BlueCross BlueShield of Tennessee Medical Policy Manual

Testosterone Pellets for Subcutaneous Implantation

NDC CODE(S)

66887-0004-XX Testopel 75 MG PLLT (ENDO PHARMACEUTICALS)

DESCRIPTION

Testosterone is a steroid classified as an androgen.  Endogenous male androgens are responsible for the development and maintenance of the primary and secondary male sex characteristics.  These include the growth and development of the prostate, seminal vesicles, penis, scrotum, testicles, distribution of male hair (i.e., beard, pubic, chest and axillary), laryngeal enlargements, vocal cord thickening, altered body musculature and fat distribution.

Exogenous androgens can cause the body to retain nitrogen, phosphorous, potassium, sodium and cause decreased urinary excretion of calcium.  They may increase protein anabolism and decrease protein catabolism.  In children, exogenous androgens speed linear growth rates but may disproportionately advance bone maturation. They may also interfere with the production of endogenous testosterone due to feedback inhibition of pituitary luteinizing hormone (LH) and in large doses may suppress spermatogenesis from feedback inhibition of pituitary follicle stimulating hormone.

Testosterone pellets are prepared by combining crystalline testosterone with the inactive ingredients of stearic acid and polyvinylpyrrolidone.  Upon subcutaneous implantation, the specified dosage of testosterone is slowly released into the system, reaching peak levels at around 65 days. As a delivery system, pellet implantation is significantly less flexible for dosage adjustment than oral administration or intramuscular injections.

POLICY

MEDICAL APPROPRIATENESS

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Hypogonadism   150 mg to 450 mg (2 to 6 pellets) sq every 3 to 6 months with a maximum of 11 pellets every 3 months, per BCBST’s P&T Committee
Delayed puberty 150 mg to 300 mg (2 to 4 pellets) sq mg every 4 to 6 months with a maximum of 11 pellets every 3 months, per BCBST’s P&T Committee
Gender reassignment Generally 2 (two) 75mg pellets sq for each 25mg testosterone propionate required weekly as needed for 6 months with a maximum of 11 pellets every 3 months, per BCBST’s P&T Committee

Note:

LENGTH OF AUTHORIZATION

Coverage will be provided for six months initially and may be renewed annually thereafter

Click here to view DOSAGE LIMITS

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.

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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validate the use of testosterone pellets for subcutaneous implantation for the treatment or prevention of other conditions or diseases.

SOURCES

Auxilium Pharmaceuticals, Inc. (2016, October) Testopel [package insert]. Malvern, PA; October 2016. Retrieved February 5, 2018 from http://www.endo.com/File%20Library/Products/Prescribing%20Information/Testopel_prescribing_information.html.

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Testosterone Replacement Therapies (5.01.23). Retrieved February 5, 2018 from BlueWeb.

Lexi-Comp Online. (2018, January). AHFS DI. Testosterone, testosterone cypionate, testosterone enanthate, testosterone undecanoate. Retrieved February 5, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, January). Testosterone. Retrieved February 5, 2018 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE:  7/17/2014

MOST RECENT REVIEW DATE:  3/13/2018

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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.

 

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

Billable Unit

Maximum Units

All indications 1 billable unit = 75 mg 6 billable units (450 mg) every 90 days