Undecatrex — Blue Cross Blue Shield of Oklahoma

Initial criteria

• For sex hormone treatment: patient is continuing therapy with sex hormone treatment AND all of the following: being monitored at least once per year; not continuing treatment in excluded states (Alabama, Idaho, Indiana, Iowa, Louisiana, Mississippi, Oklahoma, Puerto Rico, South Carolina, South Dakota, or Tennessee); and meeting state-specific continuation requirements when applicable.
• For adults (age ≥ 18 years, ≥19 in Alabama, ≥21 in Puerto Rico): If initiating sex hormone treatment, all of the following: persistent diagnosis of gender dysphoria/gender incongruence that is marked and sustained over time; other possible causes excluded; informed and counseled on effects, side effects, and fertility; sufficient maturity to provide informed consent; coexisting conditions addressed; if in Florida, written informed consent obtained from in-person visit.
• For adults continuing sex hormone treatment: one of the following testosterone level conditions met (total testosterone within/below normal range or <300 ng/dL; or free testosterone within/below normal range; or other clinical support for continuation); monitored at least annually; if in Florida, written informed consent obtained from in-person visit.
• For delayed puberty in adolescents: patient’s sex is male OR support that requested agent is medically appropriate for patient’s sex.
• For breast cancer: ONE of the following: both (1–5 years postmenopausal AND has inoperable metastatic breast cancer) OR all (premenopausal, benefitted from oophorectomy, and hormone-responsive tumor).
• For endometriosis amenable to hormone management: indication supported.
• For prevention of hereditary angioedema attacks: indication supported.
• For myelofibrosis-associated anemia: EPO ≥500 mU/mL OR EPO <500 mU/mL and failed ESA; no FDA labeled contraindications; AND either not combined with an aromatase inhibitor, antiestrogen, or SERM; OR if combined, not for appearance/performance enhancement.
• For brand agents listed: ONE of the following: both of the following—patient has stage IV advanced metastatic cancer and agent used for cancer or related condition, and use consistent with FDA approval and evidence-based literature; OR patient stable on agent; OR patient tried and had inadequate response to generic androgen or anabolic steroid; OR discontinued generic due to lack of efficacy, diminished effect, or adverse event; OR intolerance or hypersensitivity to generics not expected with brand; OR FDA contraindication to all generics; OR generic expected to be ineffective or adversarial due to patient-specific characteristics; OR use of generic not in patient’s best medical interest; OR tried another drug in same class with inadequate response or adverse event.
• Therapy not to be in combination with another androgen/anabolic steroid unless supported for combination use.

Reauthorization criteria

• Continuation requires documentation that patient remains stable on therapy and meets applicable monitoring and state-specific consent or continuation requirements.

Approval duration

6–12 months