DESCRIPTION
Bioidentical Compounded Hormone Therapy - Compounded hormone prescriptions are purportedly customized to an individual’s particular hormonal needs (e.g., Biest [biestrogen], Triest [triestrogen], dehydroepiandrosterone [Prasterone], pregnenolone, estrone sulfate, estriol [Ovestin, Ortho-Gynst], ethinyl estradiol, estradiol valerate, estradiol cypionate estradiol benzoate, medroxyprogesterone, estradiol cypionate, estriol dehydroepiandrosterone, pregnenolone, testosterone cypionate, testosterone propionate, testosterone enanthate, DHEA [Diandrone, Intrarosa, Gynodian Depot], 7-Keto DHEA,). These compounded preparations are very heavily marketed to be “all-natural”, more effective, and safer than standard drugs for hormone therapy. Compounded preparations are not approved by the FDA and therefore exempt from including contraindications and warnings in package inserts. It introduces the possibility of multiple compounding sources, creating adverse effects and difficulty identifying the responsible active agent. Additional risks are intrinsic to compounding, such as variable bioavailability and bioactivity, creating overdosage and underdosage concerns.
Bioidentical Compound Hormone Therapy was previously addressed as investigational within BCBST’s Complementary & Alternative Medicine policy (2014 - 2022). The topic is now addressed separately within this medical policy document.
POLICY
Bioidentical compounded hormone therapy for the diagnosis, prevention, and/or treatment of diseases and health related symptoms or conditions are considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
A few “bioidentical” hormones available from retail pharmacies, are produced under FDA supervision (monitored for dosage and purity) and have structures identical to endogenous hormones. They can be obtained as FDA-approved preparations (i.e., oral estradiol, transdermal estradiol patches, gels, sprays, lotions, estradiol vaginal cream, tablets, rings, inserts, oral or vaginal progesterone). However, even FDA-monitored “bioidentical” hormones have not been examined in head-to-toe randomized controlled trials with clinical outcomes such as cardiovascular events and fractures, therefore they have unproven safety and efficacy.
SOURCES
Agency for Healthcare Research and Quality. (AHRQ). (2015, March). Menopausal symptoms: comparative effectiveness of therapies executive summary. Retrieved June 27, 2022 from https://effectivehealthcare.ahrq.gov/.
American College of Obstetrics and Gynecologists. (2012, reaffirmed 2020). Compounded Bioidentical Menopausal Hormone Therapy. Committee Opinion No. 532: Retrieved October 29, 2021 from www.acog.org.
Endocrine Society. (2019, September). Compounded bioidentical hormone therapy position statement. Retrieved August 26, 2022 from https://www.endocrine.org/.
Liu, Y., Yuan, Y., Day, A.J., Zhang, W., John, P., Ng, D.J., et al. (2022). Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials. The Journal of The North American Menopause Society, 29 (4), 465-482. (Level 1 evidence)
National Center for Complementary and Integrative Health. (NICCIH). (2017, May) Menopausal symptoms: in depth. Retrieved August 18, 2023 from http://www.nccih.nih.gov.
National Institute for Health and Care Excellence. (NICE). (2019, December) Menopause: diagnosis and management. Retrieved August 18, 2023 from http://www.nice.org.uk.
U.S. Preventive Service Task Force. (2013, January). Menopausal hormone therapy for the primary prevention of chronic conditions: u.s. preventive services task force recommendation statement. Retrieved June 27, 2022 from www.USPreventiveServicesTaskForce.org.
ORIGINAL EFFECTIVE DATE: 7/14/2022
MOST RECENT REVIEW DATE: 10/12/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.