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Tlando — Blue Cross Blue Shield of Montana

breast cancer

Initial criteria

  • Patient continuing therapy with sex hormone treatment AND ALL of: monitored at least once per year; NOT continuing treatment in Alabama, Idaho, Indiana, Iowa, Louisiana, Mississippi, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee; and state-specific continuation conditions (Florida: treatment began prior to 05/17/23 with parental consent; Kentucky: provider documented harm if terminated abruptly and instituted taper; North Carolina: treatment began prior to 08/01/2023; North Dakota: treatment began prior to 04/21/2023; Texas BCBS TX ASO municipalities/counties/schools: initiated prior to 6/1/23 and taper instituted) OR
  • Patient is adult (age ≥18 years; ≥19 years in Alabama; ≥21 years in Puerto Rico) AND ONE of: initiating sex hormone treatment meeting ALL of: persistent gender dysphoria diagnosis, exclusion of other causes, informed consent, counseling, maturity, monitoring, and state-specific informed consent (Florida: written in-person consent) OR continuing on treatment with documentation of testosterone levels/reason for continuation and monitoring requirements and Florida consent clause.
  • If request for delayed puberty in adolescent, then patient’s sex is male OR there is support that the agent is medically appropriate for the patient’s sex.
  • If request is for breast cancer, then EITHER (patient 1–5 years postmenopausal with inoperable metastatic breast cancer) OR (premenopausal, benefitted from oophorectomy, and has hormone-responsive tumor).
  • If request is for endometriosis amenable to hormonal management OR prevention of hereditary angioedema attacks, patient meets diagnosis conditions.
  • If request is for myelofibrosis-associated anemia, then EPO ≥500 mU/mL OR (<500 with no response or loss of response to ESA), no FDA contraindications, proper therapy combination restrictions (not used with aromatase inhibitor/antiestrogen/SERM unless medically necessary and not for performance enhancement).
  • For brand agents listed, approval if ONE of: (a) patient has stage IV metastatic cancer using agent for cancer or cancer-related condition consistent with best practices; OR (b) patient is stable on brand agent; OR (c) tried and failed generic or stopped due to lack of efficacy/adverse event/intolerance/contraindication; OR (d) generic is expected to be ineffective or not in best interest due to comorbidity/adherence/functional barriers/adverse reaction risk; OR (e) tried another drug in same class that failed.
  • Patient will not use agent in combination with another androgen/anabolic steroid unless supported.

Reauthorization criteria

  • Patient remains compliant with therapy, continues to meet initial criteria, monitored annually, and remains within accepted testosterone level and indication-specific parameters.

Approval duration

12 months (BCBSIL/BCBSMT); all other plans: 6 months (delayed puberty only), 12 months (others)