Undecatrex — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process OR meets initial criteria
• For gender dysphoria/gender incongruence within BCBS IL Fully Insured, HIM, or ASO/Self‐insured municipalities/counties/schools members: patient is an adolescent (age ≤ 17 years) initiating or continuing sex hormone treatment per state authorization restrictions, OR an adult (age ≥ 18 years) meeting state consent and age requirements (Florida: written informed consent with in‑person physician visit; Alabama: age ≥ 19 years; Puerto Rico: age ≥ 21 years)
• For hypogonadism: patient has primary or secondary hypogonadism with total or free serum testosterone level within or below reported laboratory normal range, or total serum testosterone < 300 ng/dL
• For gender dysphoria: patient’s plan covers Gender Identity Disorder, monitoring occurs at least annually, and testosterone results meet gender‑appropriate thresholds
• Patient has no FDA labeled contraindications to the requested agent
• For brand agents listed, one of the following must apply: (A) patient with stage 4 advanced, metastatic cancer treated for the cancer or associated condition with evidence support; OR (B) patient is currently stable on the requested agent; OR (C) patient has tried and had inadequate response or intolerance to a generic androgen/anabolic steroid supported for the indication; OR (D) generic agent discontinued for lack of efficacy or adverse event; OR (E) hypersensitivity expected to be avoided with brand; OR (F) FDA labeled contraindication to all generics not expected with brand; OR (G) generic expected to be ineffective or unsafe based on patient characteristics; OR (H) best interest of patient based on medical necessity; OR (I) patient previously tried another drug in the same class discontinued for lack of effect or adverse event
• Requested agent will not be used in combination with another androgen/anabolic steroid unless supported rationale provided

Reauthorization criteria

• Patient previously approved through plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• For hypogonadism: current testosterone level remains within/below the normal range
• For gender dysphoria/gender incongruence: monitored at least annually and continues to meet age and state restrictions with supporting testosterone levels
• Patient continues not to have FDA labeled contraindications
• For brand agents: meets one of the same brand exception conditions (stability, prior inadequate response/intolerance to generics, etc.)
• Requested agent not combined with another androgen/anabolic steroid unless medically justified

Approval duration

12 months