Pharmacy Prior Authorization Criteria

Imcivree (setmelanotide) – PA, NF

Indications for Prior Authorization

Imcivree (setmelanotide)

• For diagnosis of Obesity
  Indicated for chronic weight management in adult and pediatric patients 6 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 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: • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign • Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, 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 POMC, PCSK1, LEPR Deficiency

• Patient is 6 years of age or older
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
• Weight greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Diagnosis is due to one of the following genetic deficiencies:
• Proopiomelanocortin (POMC)
• Proprotein convertase subtilisin/kexin type 1 (PCSK1)
• Leptin receptor (LEPR)
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)

Imcivree

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of POMC, PCSK1, LEPR Deficiency

• Both of the following: [A]
• 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
• Weight loss of greater than or equal to 10% of baseline body weight

Imcivree

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of POMC, PCSK1, LEPR Deficiency

• Patient is 6 years of age or older
AND
• Submission of medical records (e.g., chart notes) confirming diagnosis of obesity as defined by one of the following:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• Weight greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Submission of medical records (e.g., chart notes) confirming diagnosis is due to one of the following genetic deficiencies:
• Proopiomelanocortin (POMC)
• Proprotein convertase subtilisin/kexin type 1 (PCSK1)
• Leptin receptor (LEPR)
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)

Imcivree

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of POMC, PCSK1, LEPR Deficiency

• Submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following: [A]
• 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
• Weight loss of greater than or equal to 10% of baseline body weight

Imcivree

Prior Authorization (Initial Authorization)

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

• Diagnosis of Bardet-Biedl syndrome (BBS)
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
• Weight greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Patient is 6 years of age or older
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)

Imcivree

Prior Authorization (Reauthorization)

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

• Both of the following: [B]
• Patient has been on therapy for 12 months or more
• Weight loss of greater than or equal to 5% of baseline body weight

Imcivree

Non Formulary (Initial Authorization)

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

• 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:
• BMI greater than or equal to 30 kg/m2 for adults 18 years of age or older
• Weight greater than or equal to 95th percentile using growth chart assessments for pediatric patients
AND
• Patient is 6 years of age or older
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)

Imcivree

Non Formulary (Reauthorization)

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

• Submission of medical records (e.g., chart notes) confirming both of the following: [B]
• Patient has been on therapy for 12 months or more
• Weight loss of greater than or equal to 5% of baseline body weight

P & T Revisions

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. June 2022.
2. Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): IBM Corporation.; Updated periodically. Available by subscription at: https://www.micromedexsolutions.com/. Accessed January 8, 2021.
3. Perreault, M. Genetic contribution and pathophysiology of obesity. UpToDate. www.uptodate.com. Updated November 22, 2019. Accessed January 8, 2021.
4. 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.

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End Notes

1. For obesity due to POMC, PCSK1, or LEPR deficiency, 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. [1]
2. For obesity due to BBS, patient should be evaluated for response to Imcivree after one year of treatment. If a patient has not lost at least 5% of baseline body weight or 5% of baseline BMI for patients aged less than 18 years, discontinue Imcivree as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. [1]

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Revision History

• 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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