CurrentCignaPolicy N/A

Emgality Drug Quantity Management Policy -Per Days

Defines quantity limits, one-time override rules, and coverage criteria for Emgality (galcanezumab-gnlm) prefilled pens and syringes for Cigna-administered health benefit plans. Applies to retail and home delivery dispensing and manages potential dose escalation.

Policy Summary

PayerCigna

PolicyEmgality Drug Quantity Management Policy -Per Days

Policy CodePolicy N/A

Change TypeAnnual revisions (no material criteria changes)

Effective Date

Next Review Date

Key ActionIf the Drug Quantity Management rule is not met at point of service, coverage will be determined by the policy criteria; providers may request a one-time override where allowed (30-day duration).

POLICY UPDATE CHANGES

Policy statement updated to note that 'one-time' approvals are provided for 30 days in duration.

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

Annual revisions with no criteria changes recorded on 03/27/2024 and 03/06/2025.

3 mLMax retail per 30 days (100 mg/mL)

9 mLMax home delivery per 90 days (100 mg/mL)

1 mLMax retail per 30 days (120 mg/mL)

3 mLMax home delivery per 90 days (120 mg/mL)

Coverage Summary & Policy Statement

General Policy Statement

Calcitonin Gene-Related Peptide Inhibitors - Emgality Drug Quantity Management Policy - Per Days product(s) is(are) covered as medically necessary when the following criteria is(are) met. Any other exception is considered not medically necessary.

Drug Quantity Limits applied as specified for strength/form and dispensing channel
See specified retail and home delivery maximums by strength and form
Point-of-service enforcement: If Drug Quantity Management rule is not met at point of service, coverage determined by criteria below
Coverage determined per policy criteria and benefit plan
One-time override duration: 'One-time' overrides are provided for 30 days in duration30 days
One-time approvals granted for temporary exception (30-day)

Drug Quantity Limits - specifics: Emgality 100 mg/mL prefilled syringes: Retail max per 30 days = 3 mL (3 syringes); Home delivery max per 90 days = 9 mL (9 syringes). Emgality 120 mg/mL prefilled syringes and pens: Retail max per 30 days = 1 mL (1 syringe or 1 pen); Home delivery max per 90 days = 3 mL (3 syringes or 3 pens)See policy thresholds

Specified by strength/form and channel

Applies to Emgality (galcanezumab-gnlm) single-dose prefilled pens and prefilled syringes for Cigna-administered health benefit plans, covering both retail and home delivery dispensing channels and designed to manage potential dose escalation. Policy includes rules for quantity limits, specifies one-time overrides (temporary exceptions) and notes that one-time approvals are provided for 30 days. Prescribing information is cited as the evidence source for indications and dosing.

Initial Therapy Criteria (one-time overrides)

Emgality 120 mg/mL prefilled pens and syringes - Initiation (preventative treatment of migraine)

When patient is initiating therapy for preventative treatment of migraine:

"text":"Approve a one-time override for two pens or syringes (2 mL) at retail","threshold":"2 mL (2 pens or syringes)","note":"One-time approval for initiation of migraine preventive therapy; duration 30 days","children":[]}

Emgality 100 mg/mL prefilled syringes

No overrides recommended.

No one-time override recommended (100 mg/mL): No one-time override recommended for 100 mg/mL prefilled syringes

Overrides are not recommended for the 100 mg/mL strength/form

Quantity Limits & Thresholds

Quantity limits vary by strength/form and dispensing channel. For 100 mg/mL prefilled syringes, the retail maximum per 30 days is 3 mL (3 syringes) and the home delivery maximum per 90 days is 9 mL (9 syringes). For 120 mg/mL prefilled syringes, the retail maximum per 30 days is 1 mL (1 syringe) and the home delivery maximum per 90 days is 3 mL (3 syringes). For 120 mg/mL prefilled pens, the retail maximum per 30 days is 1 mL (1 pen) and the home delivery maximum per 90 days is 3 mL (3 pens). Initiation for migraine prevention allows a one-time override of 2 mL at retail or 4 mL via home delivery for 120 mg/mL pens or syringes.

Provider Actions & Billing Guidance

Prior Authorization

Drug Quantity Management rule enforcement

If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the policy criteria; providers may request a one-time override where allowed. One-time overrides are temporary approvals provided for a 30-day duration.

Documentation Required

Initiation justification for one-time override

When requesting a one-time override for initiation with 120 mg/mL pens or syringes, document that the patient is initiating therapy for the preventative treatment of migraine.

Applicable Product Codes

Drug product codes (descriptive – no specific NDCs provided)mixed

Emgality 100 mg/mL prefilled syringes	Strength and form referenced; max quantity per 30 days = 3 mL (3 syringes); home delivery max per 90 days = 9 mL (9 syringes)
Emgality 120 mg/mL prefilled syringes	Strength and form referenced; retail max per 30 days = 1 syringe (1 mL); home delivery max per 90 days = 3 syringes (3 mL)
Emgality 120 mg/mL prefilled pens	Strength and form referenced; retail max per 30 days = 1 pen (1 mL); home delivery max per 90 days = 3 pens (3 mL)

Background & Clinical Evidence

Emgality (galcanezumab-gnlm) is indicated for episodic cluster headache treatment in adults and for migraine prevention in adults. Dosing differs by indication: for migraine prevention a 240 mg loading dose (two consecutive 120 mg SC injections) is given followed by 120 mg SC once monthly maintenance; for episodic cluster headache an initial 300 mg dose (three consecutive 100 mg SC injections) is given at the onset of the cluster period, then monthly thereafter until the end of the cluster period. Emgality is available as 120 mg/mL prefilled pens and syringes and 100 mg/mL prefilled syringes.

Prescribing information: Emgality subcutaneous injection; Eli Lilly; May 2022.

Definitions

One-time override: A temporary approved exception to the Drug Quantity Management rule provided for 30 days.

Retail: Dispensing channel with specified maximum quantity limits expressed per 30 days (retail maximums vary by strength/form).

Home delivery: Dispensing channel with specified maximum quantity limits expressed per 90 days (home delivery maximums vary by strength/form).

Policy Revision History

03/23/2023annual_revision

Annual revision recorded with no changes to coverage criteria; policy updated to reflect existing quantity limits when product is obtained via home delivery.

03/27/2024annual_revision

Annual revision recorded with no changes to coverage criteria; policy statement updated to note that 'one-time' approvals are provided for 30 days in duration.

03/06/2025annual_revisionLatest

Annual revision recorded with no changes to coverage criteria; most recent review date.