IMCIVREE (setmelanotide)

IMCIVREE (setmelanotide)

SELF ADMINISTRATION - SUBCUTANEOUS

Indications for Prior Authorization:

• Imcivree is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

Limitation of use:

• Imcivree is not indicated for the treatment of obesity due to suspected POMC-, PCSK1-, or LEPR-deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign.  Imcivree is not indicated for the treatment of other types of obesity not related to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Patients must meet the following criteria:

Obesity (Initial authorization):

• Submission of medical records (i.e., chart notes, laboratory values, genetic testing) confirming diagnosis is due to one of the following genetic deficiencies:
  • Proopiomelanocortin (POMC), OR
  • Proprotein convertase subtilisin/kexin type 1 (PCSK1), OR
  • Leptin receptor (LEPR).
• Patient is 6 years of age or older; AND
• Patient has been diagnosed with obesity defined by one of the following:
  • Adults 18 years of age or older: BMI greater than or equal to 30 kg/m2 for, OR
  • Pediatric patients: weight greater than or equal to 95th percentile using growth chart assessments; AND
• Other causes or types of obesity have been ruled out (e.g., obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign; obesity associated with other genetic syndromes; polygenic obesity).

Obesity (Reauthorization):

• After 6 months of therapy: Submission of medical records showing weight loss of greater than or equal to 5% of baseline body weight.
• After 12 months of therapy: Submission of medical records showing weight loss of greater than or equal to 10% of baseline body weight.

This Medication Is Not Approvable for the Following Condition(s):

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Dosing:

• Adults and pediatric patients 12 year of age and older: maximum 3 mg (0.3 mL) once daily.
  • The starting dose is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks.
    • If the starting dose is not tolerated, reduce to 1 mg (0.1 mL) once daily.
    • If the 1 mg once daily dose is tolerated and additional weight loss is desired, titrate to 2 mg (0.2 mL) once daily.
    • If the 2 mg daily dose is tolerated, increase the dose to 3 mg (0.3 mL) once daily.
    • If the 3 mg once daily dose is not tolerated, maintain administration of 2 mg (0.2 mL) once daily.
• Pediatric patients 6 year of age to less than 12 years of age: maximum 3 mg (0.3 mL) once daily.
  • The starting dose is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks.
    • If the starting dose is not tolerated, reduce to 0.5 mg (0.05 mL) once daily dose.
    • If the 0.5 mg once daily dose is tolerated and additional weight loss is desired, titrate to 1 mg (0.1 mL) once daily.
    • If the 1 mg dose is tolerated, increase the dose to 2 mg (0.2 mL) once daily.
    • If the 2 mg once daily dose is not tolerated, reduce to 1 mg (0.1 mL) once daily.
    • If the 2 mg once daily dose is tolerated and additional weight loss is desired, the dose may be increased to 3 mg (0.3 mL) once daily.

Approval:

• Initial: up to 6 months.
• Reauthorization: up to 12 months.

Additional Information:

• Patient should be evaluated for response to Imcivree after 12-16 weeks of treatment. If a patient has not lost at least 5% of baseline body weight or 5% of baseline BMI, it is recommended to discontinue Imcivree as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Review History:

• 04/20/2021- New policy.

References:

• Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362.
• Clement K, van den Akker E, Argente J, et al. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicenter, phase 3 trials. Lancet Diabetes and Endocrinol. 2020;8(12):960-970.
• Imcivree Prescribing Information. Rhythm Pharmaceuticals, Inc. Boston, MA. December 2020.
• Must A, Anderson SE. Body mass index in children and adolescents: considerations for population-based applications. Int J Obes (Lond). 2006;30(4):590-4.
• National Institutes of Health (NIH). Managing overweight and obesity in adults: systematic evidence review from the obesity expert panel. 2013. Web site. https://www.nhlbi.nih.gov/sites/default/files/media/docs/obesity-evidence-review.pdf.  Accessed April 06, 2021