Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: postmenopausal atrophic vaginitis

Treatment: Intrarosa (prasterone)

The insurer denied coverage for Intrarosa (prasterone)

The denial is overturned

The insurer has denied coverage for a Formulary Exception for Intrarosa (prasterone) to treat postmenopausal atrophic vaginitis. In their Final Adverse Determination letter they write that their policy states that this medication may be approved when the patient is unable to take the required number of formulary alternatives. Formulary alternatives are: estradiol vaginal cream, Imvexxy, Vagifem. Requirement: 3 in a class with 3 or more alternatives. The patient's doctor is appealing. In an appeal letter the doctor writes that the patient has tried all the formulary alternatives (estradiol vaginal cream and estradiol vaginal tablets - Imvexxy and Vagifem) without relief of symptoms. All three caused adverse effects - worsening of long-standing vulvodynia.

Vaginal atrophy (also referred to as vulvovaginal atrophy, urogenital atrophy, or atrophic vaginitis) is the cause of dyspareunia. It results from estrogen loss and is often associated with vulvovaginal complaints (e.g., dryness, burning, dyspareunia) in menopausal women. The primary indication for treatment of vaginal atrophy is the relief of bothersome symptoms in a menopausal woman who is distressed by them.
 
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. 

The agents for vaginal estrogen therapy that are commercially available in the United States are conjugated estrogens (cream) and estradiol (cream, tablet, and ring). A systematic review of 19 randomized trials including over 4,000 women that investigated local estrogen treatment found that creams, tablets, and rings were all similarly effective in relieving symptoms of vaginal atrophy. 

For most women with symptomatic vulvovaginal atrophy who do not improve with vaginal lubricants and moisturizers and who are candidates for hormonal therapy, low-dose vaginal estrogen therapy rather than vaginal dehydroepiandrosterone is recommended (Grade 2C). There is more clinical experience and data regarding vaginal estrogen, and the twice-weekly dosing is likely to be easier for most patients.

Intrarosa prasterone, another name for dehydroepiandrosterone (DHEA), is another treatment option for dyspareunia associated with genitourinary syndrome of menopause. 

The prior authorization (PA) criteria and provider appeal letter note that the patient cannot tolerate vaginal estradiol cream, tablet or ring due to worsening of vaginal pain with use. The provider states that all the formulary alternatives (estrogens) cause the patient vulvodynia.

The formulary drugs are expected to cause adverse effects, based on the physician assistant criteria notes and the provider's appeal letter stating that the formulary drugs were tried and caused the patient side effects (reported worsening of long-standing vulvodynia). 
 
The formulary drugs have been tried and the patient had an adverse reaction or contraindication.

The formulary drugs are expected to be ineffective, having been tried and caused side effects.

The non formulary drug may be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Intrarosa (prasterone) to treat atrophic vaginitis is overturned.