Zepbound — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• 1. Patient has diagnosis of obstructive sleep apnea (OSA) AND ALL of the following:
• - Patient has had polysomnography (PSG) or home sleep apnea test
• - Apnea hypopnea index (AHI) ≥ 15 events/hour from baseline (prior to initiation of pharmacotherapy)
• - Requested agent is Zepbound
• - Body mass index (BMI) ≥ 30 kg/m^2
• OR
• 2. Requested use is to reduce risk of major adverse cardiovascular events in adults with established cardiovascular disease AND ALL of the following:
• - Requested agent is FDA labeled for the indication and route of administration
• - History of myocardial infarction, stroke, or peripheral artery disease as defined
• - BMI ≥ 27 kg/m^2
• - Patient will use optimized pharmacotherapy for established cardiovascular disease in combination with requested agent
• OR
• 3. Patient is overweight or obese using requested agent for weight management AND ALL of the following:
• - Obesity not excluded from coverage
• - Patient is new to therapy, new to Prime, or repeating course
• - BMI and age meet ONE of the following:
• • Adult (age ≥ 18 years) AND (BMI ≥ 30 kg/m^2 OR BMI ≥ 25 kg/m^2 if South/Southeast/East Asian OR BMI ≥ 27 kg/m^2 with ≥1 comorbidity: hypertension, T2DM, OSA, cardiovascular disease, dyslipidemia)
• • Pediatric (age 12–17 years) AND (BMI ≥ 95th percentile OR BMI ≥ 30 kg/m^2 OR BMI ≥ 85th percentile with ≥1 comorbidity: hypertension, dyslipidemia, T2DM, OSA)
• - Patient has been on a weight loss regimen of low-calorie diet, increased physical activity, and behavioral modification for ≥ 6 months
• - ONE of the following:
• • No prior targeted weight loss agent (Saxenda, Wegovy, Zepbound) in past 12 months
• • Tried a targeted weight loss agent in past 12 months AND prescriber anticipates success with repeat therapy
• - Requested agent-specific criteria:
• • For Zepbound: starting therapy OR received < 52 weeks of therapy OR achieved ≥ 5% weight loss from baseline OR another FDA-labeled indication for requested route
• - Patient will NOT use requested agent with another weight loss agent (Contrave, phentermine, Qsymia, Xenical)
• - BOTH of the following:
• • Patient is currently on and will continue low-calorie diet, physical activity, behavioral modifications
• • Age within FDA labeling for indication OR supported use for age
• - Patient will NOT use requested agent in combination with another GLP-1 receptor agonist (Saxenda, Wegovy, Zepbound, Bydureon, Byetta, Mounjaro, Ozempic, Rybelsus, Trulicity, Victoza)
• - Patient has no FDA-labeled contraindications

Reauthorization criteria

• Patient previously approved for requested agent through plan prior authorization process
• AND ONE of the following:
• 1. Diagnosed with OSA AND BOTH:
• - Requested agent is Zepbound
• - Patient has had clinical benefit (e.g., reduction in AHI, decrease in Epworth Sleepiness Scale)
• OR
• 2. Requested for reduction of major adverse cardiovascular events AND ALL:
• - Requested agent is FDA labeled for indication and route
• - Patient using optimized cardiovascular pharmacotherapy
• - Clinical benefit documented
• OR
• 3. Requested for weight management AND ALL:
• - Obesity not excluded from coverage
• - Continuing current weight loss therapy
• - Pediatric (age 12–17 years): BMI ≥ 85th percentile for age and sex
• - Agent-specific criteria:
• • For Zepbound: patient received < 52 weeks of therapy on maximum tolerated dose OR achieved ≥ 5% weight loss from baseline OR another FDA-labeled indication with clinical benefit
• - Patient will NOT use requested agent with another weight loss agent (Contrave, phentermine, Qsymia, Xenical)
• - BOTH:
• • Patient remains on low-calorie diet, physical activity, behavioral modifications
• • Will continue these measures with requested agent
• - Patient will NOT use requested agent in combination with another GLP-1 receptor agonist (Saxenda, Wegovy, Zepbound, Bydureon, Byetta, Mounjaro, Ozempic, Rybelsus, Trulicity, Victoza)
• - Patient has no FDA-labeled contraindications

Approval duration

12 months