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Fortesta — Blue Cross Blue Shield of Texas

delayed puberty in adolescents

Initial criteria

  • Patient meets one of the following:
  • • Continuing sex hormone therapy AND all:
  • – Monitored at least annually
  • – Meets State-specific restrictions (no continuation in certain listed states unless exceptions specified for FL, KY, NC, ND, TX)
  • • OR adult (age ≥18 years; ≥19 in AL; ≥21 in PR) AND:
  • – Initiating sex hormone treatment requires ALL:
  • • Persistent diagnosis of gender dysphoria/gender incongruence
  • • Other causes excluded
  • • Informed consent provided and counseling given on effects, side effects, and fertility
  • • Sufficient emotional and cognitive maturity
  • • Coexisting mental/physical conditions addressed
  • • State-specific requirements for Florida: written informed consent from in-person physician visit
  • – OR currently on sex hormone therapy AND:
  • • Current testosterone levels within/below normal range for gender identity or <300 ng/dL OR justification for continuation
  • • Monitored ≥ annually
  • • Florida requires written informed consent from in-person physician visit
  • • OR indication for delayed puberty in adolescent AND patient sex male OR supported for patient’s sex
  • • OR breast cancer, meeting one of: (a) 1–5 years postmenopausal with inoperable metastatic cancer OR (b) premenopausal with hormone-responsive tumor and benefitted from oophorectomy
  • • OR endometriosis amenable to hormone management
  • • OR prevention of hereditary angioedema attacks
  • • OR myelofibrosis-related anemia with one of:
  • – EPO ≥500 mU/mL OR
  • – EPO <500 mU/mL and inadequate response/loss of response to ESA
  • • No FDA labeled contraindications to requested agent
  • • ONE of the following regarding concomitant therapy:
  • – Will not use with aromatase inhibitor, antiestrogen, or SERM OR
  • – Use in combination supported and not for appearance/performance enhancement
  • For brand agents (list above), ONE of:
  • – Stage 4 advanced/metastatic cancer scenario meeting criteria, OR
  • – Currently stable on requested agent (chart notes), OR
  • – Tried and had inadequate response/lack of efficacy/intolerance/hypersensitivity/FDA contraindication to generic androgen or anabolic steroid supported for indication (chart notes), OR
  • – Generic agent expected ineffective or harmful or not in best interest (chart notes), OR
  • – Tried another drug in same class with inadequate response/adverse event (chart notes)
  • And ONE of:
  • – Not using agent in combination with another androgen/anabolic steroid OR
  • – Therapy with more than one agent is supported
  • Additional approval allowed for NM or OH members under specific criteria for rare diseases or supported compendia/FDA labeled uses with literature evidence

Reauthorization criteria

  • Continuation requires ongoing monitoring at least annually, persistent diagnosis where applicable, absence of contraindications, and documentation of benefit or stability on current therapy

Approval duration

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