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Undecatrex (testosterone undecanoate) capsule — Highmark

Hypogonadism in males (ICD-10: E29.1)

Preferred products

  • generic methyltestosterone capsules
  • generic testosterone topical product

Initial criteria

  • The member is male.
  • The member has a diagnosis of hypogonadism (ICD-10: E29.1).
  • The member meets one (1) of the following criteria (i. through v.):
  • i. Primary or secondary hypogonadism with testicular failure due to one (1) of the following: bilateral torsions, chemotherapy damage, cryptorchidism, Klinefelter's syndrome, orchitis, radiation damage, single orchidectomy, surgery damage, toxic damage, or vanishing testis syndrome.
  • ii. Primary or secondary hypogonadism in males with symptoms of low testosterone.
  • iii. The member has a diagnosis of secondary hypogonadism due to hypopituitarism (pituitary hormone deficiencies).
  • iv. The member is experiencing weight loss due to HIV-infection.
  • v. The member is on chronic steroid treatment.
  • The provider submits documentation of low testosterone levels supported by one (1) of the following criteria:
  • i. Two (2) morning total testosterone levels drawn before 11:00 a.m. < 264 ng/dL (9.2 nmol/L) or below the normal range per the laboratory reference range.
  • ii. Two (2) morning total testosterone levels drawn before 11:00 a.m. < 300 ng/dL (10.4 nmol/L) or near the lower limit of the normal range per the laboratory reference range AND two (2) morning free testosterone levels < 65 pg/mL (225 pmol/L) or below the normal range per the laboratory reference range.
  • iii. Documentation that the member is not producing any testosterone.
  • If the request is for brand Methitest, the member has experienced therapeutic failure or intolerance to plan-preferred, generic methyltestosterone capsules.
  • If the request is for brand Androgel 1%, Androgel 1.62%, Fortesta, Testim, Vogelxo, Natesto, Jatenzo, Kyzatrex, Tlando, Undecatrex, or Xyosted, the member has experienced therapeutic failure or intolerance to one (1) plan‑preferred, generic testosterone topical product.