Saxenda — Blue Cross Blue Shield of Montana

Initial criteria

• Diagnosis of OSA with polysomnography or home sleep apnea test showing apnea-hypopnea index ≥ 15 events/hour (baseline prior to therapy)
• Requested agent is Zepbound
• Pretreatment BMI ≥ 30 kg/m^2
• OR diagnosis of NASH or MASH with stage F1–F3 fibrosis confirmed by FIB-4 score and one of liver biopsy, VCTE, ELF score or MRE
• Requested agent is Wegovy
• Patient age ≥ 18 years
• Pretreatment BMI > 25 kg/m^2 OR > 23 kg/m^2 if of South Asian, Southeast Asian, or East Asian descent
• Alcohol use < 20 g/day for females OR < 30 g/day for males
• Patient monitored/treated for comorbidities (cardiovascular disease, diabetes, dyslipidemia, hypertension)
• No decompensated cirrhosis, moderate/severe hepatic impairment, or other chronic liver disease
• Prescriber is or has consulted a relevant specialist
• OR for risk reduction of major adverse cardiovascular events, patient has established atherosclerotic cardiovascular disease (e.g., MI, stroke, PAD)
• Requested agent is Wegovy
• Pretreatment BMI ≥ 27 kg/m^2
• Patient will use optimized pharmacotherapy for established cardiovascular disease with agent
• OR for weight management, patient new to therapy/new to plan/or repeating course
• Adult (age ≥ 18 years) with BMI ≥ 30 kg/m^2 OR ≥ 25 kg/m^2 if Asian descent OR ≥ 27 kg/m^2 with ≥ 1 weight-related comorbidity
• OR pediatric (age 12–17 years) with BMI ≥ 95th percentile OR ≥ 30 kg/m^2 OR ≥ 85th percentile with ≥ 1 weight-related comorbidity
• Inadequate response to ≥ 6 months of low-calorie diet, physical activity, and behavioral modification
• If requested agent is Saxenda: starting therapy OR <16 weeks (<20 weeks for pediatric) OR weight/BMI reduction goals met
• If Wegovy: starting therapy OR <52 weeks OR ≥5% weight reduction from baseline (adults or pediatric BMI reduction ≥5%)
• If Zepbound: starting therapy OR <52 weeks OR ≥5% weight reduction from baseline
• Agent will not be used in combination with another weight-loss agent
• Patient is on and will continue low-calorie diet, physical activity, and behavioral modifications
• Age within FDA labeling or supported for requested indication
• Agent will not be used with another GLP-1 receptor agonist
• No FDA-labeled contraindications

Reauthorization criteria

• Previously approved for Wegovy, Saxenda, or Zepbound
• For OSA: requested agent is Zepbound and patient has achieved clinical benefit (e.g., reduction in AHI, decrease in Epworth Sleepiness Scale)
• For NASH/MASH: requested agent is Wegovy and patient maintains limited alcohol use (<20 g/day female, <30 g/day male)

Approval duration

Wegovy/Zepbound 12 months; Saxenda adults 4 months; Saxenda pediatric 5 months