Tlando — Blue Cross Blue Shield of Illinois
primary hypogonadism
Initial criteria
- DrugDex level 1, 2A or 2B, AHFS-DI (narrative text supportive) or NCCN 1 or 2A, DrugDex level 1, 2A or 2B, AHFS-DI, Clinical Pharmacology (narrative text supportive), LexiDrugs evidence level A, or peer-reviewed medical literature may support indication
Reauthorization criteria
- Patient previously approved through plan PA process
- ONE of the following:
- A. ALL of the following:
- 1. Requested indication is gender dysphoria/gender incongruence AND
- 2. Request is for BCBS IL Fully Insured, HIM, or ASO/self-insured municipalities/counties/schools member AND
- 3. ONE of the following:
- A. Patient is adolescent (age ≤ 17 years) AND meets state-specific continuation requirements (treatment not in specified restricted states; consent/continuation conditions met for FL, KY, NC, ND) OR
- B. Patient is adult (age ≥ 18 years) AND meets informed consent and state age requirements (FL, AL, PR) OR
- B. ALL of the following:
- 1. Patient has had clinical benefit with requested agent AND
- 2. ONE of the following:
- A. Patient has primary or secondary hypogonadism AND current testosterone level within or below normal range or <300 ng/dL (total) or within/below normal range (free) OR
- B. Patient has gender dysphoria/gender incongruence AND coverage for Gender Identity Disorder AND meets age, monitoring, and state-specific consent/continuation conditions (as above) OR
- C. Patient has another diagnosis supported by cited compendia AND
- 3. Patient has no FDA-labeled contraindications to requested agent AND
- 4. If request is for brand product listed, then ONE of the following:
- A. Patient has stage 4 advanced/metastatic cancer and use is for cancer or associated condition; consistent with evidence-based literature; FDA-approved, OR
- B. Patient is currently treated and stable on requested agent [chart notes required], OR
- C. Patient tried and had inadequate response to generic androgen/anabolic steroid for indication [chart notes required], OR
- D. Generic agent discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required], OR
- E. Patient has intolerance/hypersensitivity to generic not expected with brand [chart notes required], OR
- F. Patient has FDA-labeled contraindication to all supported generics not expected with brand [chart notes required], OR
- G. Supported generic expected ineffective due to patient characteristics, adherence barriers, comorbidities, functional impairment, or harm risk [chart notes required], OR
- H. Supported generic not in best interest based on medical necessity [chart notes required], OR
- I. Patient tried another drug same class/mechanism as supported generic and discontinued due to poor effect or adverse event [chart notes required], AND
- 5. ONE of the following:
- A. Patient will not use requested agent in combination with another androgen/anabolic steroid for indication, OR
- B. There is support for therapy with more than one androgen/anabolic steroid agent
Approval duration
12 months