Testopel — Blue Cross Blue Shield of New Mexico

Initial criteria

• Patient does not reside or continue treatment in prohibited states unless conditions are met (state-specific conditions as listed for Alabama, Idaho, Indiana, Iowa, Louisiana, Mississippi, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Florida, Kentucky, North Carolina, North Dakota, Texas municipal ASO)
• Adult patient (age ≥18 years; ≥19 in Alabama; ≥21 in Puerto Rico) AND all of the following:
• - Initiating sex hormone treatment requires: persistent diagnosis of gender dysphoria/gender incongruence marked over time; other causes excluded; informed counseling on effects/side effects including irreversible changes and fertility effects; sufficient emotional and cognitive maturity; consent obtained; mental/physical conditions addressed; if in Florida, written in-person consent required
• - Continuing sex hormone treatment requires: testosterone level within/below normal or <300 ng/dL OR support for continuation with current level; monitored at least yearly; if in Florida, written in-person consent required
• If for delayed puberty: patient’s sex is male OR agent is medically appropriate for sex
• If for breast cancer: EITHER postmenopausal (1–5 years) with inoperable metastatic breast cancer OR premenopausal patient after oophorectomy with hormone-responsive tumor
• If for myelofibrosis with anemia: EPO ≥500 mU/mL OR EPO <500 with no or lost ESA response; no FDA contraindications; not using in combination with aromatase inhibitors, antiestrogens, or SERMs unless combination not for appearance/performance enhancement
• For brand agents listed: must meet one of the following (chart notes required):
• - Diagnosed with stage 4 advanced metastatic cancer using for treatment or associated condition; OR use consistent with best practices supported by literature and FDA approval; OR currently stable on the requested agent; OR failed or had inadequate response to a generic androgen/anabolic steroid supported for indication; OR discontinued generic due to lack of effect or adverse event; OR intolerance/hypersensitivity to generics; OR contraindication to all generics; OR generic expected ineffective/harmful based on patient characteristics; OR generic not in best interest medically; OR failed similar agent in class due to lack of effect/adverse event
• Patient will not use agent in combination with another androgen/anabolic steroid for same indication unless supported for combination therapy
• Rare disease exceptions: For BCBS NM Fully Insured/HIM, no contraindication AND indication is rare AND has FDA indication or compendia-supported indication for same route
• For Fully Insured or HIM Shop members in Ohio: no contraindication AND has FDA/compendia-supported indication or two peer-reviewed journal articles supporting proposed use

Approval duration

6 months (delayed puberty); 12 months (others)