Anthem Blue Cross California Imcivree (setmelanotide) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Imcivree (setmelanotide). Imcivree is a melanocortin-4 receptor (MC4R) agonist that is intended to treat certain individuals with obesity by partially or completely restore signaling at the MC4 receptor. Imcivree is indicated for adult and pediatric patients 6 years of age or older with monogenic or syndromic obesity due to one of the following: 1. Proopiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK 1), or Leptin receptor (LEPR) deficiency. Patients should be selected for therapy based on genetic testing demonstrating gene variants that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS); 2. Bardet-Biedl syndrome (BBS). Patients should be selected for therapy who have a clinical diagnosis of BBS. Imcivree is the first FDA approved treatment for chronic weight management in obese patients with confirmed POMC, PCSK1, and LEPR deficiency. Individuals with these specific genetic aberrations experience excessive appetite and weight gain, resulting in morbid obesity, even as early as infancy. Individuals may experience other disorders of the endocrine system due to involvement in various hormone signaling pathways. Comorbidities may include postprandial hypoglycemia, hypogonadism, hypothyroidism, adrenal insufficiency, and high risk of infection. Imcivree is also the first FDA approved treatment for chronic weight management in obese patients with Bardet-Biedl syndrome (BBS). BBS is an autosomal recessive syndrome associated with mutations in at least 15 genes. It is characterized by obesity and several other abnormalities such as intellectual disability, eye, dental, and renal abnormalities, and/or other unique physical features. Historically, patients with these conditions have relied on management of excessive appetite with calorie restrictions, lifestyle modification, and close supervision to control weight. Imcivree can partially or completely restore signaling at the MC4 receptor resulting in appetite suppression and weight loss in certain individuals. Imcivree was studied in two open label, single-arm, multicenter, multi-phase trials which enrolled individuals with genetically confirmed or suspected POMC, PCSK1, or LEPR deficiency. Individuals were classified as obese based on ≥BMI 30 kg/m2 for adults or weight ≥95th percentile using growth chart assessments for pediatric patients. The clinical trial for BBS enrolled individuals with a clinical diagnosis of BBS and classified as obese based on ≥BMI 30 kg/m2 for adults or weight ≥97th percentile using growth chart assessments for pediatric patients. Pediatric BMI may be assessed using tools on the CDC website located here. After 1 year of treatment, results showed that 8/10 individuals with POMC/PSCK1 variants (80%) and 5/11 individuals with LEPR variants (45.5%) achieved at least 10% weight loss after treatment with Imcivree. In individuals with BBS, 38.7% of individuals achieved at least 10% BMI loss at 52 weeks. Imcivree labeling includes warnings for disturbances in sexual arousal, skin pigmentation, and depression and suicidal ideation. Individuals with suicidal ideation/behavior or history of suicide attempt were excluded from clinical trials; and individuals should be monitored for new onset or worsening depression during treatment. Response to Imcivree treatment should be monitored closely: initially after 12-16 weeks of therapy for POMC/PSCK1/LEPR deficiency and after 1 year for BBS. Treatment should be discontinued if individual does not lose at least 5% of baseline bodyweight or 5% of baseline BMI in patients with continued growth potential. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Imcivree (setmelanotide) Initial requests for Imcivree (setmelanotide) for POMC/PCSK1/LEPR deficiency may be approved if the following criteria are met: I. II. Individual is 6 years of age or older; AND Documentation is provided that individual has a diagnosis of obesity, defined as: 1 A. BMI of 30 kg/m2 or greater for adults; OR B. Bodyweight of more than the 95th percentile for age on growth chart assessment for pediatric individuals (<18 years of age); AND III. IV. V. Documentation is provided that obesity is due to Proopiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK 1), or Leptin receptor (LEPR) deficiency, verified by genetic testing; AND Genetic testing demonstrates that variants in POMC, PCSK1, or LEPR genes are pathogenic, likely pathogenic, or of uncertain significance; AND Individual is NOT receiving two or more medications for weight loss at the same time. Initial Authorization Period for POMC, PCSK1, or LEPR deficiency: 16 weeks. Initial requests for Imcivree (setmelanotide) for BBS may be approved if the following criteria are met: I. II. Individual is 6 years of age or older; AND Documentation is provided that individual has a diagnosis of obesity, defined as: A. BMI of 30 kg/m2 or greater for individuals 16 years of age and above; OR B. Bodyweight of more than the 97th percentile for age on growth chart assessment for individuals aged 6-15 years; AND Obesity is due to Bardet-Biedl syndrome (BBS), as defined by one of the following [A or B] (Haws 2021): III. 1. A. Four (4) primary features of BBS: Primary Features: a. Rod-cone dystrophy b. c. Obesity d. Learning disabilities e. Hypogonadism in males Renal anomalies; f. Polydactyly OR B. Three (3) primary features [above] AND 2 secondary features of BBS: 1. Speech disorder/delay Strabismus/cataracts/astigmatism Brachydactyly/syndactyly Secondary Features: a. b. c. d. Developmental delay e. f. g. Mild spasticity (especially lower limbs) h. Diabetes mellitus i. j. k. Polyuria/polydipsia (nephrogenic diabetes insipidus) Ataxia/poor coordination/imbalance Dental crowding/hypodontia/small roots/high arched palate Left ventricular hypertrophy/congenital heart disease Hepatic fibrosis; AND IV. Individual is NOT receiving two or more medications for weight loss at the same time. Initial Authorization Period for BBS: 1 year. Requests for subsequent authorization for Imcivree (setmelanotide) may be approved if the individual meets ALL of the following criteria: I. II. Documentation is provided that individual has achieved/maintained weight loss of at least 5% of baseline body weight or 5% of baseline BMI for patients with continued growth potential; AND Individual is NOT receiving two or more medications for weight loss at the same time. Subsequent Authorization Period [all diagnoses]: 6 months. Requests for Imcivree (setmelanotide) may not be approved for any of the following: I. Obesity with POMC, pCSK1, or LEPR variants classified as benign or likely benign (for POMC/PCSK1/LEPR deficiency requests); OR Individual has end stage renal disease (eGFR less than 15 mL/min/1.73 m2; OR II. III. When the above criteria are not met and for all other indications. Quantity Limits 2 Imcivree (setmelanotide) Quantity Limit Imcivree 10 mg/mL multi-dose vial 9 vials per 30 days Drug Limit Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J3590 C9399 Unclassified biologics (when specified as [Imcivree] (setmelanotide)) Unclassified drugs or biologicals (when specified as [Imcivree] (setmelanotide)) ICD-10 Diagnosis All diagnosis pend Document History Revised: 05/19/2023