setmelanotide acetate — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has a diagnosis of monogenic obesity due to POMC deficiency, PCSK1 deficiency, or LEPR deficiency AND genetic testing with an FDA-approved test has confirmed variants in POMC, PCSK1, or LEPR genes (medical records required)
• The patient's genetic status is bi-allelic, homozygous, or compound heterozygous (NOT double heterozygous)
• The patient’s genetic variant is interpreted as pathogenic, likely pathogenic, OR of uncertain significance (VUS)
• The patient’s genetic variant is NOT classified as benign or likely benign
• OR the patient has a diagnosis of syndromic obesity due to Bardet-Biedl syndrome (BBS) AND the diagnosis has been clinically confirmed by four primary features OR three primary and two secondary features (medical records required)
• If the patient has an FDA labeled indication, then ONE of the following: age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient’s age for the requested indication
• ONE of the following: for adult patients, BMI ≥ 30 kg/m² OR for pediatric patients, weight ≥ 95th percentile (for POMC, PCSK1, or LEPR) or ≥ 97th percentile (for BBS) using growth chart assessments
• ONE of the following: patient is newly starting therapy OR for POMC/PCSK1/LEPR deficiency, currently treated with less than 16 weeks of therapy OR has achieved ≥ 5% weight loss of baseline body weight or baseline BMI after at least 16 weeks of therapy; OR for BBS, currently treated with less than one year of therapy OR achieved ≥ 5% weight loss of baseline body weight or baseline BMI after at least one year of therapy
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, metabolic disorders) or has consulted with a specialist in that area
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• ONE of the following: for adult patients, achieved and maintained weight loss ≥ 5% of baseline body weight OR for POMC, PCSK1, or LEPR deficiency with continued growth potential, achieved and maintained weight loss ≥ 5% baseline BMI OR for BBS patients < 18 years, achieved and maintained weight loss ≥ 5% baseline BMI
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, metabolic disorders) or has consulted with a specialist in that area
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

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