Androgens - NC Standard

All testosterone products require medical necessity review.

Restriction applies to brand and generic products

• Aveed (testosterone undeconate)
• Azmiro (testosterone cypionate)
• Depo-Testosterone (testosterone cypionate) 
• Jatenzo (testosterone undecanoate) 
• Kyzatrex (testosterone undecanoate) 
• Methitest (methyltestosterone) 
• Methyltestosterone 
• Tlando (testosterone undecanoate)
• Undecatrex (testosterone undecanoate)
• Xyosted (testosterone enanthate) 
• Topicals 
  • Androderm (testosterone) 
  • Androgel (testosterone) 
  • Fortesta (testosterone) 
  • Natesto (testosterone) 
  • Testim (testosterone)
  • Testosterone 1.62% gel (generic Androgel) 
  • Testosterone solution 30mg/1.5 mL pump bottle
  • testosterone gels 
  • Vogelxo (testosterone)

• For replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. 
• For primary hypogonadism (congenital or acquired): Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. 
• For hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. 
• For delayed puberty: To stimulate puberty in carefully selected males with clearly delayed puberty. 
• For metastatic mammary cancer in women: Used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal.

*Coverage may vary by state. Check applicable state laws for more information.

1. ONE of the following:
   1. The patient has a diagnosis of hypogonadism; AND
      1. The patient has symptoms of androgen deficiency or had symptoms at the time of diagnosis; OR
         1. The patient has a diagnosis of human immunodeficiency virus (HIV) with unexplained weight loss or low bone mineral density; AND
      2. The patient has a baseline, early morning, level (either free serum or total testosterone) that is below the testing laboratory’s lower limit of the normal range (medical record documentation required); AND
      3. The patient has had a second, early morning, level (either free serum or total testosterone) drawn on a subsequent day to confirm the diagnosis (medical record documentation required); OR
   2. The patient is using for the palliative treatment of metastatic inoperable breast cancer; OR
   3. The patient has a diagnosis of delayed puberty; OR
   4. The patient has a diagnosis of gender dysphoria; AND
      1. The patient is 18 years of age or older; AND
         1. The patient has persistent, well-documented gender dysphoria; AND
         2. The patient has the capacity to make a fully informed decision and to consent for treatment; AND
         3. Mental health concerns, if present, are reasonably well controlled; OR
      2. The patient is under the age of 18 years of age; AND
         1. ALL of the following
            1. A qualified mental health provider* has confirmed:
               1.  The persistence of gender dysphoria; AND
               2.  Any coexisting psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start sex hormone treatment; AND
               3. The patient has sufficient mental capacity to estimate the consequences of this (partly) irreversible treatment, weigh the benefits and risks, and give informed consent to this (partly) irreversible treatment; AND
            2. The patient has been informed of the (irreversible) effects and side effects of treatment (including potential loss of fertility and options to preserve fertility); AND
            3. The patient has given informed consent and the parents or other caretakers, or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process; OR
         2. The treating clinician must submit information indicating why it would be clinically inappropriate to require the candidate to meet these criteria (medical record documentation required); AND
2. If the request is a brand name topical testosterone product, the patient has tried and failed or has a clinical intolerance or contraindication to two generic testosterone products; AND
3. For Enhanced and Net Results formularies: If the request is for Xyosted, the patient has tried and failed or has a clinical intolerance or contraindication to one generic testosterone product; AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

*Qualified mental health provider, including but not limited to: psychiatrist (M.D., D.O.), Psy.D, Ph.D, psychiatric physician assistant, psychiatric nurse practitioner, D.S.W., LCSW, or LCMHC.

Duration of approval: 365 days (1 year)

1. The patient was approved through Blue Cross NC initial criteria for approval; OR
   1. The patient would have met initial criteria for approval at the time they started therapy; AND
2. The patient has demonstrated a positive clinical response while using the medication; AND
3. ONE of the following:
   1. The patient has a diagnosis of hypogonadism; AND
      1. The patient has had a total serum or free serum testosterone level checked in the past year; OR
   2.  The patient is using for the palliative treatment of metastatic inoperable breast cancer; OR
   3.  The patient has a diagnosis of delayed puberty; OR
   4.  The patient has a diagnosis of gender dysphoria.

Duration of approval: 365 days (1 year)

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of approval: 365 days (1 year)

 All information referenced is from FDA package insert unless otherwise noted below.

Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018 May 1;103(5):1715-1744

World Professional Association for Transgender Health. Standards of care for the health of transgender and gender diverse people. https://wpath.org/publications/soc (Accessed on October 28, 2022).

Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017; 102:3869. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

February 2025: Criteria change (Jatenzo, Tlando): Removed step therapy requirement from Jatenzo and Tlando. Removed obsolete Delatestryl from policy.

November 2024: Criteria update: Added new to market Azmiro to policy.

October 2024: Criteria update: Added new to market Undecatrex to policy

September 2024: Criteria change (Xyosted): Updated Xyosted from a two-step requirement to a one-step requirement for the Enhanced formularies.

April 2024: Criteria change: Added criteria to allow coverage for patients with HIV diagnosis and unexplained weight loss or bone mineral density. Updated Xyosted from a two-step requirement to a one-step requirement for the Net Results formularies only.

October 2023: Criteria update: Addition of notation to policy “Coverage may vary by state. Check applicable state laws for more information.”

January 2023: Criteria change: Annual criteria review. Added continuation criteria. Removed discontinued products, Striant and Brand Axiron, from the policy.

September 2022: Criteria update: Added new to market Kyzatrex to policy.

July 2022: Criteria change: Jatenzo 158mg capsule QL updated to 120 capsules per 30 days.

April 2022: Criteria update: Added new to market Tlando to policy.

December 2021: Criteria change: Updated gender dysphoria requirements. Removed requirement of letter of medical necessity for members 18 years of age. Changed duration of approval to 365 days.

January 2019: Removed brand Androgel from preferred category.

November 2018: Added new to market Xyosted injection to the policy.

October 2018: Added new to market generic testosterone 1.62% gel (Androgel) to the policy and updated step thru two generic testosterone products.

July 2017: Criteria point 3 added to letters of medical necessity to clarify the intent of the letters.

Mar 2018: Removed suggested alternatives section; no change to criteria.

Jan 2018: Step added to brand Axiron through preferred Androgel; Second testosterone level added for newly diagnosed members.

Jul 2017: removed step through criteria on generic product.

Jul 2017: Reformatted criteria.

Feb 2017: Placed requirement for letter of medical necessity on those under 18 years of age only.

Jan 2017: Reviewed for ASO Net Results; coverage of gender identity disorder added.

Oct 2016: Quantity limits added to all medications.

Aug 2015: Revised UM criteria. Added the branded testosterone gel and testosterone gel pump products to the topical products section nonpreferred.

Jan 2011: Original utilization management criteria issued.