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Androgel — Blue Cross Blue Shield of Kansas

Myelofibrosis associated anemia

Initial criteria

  • 1. Diagnosis-based criteria:
  • A. If request for Androderm, Androgel, Aveed, Fortesta, Jatenzo, Kyzatrex, Natesto, Testim, testosterone topical solution, Tlando, Undecatrex, Vogelxo, or Xyosted → diagnosis of Primary or secondary hypogonadism OR Gender dysphoria/gender incongruence.
  • B. If request for Azmiro, Depo-Testosterone, or Testopel → diagnosis of Primary or secondary hypogonadism OR Delayed puberty in an adolescent OR Gender dysphoria/gender incongruence.
  • C. If request for testosterone enanthate IM solution → diagnosis of Primary or secondary hypogonadism OR Delayed puberty in an adolescent OR Breast cancer OR Gender dysphoria/gender incongruence.
  • D. If request for danazol → diagnosis of Endometriosis amenable to hormone management OR Hereditary angioedema (prevention of attacks) OR Myelofibrosis associated anemia.
  • E. If request for methyltestosterone/Methitest → diagnosis of Primary or secondary hypogonadism OR Breast cancer OR Delayed puberty in an adolescent.
  • 2. For primary or secondary hypogonadism:
  • A. If not currently on testosterone → must have sign/symptom of hypogonadism AND total testosterone below normal/<300 ng/dL OR low free testosterone.
  • B. If currently on testosterone → current total or free testosterone within/below lab normal or <300 ng/dL.
  • 3. For gender dysphoria/gender incongruence:
  • A. Adolescent initiation → comprehensive biopsychosocial assessment, parental involvement (if feasible), persistent diagnosis, age ≥16 years or justification if <16, counseling regarding effects, emotional/cognitive maturity, informed consent, and coexisting conditions addressed.
  • B. Adolescent continuation → monitored at least annually.
  • C. Adults initiation → persistent diagnosis, other causes excluded, counseling provided, emotional/cognitive maturity, informed consent, coexisting conditions addressed.
  • D. Adults continuation → monitored annually AND testosterone within/below normal for gender identity OR supported for continuation.
  • 4. For delayed puberty (adolescent) → patient’s sex is male OR medical support for appropriateness to patient’s sex.
  • 5. For breast cancer → either (postmenopausal 1–5 years with inoperable metastatic disease) OR (premenopausal, benefitted from oophorectomy, and tumor hormone-responsive).
  • 6. For myelofibrosis anemia → EPO ≥500 mU/mL OR EPO <500 mU/mL and no/loss of response to ESA.
  • 7. No FDA-labeled contraindications to requested agent.
  • 8. For brand requests (Androderm, Androgel/Testosterone gel, Aveed, Azmiro, Fortesta/Testosterone gel, Jatenzo, Kyzatrex, Methitest, Natesto, Testim, Testopel, Tlando, Undecatrex, Vogelxo/Testosterone gel, Xyosted):
  • A. Tried and inadequate response to generic androgen/anabolic steroid for indication OR
  • B. Intolerance/hypersensitivity to generic not expected with brand OR
  • C. Contraindication to all generic agents not expected with brand.
  • 9. Not used in combination with another androgen/anabolic steroid for same indication unless justified.

Reauthorization criteria

  • 1. Previously approved through plan’s PA process.
  • 2. Demonstrated clinical benefit with therapy.
  • 3. One of the following:
  • A. For primary or secondary hypogonadism → current total or free testosterone within/below lab normal or <300 ng/dL.
  • B. For gender dysphoria/gender incongruence:
  • • Adults: monitored at least annually AND testosterone within/below lab normal for gender identity OR support for continuation.

Approval duration

6 months (delayed puberty); 12 months (all other indications)