Fortesta — Blue Cross Blue Shield of Texas

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)