Imcivree (setmelanotide) — Point32Health

Initial criteria

• Documented diagnosis of obesity due to one (1) of the following: a. Genetically determined or suspected deficiency of POMC, PCSK1, or LEPR based on genetic variants interpreted as pathogenic, likely pathogenic, or of uncertain significance OR b. Bardet-Biedl syndrome (BBS)
• Documentation the patient is obese, defined as one (1) of the following: a. For patients age ≥ 18 years, baseline body mass index ≥ 30 kg/m2 OR b. For patients age 6–17 years: i. POMC, PCSK1, and LEPR deficiencies ≥ 95th percentile using growth chart assessments OR ii. BBS ≥ 97th percentile using growth chart assessments
• Prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders
• Patient age ≥ 6 years
• Documentation of baseline body weight and body mass index

Reauthorization criteria

• Documented diagnosis of obesity due to one (1) of the following: a. Genetically determined or suspected deficiency of POMC, PCSK1, or LEPR based on genetic variants interpreted as pathogenic, likely pathogenic, or of uncertain significance OR b. Bardet-Biedl syndrome (BBS)
• Prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders
• Patient age ≥ 6 years
• Documentation patient has experienced a therapeutic response as defined by at least one (1) of the following: a. Loss of ≥ 5% body weight from baseline OR b. Loss of ≥ 5% body mass index if continued growth potential

Approval duration

initial 4 months; reauth 12 months