Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Personal history of other endocrine, nutritional and metabolic disease.
Treatment:  Estradiol 0.5 milligram gel.

The insurer denied the Estradiol.  The denial has been upheld. 

No, the health plan should not cover the proposed treatment because the patient has not tried and failed the estradiol patch.

The patient is a female with menopausal symptoms including vasomotor symptoms. She tried gabapentin with some relief, and the request is for Estrogel.  This was denied because the patient has not tried and failed the formulary options. This is being appealed.

The formulary medication, estradiol patch, would be effective for this patient, and it would be as effective as the requested non-formulary drug.  There is no latex in this formulation, so there is not a concern for an adverse effect on this product.  The other formulary options, estradiol tablet, menest tablet, and Premarin tablet do pose an increase risk to this patient and are not equivalent.

According to the American College of Obstetrics and Gynecology, studies of the efficacy of hormone therapy (HT) for the treatment of vasomotor symptoms have principally investigated standard doses of hormone therapy. Although hormone therapy is well tolerated by most women, standard doses may cause adverse effects, such as breast tenderness, vaginal bleeding, bloating, and headaches. Low-dose and ultra-low systemic doses of estrogen may be associated with a better adverse effect profile than standard doses and may reduce vasomotor symptoms in some women.  Examples of low-dose systemic estrogen therapy formulations include 0.3-0.45 milligrams per day (mg/d) of oral conjugated equine estrogen, 0.5 milligrams per day of oral micronized estradiol, 5 micrograms per day of ethinyl estradiol, and 0.025-0.0375 milligrams per week of transdermal estradiol (patch). There also are low-dose formulations of estradiol available in topical gels, creams, and sprays that are approved by the Unites States Food and Drug Administration (FDA). There is good evidence that oral and transdermal low-dose estrogen regimens effectively alleviate vasomotor symptoms in women. The Heart Outcomes Prevention Evaluation, a large trial that assessed the efficacy of different doses of hormone therapy on vasomotor symptoms in more than 2,500 postmenopausal women, found a similar reduction in vasomotor symptoms with a conjugated equine estrogen dosage of 0.625 milligrams per day and all lower combination doses. Another study of 333 women randomized to receive various doses of estradiol or placebo found that a dosage as low as 0.5 milligrams per day of oral estradiol is effective in treating hot flushes.

In review of the medical record and current literature the goal of treatment is to individualize care and to treat with the lowest effective dose for the shortest duration that is needed to relieve symptoms.  The formulary options that are systemic to help with vasomotor symptoms include estradiol patch, estradiol tablet, menest tablet, and Premarin tablet.  These are not equivalent to the requested medication in mode of action except for the estradiol patch.  The formulary options of menest, estradiol tablet, and Premarin tablet are oral forms and have a higher risk of venous thromboembolism, posing increased health risk.  There is not any information in the literature that the patch contains latex.  Therefore, there is not any evidence that the requested medication is more effective that the estradiol patch.  Therefore, the health plan should not cover the proposed treatment because the patient has not tried and failed the estradiol patch.