CurrentCignaPolicy N/A

Metabolic Disorders - Imcivree Drug Quantity Management Policy - Per Days

Cigna drug quantity management policy governing maximum dispensed quantities and coverage criteria for Imcivree (setmelanotide subcutaneous injection) vials for retail and home delivery; approvals are for 1 year when criteria met.

Policy Summary

PayerCigna

PolicyMetabolic Disorders - Imcivree Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeQuantity limit revision; home delivery clarification

Effective Date

Next Review Date

Key ActionAll approvals are provided for 1 year in duration.

POLICY UPDATE CHANGES

Quantity limits were changed to 9 mL (9 vials) per 28 days at retail and 27 mL (27 vials) per 84 days at home delivery (prior limits 6 mL/18 mL).

Policy updated to reflect existing quantity limits when a product is obtained via home delivery.

Annual revision with no criteria changes noted on 02/07/2024.

9 mL / 30 daysRetail max quantity

27 mL / 90 daysHome delivery max quantity

1 yearApproval duration

Coverage Summary

Provider Actions & Billing Rules

Documentation Required

Approval duration

All approvals are provided for 1 year in duration.

Billing Rule

Quantity limit enforcement at point of service

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the policy criteria. Quantity limits are enforced at point of service: retail maximum is 9 mL (9 vials) per 30 days and home delivery maximum is 27 mL (27 vials) per 90 days. These limits provide a sufficient quantity for a 3 mg once-daily dose for 30 days (retail) or 90 days (home delivery).

Retail max: 9 mL (9 vials) per 30 days
Home delivery max: 27 mL (27 vials) per 90 days
Enforcement: coverage determined by criteria if quantity rule not met at point of service

Background

Prescribing information: Imcivree subcutaneous injection [prescribing information], Rhythm; December 2024.

Imcivree (setmelanotide) is a melanocortin 4 receptor agonist indicated for chronic weight management in patients ≥ 2 years with monogenic or syndromic obesity due to Proopiomelanocortin (POMC), PCSK1, or leptin receptor (LEPR) deficiency confirmed by genetic testing, or Bardet‑Biedl Syndrome. Imcivree is available as 10 mg/1 mL multi-dose vials.

QD = Once daily.

Revision History

02/05/2025annual_revisionLatest

Annual revision: Quantity limits were changed to 9 mL (9 vials) per 28 days at retail and 27 mL (27 vials) per 84 days at home delivery (previously 6 mL/18 mL). Override criteria were removed; no overrides apply to the updated quantity limits. Other policy language updated to reflect home delivery quantity limits and management.

02/07/2024annual_revision