Medical Policy: 02.01.49
Original Effective Date: June 2012
Reviewed: February 2016
Revised: February 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Menopause is a normal, natural sign of aging. There is a long list of physical changes that geno typical women may experience around menopause, which may be related to menopause or aging- or both. Some of these symptoms include hot flashes, sleep disturbances, night sweats and vaginal dryness and decreased sex drive.
Several prescription drugs are available to help relieve menopause-related symptoms. Hormone therapy has been shown to be the most effective intervention for management of these symptoms.
This policy is specifically related to subcutaneously implanted hormone pellets. The individual pellets are smaller than a grain of rice and are implanted into the subcutaneous tissue, where they provide a slow continuous release of hormone into the bloodstream. The pellets are implanted in the lower abdomen or buttocks. The procedure is done in a physician's office with the use of a local anesthetic and a small incision for insertion. The release of the drug continues over a 3-6 month period.
Subcutaneous implantable pellets made up of estradiol, estrogen, or testosterone in combination with estrogen or estradiol has been custom compounded by pharmacists according to physician specifications. However, none of these are FDA approved for U.S. distribution and their safety and efficacy has not been adequately demonstrated in well-designed clinical trials.
The American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice and the Practice Committee of the American Society for Reproductive Medicine make the following conclusions and recommendations:
US Food and Drug Administration
In 2015, the FDA issued a drug safety communication stating that prescription testosterone products are approved only for males with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. They cautioned that the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging. The FDA also concluded that there is a possible increased risk of heart attacks and strokes associated with testosterone use.
US Food and Drug Administration
Subcutaneous hormone pellets containing estrogen alone or estrogen combinations (including bioidentical hormone formulations) are considered INVESTIGATIVE for all indications including, but not limited to, symptoms associated with geno typical female menopause because there are no FDA-approved formulations of these products.
The use of testosterone pellets specifically Testopel, in geno typical women is considered investigational as the FDA indications are only for the use in geno typical males. The literature does not support off-label use for menopausal symptoms or decreased libido.
Testopel use in geno typical males is considered medically necessary for the following conditions:
The use of subcutaneous hormone pellets in geno typical men, outside of the use of Testopel, is considered investigational. Testopel is the only FDA approved subcutaneous pellet approved at this time.
The use of Testopel is considered investigational for geno typical male menopause, hypogonadism due to aging, erectile dysfunction, and for all other conditions not listed above.
The use of Testopel dosage is limited to a maximum number of pellets per injection, based on labeling indications.
At the current time, there is lack of medical and scientific evidence to support the efficacy and safety of customized subcutaneous hormone replacement regimes utilizing bioidentical hormones. Well-designed and controlled clinical trials are needed to provide evidence of improved net health outcomes with compounded bioidentical hormone replacement, subcutaneously inserted over conventional hormone therapies. The FDA issed a safety communication in 2015, warning against the use of testosterone products for low testosterone due to aging.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.