Imcivree®

Drug - Imcivree® (setmelanotide solution) [Rhythm Pharmaceuticals, Inc.]

March 2025

Therapeutic Area - Genetic, Enzyme, or Protein Disorder Treatment

Initial approval criteria

Obesity Due to Proopiomelanocortin (POMC), Proprotein Convertase Subtilisin/Kexin Type 1 (PCSK1), or Leptin Receptor (LEPR) Deficiency

Patient is at least 6 years of age; AND
Patient’s baseline body mass index (BMI) ≥ 30 kg/m2 (if patient is at least 18 years of age); OR
Patient’s baseline weight ≥ 95th percentile for age on growth chart assessment (if patient is under 18 years of age); AND
Patient has POMC, PCSK1, or LEPR deficiency as determined by an FDA-approved test; AND
The genetic variant is interpreted as pathogenic, likely pathogenic, or of uncertain significance; AND
Patient or caregiver has been instructed on appropriate administration techniques as documented in patient chart notes; AND
Imcivree is prescribed by or in consultation with an endocrinologist, geneticist; or a physician specializing in metabolic disorders; AND
Initial approval is for 4 months

Obesity Due to Bardet-Biedl Syndrome

Patient is at least 6 years of age; AND
Patient’s baseline body mass index (BMI) ≥ 30 kg/m2 (if patient is at least 18 years of age); OR
Patient’s baseline weight ≥ 97th percentile for age on growth chart assessment (if patient is under 18 years of age); AND
Patient has a clinical diagnosis of Bardet-Biedl Syndrome as documented in patient chart notes; AND
Patient or caregiver has been instructed on appropriate administration techniques as documented in patient chart notes; AND
Imcivree is prescribed by or in consultation with an endocrinologist, geneticist; or a physician specializing in metabolic disorders; AND
Initial approval is for 12 months

Patient continues to meet above criteria; AND
Patient has not experienced treatment-limiting adverse reactions (e.g. gastrointestinal intolerability below labeled dosing for age, sexual adverse effects, depression or suicidal ideation); AND
Patient has experienced at least 5% reduction of baseline body weight (if patient is under 18 years of age); OR
Patient has experienced at least 5% reduction of baseline BMI (if patient is at least 18 years of age); AND
Renewal approval is for 12 months

Imcivree is not indicated for the treatment of patients with the following conditions as Imcivree would not be expected to be effective:

Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign.
Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity.

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