Pharmacy Prior Authorization Criteria

Testosterone

Indications for Prior Authorization

Androderm (testosterone [T] patch), Androgel (T gel and pump), Fortesta (T gel), Natesto (T nasal gel), Testim (T gel), and Vogelxo (T gel and pump)

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) is testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy or toxic damage from alcohol or heavy metals. These men usually have low testosterone serum levels and gonadotropins (FSH, LH) above the normal range. Important limitations of use: Safety and efficacy in men with "age-related hypogonadism (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy in males less than 18 years old have not been established. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Important limitations of use: Safety and efficacy in men with "age-related hypogonadism (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy in males less than 18 years old have not been established. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Methitest (methyltestosterone) tablet

• For diagnosis of Delayed puberty in males
  Indicated for stimulation of puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.

• For diagnosis of Metastatic mammary cancer in females
  Indicated for secondary use in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) is testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome, or orchidectomy.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Hypogonadotropic hypogonadism (congenital or acquired) is idiopathic gonadotropin or LHRH deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Depo-Testosterone (testosterone cypionate) injection

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchiectomy. Safety and efficacy of Depo-Testosterone (testosterone cypionate) in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Hypogonadotropic hypogonadism (congenital or acquired) - Gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of Depo-Testosterone (testosterone cypionate) in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

Testopel (testosterone) pellet

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchiectomy. 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 in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism" have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. 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 in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism" have not been established.

• For diagnosis of Delayed puberty in males
  Indicated for stimulation of puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.

Aveed (testosterone undecanoate) injection

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis. Limitations of use: Safety and efficacy of Aveed in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of Aveed in males less than 18 years old have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis. Limitations of use: Safety and efficacy of Aveed in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of Aveed in males less than 18 years old have not been established.

Testone CIK (testosterone cypionate) injection

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Limitations of Use: Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Limitations of Use: Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Xyosted (testosterone enanthate) injection

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) - Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range. Safety and efficacy of Xyosted in males less than 18 years old have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Hypogonadotropic hypogonadism (congenital or acquired) - Gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Safety and efficacy of Xyosted in males less than 18 years old have not been established.

Jatenzo (testosterone undecanoate) capsule

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) is testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Limitations of Use: Safety and efficacy of Jatenzo in males less than 18 years old have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Hypogonadotropic hypogonadism (congenital or acquired) is gonadotropin or luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of Use: Safety and efficacy of Jatenzo in males less than 18 years old have not been established.

Tlando (testosterone undecanoate) capsule

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) is testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Limitations of Use: Safety and efficacy of Tlando in males less than 18 years old have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Hypogonadotropic hypogonadism (congenital or acquired) is gonadotropin or luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of Use: Safety and efficacy of Tlando in males less than 18 years old have not been established.

Kyzatrex (testosterone undecanoate) capsule

• For diagnosis of Primary hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) is testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Limitations of Use: Safety and efficacy of Kyzatrex in males less than 18 years old have not been established.

• For diagnosis of Hypogonadotropic hypogonadism (congenital or acquired)
  Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Hypogonadotropic hypogonadism (congenital or acquired) is gonadotropin or luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of Use: Safety and efficacy of Kyzatrex in males less than 18 years old have not been established.

Androderm, Androgel, Aveed, Depo-Testosterone, Fortesta, Methitest, Natesto, Testone CIK, Testim, Testopel, Vogelxo, Xyosted

• For diagnosis of Transgender male (female-to-male) - Gender Dysphoria/Gender Incongruence [11-12, 17, 28-29]
  Testosterone in 3 different formulations, including transdermal gel, significantly increased testosterone levels from the physiological range for women to the normal male range by week 30 of treatment in an observational study in transgender male (female-to-male) individuals. Hormonal sex reassignment therapy was associated with significantly fewer symptoms related to social distress, anxiety, and depression compared with those not receiving hormonal therapy in 1 cross-sectional study. Gender transition treatment can be initiated in adults and adolescents with confirmed persistent gender dysphoria/gender incongruence who have the capacity to make fully informed decisions and consent, usually by age 16 years, and have well-controlled, if any, mental health concerns. The goals of therapy are to suppress endogenous sex hormones of the designated gender and to replace these with endogenous sex hormones of the affirmed gender. Either parenteral or transdermal testosterone may be used to achieve and maintain testosterone levels in the normal male range. Avoid sustained supraphysiologic levels to reduce risk of adverse reactions. Compelling reasons may exist to initiate therapy at younger than 16 years; although, studies in this population are minimal. Initial therapy to undergo suppression of pubertal development at Tanner stages G2/B2 is suggested. Neither puberty suppression nor gender-affirming hormone therapies are recommended in pre-pubertal children.

Criteria

Androderm, Brand Androgel gel and pump (1%), Brand Androgel gel and pump (1.62%), Generic testosterone gel and pump 20.25 mg/1.25 g, 40.5 mg/2.5 g (1.62%), Natesto, Generic testosterone gel 25 mg/2.5 g (1%), Generic testosterone gel 50 mg/5 g (1%), Generic testosterone gel pump (1%), Generic testosterone topical solution 30 mg/act, Generic testosterone gel 10 mg/act (2%), Aveed, Generic testosterone enanthate, Brand Depo-Testosterone, Brand Fortesta, Brand Testim, Brand Testosterone Cypionate, Testone CIK, Testopel, Testosterone implant pellets, Xyosted, Brand Vogelxo

**This may require treatment to be temporarily held.

Prior Authorization (Initial Authorization)

Length of Approval: 6 months for patients new to testosterone therapy; or 12 months for patients continuing testosterone therapy but without a current authorization on file with OptumRx [B]
For diagnosis of Male hypogonadism

• Diagnosis of hypogonadism (e.g., testicular hypofunction, male hypogonadism)
AND
• Male patient at birth [C]
AND
• Patient is 18 years of age or older
AND
• One of the following:
• Two pre-treatment serum total testosterone levels less than 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab** [7, 9]
OR
• Both of the following:
• Patient has a condition that may cause altered sex-hormone binding globulin (SHBG) (e.g., thyroid disorder, HIV disease, liver disorder, diabetes, obesity)
AND
• One pre-treatment calculated free or bioavailable testosterone level less than 5 ng/dL (< 0.17 nmol/L) or less than the reference range for the lab**
OR
• Patient has a history of one of the following:
• Bilateral orchiectomy
• Panhypopituitarism
• A genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)
OR
• Both of the following:
• Patient is continuing testosterone therapy
AND
• One of the following:
• Follow-up total serum testosterone level or calculated free or bioavailable testosterone level drawn within the past 12 months is within or below the normal limits of the reporting lab
OR
• Follow-up total serum testosterone level or calculated free or bioavailable testosterone level drawn within the past 12 months is outside of upper limits of normal for the reporting lab and the dose is adjusted
AND
• Trial and failure or intolerance to both of the following (applies to Aveed, Testopel, Testosterone implant pellets, Testone CIK, Brand Depo-Testosterone, Brand Testosterone Cypionate only):
• Generic testosterone cypionate
• Generic testosterone enanthate
AND
• Trial and failure or intolerance to one of the following (applies to Xyosted only):
• Generic testosterone cypionate
• Generic testosterone enanthate
AND
• Trial and failure or intolerance to generic testosterone gel (applies to Brand Androgel, Brand Fortesta, Brand Testim, Brand Vogelxo, and Brand Natesto only)

Generic testosterone cypionate

**This may require treatment to be temporarily held.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Male hypogonadism

• Diagnosis of hypogonadism (e.g., testicular hypofunction, male hypogonadism)
AND
• Male patient at birth [C]
AND
• Patient is 18 years of age or older
AND
• One of the following:
• Two pre-treatment serum total testosterone levels less than 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab** [7, 8]
OR
• Both of the following:
• Patient has a condition that may cause altered sex-hormone binding globulin (SHBG) (e.g., thyroid disorder, HIV disease, liver disorder, diabetes, obesity)
AND
• One pre-treatment calculated free or bioavailable testosterone level less than 5 ng/dL (< 0.17 nmol/L) or less than the reference range for the lab**
OR
• Patient has a history of one of the following:
• Bilateral orchiectomy
• Panhypopituitarism
• A genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)
OR
• Both of the following:
• Patient is continuing testosterone therapy
AND
• One of the following:
• Follow-up total serum testosterone level or calculated free or bioavailable testosterone level drawn within the past 12 months is within or below the normal limits of the reporting lab
OR
• Follow-up total serum testosterone level or calculated free or bioavailable testosterone level drawn within the past 12 months is outside of upper limits of normal for the reporting lab and the dose is adjusted

Methitest, Generic methyltestosterone, Jatenzo, Kyzatrex, Tlando,Undecatrex

***This may require treatment to be temporarily held.

Prior Authorization (Initial Authorization)

Length of Approval: 6 months for patients new to testosterone therapy; or 12 months for patients continuing testosterone therapy but without a current authorization on file with OptumRx [B]
For diagnosis of Male hypogonadism

• Diagnosis of hypogonadism (e.g., testicular hypofunction, male hypogonadism)
AND
• Male patient at birth [C]
AND
• Patient is 18 years of age or older
AND
• One of the following:
• Two pre-treatment serum total testosterone levels less than 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab*** [7, 8]
OR
• Both of the following:
• Patient has a condition that may cause altered sex-hormone binding globulin (SHBG) (e.g., thyroid disorder, HIV disease, liver disorder, diabetes, obesity)
AND
• One pre-treatment calculated free or bioavailable testosterone level less than 5 ng/dL (< 0.17 nmol/L) or less than the reference range for the lab***
OR
• Patient has a history of one of the following:
• Bilateral orchiectomy
• Panhypopituitarism
• A genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)
OR
• Both of the following:
• Patient is continuing testosterone therapy
AND
• One of the following:
• Follow-up total serum testosterone level or calculated free or bioavailable testosterone level drawn within the past 12 months is within or below the normal limits of the reporting lab
OR
• Follow-up total serum testosterone level or calculated free or bioavailable testosterone level drawn within the past 12 months is outside of upper limits of normal for the reporting lab and the dose is adjusted
AND
• Trial and failure or intolerance to both of the following:
• Androderm (testosterone patch)
• Generic testosterone gel

Androderm, Brand Androgel gel and pump (1%), Generic testosterone gel 25 mg/2.5 g (1%), Brand Androgel gel and pump (1.62%), Generic testosterone gel and pump 20.25 mg/1.25 g, 40.5 mg/2.5 g (1.62%), Generic testosterone topical solution 30 mg/act, Brand Fortesta, Generic testosterone gel 10 mg/act (2)%, Jatenzo, Kyzatrex, Methitest, Natesto, Brand Testim, Generic methyltestosterone, Brand Vogelxo gel and pump (1%), Generic testosterone gel 50 mg/5 g (1%), Generic testosterone pump (1%), Aveed, Generic testosterone enanthate, Brand Depo-Testosterone, Brand Testosterone Cypionate, Testone CIK, Testopel, Testosterone implant pellets, Tlando, Xyosted,Undecatrex

Prior Authorization (Initial Authorization)

Length of Approval: 6 months for patients new to testosterone therapy; or 12 months for patients continuing testosterone therapy but without a current authorization on file with OptumRx [B]
For diagnosis of Gender Dysphoria/Gender Incongruence (off-label) [11-12, 17, 26 D]

• Diagnosis of gender dysphoria/gender incongruence [11-12, 17, 26]
AND
• Using hormones to change characteristics to align with gender expression [11, 17, 28-29]
AND
• Trial and failure or intolerance to both of the following (applies to Aveed, Testopel, Testosterone implant pellets, Testone CIK, Brand Depo-Testosterone, Brand Testosterone Cypionate):
• Generic testosterone cypionate
• Generic testosterone enanthate
AND
• Trial and failure or intolerance to one of the following (applies to Xyosted only):
• Generic testosterone cypionate
• Generic testosterone enanthate
AND
• Trial and failure or intolerance to generic testosterone (applies to Brand Androgel, Brand Fortesta, Brand Testim, Brand Vogelxo, Brand Natesto only)

Generic testosterone cypionate

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Gender Dysphoria/Gender Incongruence (off-label) [11-12, 17, 26 D]

• Diagnosis of gender dysphoria/gender incongruence [11-12, 17, 26]
AND
• Using hormones to change characteristics to align with gender expression [11, 17, 28-29]

Androderm, Brand Androgel gel and pump (1%), Generic testosterone gel 25 mg/2.5 g (1%), Brand Androgel gel and pump (1.62%), Generic testosterone gel and pump 20.25 mg/1.25 g, 40.5 mg/2.5 g (1.62%), Generic testosterone topical solution 30 mg/act, Brand Fortesta, Generic testosterone gel 10 mg/act (2)%, Jatenzo, Kyzatrex, Methitest, Natesto, Brand Testim, Generic methyltestosterone, Brand Vogelxo gel and pump (1%), Generic testosterone gel 50 mg/5 g (1%), Generic testosterone pump (1%), Aveed, Generic testosterone enanthate, Brand Depo-Testosterone, Brand Testosterone Cypionate, Generic testosterone cypionate, Testone CIK, Testopel, Testosterone implant pellets, Tlando, Xyosted,Undecatrex

Prior Authorization (Reauthorization)

Length of Approval: 12 Month [B]
For diagnosis of Male hypogonadism, Gender dysphoria/Gender incongruence

• One of the following:
• Follow-up total serum testosterone level drawn within the past 6 months for patients new to testosterone therapy, or 12 months for patients continuing testosterone therapy, is within or below the normal limits of the reporting lab
OR
• Follow-up total serum testosterone level drawn within the past 6 months for patients new to testosterone therapy, or 12 months for patients continuing testosterone therapy, is outside of upper limits of normal for the reporting lab and the dose is adjusted
OR
• Both of the following:
• Patient has a condition that may cause altered sex-hormone binding globulin (SHBG) (e.g., thyroid disorder, HIV disease, liver disorder, diabetes, obesity)
AND
• One of the following:
• Follow-up calculated free or bioavailable testosterone level drawn within the past 6 months for patients new to testosterone therapy, or 12 months for patients continuing testosterone therapy, is within or below the normal limits of the reporting lab
OR
• Follow-up calculated free or bioavailable testosterone level drawn within the past 6 months for patients new to testosterone therapy, or 12 months for patients continuing testosterone therapy, is outside of upper limits of normal for the reporting lab and the dose is adjusted
AND
• Trial and failure or intolerance to one of the following (applies to Xyosted only):
• Generic testosterone cypionate
• Generic testosterone enanthate

Methitest, Generic testosterone enanthate, Testopel, Testosterone implant pellets, Generic methyltestosterone, Brand Testosterone Cypionate [off-label]

Prior Authorization

Length of Approval: 6 Month(s)
For diagnosis of Delayed puberty [E]

• Diagnosis of delayed puberty [A]
AND
• Male patient at birth [C]
AND
• Trial and failure or intolerance to both of the following (applies to Testopel and Testosterone implant pellets only):
• Generic testosterone cypionate [F]
• Generic testosterone enanthate

Generic testosterone cypionate [off-label]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Delayed puberty [E]

• Diagnosis of delayed puberty [A]
AND
• Male patient at birth [C]

Methitest, Generic methyltestosterone, Generic testosterone enanthate

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Inoperable breast cancer in women

• Diagnosis of breast cancer
AND
• Breast cancer is inoperable
AND
• Used for palliative treatment
AND
• Female patient at birth [C]

P & T Revisions

2024-11-26, 2024-06-05, 2024-03-14, 2023-10-25, 2023-09-14, 2023-09-13, 2023-08-22, 2023-04-05, 2023-03-03, 2023-02-04, 2023-01-03, 2022-11-02, 2022-08-26, 2022-08-22, 2022-08-22, 2022-05-04, 2022-02-21, 2021-07-02, 2021-05-25, 2021-03-18, 2020-07-23, 2020-03-05, 2020-02-25, 2020-02-18, 2019-10-30

References

1. Androderm Prescribing Information. Allergan Inc. Madison, NJ. May 2020.
2. Androgel Prescribing Information. Abbvie, Inc. North Chicago, IL. May 2019.
3. Androgel 1.62% Prescribing Information. AbbVie Inc. North Chicago, IL. February 2019.
4. Fortesta Prescribing Information. Endo Pharmaceuticals. Malvern, PA. June 2020.
5. Methitest Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. October 2018.
6. Testim Prescribing Information. Endo Pharmaceuticals Inc. Malvern, PA. August 2021.
7. Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol 2018; S0022-5347(18)42817-0.
8. 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; 103(5):1715-1744.
9. Palmert MR, Dunkel L. Clinical practice. Delayed puberty. N Engl J Med. 2012; 2;366(5):443-53.
10. Vogelxo Prescribing Information. Upsher-Smith Laboratories, Inc. Maple Grove, MN. April 2020.
11. Hembree, Wylie C, et al. "Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline." J Clin Endocrinol Metab. November 2017, 102(11):3869-3903.
12. DRUGDEX ® [Internet database]. Greenwood Village, Colo: Thomson MICROMEDEX, updated periodically. Accessed February 7, 2022.
13. Natesto Prescribing Information. Trimel BioPharma SRL. Eaglewood, CO. September 2017.
14. Testosterone Prescribing Information. Upsher-Smith Laboratories, Inc. Maple Grove, MN. July 2017.
15. Testosterone Pump Prescribing Information. Upsher-Smith Laboratories, Inc. Maple Grove, MN. July 2017.
16. Methyltestosterone Prescribing Information. Impax Generics. Hayward, CA. January 2017.
17. Coleman E, Bockting W, Botzer M et al. Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People, Version 7. International Journal of Transgenderism. 13:165-232, 2011.
18. Depo-Testosterone Prescribing information. Pfizer. New York, NY. November 2018.
19. Testosterone Enanthate Prescribing Information. Actavis Pharma, Inc. Corona, CA. December 2017.
20. Testopel Prescribing Information. Slate Pharma. Rye, NY. August 2018.
21. Aveed Prescribing Information. Endo Pharmaceuticals Solutions Inc. August 2021.
22. Testone CIK Prescribing Information. Asclemed USA, Inc. Torrance, CA. November 2018.
23. Xyosted Prescribing Information. Antares Pharma, Inc. Ewing, NJ. November 2019.
24. Jatenzo Prescribing Information. Clarus Therapeutics, Inc. Northbrook, IL. June 2019.
25. Per clinical consultation with endocrinology specialist, March 02, 2020.
26. World Health Organization. ICD-11: International classification of diseases (11th revision).
27. Tlando Prescribing Information. Antares Pharma, Inc. Ewing, NJ. March 2022.
28. Deutsch, MB, Amato P, Coureu M, et al. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People; 2nd edition. UCSF Gender Affirming Health Program, Department of Family and Community Medicine, University of California San Francisco. June 2016
29. Health Care for Transgender and Gender Diverse Individuals: ACOG Committee Opinion, Number 823. American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.137(3):e75-e88, 2021
30. Kyzatrex Prescribing Information. Marius Pharmaceuticals. Raleigh, NC. July 2022.

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End Notes

1. Delayed puberty is defined as the lack of the initial signs of sexual maturation by an age that is more than 2-2.5 standard deviations above the mean for the population (traditionally, the age of 14 years in boys and 13 years in girls). In most cases, delayed puberty is not due to an underlying pathology, but instead represents an extreme end of the normal spectrum of pubertal timing, a developmental pattern referred to as constitutional delay of growth and puberty (CDGP). CDGP is the most common cause of delayed puberty in both sexes, but it can be diagnosed only after underlying conditions have been ruled out. Management of CDGP may involve expectant observation or therapy with low-dose sex steroids. [9]
2. Initial authorization of 6 months, and reauthorization of 12 months is based on the Endocrine Society's Clinical Practice Guideline's recommendation to monitor testosterone level 3 to 6 months after initiation of testosterone therapy, and then annually to assess whether symptoms have responded to treatment and whether the patient is suffering from any adverse effects. [8]
3. The gender criteria in place for male hypogonadism, delayed puberty, and inoperable breast cancer are to ensure safe and effective medication utilization due to FDA-approved labeling supporting the gender restriction [refer to individual Package Inserts]. Age and/or gender criteria will remain in the guideline, consistent with the following direction approved by OptumRx Legal & Regulatory: “Age and gender edits in place due to FDA safety guidance, labeling or supported by medical literature to satisfy medical necessity criteria would not be inconsistent with the [Section 1557 HCR non-discrimination] regulation."
4. According to DRUGDEX, for the treatment of transgender male (female-to-male) patients with gender dysphoria, various forms and dosages of testosterone have been used. [12] Clinical studies have also demonstrated the efficacy of several different androgen preparations to induce masculinization in female-to-male transgender persons. Regimens to change secondary sex characteristics follow the general principle of hormone replacement treatment of male hypogonadism. Either parenteral or transdermal preparations can be used to achieve testosterone values in the normal male range. [11]
5. An X-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal center [19-20].
6. Per consult with specialist, the pharmacokinetics of T. cypionate and T. enanthate are quite similar and physiologically produce similar results. The two agents are very close in efficacy and behavioral effects. Although T. cypionate isn't FDA-approved for delayed puberty, it is used in practice due to its similarity to T. enanthate. [25]

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Revision History

• 2024-11-26: Added new ABA for Kyzatrex
• 2024-06-05: Addition of new strengths for brand testosterone implant pellets
• 2024-03-14: 2024 Annual Review - no criteria changes
• 2023-10-25: Update Xyosted criteria to require t/f/c/i to generic testosterone cypionate OR generic testosterone enanthate
• 2023-09-14: Removed mentions of obsolete "Brand Testosterone Propionate" in criteria.
• 2023-09-13: GPI clean-up
• 2023-08-22: GPI clean-up.
• 2023-04-05: Updated the step through both Generic testosterone cypionate and Generic testosterone enanthate as drug shortage has been resolved
• 2023-03-03: 2023 Annual Review
• 2023-02-04: Updated the step through both Generic testosterone cypionate and Generic testosterone enanthate to only one of the products due to drug shortages.
• 2023-01-03: For generic testosterone cypionate, extended initial auth approval length from 6 to 12 months.
• 2022-11-02: Addition of new product, Kyzatrex
• 2022-08-26: Attached generic T. cypionate as target drug to delayed puberty criteria.
• 2022-08-22: Update to gender dysphoria/gender incongruence criteria
• 2022-08-22: Removal of Brand Testosterone Enanthate
• 2022-05-04: Updated guideline to include new product, Tlando
• 2022-02-21: 2022 UM Annual Review.
• 2021-07-02: Changed OptumRx SP - EHB to OptumRx - EHB
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-18: 2021 UM Annual Review
• 2020-07-23: Per PA team feedback, added Brand Androgel gel and pump (1%) product to male hypogonadism criteria for completeness.
• 2020-03-05: 2020 UM Annual Review. No changes to criteria.
• 2020-02-25: Added Jatenzo to reauthorization criteria for diagnosis of male hypogonadism.
• 2020-02-18: Updated guideline to include new product, Jatenzo. Removed Android, Axiron, and Testred because products discontinued.
• 2019-10-30: Updated criteria for Nov P&T Review - SL - 10.29.19

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