Pharmacy Prior Authorization Criteria

Imcivree (setmelanotide) - PA, NF

Indications for Prior Authorization

Imcivree (setmelanotide)

• For diagnosis of Syndromic or Monogenic Obesity
  Indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with monogenic or syndromic obesity due to:

  1) Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS)

  2) Bardet-Biedl Syndrome (BBS)

• For diagnosis of Hypothalamic Obesity
  Indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity (HO)

• For diagnosis of Limitations of Use
  Imcivree is not indicated for the treatment of patients with the following conditions as Imcivree would not be expected to be effective: 1) Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign 2) Other types of obesity not related to acquired HO, BBS, POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

Criteria

Imcivree

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Obesity due to POMC, PCSK1, LEPR deficiency

• Patient has been diagnosed with obesity defined by one of the following:
• Both of the following:
• Patient is 6 years of age or older
AND
• One of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
OR
• Both of the following:
• Patient is 2 years of age to less than 6 years of age
AND
• Both of the following: [6-7]
• Patient weighs at least 15 kg
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Disease is confirmed by the presence of variants in POMC, PCSK1 or LEPR as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
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)
AND
• Patient’s BMI z-score has been recorded at baseline [A, 6]

Imcivree

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Obesity due to POMC, PCSK1, LEPR deficiency

• For patients 6 years of age or older, one of the following:
• Both of the following:
• Patient has been on therapy for less than 12 months
• Weight loss of greater than or equal to 5% of baseline body weight
OR
• Both of the following:
• Patient has been on therapy for 12 months or more
AND
• One of the following:
• Weight loss of greater than or equal to 10% of baseline body weight
• Reduction in BMI z-score of 0.2 points or greater from baseline [5]
OR
• For patient 2 years of age to less than 6 years of age, a reduction in BMI z-score of 0.2 points or greater from baseline [6]

Imcivree

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Obesity due to POMC, PCSK1, LEPR deficiency

• Submission of medical records (e.g., chart notes) confirming diagnosis of obesity as defined by one of the following:
• Both of the following:
• Patient is 6 years of age or older
AND
• One of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
OR
• Both of the following:
• Patient is 2 years of age to less than 6 years of age
AND
• Both of the following: [6-7]
• Patient weighs at least 15 kg
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Submission of medical records (e.g., chart notes) confirming the presence of variants in POMC, PCSK1 or LEPR as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Submission of medical records (e.g., chart notes) confirming 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)
AND
• Submission of medical records (e.g., chart notes) confirming patient’s BMI z-score has been recorded at baseline [5]

Imcivree

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Obesity due to POMC, PCSK1, LEPR deficiency

• For patients age 6 years of age or older, submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient has been on therapy for less than 12 months
• Weight loss of greater than or equal to 5% of baseline body weight
OR
• Both of the following:
• Patient has been on therapy for 12 months or more
AND
• One of the following:
• Weight loss of greater than or equal to 10% of baseline body weight
• Reduction in BMI z-score of 0.2 points or greater from baseline [5]
OR
• For patients 2 years of age to less than 6 years of age, submission of medical records (e.g., chart notes) confirming a reduction in BMI z-score of 0.2 points or greater from baseline [6]

Imcivree

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Obesity Due to Bardet-Biedl syndrome (BBS)

• Diagnosis of Bardet-Biedl syndrome (BBS)
AND
• Patient has been diagnosed with obesity defined by one of the following:
• Both of the following:
• Patient is 6 years of age or older
AND
• One of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
OR
• Both of the following: [6-7]
• Patient is 2 years of age to less than 6 years of age
AND
• Both of the following:
• Patient weighs at least 15 kg
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
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)
AND
• Patient's BMI z-score has been recorded at baseline [A][6]

Imcivree

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Obesity Due to Bardet-Biedl syndrome (BBS)

• For patients 6 years of age or older, one of the following:
• Both of the following:
• Patient has been on therapy for less than 12 months
• Weight loss of greater than or equal to 5% of baseline body weight
OR
• Both of the following:
• Patient has been on therapy for 12 months or more
AND
• One of the following:
• Weight loss of greater than or equal to 10% of baseline body weight
• Reduction in BMI z-score of 0.2 points or greater from baseline [5]
OR
• For patients 2 years of age to less than 6 years of age, a reduction in BMI z-score of 0.2 points or greater from baseline [A, 6]

Imcivree

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Obesity Due to Bardet-Biedl syndrome (BBS)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Bardet-Biedl syndrome (BBS)
AND
• Submission of medical records (e.g., chart notes) confirming diagnosis of obesity as defined by one of the following:
• Both of the following:
• Patient is 6 years of age or older
AND
• One of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
OR
• Both of the following: [6-7]
• Patient is 2 years of age to less than 6 years of age
AND
• Both of the following:
• Patient weighs at least 15 kg
• BMI greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Submission of medical records (e.g., chart notes) confirming 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)
AND
• Submission of medical records (e.g., chart notes) confirming patient’s BMI z-score has been recorded at baseline [A, 6]

Imcivree

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Obesity Due to Bardet-Biedl syndrome (BBS)

• For patent age 6 years of age or older, submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient has been on therapy for less than 12 months
• Weight loss of greater than or equal to 5% of baseline body weight
OR
• Both of the following:
• Patient has been on therapy for 12 months or more
AND
• One of the following:
• Weight loss of greater than or equal to 10% of baseline body weight
• Reduction in BMI z-score of 0.2 points or greater from baseline [5]
OR
• For patients 2 years of age to less than 6 years of age, submission of medical records (e.g., chart notes) confirming a reduction in BMI z-score of 0.2 points or greater from baseline [A, 6]

Imcivree

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypothalamic Obesity

• Diagnosis of acquired hypothalamic obesity (HO)
AND
• Patient is 4 years of age or older
AND
• Both of the following:
• Weight gain is associated with hypothalamic injury (e.g., traumatic brain injury, neurosurgery, tumor) [9]
AND
• Other causes or types of obesity have been excluded (e.g., PPL [POMC, PCSK1, LEPR, collectively], BBS, obesity associated with other genetic syndromes; polygenic obesity)
AND
• Patient has been diagnosed with obesity defined by one of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• BMI greater than or equal to 95th percentile using growth assessment charts for pediatric patients
AND
• Patient’s BMI z-score is recorded at baseline

Imcivree

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypothalamic Obesity

• Both of the following:
• Patient is 18 years of age or older
• Reduction in BMI of greater than or equal to 5% from baseline
OR
• Both of the following
• Patient is 4 years of age to less than 18 years of age
• Reduction in BMI z-score of greater than or equal to 0.2 points from baseline

Imcivree

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypothalamic Obesity

• Submission of medical records (e.g., chart notes) confirming diagnosis of acquired hypothalamic obesity (HO)
AND
• Patient is 4 years of age or older
AND
• Submission of medical records (e.g., chart notes) confirming both of the following:
• Weight gain is associated with hypothalamic injury (e.g., traumatic brain injury, neurosurgery, brain tumor) [9]
AND
• Other causes or types of obesity have been excluded (e.g., PPL [POMC, PCSK1, LEPR, collectively], BBS, obesity associated with other genetic syndromes; polygenic obesity)
AND
• Submission of medical records (e.g., chart notes) confirming one of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• BMI greater than or equal to 95th percentile using growth assessment charts for pediatric patients
AND
• Submission of medical records (e.g., chart notes) confirming patient’s BMI z-score has been recorded at baseline

Imcivree

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypothalamic Obesity

• Both of the following:
• Patient is 18 years of age or older
• Submission of medical records (e.g., chart notes) confirming reduction in BMI of greater than or equal to 5% from baseline
OR
• Both of the following
• Patient is 4 years of age to less than 18 years of age
• Submission of medical records (e.g., chart notes) confirming reduction in BMI z-score of greater than or equal to 0.2 points from baseline

P & T Revisions

1970-01-01, 2026-05-13, 2025-05-01, 2025-02-05, 2024-03-05, 2023-02-27, 2022-08-11, 2022-06-09, 2022-01-10, 2021-03-30, 2021-02-09

References

1. Imcivree Prescribing Information. Rhythm Pharmaceuticals, Inc. Boston, MA. December 2024.
2. Barlow SE and the Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics 2007;120 Supplement December 2007:S164—S192.
3. Clinical Consult January 30, 2025.
4. ClinicalTrials.gov. Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity. Available at: https://clinicaltrials.gov/study/NCT04966741?cond=NCT04966741&rank=1#participation-criteria. Accessed January 21, 2025.
5. Argente, J., Verge, C., Okorie, U., et al. Setmelanotide in patients aged 2–5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial. Available at: file:///C:/Users/kdekhtaw/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/3J33L6NQ/Argente%20et%20al%202025.pdf. Accessed January 21, 2025.
6. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics February 2023; 151 (2): e2022060640. 10.1542/peds.2022-060640
7. A Trial of Setmelanotide in Acquired Hypothalamic Obesity (NCT05774756) Clinicaltrials.gov.
8. Obesity in children - Symptoms, diagnosis and treatment | BMJ Best Practice
9. Dimitri P (2022) Treatment of Acquired Hypothalamic Obesity: Now and the Future. Front. Endocrinol. 13:846880. doi: 10.3389/fendo.2022.846880
10. Evidence-Based Guidelines for Child Obesity | Obesity | CDC. Accessed April 2026.

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End Notes

1. The co-primary endpoints at week 52 were the percentage of patients reaching a 0.2-point decrease or greater in BMI Z score (a statistical measure used to assess BMI in paediatric patients considering a patient’s BMI and comparing it to reference values for the same age and sex) and mean percent change in BMI. A reduction in BMI Z score of 0.2 points or more has been defined as clinically important weight loss associated with cardiometabolic improvements. [6]

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Revision History

• 2026-05-13: New criteria created for new indication of hypothalamic obesity (HO). Annual review of existing criteria.
• 2025-05-01: Annual review: Updated diagnostic criteria for indication of Obesity Due to Bardet-Biedl syndrome (BBS) to reflect a weight greater than or equal to 97th percentile using growth chart assessments for pediatric patients to align with PI.
• 2025-02-05: update guideline
• 2024-03-05: Annual Review - No criteria changes
• 2023-02-27: Annual review - No criteria changes
• 2022-08-11: Added new indication for Bardet-Biedl syndrome. Separated PA criteria from NF criteria. Added additional requirements for submission of MR for NF criteria in initial and reauth. Updated background and references.
• 2022-06-09: Removed submission of medical records and/or paid claims requirement from prior authorization criteria
• 2022-01-10: Annual review - No criteria changes
• 2021-03-30: Updated guideline name and type to say prior authorization, non-formulary (PA, NF).
• 2021-02-09: New Program

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