ModifiedCignaPolicy CNF654

Metabolic Disorders – Imcivree Prior Authorization Policy - (CNF654)

Defines prior authorization criteria, coverage indications, duration of approval, prescriber requirements, and non-covered uses for Imcivree (setmelanotide) across FDA-approved indications: acquired hypothalamic obesity, Bardet-Biedl syndrome, and POMC/PCSK1/LEPR deficiency. Also lists criteria for continuation of therapy (response thresholds).

Policy Summary

PayerCigna

PolicyMetabolic Disorders – Imcivree Prior Authorization Policy - (CNF654)

Policy CodePolicy CNF654

Change TypeModified (added hypothalamic obesity; age and pediatric criteria updated)

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (genetic testing or clinical criteria) and ensure Imcivree is prescribed by or in consultation with the specified specialists; note time-limited approvals (4 months for initial POMC/PCSK1/LEPR; 1 year for other indications and continuations).

SourceLink

POLICY UPDATE CHANGES

Obesity Due to Acquired Hypothalamic Obesity condition of approval was added to the policy.

Age criteria for POMC/PCSK1/LEPR deficiency and Bardet-Biedl syndrome were updated to ≥ 2 years (previously ≥ 6 years) and pediatric weight percentile criteria added for ages 2–5.

Terminology change: 'mutations' replaced with 'variants' for genetic testing requirement.

Summary of Changes entry notes 'No criteria changes' for an annual revision.

3Covered Indications

≥2 yrsMin age (some indications)

≥5%

Coverage Summary

Overview: Imcivree (setmelanotide) is covered with prior authorization for FDA‑approved indications including Obesity due to Acquired Hypothalamic Obesity, Bardet‑Biedl syndrome, and POMC, PCSK1, or LEPR deficiency. Prior authorization is required and approvals are time‑limited as specified per indication.

Duration and initial approval: For POMC, PCSK1, or LEPR deficiency the policy specifies an initial approval of 4 months (with continuation approvals of 1 year if response criteria are met). For Bardet‑Biedl syndrome and Acquired hypothalamic obesity initial approvals are for 1 year. These durations and the addition of acquired hypothalamic obesity to the policy are reflected in the policy history.

Prescriber requirement and response thresholds: Imcivree must be prescribed by or in consultation with an appropriate specialist (endocrinologist, geneticist when indicated, physician who specializes in metabolic disorders, or neurologist for hypothalamic obesity). Continuation requires documentation of treatment response, defined as ≥ 5% reduction in baseline body weight (or ≥ 5% reduction in baseline BMI for pediatric patients with continued growth potential), with assessment timing per indication.

Key thresholds & quick facts

Adult BMI obesity thresholdBMI ≥ 30 kg/m2

Pediatric weight ≥95th percentileweight ≥ 95th percentile for age (growth chart)

Pediatric weight ≥97th percentileweight ≥ 97th percentile for age (growth chart)

Response - weight loss ≥5%≥ 5% baseline body weight

Minimum age (some indications)≥ 2 yrs

Covered indications3

Medical Necessity Criteria (by indication)

Coding

DrugNDC|HCPCSCovered

Imcivree (setmelanotide)

setmelanotide subcutaneous injection (Rhythm) - covered product; specific NDC/HCPCS not listed in document

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for Imcivree; approvals are time-limited. Initial approvals for POMC, PCSK1, or LEPR deficiency are approved for 4 months; initial approvals for Bardet-Biedl syndrome and acquired hypothalamic obesity are approved for 1 year. Continuation approvals (when criteria met) are generally for 1 year as specified per indication.

POMC/PCSK1/LEPR deficiency — initial approval: 4 months; continuation: 1 year
Bardet-Biedl syndrome — initial and continuation approvals: 1 year
Acquired hypothalamic obesity — initial and continuation approvals: 1 year

Documentation Required

Prescriber specialty requirement

Medication must be prescribed by or in consultation with an endocrinologist, geneticist (when indicated), a physician who specializes in metabolic disorders, or a neurologist (for hypothalamic obesity) as specified per indication.

Background & Evidence

Background: Imcivree is an MC4R (melanocortin‑4 receptor) agonist indicated to reduce excess body weight and maintain weight reduction long term by reducing hunger and food intake and increasing energy expenditure in patients with specific monogenic or syndromic forms of obesity (POMC, PCSK1, or LEPR deficiency and Bardet‑Biedl syndrome) and in patients ≥ 4 years of age with acquired hypothalamic obesity.

Clinical trial definitions and response: Clinical trials supporting these indications used age‑specific definitions of obesity and age‑specific response thresholds. For POMC/PCSK1/LEPR indications, obesity definitions varied by age (for example, ≥ 95th percentile for ages 6 to <18 and BMI ≥ 30 kg/m2 for adults), and for Bardet‑Biedl and acquired hypothalamic obesity trials pediatric and adult BMI/percentile criteria were applied. Efficacy endpoints assessed percent body weight loss or percent BMI change, and patients with < 5% weight loss or < 5% BMI loss were considered non‑responders at the specified trial assessment times.

Pivotal trial evidence

Key references

Revision History

04/01/2026materialLatest

Selected Revision (Review Date = 04/01/2026): Obesity Due to Acquired Hypothalamic Obesity condition of approval was added to the policy.

01/08/2025material/revised

Annual Revision (Review Date = 01/08/2025): Age criteria for POMC/PCSK1/LEPR deficiency and Bardet-Biedl syndrome were updated to ≥ 2 years (previously ≥ 6 years) and pediatric weight percentile criteria added for ages 2–5.

01/08/2025non-material

Policy Summary

PayerCigna

PolicyMetabolic Disorders – Imcivree Prior Authorization Policy - (CNF654)

Policy CodePolicy CNF654

Change TypeModified (added hypothalamic obesity; age and pediatric criteria updated)

Effective Date

Next Review Date

SourceLink

On This Page

Documentation Required

Genetic testing documentation

For POMC, PCSK1, or LEPR deficiency coverage, submit genetic testing demonstrating homozygous or compound heterozygous variants in POMC, PCSK1, or LEPR. The genetic variant must be interpreted as pathogenic, likely pathogenic, or of uncertain significance.

Documentation Required

Clinical diagnosis documentation for Bardet-Biedl syndrome

Document clinical features meeting Beales criteria for Bardet-Biedl syndrome: either at least four primary features OR at least three primary features plus at least two secondary features. Primary and secondary features are listed in the policy criteria.

Primary features include: rod-cone dystrophy, polydactyly, obesity, learning disability, renal anomalies, or male hypogonadism.
Secondary features include: speech disorder/delay; strabismus/cataracts/astigmatism; brachydactyly/syndactyly; developmental delay; polyuria/polydipsia (nephrogenic diabetes insipidus); 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.

Documentation Required

Treatment response monitoring

For continuation of therapy, document a treatment response of at least 5% reduction from baseline in body weight (or ≥5% reduction in BMI for pediatric patients with continued growth potential) after the specified trial periods. Assessments occur after 4 months for initial POMC/PCSK1/LEPR initial therapy (with continuation criteria thereafter) and after 1 year for Bardet-Biedl syndrome and acquired hypothalamic obesity.

Response threshold: ≥ 5% baseline body weight reduction
Pediatric response threshold: ≥ 5% baseline BMI reduction for those with continued growth potential
Timing: assess at 4 months for initial POMC/PCSK1/LEPR; assess at 1 year for Bardet-Biedl and acquired hypothalamic obesity

Denial Risk

Non-covered uses

Claims for Imcivree used for indications other than the specified FDA-approved uses will be considered not medically necessary and denied. This includes other genetic obesity syndromes beyond POMC, PCSK1, LEPR deficiency or Bardet-Biedl syndrome, and general (polygenic) obesity.

Annual Revision (Review Date = 01/08/2025): Terminology change — 'mutations' was replaced with 'variants' for the genetic testing requirement.

01/10/2024non-material

Annual Revision (Review Date = 01/10/2024): Summary of Changes entry notes 'No criteria changes' for an annual revision.