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.

REFER TO DECISION SUPPORT TREE

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

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 implant for the treatment or prevention of any other condition or disease.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2014). Testosterone Replacement Therapies (5.01.23). Retrieved February 25, 2015 from BlueWeb.

National Institutes of Health. (2013, June) National Library of Medicine Daily Med. Testopel® (testosterone) pellet [Slate Pharma]. Retrieved February 25, 2015 from http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a1741a0b-3d4c-42dc-880d-a06e96cce9ef&type=display.

ORIGINAL EFFECTIVE DATE:  7/17/2014

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Testosterone Pellets for Subcutaneous Implantation (Testopel®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #8

  1. Does the individual have a diagnosis of ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will implantation of an agent FDA-approved for marketing (i.e., not a compounded product) be performed in a physician’s office?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of delayed puberty in a male from birth with ALL of the following?

If yes, go to question #7

If no, go to question #5

  1. Does the individual have a diagnosis of hypogonadism (primary or secondary) in a male from birth with ALL of the following?

If yes, go to question #7

If no, go to question #6

  1. Is the request for gender reassignment therapy for a female-to-male individual with inadequate response, contraindication or intolerance to a three or more month trial of ALL (BOTH FORMULATIONS) of the following?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 11 billable units or less (1 billable unit = 75 mg) every 90 days for dosages of the following?

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, female-to-male

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

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity or infection from the implant, e.g., alteration in liver function, excessive bleeding, venous thromboembolism, gynecomastia, shortness of breath, sleep apnea, stroke, myocardial infarction, fluid/electrolyte disturbances, prostatic hypertrophy, polycythemia?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are testosterone levels taken within the preceding 28 days within the upper limit of the normal range for the testing laboratory (generally mid-range is targeted)?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of female-to-male gender reassignment?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #12

  1. Does the individual have a diagnosis of hypogonadism (primary or secondary) with an improvement in signs and symptoms after initial treatment?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #13

  1. Does the individual have a diagnosis of delayed puberty and continues to be monitored for bone maturation and to require testosterone supplementation in order to complete development of secondary sexual characteristics?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.