Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Menopausal symptoms
Treatment: Formulary exception for Bijuva
The insurer denied: Formulary exception for Bijuva
The denial is upheld.

The patient is an adult female who had her last menses last year. Several months ago, she sought care for menopausal symptoms, including hot flashes, sweats, and poor sleep. She was started on Activella, which did not control symptoms, she then tried estradiol/medroxyprogesterone, but had some postmenopausal bleeding. She was switched to Bijuva samples in August, and the request is to continue. The request has been denied coverage by the health plan, because the patient is not documented to have tried and failed the formulary options. This denial is being appealed.

The health plan should not cover the Formulary exception for Bijuva.

The formulary drugs are not documented to have been effective for the patient. The formulary drugs are expected to be as effective as the requested non-formulary drug. The formulary drugs would not be expected to have adverse effects for the patient. 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 HT (hormone therapy). Although HT (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. There also are low-dose formulations of estradiol available in topical gels, creams, and sprays that are approved by the United States Food and Drug Administration (FDA). There are 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 HT (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/day and all lower combination doses (Utian et al). Another study of 333 women randomized to receive various doses of estradiol or placebo found that a dosage as low as 0.5 milligrams/day of oral estradiol is effective in treating hot flushes (Notelovitz et al).
The degree of improvement of vasomotor symptoms from low-dose and ultra-low dose preparations has not been as extensively studied as with standard-dose preparations. Although women will experience improvement in symptoms with low and ultra-low doses of HT (hormone therapy), lower doses do not appear to be as effective as traditional doses of HT (hormone therapy) in alleviating vasomotor symptoms. Nonetheless, given the variable response to HT (hormone therapy) and the associated risks, it is recommended that health care providers individualize care and treat women with the lowest effective dose for the shortest duration that is needed to relieve vasomotor symptoms.
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. There is no evidence that one formulation is better than another; only that care needs to be individualized. The information provided does not indicate that the Bijuva has been working for the patient. There are multiple formulary options that have not been tried and have been demonstrated to provide relief of menopausal symptoms. Therefore, at this time there is no evidence that the formulary options would be ineffective for this patient or cause adverse events. There is no evidence that Bijuva is better than the formulary options. Therefore, at this time the plan should not cover the formulary exception request.