18 pg/mL (picograms per milliliter) and estradiol from 2 to 3 pg/mL.

Prasterone was found to be an effective treatment for dyspareunia in a randomized trial that assigned postmenopausal patients with dyspareunia to prasterone or placebo for 12 weeks and found improved Female Sexual Function Index (FSFI) overall scores and in the pain and satisfaction domains. At 12 weeks, treatment with vaginal DHEA resulted in a significant increase from baseline in serum DHEA, testosterone, and estrone but not estradiol levels, although DHEA, estradiol, estrone, and testosterone remained within the range of an average postmenopausal patient.

DHEA has been studied as a potential medication to increase libido in postmenopausal patients, but its efficacy is uncertain, and the serum DHEA levels with this dose of vaginal prasterone are unlikely to have an impact. Also, libido often improves with any adequate treatment of dyspareunia.

In review of the medical record and the literature, the use of intrarosa is FDA-approved for the treatment of dyspareunia secondary to vaginal atrophy from menopause. There are randomized controlled trials demonstrating safety and efficacy and improvement in dyspareunia.

There is no evidence in the record provided that the indication for this patient is for dyspareunia. Therefore, the FDA-approved indication is not met and the plan should not cover this medication, since there is still the alternative of Vagifem that has not been tried.