Appeal type: Experimental/Investigational
Decision: Upheld

A 60-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Tri-Est (Estrogel) 0.3gm/progesterone 3.0gm/testosterone 0.06gm/propylene glycol 2.90ml/HRT base 25.10gm compounded hormone replacement therapy (topical medication).  The Health Plan has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees menopausal symptoms.  Findings:  Three physician reviewers found that the patient has been using a compounded hormone preparation topical cream containing an estrogen, progesterone, and testosterone for menopausal symptoms.   Per the submitted documentation, she has tried oral PremPro, but discontinued it due to side effects.  The patient reported that she has a family history of strokes, heart disease, and breast cancer.  She has requested reimbursement and prospective authorization and coverage for Tri-Est (Estrogel) 0.3gm/progesterone 3.0gm/testosterone 0.06gm/propylene glycol 2.90ml/HRT base 25.10gm compounded hormone replacement therapy (topical medication).  Patients are sometimes prescribed compounded (often described as bioidentical) hormones, usually as topical therapies, that are presented as being more natural or more safe than pharmaceutically manufactured FDA-approved hormone preparations.  Because they are sold as supplements, they are outside the regulatory control of the FDA.  Thus, they are exempt from testing and confirmation of safety, and they do not have labeling that accurately depicts risks.  The American Congress of Obstetrics and Gynecology Committee Opinion notes that most compounded products have not undergone any rigorous clinical testing for either safety or efficacy, and issues of quality assurance regarding the purity, potency, and quality of compounded products are a concern. The Committee Opinion noted that there is a lack of scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens.As noted by Boothby and colleagues, there are few observational studies and clinical trials comparing conventional hormone therapy with bioidentical hormone therapy.  The authors noted that there is no proven advantage of individualized hormonal products over conventional hormone therapies, and their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy.  Fugh-Berman and Bythrow noted that there is a lack of data demonstrating that bioidentical compounded estrogen preparations are safe alternatives to conventional menopausal hormone therapy.   As noted by the authors, natural hormones, including estradiol, estriol, estrone, and progesterone, can be expected to have the same adverse event profile as conventional menopausal hormone regimens.Thus, there is a lack of evidence demonstrating that compounded topical hormones are safer or more efficacious than standard FDA-approved and tested options.  In fact, because of issues related to compounding, dosing is frequently inconsistent, which may add to associated risks.  In this case, the patient raises safety concerns regarding the use of hormone therapy in the setting of her family history of stroke, heart disease and breast cancer.  There is no medical basis to claims that her topical compounded therapies are safer than other available FDA-approved hormone preparations in terms of blood clots or breast cancer risks.  All told, the medication at issue was not and is not likely to be superior over other available treatment options.