Testosterone oral agents (JATENZO, TLANDO, KYZATREX)

Oral Testosterone Agents

Jatenzo (testosterone undecanoate), oral capsule

Tlando (testosterone undecanoate), oral capsule

Kyzatrex (testosterone undecanoate), oral capsule

Self-Administration - oral

Diagnosis considered for coverage:

• 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 conditions such as 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.
  • Hypogonadotropic hypogonadism (congenital or acquired): 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 in males less than 18 years old have not been established.

Coverage Criteria:

Request for Jatenzo, Tlando, or Kyzatrex:

• • Dose does not exceed the U.S. Food and Drug Administration (FDA) labeled maximum recommended dose for the condition:
    • Jatenzo: 396 mg orally twice daily
    • Tlando: 225 mg orally twice daily
    • Kyzatrex 400 mg orally twice daily; AND
  • Patient is 18 year of age or older; AND
  • Being used for the treatment of testosterone deficiency in a male-at-birth patient (i.e., testicular hypofunction or male hypogonadism [primary and hypogonadotropic types]); AND
  • One of the following:
    • Patient has two separate pre-treatment serum total testosterone levels less than 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab.
    • 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); AND
  • Trial and failure, intolerance, or contraindication to both of the following:
    • generic topical testosterone agent (gel, solution)
    • generic injectable testosterone agent (cypionate, enanthate)

Reauthorization Criteria:

Request for continuing coverage of Jatenzo, Tlando, or Kyzatrex:

• • Dose does not exceed the U.S. Food and Drug Administration (FDA) labeled maximum recommended dose for the condition:
    • Jatenzo: 396 mg orally twice daily
    • Tlando: 225 mg orally twice daily
    • Kyzatrex 400 mg orally twice daily; AND
  • Documentation shows a follow-up total serum testosterone level or calculated free or bioavailable testosterone level has been drawn within the past 12 months.

Coverage Duration:

• One year

Authorization is not covered for the following:

• The use of this drug for the following indication and others not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
  • Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies.

Additional Information:

• Individualize the dosage of JATENZO based on the patient’s serum testosterone concentration response to the drug. The recommended starting dose is 237 mg taken orally twice daily, once in the morning and once in the evening. The minimum recommended dose is 158 mg twice daily. The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily. Administer the same dose in the morning and evening. See JATENZO’s prescribing information for additional details.
• The recommended dosage of TLANDO is 225 mg (taken as two 112.5 mg capsules), orally twice daily, once in the morning and once in the evening.
• The recommended dosage of KYZATREX is starting 200 mg, orally twice daily, once in the morning and once in the evening, up to a maximum of 400 mg twice daily.
• 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. If primary hypogonadism occurs 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.
• Hypogonadotropic hypogonadism (HH) (congenital or acquired) is a form of hypogonadism that is due to a problem with the pituitary gland or hypothalamus including idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.  If HH occurs 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.
• An orchiectomy (or orchidectomy) is a surgical procedure to remove one or both testicles.
• Panhypopituitarism is a rare condition in which the pituitary gland stops making most or all hormones.

Policy Updates:

• 08/16/2022 – New testosterone undecanoate oral capsule (Tlando, Jatenzo) policy approved by P&T; Jatenzo criteria retired.
• 02/15/2023 – Add Kyzatrex to oral testosterone policy with QLs.

References: 

1. 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.
2. Jatenzo Prescribing Information. Clarus Therapeutics, Inc. Northbrook, IL. June 2019.
3. Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol 2018; S0022-5347(18)42817-0.
4. Tlando Prescribing Information. Antares Pharma, Inc. Ewing, NJ. March 2022.
5. Kyzatrex Prescribing Information. Marius Pharmaceuticals. Raleigh, NC. July 2022.