ModifiedAnthemPolicy CC-0188

Imcivree (setmelanotide) — Clinical coverage criteria

Clinical coverage criteria for Imcivree (setmelanotide) for treatment of obesity due to POMC, PCSK1, LEPR deficiencies, and Bardet-Biedl syndrome (BBS) in pediatric and adult patients; defines eligibility, exclusions, authorization periods, and quantity limits for Anthem.

Policy Summary

PayerAnthem

PolicyImcivree (setmelanotide) — Clinical coverage criteria

Policy CodePolicy CC-0188

Change TypeAge expansioncriteria and coding revisions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of age, BMI/percentile, and genetic testing results verifying pathogenic/likely pathogenic/VUS variants or clinical/genetic diagnosis for BBS.

SourceLink

POLICY UPDATE CHANGES

Expanded FDA approved age to 2 years for both approved indications (POMC/PCSK1/LEPR deficiency; BBS) and updated baseline BMI requirements for this age expansion.

Expanded FDA approved age to 2 years old for both approved indications (POMC/PCSK1/LEPR deficiency; BBS) and updated baseline BMI requirements for this age expansion.

Updated severe renal deficiency age exclusions and added restrictions for approval in those 6 to <12 years old with severe renal impairment and in those with a history of suicide attempts or active suicidal ideation.

Coding reviewed: Removed HCPCS NOC J3590 and added J3490; removed HCPCS J3490 and added C9399 at earlier updates; added ICD-10-CM E88.82 and Q87.83.

2min approved age

16w

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Coverage Criteria for Imcivree (setmelanotide)

Initial Therapy - POMC/PCSK1/LEPR

Covered when ALL of the following are met for POMC/PCSK1/LEPR deficiency:

POMC/PCSK1/LEPR initial criteria: I. Individual is 2 years of age or older; AND II. Documentation is provided that individual has a diagnosis of obesity, defined as: 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 individuals aged 6 to 17 years; OR C. Baseline BMI greater than or equal to the 97th percentile for age and sex, and body weight of at least 20 kg for individuals aged 2-5 years; AND III. Documentation is provided that obesity is due to Proopiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK1), or Leptin receptor (LEPR) deficiency, verified by genetic testing; AND IV. Genetic testing demonstrates that variants in POMC, PCSK1, or LEPR genes are pathogenic, likely pathogenic, or of uncertain significance; AND V. Individual is NOT receiving two or more medications for weight loss at the same time.

Initial authorization period: 16 weeks.

Initial Therapy - Bardet-Biedl syndrome (BBS)

Covered when ALL of the following are met for Bardet-Biedl syndrome (BBS):

BBS initial criteria: I. Individual is 2 years of age or older; AND II. 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; OR C. Baseline BMI greater than or equal to the 97th percentile for age and sex, and body weight of at least 20 kg for individuals aged 2-5 years; AND III. Obesity is due to Bardet-Biedl syndrome (BBS), as defined by either A. Four (4) primary features (rod-cone dystrophy; polydactyly; obesity; learning disabilities; hypogonadism in males; renal anomalies) OR B. Three (3) primary features plus two (2) secondary features (speech disorder/delay; strabismus/cataracts/astigmatism; brachydactyly/syndactyly); AND IV. For individuals less than 6 years old, genetic testing demonstrates homozygous or compound heterozygous loss-of-function variants in BBS genes; AND V. Individual is NOT receiving two or more medications for weight loss at the same time.

Initial authorization period: 1 year.

Continuation Therapy

Covered when ALL of the following are met for continuation:

Subsequent authorization: I. 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 II. Individual is NOT receiving two or more medications for weight loss at the same time.

Subsequent authorization period: 6 months.

Updated Coverage Criteria Summary

Policy updated coverage elements include:

Age and Indication: FDA approved age expanded to 2 years for POMC/PCSK1/LEPR deficiency and Bardet-Biedl syndromeage >= 2 years

Baseline BMI requirements updated for this age expansion

Diagnosis verification for BBS: Genetic testing required to verify clinical diagnosis for Bardet-Biedl syndrome for those 2 years to less than 6 years oldgenetic test positive

Genetic testing must demonstrate homozygous or compound heterozygous loss-of-function variants in BBS genes for <6 years

Renal and behavioral exclusions: Do not approve in individuals 6 to <12 years old with severe renal impairment; do not approve in those with history of suicide attempts or active suicidal ideation

Safety exclusions per label and document history

Requests for Imcivree (setmelanotide) will be denied when specific exclusion criteria are met. Key non‑approvable situations include: POMC/PCSK1/LEPR variants classified as benign or likely benign (for POMC/PCSK1/LEPR deficiency requests); end‑stage renal disease (eGFR <15 mL/min/1.73 m2); children 2 to <6 years of age with weight <20 kg and severe renal impairment (eGFR 15–29 mL/min/1.73 m2); a history of suicide attempts or active suicidal ideation; and requests that do not meet the policy criteria or are for other indications not covered by this policy.

The policy includes safety‑based age and renal exclusions. Notably, the document history specifies an update adding the restriction that Imcivree may not be approved in individuals 6 to less than 12 years old with severe renal impairment, and reiterates the exclusion for those with a history of suicide attempts or active suicidal ideation. These exclusions align with prior listed non‑approvable conditions such as end‑stage renal disease and age‑/weight‑specific renal impairment thresholds.

The policy text does not include a separate, explicit "not medically necessary" section in the excerpt provided; instead, non‑approvable situations are enumerated under exclusions. Updated items in the document history clarify expanded age indications and added genetic‑testing verification for Bardet‑Biedl syndrome ages 2 to <6, while also restating renal and suicide‑risk exclusions that render requests non‑approvable.

Coding, Diagnosis, and Thresholds

HCPCSHCPCS

J3490	Unclassified biologics/drugs when specified as Imcivree (setmelanotide)
C9399	Unclassified drugs or biologicals (when specified as Imcivree (setmelanotide))

ICD-10 DiagnosisICD-10

E88.82	Obesity due to disruption of MC4R pathway [Proopiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK1), or Leptin receptor (LEPR) deficiency]
Q87.83	Bardet-Biedl syndrome

Documented HCPCS/ICD-10 changesmixed

J3490	Unclassified drug, previously added/removed per coding review
C9399	Miscellaneous drug or biological, previously added per coding review
E88.82	ICD-10-CM code added to document
Q87.83	ICD-10-CM code added to document

Obesity thresholds (by age/group)

AdultsBMI ≥30 kg/m2

Ages 6–17 (POMC/PCSK1/LEPR)Bodyweight >95th percentile for age on growth chart assessment

Ages 6–15 (BBS)Bodyweight >97th percentile for age on growth chart assessment

Ages 2–5Baseline BMI ≥97th percentile for age and sex AND body weight ≥20 kg (trial context noted body weight ≥15 kg in VENTURE)

FDA approved minimum age

Minimum FDA-approved age2 years of age or older

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imcivree (setmelanotide). Initial and subsequent authorization timeframes: initial authorization for POMC/PCSK1/LEPR deficiency = 16 weeks; initial authorization for Bardet-Biedl syndrome (BBS) = 1 year; subsequent authorization (all diagnoses) = 6 months.

Prior authorization required for Imcivree (setmelanotide).
Initial authorization: POMC/PCSK1/LEPR deficiency — 16 weeks.
Initial authorization: BBS — 1 year.
Subsequent authorization period (all diagnoses) — 6 months.

Documentation Required

Required Documentation

Documentation must include patient age and evidence of obesity using the specified baseline measures, and genetic testing results as applicable.

Definitions and Diagnostic Criteria

Bardet-Biedl syndrome (BBS)

DefinitionAutosomal recessive syndrome caused by mutations in multiple BBS genes characterized by obesity and features such as intellectual disability, retinal dystrophy (rod-cone dystrophy), polydactyly, renal anomalies, hypogonadism in males, and other physical abnormalities.

GeneticsAssociated with mutations in at least 15 genes; inheritance is autosomal recessive.

Clinical featuresTypical features include obesity, intellectual disability, retinal/eye abnormalities, dental and renal anomalies, polydactyly, and other multisystem findings.

POMC/PCSK1/LEPR deficiency

DefinitionMonogenic causes of severe, early-onset obesity due to pathogenic, likely pathogenic, or variants of uncertain significance in POMC, PCSK1, or LEPR genes leading to disrupted MC4R pathway signaling and hyperphagia.

Selection for therapy

Background

Imcivree (setmelanotide) is a melanocortin‑4 receptor (MC4R) agonist indicated for chronic weight management in patients with obesity due to select genetic causes. The agent is approved for treatment of obesity resulting from POMC, PCSK1, or LEPR deficiency and for patients with Bardet‑Biedl syndrome (BBS). The policy reflects the FDA‑approved mechanism and indications and notes a recent update expanding the minimum approved age to 2 years for both indications, with corresponding updates to baseline BMI/weight requirements and safety‑based exclusions.

Policy Summary

PayerAnthem

PolicyImcivree (setmelanotide) — Clinical coverage criteria

Policy CodePolicy CC-0188

Change TypeAge expansioncriteria and coding revisions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of age, BMI/percentile, and genetic testing results verifying pathogenic/likely pathogenic/VUS variants or clinical/genetic diagnosis for BBS.

SourceLink

On This Page

Age documentation (Imcivree indicated for patients 2 years and older for POMC/PCSK1/LEPR deficiency and BBS).
Obesity documentation: Adults BMI ≥30 kg/m2; Ages 6–17: bodyweight >95th percentile (POMC/PCSK1/LEPR) or >97th percentile (BBS for 6–15 years); Ages 2–5: BMI ≥97th percentile and body weight ≥20 kg.
Genetic testing results to verify POMC, PCSK1, or LEPR pathogenic/likely pathogenic/VUS variants for POMC/PCSK1/LEPR deficiency.
Added requirement: genetic testing to verify clinical diagnosis of BBS for those aged 2 to <6 years (homozygous or compound heterozygous loss-of-function variants in BBS genes).

Denial Risk

Denial / Non-Approval Triggers

Imcivree may not be approved for specified conditions or findings.

May not approve if POMC, PCSK1, or LEPR variants are classified as benign or likely benign (for POMC/PCSK1/LEPR deficiency requests).
May not approve for individuals with end-stage renal disease (eGFR <15 mL/min/1.73 m2).
May not approve for individuals aged 2 to <6 years with weight <20 kg and severe renal impairment (eGFR 15–29 mL/min/1.73 m2).
May not approve for individuals with a history of suicide attempts or active suicidal ideation.
May not approve when required criteria are not met or for all other unlisted indications.

BBS diagnosis verification via genetic testing for ages 2 to <6

Age-specific genetic requirement (2 to <6 years)For individuals under 6 years, genetic testing must demonstrate homozygous or compound heterozygous loss-of-function variants in BBS genes to verify diagnosis.

Purpose of testingAdded to verify clinical diagnosis for Bardet-Biedl syndrome in ages 2 to less than 6 as part of prior authorization requirements.

DocumentationGenetic test results must be provided with the request to confirm BBS diagnosis in this age group.