CurrentCignaPolicy IP0104

Imcivree

Defines medical necessity, documentation, and coverage criteria for Imcivree (setmelanotide) for Cigna-administered plans, including indications, approval durations, dosing limits, and exclusions for genetic and syndromic obesity.

Policy Summary

PayerCigna

PolicyImcivree

Policy CodePolicy IP0104

Change TypeRevised genetic and pediatric weight criteriadocumentation added

Effective DateApr 15, 2025

Next Review Date

Key ActionObtain prior authorization with required documentation including genetic test reports and growth chart or BMI documentation for the indicated diagnosis.

SourceLink

POLICY UPDATE CHANGES

Updated the genetic testing requirement by changing biallelic variants to homozygous or compound heterozygous pathogenic variants.

Changed age 6-17 BMI requirement to a body weight requirement (≥ 95th percentile) for POMC/PCSK1/LEPR indication.

Removed age requirements from the continuation of therapy weight loss requirement for adults in POMC/PCSK1/LEPR indication.

Updated Bardet-Biedl syndrome pediatric criterion from BMI to body weight ≥ 97th percentile and removed an adult age requirement from continuation criteria.

Added a Documentation paragraph preceding medical necessity criteria and added documentation requirements throughout criteria.

Added clinical trial outcome information and examples to 'Other Genetic Obesity Syndromes' in Conditions Not Covered.

≥2min age eligible

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Coverage Criteria for Imcivree (setmelanotide)

Initial Therapy — POMC/PCSK1/LEPR

Covered when ALL of the following are met

Initial POMC/PCSK1/LEPR: Patient is ≥ 2 years of age; AND genetic testing demonstrates homozygous or compound heterozygous variants in POMC, PCSK1, or LEPR interpreted as pathogenic, likely pathogenic, or of uncertain significance; AND patient meets one of the following age/weight/BMI criteria: (a) Patient is ≥ 18 years: BMI ≥ 30 kg/m2; OR (b) Patient is 6–17 years: body weight ≥ 95th percentile for age on growth chart assessment; OR (c) Patient is 2–5 years: body weight ≥ 97th percentile for age on growth chart assessment; AND the medication is prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders.approve for 4 months

Dosing up to 3 mg subcutaneously once daily

Continuation Therapy — POMC/PCSK1/LEPR

Covered when ALL of the following are met

Continuation POMC/PCSK1/LEPR: Patient is ≥ 2 years of age; AND genetic testing demonstrates homozygous or compound heterozygous variants in POMC, PCSK1, or LEPR interpreted as pathogenic, likely pathogenic, or of uncertain significance; AND patient has either lost ≥ 5% of baseline body weight since initiating Imcivree OR, if the patient has continued growth potential, lost ≥ 5% of baseline BMI since initiating Imcivree; AND the medication is prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders.approve for 1 year

For patients who have not completed at least 4 months of therapy, refer to Initial Therapy; dosing up to 3 mg subcutaneously once daily

Initial Therapy — Bardet-Biedl Syndrome

Covered when ALL of the following are met

Initial Bardet-Biedl: Patient is ≥ 2 years of age; AND clinical diagnosis of Bardet-Biedl syndrome defined as either: (A) documentation of at least FOUR primary features (rod-cone dystrophy, polydactyly, obesity, learning disability, renal anomalies, or male hypogonadism); OR (B) documentation of at least THREE primary features plus at least TWO secondary features (speech disorder/delay; strabismus/cataracts/astigmatism; brachydactyly/syndactyly; developmental delay; polyuria/polydipsia; ataxia/poor coordination/imbalance; mild spasticity; diabetes mellitus; dental crowding/hypodontia/small roots/high arched palate; left ventricular hypertrophy/congenital heart disease; or hepatic fibrosis); AND patient meets one of the following age/weight criteria: (a) Patient is ≥ 18 years: BMI ≥ 30 kg/m2; OR (b) Patient is < 18 years: body weight ≥ 97th percentile for age on growth chart assessment; AND the medication is prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders.approve for 1 year

Dosing up to 3 mg subcutaneously once daily

Continuation Therapy — Bardet-Biedl Syndrome

Covered when ALL of the following are met

Continuation Bardet-Biedl: Patient is ≥ 2 years of age; AND evidence of response defined as either: (a) documentation of ≥ 5% loss of baseline body weight since initiating Imcivree; OR (b) patient is < 18 years of age and documentation of ≥ 5% loss of baseline BMI since initiating Imcivree; AND the medication is prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders.approve for 1 year

For patients who have not completed at least 1 year of therapy, refer to Initial Therapy; dosing up to 3 mg subcutaneously once daily

Imcivree is not indicated for genetic obesity syndromes other than POMC-, PCSK1-, or LEPR-deficient obesity or Bardet‑Biedl syndrome. Use in other syndromic disorders (for example, Prader‑Willi or Alström syndromes) is considered experimental, investigational, or unproven; the policy notes a Phase III trial in six patients with Alström syndrome in which none met the primary endpoint (≥ 10% weight loss at 52 weeks).

Any use of Imcivree outside the specified indications—namely POMC-, PCSK1-, or LEPR-deficient obesity or Bardet‑Biedl syndrome—is considered not medically necessary/experimental/unproven and may be denied.

Coding, Age/Weight Thresholds, and Response Requirements

Covered codes (not specified)mixed

NDC or CPT not specified

No explicit procedure, diagnosis, or NDC codes listed in the policy document.

Age and weight/BMI thresholds

Minimum eligible agePatient ≥ 2 years of age

Adult threshold (≥18 years)Body mass index (BMI) ≥ 30 kg/m2

Children 6–17 yearsBody weight ≥ 95th percentile for age on growth chart assessment

Children 2–5 yearsBody weight ≥ 97th percentile for age on growth chart assessment

Pediatric Bardet-BiedlPatients <18 years: body weight ≥ 97th percentile for age on growth chart assessment

Response threshold for continuation

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required. Requests must include documentation demonstrating the member meets medical necessity criteria, including genetic test reports and growth/BMI documentation as specified in the criteria.

PA required with supporting documentation (genetic test reports, growth charts/BMI documentation, weight change records)
Prescriptions must be by or in consultation with an endocrinologist, geneticist, or metabolic specialist

Step Therapy

Prescriber / Step Therapy Requirement

There is no formal step therapy requiring trial of other agents prior to Imcivree. However, the prescriber must be an endocrinologist, geneticist, or physician who specializes in metabolic disorders, or the request must document consultation with one of these specialists.

No step-therapy trials required
Specialty prescriber or documented consultation required (endocrinologist, geneticist, or metabolic disorder specialist)

Background on Imcivree (setmelanotide)

Imcivree (setmelanotide) is a melanocortin‑4 receptor (MC4R) agonist indicated to reduce excess body weight in patients aged ≥ 2 years with genetic obesity due to POMC, PCSK1, or LEPR deficiency or with Bardet‑Biedl syndrome. Monogenic obesity and syndromic forms like Bardet‑Biedl typically present with early‑onset severe obesity and hyperphagia; clinical trials assessed response by percent change in body weight or BMI, and the policy uses these same thresholds to define continuation criteria (response defined as ≥ 5% loss of baseline body weight or, if growth potential remains, ≥ 5% BMI reduction). The 2024 revision clarified genetic testing requirements (homozygous or compound heterozygous variants) and updated pediatric criteria to use weight percentiles for younger patients.

Definitions and Genetic Diagnostic Criteria

Bardet-Biedl syndrome (clinical diagnostic criteria)

Diagnostic rule (Beales criteria)Clinical diagnosis requires either at least FOUR primary features OR THREE primary features plus TWO secondary features

Primary features (examples)Rod–cone dystrophy, polydactyly, obesity, learning disability, renal anomalies, male hypogonadism

Secondary features (examples)Speech disorder/delay; strabismus/cataracts/astigmatism; brachydactyly/syndactyly; developmental delay; polyuria/polydipsia; ataxia/poor coordination; mild spasticity; diabetes; dental anomalies; cardiac manifestations; hepatic fibrosis

POMC/PCSK1/LEPR genetic criteria

Required genetic findingDocumentation of homozygous or compound heterozygous variants in POMC, PCSK1, or LEPR interpreted as pathogenic, likely pathogenic, or of uncertain significance

Interpretation guidance

Policy Summary

PayerCigna

PolicyImcivree

Policy CodePolicy IP0104

Change TypeRevised genetic and pediatric weight criteriadocumentation added

Effective DateApr 15, 2025

Next Review Date

Key ActionObtain prior authorization with required documentation including genetic test reports and growth chart or BMI documentation for the indicated diagnosis.

SourceLink

On This Page

Documentation Required

Required Documentation

Documentation is required where noted in the medical necessity criteria. Acceptable documentation includes chart notes, laboratory test results, genetic test reports, growth charts, BMI calculations, claims records, prescription receipts, and other relevant medical records. Documentation must specifically support the genetic diagnosis, age, baseline and follow-up weight/BMI, and response to therapy where applicable.

Acceptable documentation: chart notes, labs, genetic test reports, growth charts, BMI documentation, claims, prescription receipts
Documentation must show age, genetic test findings (gene, zygosity, and variant interpretation), baseline weight/BMI percentile, and percent weight or BMI change on therapy when required

Documentation Required

Documentation for Indications

For FDA‑approved indications, providers must supply genetic testing reports demonstrating homozygous or compound heterozygous variants in POMC, PCSK1, or LEPR with variant interpretation (pathogenic, likely pathogenic, or VUS) when applicable, and current growth/BMI documentation as specified by age group (BMI ≥30 kg/m2 for adults; ≥95th percentile weight for ages 6–17; ≥97th percentile weight for ages 2–5). For continuation requests, provide documentation of baseline weight/BMI and documentation of ≥5% weight loss (or ≥5% BMI reduction for children with continued growth potential) since initiating therapy.

Initial therapy: genetic test report with gene and variant interpretation, plus current BMI or growth-chart percentile per age criteria
Continuation therapy: genetic test report (if not previously provided), baseline weight/BMI and documentation of ≥5% weight loss or ≥5% BMI reduction (as applicable)

Denial Risk

Excluded Indications

Use of Imcivree for genetic obesity syndromes other than POMC-, PCSK1-, or LEPR-deficient obesity and Bardet‑Biedl syndrome is considered experimental, investigational, or unproven and is not covered. General (polygenic) obesity is also not an indicated or covered use.

Not covered for other genetic obesity syndromes (e.g., Prader‑Willi syndrome, Alström syndrome) or for general/polygenic obesity