Imcivree — Blue Cross Blue Shield of New Mexico

Initial criteria

• The patient has ONE of the following: (A) ALL of the following for monogenic obesity: (1) Diagnosis of POMC, PCSK1, or LEPR deficiency AND (2) Genetic testing with an FDA-approved test confirms variants in POMC, PCSK1, or LEPR genes (medical records required) AND (3) Genetic status is bi-allelic, homozygous, or compound heterozygous (NOT double heterozygous) AND (4) Variant interpreted as pathogenic, likely pathogenic, or of uncertain significance AND (5) Variant is NOT classified as benign or likely benign OR (B) BOTH of the following for BBS: (1) Diagnosis of syndromic obesity due to Bardet-Biedl syndrome AND (2) Diagnosis clinically confirmed by four primary features OR three primary and two secondary features (medical records required) [primary features: rod-cone dystrophy, polydactyly, obesity, genital anomalies, renal anomalies, learning difficulties; secondary features: 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: (A) Age within FDA labeling for the requested indication for the requested agent OR (B) Support for use at the patient’s age for the requested indication
• ONE of the following: (A) For adult patients, BMI ≥ 30 kg/m^2 OR (B) For pediatric patients, weight ≥ 95th percentile (for POMC, PCSK1, or LEPR) or ≥ 97th percentile (for BBS) using growth chart assessments
• ONE of the following: (A) Patient is newly starting therapy OR (B) For POMC, PCSK1, or LEPR deficiency: (1) Patient currently treated for <16 weeks OR (2) ≥16 weeks of therapy with ≥5% weight loss from baseline body weight OR ≥5% reduction in baseline BMI (for those with growth potential); For BBS: (1) Patient currently treated for <1 year OR (2) ≥1 year of therapy with ≥5% weight loss or ≥5% BMI reduction for patients <18 years
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, metabolic disorders) OR has consulted with one
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative condition for Ohio members: Member resides in Ohio AND plan is Fully Insured or HIM Shop AND BOTH of the following: (A) No FDA labeled contraindications AND (B) ONE of the following: (1) Another FDA labeled indication exists, OR (2) Indication supported in compendia, OR (3) Prescriber submitted two peer-reviewed journal articles supporting proposed use

Reauthorization criteria

• Patient previously approved for the requested agent through the plan’s prior authorization process
• ONE of the following: (A) Adult patients achieved and maintained ≥5% weight loss from baseline body weight OR (B) For patients with POMC, PCSK1, or LEPR deficiency and continued growth potential, achieved and maintained ≥5% reduction in baseline BMI OR (C) For patients with BBS aged <18 years, achieved and maintained ≥5% reduction in baseline BMI
• Prescriber is a specialist in the area of the patient’s diagnosis or has consulted with one
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

Initial: 4 months (POMC/PCSK1/LEPR) or 12 months (BBS); Renewal: 12 months