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Imcivree (setmelanotide) — Medical Mutual

Chronic weight management due to biallelic LEPR deficiency

Initial criteria

  • Patient age ≥ 2 years; AND
  • Patient has a diagnosis of monogenic or syndromic obesity as per ONE of the following:
  • a. BMI > 30 kg/m2 for adults; OR
  • b. BMI > 95th percentile using growth chart assessments for pediatric patients age ≥ 6 years with obesity due to POMC, PCSK1, or LEPR deficiencies; OR
  • c. BMI > 97th percentile using growth chart assessments for pediatric patients with obesity due to BBS, or for pediatric patients age > 6 years with obesity due to POMC, PCSK1, or LEPR deficiencies; AND
  • Patient meets ONE of the following: a OR b
  • a. Patient has a clinical diagnosis of Bardet-Biedl syndrome (BBS), as evidenced by meeting ONE of:
  • i. At least FOUR primary features of BBS (red-cone dystrophy, polydactyly, obesity, learning disability, renal anomalies, male hypogonadism); OR
  • ii. At least THREE primary features (above) AND at least TWO secondary features of BBS (speech disorder/delay, strabismus/cataracts/astigmatism, brachydactyly/syndactyly, developmental delay, polyuria/polydipsia/nephrogenic diabetes insipidus, ataxia/poor coordination/imbalance, mild spasticity, diabetes mellitus, dental crowding/hypodontia/small roots/high arched palate, left ventricular hypertrophy/congenital heart disease, hepatic fibrosis); OR
  • b. Patient meets ALL of:
  • i. Obesity is due to a deficiency of ONE of: POMC, PCSK1, or LEPR as confirmed by genetic testing; AND
  • ii. Genetic testing demonstrates variants in POMC, PCSK1, or LEPR interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS); AND
  • Imcivree is prescribed by or in consultation with an endocrinologist, geneticist, or expert in rare genetic disorders of obesity.

Reauthorization criteria

  • Imcivree is prescribed by or in consultation with an endocrinologist, geneticist, or expert in rare genetic disorders of obesity; AND
  • Patient has used Imcivree for a minimum of 12 weeks (for obesity due to POMC, PCSK1, or LEPR deficiency) OR a minimum of 1 year (for obesity due to BBS); AND
  • Patient has lost at least 5% of baseline body weight, OR at least 5% of baseline BMI for patients with continued growth potential, within the first 12–16 weeks (for obesity due to POMC, PCSK1, or LEPR deficiency) OR within the first 1 year (for obesity due to BBS); AND
  • Patient meets ONE of: a OR b
  • a. Patient has a clinical diagnosis of Bardet-Biedl syndrome (BBS), evidenced by meeting ONE of:
  • i. At least FOUR primary features of BBS (red-cone dystrophy, polydactyly, obesity, learning disability, renal anomalies, male hypogonadism); OR
  • ii. At least THREE primary features (above) AND at least TWO secondary features of BBS; OR
  • b. Patient’s obesity is due to a deficiency of ONE of: POMC, PCSK1, or LEPR as confirmed by genetic testing; AND
  • Genetic testing demonstrates variants in POMC, PCSK1, or LEPR interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

Approval duration

Initial: 1 year for BBS; Initial: 4 months for others; Reauth: 1 year