CurrentCignaPolicy N/A

Nucala (mepolizumab) Drug Quantity Management Policy - Per Days

Defines per-days drug quantity limits and medical-necessity exception criteria for Nucala (mepolizumab) for Cigna-administered health benefit plans, including retail and home delivery dispensing limits and when higher quantities are allowed.

Policy Summary

PayerCigna

PolicyNucala (mepolizumab) Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 7, 2025

Key ActionSubmit prior authorization when requested quantity exceeds retail or home delivery limits and document medical necessity per listed exception criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 mL/28dRetail max (100 mg)

3 mL/84dHome delivery max (100 mg)

0.4 mL/28dRetail max (40 mg)

1 yrAuth duration

3 mL/28dEGPA/HES exception

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Quantity limits and exceptions

Drug quantity limits apply per formulation; exceptions are covered as medically necessary only when criteria are met.

Retail limits for 100 mg formulations: For 100 mg/1 mL autoinjector, prefilled syringe, and vial: retail maximum quantity per 28 days = 1 mL (1 device/vial)1 mL per 28 days

See home delivery limits for 84-day supply

Home delivery limits for 100 mg formulations: For 100 mg/1 mL autoinjector, prefilled syringe, and vial: home delivery maximum quantity per 84 days = 3 mL (3 devices/vials)3 mL per 84 days

Approvals provided for 1 year

Retail/home limits for 40 mg syringe: For 40 mg/0.4 mL prefilled syringe: retail maximum per 28 days = 0.4 mL (1 syringe); home delivery maximum per 84 days = 1.2 mL (3 syringes)0.4 mL per 28 days; 1.2 mL per 84 days

No overrides recommended for 40 mg formulation

Exceptions for EGPA or HES: If patient is requesting Nucala for eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES), approve 3 mL per 28 days at retail or 9 mL per 84 days at home delivery3 mL per 28 days; 9 mL per 84 days

Exception allowed only for these indications; any other exception is not medically necessary

Exceptions to the quantity limits for Nucala are only allowed when the specific medical necessity criteria are met for eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES). Any other exception to the listed quantity limits is considered not medically necessary.

Per policy, requests for quantities above the stated retail or home delivery maximums that do not meet the EGPA or HES exception criteria will be considered not medically necessary. Only exceptions meeting the criteria for EGPA or HES — as described in the criteria section — are eligible for approval.

Coding and Dispensing Thresholds

Coding guidancemixed

No codes listed

Retail/Home delivery quantity thresholds

Retail threshold (per 28 days)Retail limits apply per 28 days for each formulation (e.g., 100 mg/1 mL = 1 mL per 28 days; 40 mg/0.4 mL = 0.4 mL per 28 days)

Home delivery threshold (per 84 days)Home delivery limits apply per 84 days for each formulation (e.g., 100 mg/1 mL = 3 mL per 84 days; 40 mg/0.4 mL = 1.2 mL per 84 days)

Exception ruleExceptions to these quantity limits are covered as medically necessary only when specified criteria (EGPA or HES) are met; any other exception is not medically necessary.

Provider Actions and Billing Impact

Prior Authorization

Quantity limit prior authorization

Retail and home-delivery quantity limits are enforced. Exceptions to these limits are considered medically necessary only when the listed clinical criteria are met; other exception requests are not medically necessary.

Retail maximums per 28 days: 100 mg (1 mL) autoinjector, 100 mg (1 mL) prefilled syringe, 100 mg (1 mL) vial; 40 mg (0.4 mL) prefilled syringe = 0.4 mL (1 syringe).
Home delivery maximums per 84 days: 100 mg formulations = 3 mL (3 units) or 9 mL (9 units) when exception criteria met; 40 mg (0.4 mL) prefilled syringe = 1.2 mL (3 syringes).

Denial Risk

Coding / claims risk

Claims submitted without covered diagnosis or procedure codes that meet the policy criteria may be denied as not covered. Providers must bill using the most appropriate and supported codes for the date of service.

Step Therapy

Step / override notes

No overrides are recommended for Nucala 40 mg/0.4 mL prefilled syringes. For 100 mg formulations (autoinjectors, 100 mg prefilled syringes, or vials), approvals may be provided for increased quantities when the patient is being treated for eosinophilic granulomatosis with polyangiitis or hypereosinophilic syndrome (see criteria).

40 mg/0.4 mL prefilled syringes: no overrides recommended.
100 mg formulations: if treating eosinophilic granulomatosis with polyangiitis or hypereosinophilic syndrome, approve up to 3 mL per 28 days (retail) or 9 mL per 84 days (home delivery).

Note

Approval duration

All prior authorizations and approvals under this program are valid for 1 year from the date of approval.

Background

Nucala (mepolizumab) is an interleukin‑5 (IL‑5) antagonist monoclonal antibody used as add‑on maintenance therapy for eosinophilic asthma in patients aged ≥6 years. It is also indicated for chronic obstructive pulmonary disease with an eosinophilic phenotype (adults), chronic rhinosinusitis with nasal polyps (adults), eosinophilic granulomatosis with polyangiitis (EGPA) in adults, and hypereosinophilic syndrome (HES) in patients aged ≥12 years with disease duration ≥6 months. Dosing varies by indication and age, commonly 100 mg subcutaneous every 4 weeks for most adult indications and higher 300 mg Q4W (administered as three separate 100 mg injections) for EGPA and HES.

Initial Therapy Criteria

Dosing by indication

FDA dosing by indication

Asthma dosing: Patients ≥12 years: 100 mg SC Q4W; Patients 6–11 years: 40 mg SC Q4W.

COPD and CRSwNP dosing: Adults: 100 mg SC Q4W for COPD; 100 mg SC Q4W for chronic rhinosinusitis with nasal polyps.

EGPA and HES dosing: EGPA in adults: 300 mg SC Q4W (administered as three separate 100 mg SC injections); HES in patients ≥12 years: 300 mg SC Q4W (administered as three separate 100 mg SC injections).

Step Therapy / Overrides

Formulation	Step / Override guidance
Nucala 40 mg/0.4 mL prefilled syringe	No overrides recommended.
Nucala 100 mg/1 mL autoinjector, 100 mg/1 mL prefilled syringe, 100 mg vial	If used for eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES), approve 3 mL (three devices/vials) per 28 days at retail or 9 mL (nine devices/vials) per 84 days at home delivery; otherwise standard limits apply (no routine overrides).

Quantity Limits (Retail and Home Delivery)

Nucala 100 mg/1 mL (autoinjector, prefilled syringe, vial) — retail maximum quantity

Retail maximum (per 28 days)1 mL (1 prefilled autoinjector) per 28 days

Also applies to prefilled syringe1 mL (1 prefilled syringe) per 28 days

Also applies to vial1 mL (1 vial) per 28 days

Nucala 100 mg/1 mL (autoinjector, prefilled syringe, vial) - home delivery — home delivery maximum quantity

Home delivery maximum (per 84 days)3 mL (3 devices: autoinjectors, prefilled syringes, or vials) per 84 days

Exception for EGPA/HES (retail/home)For EGPA or HES approve 9 mL per 84 days at home delivery (9 devices) when criteria met

Applies to autoinjector, syringe, vialLimit applies across 100 mg/1 mL autoinjector, prefilled syringe, and vial formulations

Nucala 40 mg/0.4 mL prefilled syringe — retail maximum quantity

Retail maximum (per 28 days)0.4 mL (1 prefilled syringe) per 28 days

No overrides recommendedNo overrides are recommended for the 40 mg/0.4 mL prefilled syringe formulation

Related home delivery limitHome delivery limit is 1.2 mL per 84 days (3 syringes)

Nucala 40 mg/0.4 mL prefilled syringe - home delivery — home delivery maximum quantity

Home delivery maximum (per 84 days)1.2 mL (3 prefilled syringes) per 84 days

Equivalent retail mathCorresponds to 0.4 mL per 28 days if dispensed monthly

No overrides recommendedNo overrides are recommended for this formulation; exceptions for EGPA/HES apply to 100 mg formulations only