Azmiro — Blue Cross Blue Shield of Montana

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND ONE of the following:
• A. ALL of the following:
• 1. The requested indication is gender dysphoria/gender incongruence AND
• 2. The request is for a BCBS IL Fully Insured, HIM, or ASO/Self-insured municipalities/counties/schools member AND
• 3. ONE of the following:
• A. The patient is an adolescent (age ≤ 17 years) AND one of the following:
• 1. The patient is initiating sex hormone treatment AND will NOT be receiving treatment in Alabama, Florida, Idaho, Indiana, Iowa, Kentucky, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Puerto Rico, South Carolina, South Dakota, or Tennessee OR
• 2. The patient is continuing therapy AND ALL of the following apply: not continuing treatment in Alabama, Idaho, Indiana, Iowa, Louisiana, Mississippi, Oklahoma, Puerto Rico, South Carolina, South Dakota, or Tennessee; if continuing in Florida, treatment began prior to 05/17/23 with parental consent; if continuing in Kentucky, both of the following: discontinuation would cause harm and provider instituted systematic reduction; if continuing in North Carolina, treatment began prior to 08/01/2023; if continuing in North Dakota, treatment began prior to 04/21/2023.
• B. The patient is an adult (age ≥ 18 years) AND ALL of the following: if receiving treatment in Florida, both of the following: written informed consent provided, consent obtained from in-person physician visit; if in Alabama, patient age ≥ 19 years; if in Puerto Rico, patient age ≥ 21 years.
• B. ALL of the following:
• 1. The patient has had clinical benefit with the requested agent AND
• 2. ONE of the following:
• A. The patient has a diagnosis of primary or secondary hypogonadism and current testosterone level is total or free testosterone within or below the normal range or total < 300 ng/dL OR
• B. The patient has gender dysphoria/gender incongruence AND plan covers Gender Identity Disorder AND:
• 1. If adult (age ≥ 18 years): being monitored at least once per year; if in Florida, written informed consent from in-person physician visit; if in Alabama, age ≥ 19 years; if in Puerto Rico, age ≥ 21 years; and current testosterone level is within/below normal range for gender identity or < 300 ng/dL OR therapy support exists.
• 2. If adolescent (age ≤ 17 years): monitored at least once per year; not continuing treatment in Alabama, Idaho, Indiana, Iowa, Louisiana, Mississippi, Oklahoma, Puerto Rico, South Carolina, South Dakota, or Tennessee; if continuing in Florida, treatment began prior to 05/17/23 with parental consent; if in Kentucky, discontinuation would cause harm and provider instituted systematic reduction; if in North Carolina, treatment began prior to 08/01/2023; if in North Dakota, treatment began prior to 04/21/2023; if BCBS TX ASO municipalities/counties/schools member continuing in Texas, treatment initiated prior to 6/1/23 and provider instituted systematic reduction.
• C. Diagnosis other than primary or secondary hypogonadism or gender dysphoria/gender incongruence AND patient has no FDA labeled contraindications to the requested agent.
• If request for one of listed brand agents (Androgel, Aveed, Azmiro, Fortesta, Jatenzo, Kyzatrex, Methitest, Natesto, Testim, Testopel, Tlando, Undecatrex, Vogelxo, Xyosted): ONE of the following:
• A. Patient has stage four advanced, metastatic cancer and agent used to treat cancer or associated condition AND consistent with best practices and evidence-based literature OR
• B. Patient currently treated and stable on requested agent OR
• C. Tried and inadequate response to a generic androgen or anabolic steroid for the indication OR
• D. Generic androgen/anabolic steroid discontinued due to lack of efficacy or adverse event OR
• E. Intolerance or hypersensitivity to generic agent not expected with brand OR
• F. FDA labeled contraindication to all generic androgens/anabolic steroids not expected with brand OR
• G. Generic agent expected ineffective or harmful or barrier to adherence, worsen comorbid condition, or impair functional ability; OR
• H. Use of generic agent not in best medical interest of patient based on necessity; OR
• I. Patient tried another prescription in same class/MOA as generic androgen/anabolic steroid discontinued due to inadequate response or adverse event
• AND ONE of the following:
• A. Patient will NOT be using requested agent in combination with another androgen/anabolic steroid for the indication OR
• B. Support for therapy with more than one androgen/anabolic steroid.

Approval duration

12 months