Coverage Policy Manual
Policy #: 2009047
Category: Pharmacy
Initiated: February 2010
Last Review: October 2023
  Hormone Pellet Implantation for Hormone Therapy
Description:
Hormone pellets are surgically implanted under the skin through a small incision. They provide a slow continuous release of hormones into the bloodstream.   
 
This procedure is usually performed in the physician’s office through a local anesthetic.  
 
Testopel is not FDA approved for use in biologic females.
 
Although estrogen replacement can be beneficial in the treatment of menopausal symptoms, subcutaneous estrogen or estrogen containing preparations are not FDA approved and therefore not covered by the policy.
 
Coding
 
See CPT/HCPCS Code section below.
Policy/
Coverage:
Effective April 01, 2022 Prior Approval is required for Testopel implant.
 
The Step Therapy Medication Act is applicable to fully-insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart, Tyson or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
 
Effective May 15, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
1. Individual is a biological male (i.e., assigned male at birth); AND
2. Individual has failed or cannot tolerate both testosterone patch and gel; AND   
3. Individual has at least one of the following conditions:  
a. An established diagnosis of hypogonadism with androgen deficiency that includes:
i. Persistently low testosterone levels as evidenced by 2 early morning fasting serum total testosterone levels that are below 300 ng/dL on both days* (Bhasin, 2018); AND  
ii. At least 2 of the following symptoms (Shalender, 2018):
1. Incomplete or delayed sexual development.
2. Loss of axillar and/or pubic body hair.
3. Very small (less than 6 ml) or shrinking testes.  
4. Decreased libido.
5. Decreased spontaneous erections.
6. Breast discomfort and gynecomastia.
7. Eunuchoidal body proportions.
8. Infertility due to low sperm count.
9. Height loss due to vertebral fractures, low trauma fractures, low bone density.  
10. Hot flushes/sweats; OR
4. HIV-infected individuals with low testosterone levels and weight loss (Shalender, 2018); OR
5. Individual is on chronic steroid treatment with low testosterone levels; AND
6. Testosterone subcutaneous pellets will not be used for either of the following:
a. Reduced libido; OR
b. Weight loss; AND
7. Must be dosed in accordance with the FDA label.
 
*Note: The Endocrine Society has recommended a lower limit for normal levels of 300 ng/dL for total testosterone and 9.0 ng/dL for free testosterone (Bhasin et. al., 2018). Joint guidelines from several European and American specialty societies have recommended that replacement therapy be considered at serum total testosterone levels less than 350 ng/dL.
 
In biologic males whose total testosterone is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, it is recommended that a free T concentration be obtained using either equilibrium dialysis or estimating it using an accurate formula.
 
CONTINUATION OF THERAPY for 12 months:
 
1. Individual meets criteria for initial approval based on indication; AND
2. Individual has experienced a positive clinical response to implantable hormone pellets; AND
3. Must be dosed in accordance with the FDA label.
 
Dosing and Administration
Dosing per FDA Guidelines
 
The recommended dosing range is 150 to 450 mg every 3 to 6 months. For 75-mg pellets, this would correspond to the implantation of 2 to 6 pellets every 3 to 6 months. The dosing interval is individualized because some individuals will require redosing as early as every 3 months while others may not require redosing for up to 6 months.
 
Testosterone pellets are available as 75 mg testosterone pellet per vial.  
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Testosterone implants, for any indication or circumstance not described above, do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, testosterone implants, for any indication or circumstance not described above, are considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective October 2023 to May 14, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for use in adult individuals who:
 
    1. Have failed or cannot tolerate both testosterone patch and gel; AND   
    2. Have at least one of the following conditions:  
 a. An established diagnosis of hypogonadism with androgen deficiency that includes:
 i. Persistently low testosterone levels as evidenced by 2 early morning fasting serum total testosterone levels that are below 300 ng/dL on both days* (Bhasin, 2018); AND  
ii. At least 2 of the following symptoms (Shalender, 2018):
          1. Incomplete or delayed sexual development.
          2. Loss of axillar and/or pubic body hair.
          3. Very small (less than 6 ml) or shrinking testes.  
          4. Decreased libido.
          5. Decreased spontaneous erections.
          6. Breast discomfort and gynecomastia.
          7. Eunuchoidal body proportions.
          8. Infertility due to low sperm count.
          9. Height loss due to vertebral fractures, low trauma fractures, low bone density.  
          10. Hot flushes/sweats; AND
3. Will not be used for either of the following:
a. Reduced libido; OR
b. Weight loss; AND
4. Will be dosed in accordance with the FDA label.
 
*Note:  
The Endocrine Society has recommended a lower limit for normal levels of 300 ng/dL for total testosterone and 9.0 ng/dL for free testosterone (Bhasin et. al., 2018). Joint guidelines from several European and American specialty societies have recommended that replacement therapy be considered at serum total testosterone levels less than 350 ng/dL.
 
In biologic males whose total testosterone is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, it is recommended that a free T concentration be obtained using either equilibrium dialysis or estimating it using an accurate formula.
 
 OR
    • HIV-infected individuals with low testosterone levels and weight loss (Shalender, 2018);
 
OR
    • Individuals on chronic steroid treatment with low testosterone levels.
 
CONTINUATION OF THERAPY for 12 months:
 
    1. Individual meets criteria for initial approval based on indication.
    2. Individual has experienced a positive clinical response to implantable hormone pellets.
    3. Must be dosed in accordance with the FDA label unless otherwise specified.
 
Dosing and Administration
Dosing per FDA Guidelines
 
The recommended dosing range is 150 to 450 mg every 3 to 6 months. For 75-mg pellets, this would correspond to the implantation of 2 to 6 pellets every 3 to 6 months. The dosing interval is individualized because some individuals will require redosing as early as every 3 months while others may not require redosing for up to 6 months.
 
Testosterone pellets are available as 75 mg testosterone pellet per vial.  
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Testosterone implants, for any indication or circumstance not described above, do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, testosterone implants, for any indication or circumstance not described above, are considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective October 19, 2022 to September 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for use in adult individuals who:
    1. Have failed or cannot tolerate both testosterone patch and gel AND   
2. Have at least one of the following conditions:  
      •  An established diagnosis of hypogonadism with androgen deficiency that includes:
        •  Persistently low testosterone levels as evidenced by 2 early morning fasting serum total testosterone levels that are below 300 ng/dL on both days* (Bhasin, 2018), AND  
        • At least 2 of the following symptoms (Shalender, 2018):
          •  incomplete or delayed sexual development;
          • loss of axillar and/or pubic body hair;
          • very small (<6ml) or shrinking testes;  
          • decreased libido;
          • decreased spontaneous erections;
          • breast discomfort and gynecomastia;
          • eunuchoidal body proportions;
          • infertility due to low sperm count;
          • height loss due to vertebral fractures, low trauma fractures, low bone density;  
          • hot flushes/sweats;
*Note:  
The Endocrine Society has recommended a lower limit for normal levels of 300 ng/dL for total testosterone and 9.0 ng/dL for free testosterone (Bhasin et al [2018]). Joint guidelines from several European and American specialty societies have recommended that replacement therapy be considered at serum total testosterone levels less than 350 ng/dL.
 
In biologic males whose total testosterone is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, it is recommended that a free T concentration be obtained using either equilibrium dialysis or estimating it using an accurate formula.
 
 OR
 
      • HIV-infected individuals with low testosterone levels and weight loss (Shalender, 2018);
 
OR
 
      • Individuals on chronic steroid treatment with low testosterone levels.
 
CONTINUATION OF THERAPY for 12 months:
1. Individual meets criteria for initial approval based on indication.
2. Individual has experienced a positive clinical response to implantable hormone pellets.
3. Must be dosed in accordance with the FDA label unless otherwise specified.
 
Dosing and Administration
The recommended dosing range is 150 to 450 mg every 3 to 6 months. For 75-mg pellets, this would correspond to the implantation of 2 to 6 pellets every 3 to 6 months. The dosing interval is individualized because some patients will require redosing as early as every 3 months while others may not require redosing for up to 6 months.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Testosterone implants do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for all clinical indications or conditions not described above, including but not limited to, reduced libido and weight loss.
 
For contracts without primary coverage criteria, testosterone implants for all clinical indications or conditions not described above, including but not limited to , reduced libido and weight loss are considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective April 1, 2022 to October 18, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
MALES
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for use in males who:
    1. Have failed or cannot tolerate both testosterone patch and gel  
 
AND
 
2. Have at least one of the following conditions:  
 
      • An established diagnosis of hypogonadism with androgen deficiency that includes:
 
          • Persistently low testosterone levels as evidenced by 2 early morning fasting serum total testosterone levels that are below 300 ng/dL on both days* (Bhasin, 2018), AND
 
          • At least 2 of the following symptoms (Shalender, 2018):
 
              • incomplete or delayed sexual development;
              • loss of axillar and/or pubic body hair;
              • very small (<6ml) or shrinking testes;  
              • decreased libido;
              • decreased spontaneous erections;
              • breast discomfort and gynecomastia;
              • eunuchoidal body proportions;
              • infertility due to low sperm count;
              • height loss due to vertebral fractures, low trauma fractures, low bone density;  
              • hot flushes/sweats;
*Note:  
The Endocrine Society has recommended a lower limit for normal levels of 300 ng/dL for total testosterone and 9.0 ng/dL for free testosterone (Bhasin et al [2018]). Joint guidelines from several European and American specialty societies have recommended that replacement therapy be considered at serum total testosterone levels less than 350 ng/dL.
 
In men whose total testosterone is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, it is recommended that a free T concentration be obtained using either equilibrium dialysis or estimating it using an accurate formula
 
 OR
 
      • HIV-infected men with low testosterone levels and weight loss (Shalender, 2018);
 
OR
 
      • Men on chronic steroid treatment with low testosterone levels.
 
CONTINUATION OF THERAPY for 12 months:
1. Member meets criteria for initial approval based on indication.
2. Member has experienced a positve clinical response to implantable hormone pellets.
3. Dosed in accordance with FDA labeling.
 
Dosing and Administration
 
For use in men, the recommended dosing range is 150 to 450 mg every 3 to 6 months. For 75-mg pellets, this would correspond to the implantation of 2 to 6 pellets every 3 to 6 months. The dosing interval is individualized because some patients will require redosing as early as every 3 months while others may not require redosing for up to 6 months.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
FEMALES:
Implantable hormone pellets (testosterone and/or estrogen) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for females, as a method of hormone replacement therapy (HRT).
 
For contracts without primary coverage criteria, Implantable hormone pellets (testosterone and/or estrogen) as a method of hormone replacement therapy (HRT) is considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.
 
FEMALES or MALES:
Testosterone implants in females or males for the treatment of reduced libido do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used without estrogen therapy.
 
For contracts without primary coverage criteria, Testosterone implants in females or males for the treatment of reduced libido are considered investigational when used without estrogen therapy. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective October 2018 to March 31, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
MALES
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for use in males who:
    1. Have failed or cannot tolerate both testosterone patch and gel  
 
AND
 
2. Have at least one of the following conditions:  
 
      • An established diagnosis of hypogonadism with androgen deficiency that includes:
 
          • Persistently low testosterone levels as evidenced by 2 early morning fasting serum total testosterone levels that are below 300 ng/dL on both days* (Bhasin, 2018), AND
 
          • At least 2 of the following symptoms (Shalender, 2018):
 
              • incomplete or delayed sexual development;
              • loss of axillar and/or pubic body hair;
              • very small (<6ml) or shrinking testes;  
              • decreased libido;
              • decreased spontaneous erections;
              • breast discomfort and gynecomastia;
              • eunuchoidal body proportions;
              • infertility due to low sperm count;
              • height loss due to vertebral fractures, low trauma fractures, low bone density;  
              • hot flushes/sweats;
*Note:  
The Endocrine Society has recommended a lower limit for normal levels of 300 ng/dL for total testosterone and 9.0 ng/dL for free testosterone (Bhasin et al [2018]). Joint guidelines from several European and American specialty societies have recommended that replacement therapy be considered at serum total testosterone levels less than 350 ng/dL.
 
In men whose total testosterone is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, it is recommended that a free T concentration be obtained using either equilibrium dialysis or estimating it using an accurate formula
 
 OR
 
      • HIV-infected men with low testosterone levels and weight loss (Shalender, 2018);
 
OR
 
      • Men on chronic steroid treatment with low testosterone levels.
  
Dosing and Administration
 
For use in men, the recommended dosing range is 150 to 450 mg every 3 to 6 months. For 75-mg pellets, this would correspond to the implantation of 2 to 6 pellets every 3 to 6 months. The dosing interval is individualized because some patients will require redosing as early as every 3 months while others may not require redosing for up to 6 months.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
FEMALES:
Implantable hormone pellets (testosterone and/or estrogen) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for females, as a method of hormone replacement therapy (HRT).
 
For contracts without primary coverage criteria, Implantable hormone pellets (testosterone and/or estrogen) as a method of hormone replacement therapy (HRT) is considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.
 
FEMALES or MALES:
Testosterone implants in females or males for the treatment of reduced libido do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used without estrogen therapy.
 
For contracts without primary coverage criteria, Testosterone implants in females or males for the treatment of reduced libido are considered investigational when used without estrogen therapy. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective October 2015 to September 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
FEMALES
Implantable hormone pellets (estrogen and testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for females, as a method of hormone replacement therapy (HRT) for any of the following conditions:
 
    • Menopausal or postmenopausal women with an intact uterus OR
    • after a hysterectomy experiencing climacteric symptoms and risk for osteoporosis; AND
    • either failure of conservative modes of HRT (e.g., oral medications, injections, dermal patches), or clinical indications that liver metabolism should be avoided and cannot be achieved with a dermal patch.
 
MALES
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for use in males who:
 
1) have failed or cannot tolerate both testosterone patch and gel  AND
 
2) have persistently low testosterone levels as evidenced by serum levels that are below the lower limit of normal (as specified by the lab assay) on at least 2 occasions when measured early in the morning, as a method of hormone replacement for any of the following conditions:
 
      • Congenital or acquired primary hypogonadism (i.e., testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome or orchidectomy) OR
      • Congenital or acquired hypogonadotrophic hypogonadism (i.e., idiopathic or gonadotropic LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation) OR
      • For development of secondary sex characteristics when either of the above conditions occur prior to puberty, in carefully selected males. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
 
*Note- Use in men is limited to 2-6 pellets (150mg-450mg) every 3-6 months
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Testosterone implants in females or males for the treatment of reduced libido do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used without estrogen therapy.
 
For contracts without primary coverage criteria, Testosterone implants in females or males for the treatment of reduced libido are considered investigational when used without estrogen therapy. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective September 2013 – September 2015
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
Implantable hormone pellets (estrogen and testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for females, as a method of hormone replacement therapy (HRT) for any of the following conditions:
 
    • Menopausal or postmenopausal women with an intact uterus OR
    • after a hysterectomy experiencing climacteric symptoms and risk for osteoporosis; AND
    • either failure of conservative modes of HRT (e.g., oral medications, injections, dermal patches), or clinical indications that liver metabolism should be avoided and cannot be achieved with a dermal patch.
 
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for use in males who have failed or cannot tolerate both testosterone patch and gel, as a method of hormone replacement for any of the following conditions:
    • Congenital or acquired primary hypogonadism (i.e., testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome or orchidectomy) OR
    • Congenital or acquired hypogonadotrophic hypogonadism (i.e., idiopathic or gonadotropic LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation) OR
    • For development of secondary sex characteristics when either of the above conditions occur prior to puberty, in carefully selected males. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
 
*Note- Use in men is limited to 2-6 pellets (150mg-450mg) every 3-6 months
 
Testosterone implants in females or males for the treatment of reduced libido do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used without estrogen therapy.
 
For contracts without primary coverage criteria, Testosterone implants in females or males for the treatment of reduced libido are considered investigational when used without estrogen therapy. Investigational services are exclusions in most member benefit certificates of coverage.  
 
Effective April through August 2013
 
The following coverage statements apply to members with contracts with benefits for estrogen and/or testosterone use:
 
Implantable hormone pellets (estrogen and testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for females, as a method of hormone replacement therapy (HRT) for any of the following conditions:
 
    • Menopausal or postmenopausal women with an intact uterus OR
    • after a hysterectomy experiencing climacteric symptoms and risk for osteoporosis; AND
    • either failure of conservative modes of HRT (e.g., oral medications, injections, dermal patches), or clinical indications that liver metabolism should be avoided and cannot be achieved with a dermal patch.
 
Implantable hormone pellets (testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for use in males who have failed or cannot tolerate both testosterone patch and gel, as a method of hormone replacement for any of the following conditions:
 
    • Congenital or acquired primary hypogonadism (i.e., testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome or orchidectomy) OR
    • Congenital or acquired hypogonadotrophic hypogonadism (i.e., idiopathic or gonadotropic LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation) OR
    • For development of secondary sex characteristics when either of the above conditions occur prior to puberty, in carefully selected males. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
 
*Note- Use in men is limited to 2-6 pellets (150mg-450mg) every 4-6 months
 
Testosterone implants in females or males for the treatment of reduced libido do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used without estrogen therapy.
 
For contracts without primary coverage criteria, Testosterone implants in females or males for the treatment of reduced libido are considered investigational when used without estrogen therapy. Investigational services are exclusions in most member benefit certificates of coverage.  
 
Effective prior to April 2013
 
Implantable hormone pellets (estrogen and testosterone) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for females, as a method of hormone replacement therapy (HRT) for any of the following conditions:
    • Menopausal or postmenopausal women with an intact uterus OR
    • after a hysterectomy experiencing climacteric symptoms and risk for osteoporosis; AND
    • either failure of conservative modes of HRT (e.g., oral medications, injections, dermal patches), or clinical indications that liver metabolism should be avoided and cannot be achieved with a dermal patch.
 
Testosterone implants in females for the treatment of reduced libido do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used without estrogen therapy.
 
For contracts without primary coverage criteria, Testosterone implants in females for the treatment of reduced libido are considered investigational when used without estrogen therapy. Investigational services are exclusions in most member benefit certificates of coverage.  
 
Rationale:
Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
A literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
 
The pellet method of administration is reported to provide a steady low dose of hormone. Frequently, this is the last resort being used after traditional methods of administration (oral, injection or dermal patch) have failed or been intolerant due to side effects.
 
The pellets usually have a six-month duration of therapeutic effect. Some individuals will require hormone levels to determine the proper dosage.
 
In 1988, the FDA's Fertility and Maternal Health Drugs Advisory Committee unanimously agreed to terminate compassionate investigative new drug (IND) programs for estrogen pellets as a last-resort treatment of menopausal disorder (FDA, 1988).  The Committee noted “the risk of bleeding and infection, the lack of information on release rates, difficulty in reversibility of the drug, increased feasibility of over-dosage of the drug, and increased risk of non-compliance with safety measures [such as] the addition of progestin.”  F-D-C- Reports Inc. Estrogen pellets availability under compassionate INDs should be discontinued as a last resort treatment for menopausal symptoms.
 
In 2014, the Endocrine Society in a clinical practice guideline for androgen therapy in women made the following recommendations:  
 
    • We recommend against making a diagnosis of androgen deficiency syndrome in healthy women because there is a lack of a well-defined syndrome, and data correlating androgen levels with specific signs or symptoms are unavailable.
    • We recommend against the general use of T for the following indications: infertility; sexual dysfunction other than hypoactive sexual desire disorder; cognitive, cardiovascular, metabolic, or bone health; or general well-being.
    • We recommend against the routine use of dehydroepiandrosterone due to limited data concerning its effectiveness and safety in normal women or those with adrenal insufficiency.
    • We recommend against the routine prescription of T or dehydroepiandrosterone for the treatment of women with low androgen levels due to hypopituitarism, adrenal insufficiency, surgical menopause, pharmacological glucocorticoid administration, or other conditions associated with low androgen levels because there are limited data supporting improvement in signs and symptoms with therapy and no long-term studies of risk.
    • Evidence supports the short-term efficacy and safety of high physiological doses of T treatment of postmenopausal women with sexual dysfunction due to hypoactive sexual desire disorder. Importantly, endogenous T levels did not predict response to therapy. At present, physiological T preparations for use in women are not available in many countries including the United States, and long-term safety data are lacking.
    • We recommend that any woman receiving T therapy be monitored for signs and symptoms of androgen excess.
    • We outline areas for future research. Ongoing improvement in androgen assays will allow a redefinition of normal ranges across the lifespan; this may help to clarify the impact of varying concentrations of plasma androgens on the biology, physiology, and psychology in women and lead to indications for therapeutic interventions.
 
In 2018, the Endocrine Society updated its guidelines for testosterone therapy with the following conclusions:  
    • We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations.
    • We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test.
    • We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations.
    • In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone–binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula.
    • In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making.
    • We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia.
    • We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost.
    • Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy.
 
 
CPT/HCPCS:
11980Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)
J3490Unclassified drugs
S0189Testosterone pellet, 75 mg
References: AACE medical guidelines for clinical practice for management of menopause, November-December 1999. American Association of Clinical Endocrinologists (AACE). http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=001364&sSearch_strin g=menopause.

Approval letter, Testosterone pellets. FDA. August 29, 1986, http://www.fda.gov/cder/foi/nda/96/4652. 1986.

Bhasin et al.(2018) Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism, Volume 103, Issue 5, 1 May 2018, Pages 1715–1744, https://doi.org/10.1210/jc.2018-00229

Cobin RH, Futterweit W, Ginzburg SB, et al.(2006) American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocr Pract. 2006 May-Jun;12(3):315-37.

F-D-C Reports Inc. FDA advisory committee.(1988) Estrogen pellets availability under compassionate INDs should be discontinued as a last resort treatment for menopausal symptoms-FDA Advisory Committee. The Pink Sheet, January 1988; 50(4).

Hormone replacement therapy. American College of Obstetricians and Gynecologists. Educational Bulletin. May 1998; 247:1-8. 1998.

Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the women’s health initiative randomized controlled trial. Writing Group for the Women’s Health Initiative Investigators. July 17, 2002, Vol 288, No 3. 2002.

Shalender Bhasin, Juan P Brito, Glenn R Cunningham, Frances J Hayes, Howard N Hodis, Alvin M Matsumoto, Peter J Snyder, Ronald S Swerdloff, Frederick C Wu, Maria A Yialamas,(2018) Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 103, Issue 5, May 2018, Pages 1715–1744, https://doi.org/10.1210/jc.2018-00229

Utian WH, Archer DF, Bachmann GA, et al.(2008) Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause. 2008 Jul-Aug;15(4):584-602.

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