CurrentCignaPolicy N/A

Metabolic Disorders - Imcivree Drug Quantity Management Policy

Defines drug quantity limits and coverage criteria for Imcivree (setmelanotide) vials for Cigna-administered health benefit plans; affects providers prescribing and pharmacies dispensing Imcivree. Applies to the Cigna policy for metabolic disorders.

Policy Summary

PayerCigna

PolicyMetabolic Disorders - Imcivree Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeRevised limitsoverrides removed

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests that adhere to quantity limits (retail: 9 mL/9 vials per 30 days; home delivery: 27 mL/27 vials per 90 days) and required documentation to obtain approval.

SourceLink

POLICY UPDATE CHANGES

Quantity limits for Imcivree 10 mg/1 mL vials were changed to 9 mL (9 vials) per 28 days at retail and 27 mL (27 vials) per 84 days for home delivery.

Override criteria were removed from the policy.

Home delivery quantity limits were explicitly reflected in the policy.

9 mLRetail maximum quantity per 30 days

27 mLHome delivery maximum per 90 days

1 yrApproval duration

10 mg/1 mL

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No overridesOverride policy

Coverage Criteria — Drug Quantity Management

Drug Quantity Management - Coverage Criteria

Imcivree (setmelanotide) is covered as medically necessary when the Drug Quantity Management rule and specified quantity limits are met; any other exception is considered not medically necessary.

Quantity and program compliance: Requested medication quantity must be within the stated Drug Quantity Limits (retail: 9 mL/9 vials per 30 days; home delivery: 27 mL/27 vials per 90 days) and conform to the Drug Quantity Management rule at point of servicesee thresholds

Approvals provided for 1 year

Delivery route-specific limits

Retail dispensing: Requested quantity for retail dispensing does not exceed 9 mL (9 vials) per 30 days
Home delivery: Requested quantity for home delivery does not exceed 27 mL (27 vials) per 90 days

Overrides: No overrides recommended

Requests for Imcivree (setmelanotide) that exceed the stated Drug Quantity Limits are not covered. Specifically, prescriptions that request more than 9 mL (9 vials) per 30 days for retail dispensing or more than 27 mL (27 vials) per 90 days for home delivery are considered not medically necessary.

Any exception outside the specified quantity limits or that does not meet the Drug Quantity Management rule at the point of service is considered not medically necessary. The policy states that Imcivree is covered as medically necessary only when the Drug Quantity Management rule and the specified quantity limits are met; all other exceptions are not medically necessary.

Drug Strength, NDC, and Quantity Limits

NDC/Drug strength (as stated)NDC

10 mg/1 mL

Imcivree vial strength and form

Retail quantity limit (30 days)

Retail maximum quantity9 mL (9 vials) per 30 days

Applicable form and strength10 mg/1 mL multi-dose vials

Coverage implicationRequests exceeding this retail limit are considered not medically necessary

Home delivery quantity limit (90 days)

Home delivery maximum quantity27 mL (27 vials) per 90 days

Applicable form and strength10 mg/1 mL multi-dose vials

Coverage implication

Provider Actions and Prior Authorization

Prior Authorization

Drug quantity prior authorization

Prior authorization decisions apply the Drug Quantity Limits below. All approvals are provided for a 1-year duration. If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria in the policy and the request may be denied.

Approvals: 1 year

Step Therapy

Step therapy / overrides

No step therapy or overrides are recommended for this policy. Requests should follow the documented quantity limits and management rules; requests attempting to bypass quantity limits via step-therapy overrides will not be supported.

Documentation Required

Indications and Dosing Definitions

Indications for Imcivree

Indications - POMC deficiencyChronic weight management in patients ≥2 years with Proopiomelanocortin (POMC) deficiency confirmed by genetic testing

Indications - PCSK1 deficiencyChronic weight management in patients ≥2 years with proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency confirmed by genetic testing

Indications - LEPR deficiencyChronic weight management in patients ≥2 years with leptin receptor (LEPR) deficiency confirmed by genetic testing

Indications - Bardet-Biedl SyndromeChronic weight management in patients ≥2 years with Bardet-Biedl Syndrome

Dosing by age

Patients ≥12 years - starting/titrationStart 2 mg (0.2 mL) SC QD for 2 weeks; if not tolerated reduce to 1 mg (0.1 mL) QD, then retitrate; escalate to 3 mg (0.3 mL) QD as tolerated

Background — Drug Overview

Imcivree (setmelanotide) is a melanocortin 4 receptor agonist supplied as 10 mg/1 mL multi-dose vials. It is indicated for chronic weight management in patients aged ≥2 years with certain monogenic or syndromic causes of obesity (for example, POMC, PCSK1, or LEPR deficiency, or Bardet‑Biedl syndrome) with dosing that varies by age and weight. This policy implements a Drug Quantity Management program to manage potential dose escalation; coverage decisions require adherence to the program and its quantity limits, and approvals are issued for 1 year when criteria are met.

Policy Revision History

Policy Summary

PayerCigna

PolicyMetabolic Disorders - Imcivree Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeRevised limitsoverrides removed

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Requests exceeding this home delivery limit are considered not medically necessary

Required documentation for quantity limits

Prescriptions must specify Imcivree (setmelanotide) 10 mg/1 mL vial strength. Requested quantities must not exceed the retail or home delivery maximums: retail maximum = 9 mL (9 vials) per 30 days; home delivery maximum = 27 mL (27 vials) per 90 days. Ensure documentation includes the vial strength and dosing schedule to match the requested quantity.

Required vial strength: 10 mg / 1 mL
Retail maximum: 9 mL (9 vials) per 30 days
Home delivery maximum: 27 mL (27 vials) per 90 days
Prescriptions and supporting documentation must align with vial strength and requested quantity

Denial Risk

PROVIDER ACTIONS — Requests exceeding Drug Quantity Limits

Requests that exceed the Drug Quantity Limits or that do not meet the Drug Quantity Management rule may be denied. Provide clear prescribing documentation (vial strength, days supply, dosing frequency) to support any request near the quantity limits. If denied, follow the plan's coverage determination and appeal processes as applicable.

Requests exceeding retail/home delivery maximums may be denied
Include vial strength, dosing schedule, and justification in documentation to reduce denial risk
Follow payer coverage determination and appeal procedures when a request is denied

Patients 6 to <12 years - starting/titrationStart 1 mg (0.1 mL) SC QD for 2 weeks; if not tolerated reduce to 0.5 mg (0.05 mL) QD, then retitrate up to 2–3 mg QD as tolerated; maintenance 3 mg (0.3 mL) QD

Patients 2 to <6 years - starting/titrationStart 0.5 mg (0.05 mL) SC QD for 2 weeks; if not tolerated discontinue; if tolerated increase per weight-based maintenance table

Maintenance dosing (youngest group)Use weight‑based maintenance dosing per Table 1 for patients 2 to <6 years (examples: 15–<20 kg = 0.5 mg QD; 20–<30 kg escalate to 1 mg QD from week 3 onward; up to 2 mg QD for ≥40 kg over time)