Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Dyspareunia, Post Menopausal Atrophic Vaginitis
Treatment: Formulary exception for Osphena 60mg Tablet
The insurer denied the formulary exception for Osphena 60mg tablet.
The denial is upheld. 

The patient is a female. She has a diagnosis of dyspareunia and postmenopausal atrophic vaginitis. The request is for coverage for Osphena 60mg (milligrams) tablets.

The patient did not fail try or have a contraindication to all of the formulary alternatives. This includes Premarin, Yuvafem, Estring, and estradiol cream. The patient did try Vagifem previously, but is worried about the continuous effect of estrogen. In other words, the patient did not have a failure or contraindication to Vagifem.

Note that according to the submitted clinical information, the patient has introital stenosis which is different from vaginal atrophy and neither estrogens nor Osphena are treatments for this condition.

No, the health plan should not cover the formulary exception for Osphena. Osphena was denied because it is a non-formulary medication. The patient did not try and fail the formulary medications. The patient is not reported to have any contraindication or intolerance to the formulary medications.

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.

Based on the scientific evidence, the first-line therapy for symptoms of vaginal atrophy is regular use of vaginal moisturizing agents supplemented by water-based lubricants during vaginal intercourse rather than treatment with hormonal agents or vaginal dilator therapy (Grade 2B). For patients with vaginal atrophy who are not adequately treated with vaginal moisturizers and lubricants, low-dose vaginal estrogen rather than dehydroepiandrosterone (DHEA; prasterone) or ospemifene (Grade 2C) is recommended.

Available vaginal estrogen preparations are conjugated estrogens (cream) and estradiol (cream, tablet, capsule, and ring). All preparations are effective in relieving symptoms of vaginal atrophy. Systemic absorption, patient preference, and convenience should guide the choice of preparation.

Vaginal cream due to low incidence of systemic effect is the preferred method.

For patients with vaginal atrophy who want to avoid using vaginal estrogen but have no contraindications to estrogen itself and no objections to vaginal therapy, vaginal DHEA (prasterone) is an option. One disadvantage is the frequent dosing schedule (daily as compared with twice-weekly for vaginal estrogen). For patients with vaginal atrophy who cannot or prefer not to use a vaginal product, oral ospemifene is an option. Disadvantages of ospemifene include daily use and systemic side effects (e.g., hot flashes, potential risk of thromboembolism).

Note that the patient did try Vagifem previously, but is worried about the continuous effect of estrogen. In other words, the patient did not have a failure or contraindication to Vagifem.

Note that according to the submitted clinical information, the patient has introital stenosis which is different from vaginal atrophy and neither estrogens nor Osphena are treatments for this condition.

Based on all of the above, this patient could use one of the many estrogen preparations available. Osphena is not medically necessary.