Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Menopausal symptoms
Treatment: Formulary exception for Duavee
The insurer denied: Formulary exception for Duavee
The denial is overturned.

The patient is an adult female with menopausal symptoms. She has a high risk for breast cancer and a family history of osteoporosis. She had previously been on Duavee which managed her symptoms. She then stopped when it became unavailable. The patient continues with symptoms and the request is to go back on Duavee. This has been denied because the patient has not tried and failed the formulary options. This is being appealed.

The health plan should cover the proposed treatment.

Conjugated estrogens/bazedoxifene (CE/BZA or Duavee) is the first Food and Drug Administration (FDA)-approved medication that combines conjugated estrogens with an estrogen agonist/antagonist, bazedoxifene. Conjugated estrogens are an estrogen replacement therapy and work to supplement depleted estrogen levels as a woman reaches menopause. Bazedoxifene is classified as a selective estrogen receptor modulator (SERM).
The combination of conjugated estrogens/bazedoxifene has been labeled the tissue selective estrogen complex (TSEC) in the literature. It exerts estrogenic activity on the bone but displays antiestrogenic activity on the uterus and breast. Bazedoxifene helps to reduce the risk of endometrial hyperplasia, which can occur with estrogen replacement therapy. Therefore, conjugated estrogens/bazedoxifene is only indicated for those women with an intact uterus. Bazedoxifene was approved in 04/2009 in Europe for the treatment of postmenopausal osteoporosis. Other selective estrogen receptor modulators currently available include tamoxifen and toremifene (Fareston, ProStrakan), used for the treatment of breast cancer, and raloxifene (Evista, Lilly), which is approved for the treatment and prevention of osteoporosis and reduction of breast cancer risk. Prior to the approval of conjugated estrogens/bazedoxifene, preclinical data showed that bazedoxifene might have the potential for fewer uterine and vasomotor effects compared with the other selective estrogen receptor modulators. The guidelines and recommendations on menopausal hormone therapy and preventive strategies for midlife health (That is (i.e.), osteoporosis) of the International Menopause Society (IMS) were updated in 2013 and included bazedoxifene. According to the International Menopause Society, the conjugated estrogens/bazedoxifene combination has been shown to alleviate vasomotor symptoms, reduce bone turnover rates, and prevent bone loss. The report adds that while future studies are necessary, the selective estrogen receptor modulators have been shown to inhibit endometrial hyperplasia, similar to combination menopausal hormone therapy (MHT) (estrogen plus progestin), but without adversely affecting the breast. In 2014, the North American 
Menopause Society recommendations for the clinical care of midlife women noted conjugated estrogens/bazedoxifene to be an option for vasomotor symptoms as well as for prevention of 
osteoporosis. Both reports stated that the type of therapy chosen, length of treatment, and dosing should be individualized for each patient depending on the severity of menopausal symptoms and patient characteristics. In review of the medical record, the patient has vasomotor symptoms associated with 
menopause. She has a family history of osteoporosis and a high risk for breast cancer. The literature supports the use of the combination of equine estrogen and bazedoxifene for the 
treatment of vasomotor symptoms as well as the prevention of bone loss without increasing the risk of breast cancer. This is the only Food and Drug Administration (FDA) approved medication of this class. The formulary options are not equivalent to this medication and with the patient's unique clinical situation, this is the best option for the management of her vasomotor symptoms. Therefore, this would be more effective and have less adverse effects for this patient than the formulary options.