ORLISTAT CAP,ORAL

Clinical Criteria Summary

⇄ This criteria document covers 10 drugs across 4 drug classes.

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BMI > 30 kg/m² or BMI > 27 kg/m² with obesity-related conditions
Must be prescribed in conjunction with a comprehensive lifestyle intervention (CLI)
Clinically meaningful weight loss is generally considered approximately a 5% reduction from baseline body weight
WMMs should be viewed as chronic therapy; discontinuation is commonly associated with weight regain
Shared decision-making required considering efficacy, adverse effects, contraindications and warnings, comorbidities, patient preferences, cost, and applicable CFU
Review current treatment regimen for medications that may contribute to weight gain and consider alternative therapy when appropriate

Documentation of participation in CLI within the past year on at least one occasion is required for eligibility
CLI must target all three aspects of weight management: diet, physical activity, and behavioral changes
Self-management tools without clinician contact do not meet the definition of CLI
Routine lifestyle education/coaching without a standardized curriculum delivered over a series of sessions does not meet the definition of CLI
Programs targeting only one or two aspects of weight management do not meet the definition of CLI

VANF Status: PA-F (CFU)
Route/Frequency: Oral; twice daily
Avoid/Contraindications: Pregnancy, Lactation, Seizure disorder, Eating disorders, Uncontrolled hypertension, Chronic opioid use or acute opioid withdrawal, MAOI use within 14 days
Post-Marketing Considerations: Type 2 diabetes
Monitoring & Safety: Monitor blood pressure, heart rate, and mood; Precautions include suicidal behavior and ideation [Boxed Warning]
Common ADRs: Nausea, constipation, acute headache, vomiting, dizziness, insomnia, dry mouth, diarrhea, anxiety

VANF Status: PA-F (CFU)
Route/Frequency: Oral; three times daily with meals
Avoid/Contraindications: Pregnancy, Lactation, Chronic malabsorption syndrome, Cholestasis
Post-Marketing Considerations: Prediabetes, Type 2 diabetes, BP lowering
Monitoring & Safety: Monitor hepatotoxicity; Precautions include fat-soluble vitamin deficiency and oxalate nephropathy
Common ADRs: Oily spotting/stools, fecal urgency, flatulence

VANF Status: PA-F (CFU)
Route/Frequency: Oral; once daily
Avoid/Contraindications: Pregnancy, Lactation, Glaucoma, Hyperthyroidism, MAOI use within 14 days
Post-Marketing Considerations: Prediabetes, Type 2 diabetes, BP lowering
Monitoring & Safety: Monitor heart rate, blood pressure, and mood changes; Precautions include fetal toxicity (REMS), nephrolithiasis risk, and seizure risk with abrupt discontinuation
Common ADRs: Paraesthesias, dysgeusia, insomnia, constipation, dry mouth

VANF Status: NF (CFU)
Route/Frequency: Subcutaneous; once weekly (injection) / Oral; once daily on an empty stomach with up to 4 ounces of water (tablet); Eating, drinking, and taking other medications must be avoided for 30 minutes (oral)
Avoid/Contraindications: Pregnancy, Lactation
Post-Marketing Considerations: Prediabetes
Monitoring & Safety: Monitor risk of worsening diabetic retinopathy in patients with T2DM; Precautions include gallbladder disease and pancreatitis; Avoid concurrent use of a DPP-4 inhibitor due to lack of efficacy
Common ADRs: GI adverse effects (nausea, diarrhea, constipation, vomiting, abdominal pain), dyspepsia
FDA-Approved Indications: MASH, Reduction of MACE, Type 2 diabetes (under different brand and doses)
Post-Marketing Evidence: Prediabetes, HFpEF, Osteoarthritis

VANF Status: NF (CFU)
Route/Frequency: Subcutaneous; once daily
Avoid/Contraindications: Pregnancy, Lactation
Post-Marketing Considerations: Prediabetes
Monitoring & Safety: Precautions include gallbladder disease and pancreatitis
Common ADRs: GI adverse effects (nausea, diarrhea, constipation, vomiting, abdominal pain), dyspepsia
FDA-Approved Indications: Type 2 diabetes (under different doses), Reduction of MACE (in T2D)
Post-Marketing Evidence: Prediabetes, Reduction of MASH

VANF Status: NF (CFU)
Route/Frequency: Subcutaneous; once weekly
Avoid/Contraindications: Pregnancy, Lactation
Post-Marketing Considerations: Prediabetes, BP lowering
Monitoring & Safety: Monitor risk of worsening diabetic retinopathy in patients with T2DM; Precautions include gallbladder disease and pancreatitis; Avoid concurrent use of a DPP-4 inhibitor due to lack of efficacy
FDA-Approved Indications: MASH, Reduction of MACE, Type 2 diabetes (under different brand)
Post-Marketing Evidence: Prediabetes, BP lowering, HFpEF, Osteoarthritis