Imcivree (setmelanotide acetate) — Blue Cross Blue Shield of Texas

Initial criteria

• - Patient has one of the following: • ALL of the following for monogenic obesity: 1. Diagnosis of POMC, PCSK1, or LEPR deficiency 2. Genetic testing with FDA-approved test confirms variants in POMC, PCSK1, or LEPR (medical records required) 3. Genetic status is bi-allelic, homozygous, or compound heterozygous (not double heterozygous) 4. Variant interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) 5. Variant not classified as benign or likely benign OR • BOTH of the following for BBS: 1. Diagnosis of syndromic obesity due to Bardet-Biedl syndrome (BBS) 2. Diagnosis clinically confirmed by four primary features or three primary plus two secondary features (medical records required) – Primary features may include rod-cone dystrophy, polydactyly, obesity, genital anomalies, renal anomalies, learning difficulties – Secondary features may include speech delay, developmental delay, diabetes mellitus, dental anomalies, congenital heart disease, bracydactyly/syndactyly, ataxia/poor coordination, anosmia/hyposmia
• - If the patient has an FDA-labeled indication, then one of the following: • Patient’s age is within FDA labeling for the requested indication for the requested agent OR • There is support for using the agent for this age and indication
• - One of the following weight criteria: • For adults: BMI ≥ 30 kg/m² • For pediatric patients: Weight ≥ 95th percentile (POMC/PCSK1/LEPR) or ≥ 97th percentile (BBS) using growth chart assessments
• - One of the following therapy initiation/continuation scenarios: • Newly starting therapy OR • For POMC/PCSK1/LEPR deficiency: – Currently being treated <16 weeks OR – Received ≥16 weeks and achieved ≥5% weight loss from baseline body weight or ≥5% reduction in baseline BMI (with growth potential) • For BBS: – Currently being treated <1 year OR – Received ≥1 year and achieved ≥5% weight loss from baseline body weight or ≥5% reduction in baseline BMI (if <18 years old)
• - Prescriber is a specialist in patient’s diagnosis (endocrinologist, geneticist, metabolic disorders) or has consulted one
• - Patient has no FDA-labeled contraindications to the agent

Reauthorization criteria

• - Patient previously approved under plan’s PA process
• - One of the following weight criteria: • For adults: achieved and maintained ≥5% weight loss from baseline body weight • For POMC/PCSK1/LEPR deficiency patients with growth potential: maintained ≥5% reduction in baseline BMI • For BBS patients aged <18 years: maintained ≥5% reduction in baseline BMI
• - Prescriber is a specialist (endocrinologist, geneticist, metabolic disorders) or has consulted with appropriate specialist
• - Patient has no FDA-labeled contraindications

Approval duration

4 months for POMC/PCSK1/LEPR; 12 months for BBS; 12 months renewal