
202211-155179
2022
Healthfirst Inc.
Medicaid
Genitourinary/ Kidney Disorder
Pharmacy/ Prescription Drugs
Formulary Exception
Upheld
Case Summary
Diagnosis: Postmenopausal Atrophic Vaginitis
Treatment: Estring vaginal ring 2 milligrams (mg)
The health plan denied: Estring vaginal ring 2 milligrams (mg)
The health plan's determination is: Upheld.
This patient is a female who is under consideration for Estring vaginal ring 2 milligrams (mg) for the indication of postmenopausal atrophic vaginitis. She is noted to have been on this medication after undergoing a hysterectomy. She reports itching and burning with Estrace and Premarin cream. She has a remote history of endometriosis that led to a hysterectomy. In this case, there has been no documented trials and failures of any of the preferred formulary alternative agents.
The health plan's determination is upheld.
Based upon a review of the indication for the use of Estring 2 mg vaginal ring, as postmenopausal atrophic vaginitis, there would be no lack of effectiveness for the use of the formulary drugs of Estradiol patch, Estradiol tablet, Premarin cream, Menast tablet, Premarin tablet or Yuvafem for estrogen replacement in this patient post hysterectomy.
Each of these formulary agents has the same active ingredient of estrogen for replacement in the case of post hysterectomy estrogen deficiency leading to atrophic vaginitis. In this case, the patient is postmenopausal due to hysterectomy in the setting of endometriosis and has atrophic vaginitis. She is noted to vaginal atrophy resulting in dyspareunia due to her postmenopausal state. Vaginal atrophy is a direct consequence of the hypoestrogenic state associated with menopause resulting in anatomic and physiologic changes in the genitourinary tract. The North American Menopause Society estimates that 10-40% of menopausal women will experience one or more symptoms of vaginal atrophy. Vaginal atrophy causes bothersome vaginal symptoms commonly associated with menopause including, vaginal or vulvar dryness, discharge, itching, and dyspareunia. Estrogen therapy effectively alleviates atrophic vaginal symptoms related to menopause. Local therapy is advised for the treatment of women with only vaginal symptoms. All low-dose systemic estrogen formulations are Food and Drug Administration (FDA) approved for the treatment of atrophic vaginitis. Oral dosages of conjugated Equine Estrogen as low as 0.3 milligrams/deciliter (mg/d) and transdermal Estradiol dosages of 12.5 micrograms/deciliter have demonstrated improvements in vaginal atrophy. Local vaginal estradiol and local conjugated equine estrogen, which can be administered in cream, ring, and tablet formulations, are effective in treating atrophic vaginitis in menopausal women. This application can provide relief from menopausal symptoms of vaginal atrophy and dyspareunia. Each of the formulary drugs is an option for control of these symptoms and would be both effective and not likely to cause side effects/adverse effects. In this case, the formulary drugs have not been proven to have adverse effects in the management of atrophic vaginitis.