BlueCross BlueShield of Tennessee Medical Policy Manual
Testosterone Pellets (Testopel®)
IMPORTANT REMINDER
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.
POLICY
FDA-approved Indications
Males
Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
Safety and efficacy of Testopel (testosterone pellets) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Compendial Uses
Gender Dysphoria (also known as transgender or gender diverse (TGD) persons)
COVERAGE CRITERIA
Delayed Puberty
Authorization may be granted when the requested drug is being prescribed for delayed puberty when the following criteria is met:
Gender Dysphoria
*Individual is age 18 or older or the individual is less than age 18 as permissive under applicable law
Authorization may be granted when the requested drug is being prescribed for gender dysphoria in a patient who is able to make an informed decision to engage in hormone therapy when ALL of the following criteria are met:
Primary or Hypogonadotropic Hypogonadism
Authorization may be granted when the requested drug is being prescribed for primary or hypogonadotropic hypogonadism when ALL of the following criteria are met:
•The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism)
•Before the start of testosterone therapy, the patient has at least TWO confirmed low morning testosterone levels according to current practice guidelines or your standard lab reference values
CONTINUATION OF THERAPY
Delayed Puberty
All patients (including new patients) requesting authorization for continuation of therapy must meet ALL initial authorization criteria.
Gender Dysphoria
*Individual is age 18 or older or the individual is less than age 18 as permissive under applicable law
All patients (including new patients) requesting authorization for continuation of therapy must meet ALL initial authorization criteria.
Primary or Hypogonadotropic Hypogonadism
Authorization may be granted when the requested drug is being prescribed for primary or hypogonadotropic hypogonadism when ALL of the following criteria are met:
DURATION OF APPROVAL (DOA)
OTHER
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 7/17/2014
MOST RECENT REVIEW DATE: 12/31/2024
ID_CHS
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