ORLISTAT CAP,ORAL

Clinical Criteria Summary

Verifiable participation in a comprehensive lifestyle intervention (CLI) that targets all three aspects of weight management: diet, physical activity, behavioral changes
BMI is greater than or equal to 30 kg/m2 OR BMI is greater than or equal to 27 kg/m2 with at least one weight-related comorbidity
Demonstrated ability to comply with a low-fat diet
Currently taking or receives a prescription for a multivitamin

For patients who can become pregnant: Pregnancy should be excluded prior to receiving orlistat and the patient provided contraceptive counseling on potential risks vs. benefits of taking orlistat if the patient were to become pregnant

For chronic weight management in conjunction with comprehensive lifestyle intervention
Offered to patients with a body mass index (BMI) > 30 kg/m² and to those with a BMI > 27 kg/m² who also have obesity-associated conditions
Formulary status: VA National Formulary (VANF) with Prior Authorization at the Facility level (PA-F) with Criteria for Use (CFU); not a controlled substance

Documented participation in a comprehensive lifestyle intervention targeting diet, physical activity, and behavioral changes within the past year
Participation may include MOVE! programs, remote patient monitoring home telehealth (TeleMOVE!/L2), clinically supported web/mobile applications with clinical contact, or non-VA programs meeting the operational definition

Pregnancy
Breastfeeding
Uncontrolled hypertension
Seizure disorder
Bulimia or anorexia nervosa
Chronic opioid use or acute opioid withdrawal
Monoamine oxidase inhibitor (MAOI) use during or within 14 days
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs

Initial weight loss goal: ≥5% weight loss by 12 weeks
Discontinue if the 5% weight loss goal is not achieved at 12 weeks, as clinically meaningful reduction is unlikely with continued treatment
Weight maintenance goals for continued therapy: Maintenance of ≥67% initial weight loss, >5% loss from baseline weight, or continued weight loss
Discontinue if sufficient weight loss is not achieved within the first 3 months on a maximally tolerated dose or if significant weight gain/regain occurs after initial loss

Hypertension: Contraindicated in uncontrolled hypertension; may increase blood pressure or cause hypertension
Cardiac/Cerebrovascular Disease: Monitor heart rate or blood pressure per usual practice; discontinue if sustained. Unknown impact on listed comorbidities as several conditions were excluded from clinical trials
Diabetes: Improved glycemic parameters in diabetes mellitus
Mental Health Conditions/Suicidality: Boxed warning for suicidal behavior and ideation; monitor patients especially during initial months and with dose changes. Post-marketing meta-analyses support no increased risk in suicidal ideation/behavior
Seizure Disorder: Contraindicated; seizures may occur, with increased risk from factors that decrease seizure threshold
Nephrolithiasis: May increase urinary oxalate and risk of oxalate nephrolithiasis; use caution in renal impairment or history of hyperoxaluria/calcium oxalate stones; discontinue if oxalate nephropathy develops
Glaucoma: Pupillary dilation may precipitate an attack in those at risk for narrow-angle glaucoma

Boxed Warning: Suicidal behavior and ideation
Neuropsychiatric adverse events and suicide risk (noted in smoking cessation context)
Increased blood pressure and heart rate
Hepatotoxicity; adjust dose in hepatic impairment, not recommended in severe hepatic impairment
Activation of mania
Angle-closure glaucoma
Hypoglycemia with use of antidiabetic medications
Adjust dose in moderate to severe renal impairment; avoid in end-stage renal disease (ESRD)
Vulnerability to opioid overdose and precipitated opioid withdrawal

Initial refill after 12 to 24 weeks: Patient must continue participation in a comprehensive lifestyle intervention or have completed one with a follow-up visit for ongoing education/support
Refills every 6 months: Maintenance of ≥67% initial weight loss, >5% loss from baseline, or continued weight loss is the reasonable goal; no specific documentation requirement for CLI participation at this stage, though ongoing participation remains important for maintenance