ModifiedCignaPolicy N/A

Inhalers Drug Quantity Management Policy - Per Rx

Quantity limits and coverage criteria for inhaled corticosteroid (ICS) plus long‑acting beta2‑agonist (LABA) combination inhalers for Cigna-administered health benefit plans; affects prescribers and pharmacists at point of service and plan medical directors making coverage determinations.

Policy Summary

PayerCigna

PolicyInhalers Drug Quantity Management Policy - Per Rx (Pulmonary)

Policy CodePolicy N/A

Change TypeMaterial updates to generics and reliever overrides (adds Dulera overrideAdvair HFA generic addedSymbicort generic changes)

Effective DateN/A

Next Review DateJan 9, 2026

Key ActionWhen requesting an override for reliever use, document reliever therapy and request approval for up to 2 inhalers (retail) or 4 inhalers (home delivery).

SourceLink

POLICY UPDATE CHANGES

Authorized generic to Advair HFA was added to the policy and existing quantity limits for Advair HFA apply to the authorized generic product.

Authorized generic to Symbicort was removed from the policy (obsolete).

Generics to Symbicort (including Breyna) were added and existing quantity limits and overrides for Symbicort apply to the generic products.

A new override was added allowing Dulera 50/5 mcg and 100/5 mcg inhalation aerosol to be dispensed as 2 inhalers per dispensing at retail or 4 inhalers per dispensing at home delivery when used as a reliever therapy for asthma.

Updated criteria to remove the phrase 'the requested quantity, not to exceed.'

1 yearapproval duration

2 retail / 4 homereliever override

2 / 4

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Dulera reliever override

2 / 4Symbicort reliever override

Coverage Criteria for ICS/LABA Combination Inhalers

Drug Quantity Management

Coverage determined by policy criteria when quantity management rule is not met

Drug Quantity Management: This Drug Quantity Management program has been developed to prevent stockpiling, misuse and/or overuse of the corticosteroid/long-acting beta2-agonist combination inhalers.per-Rx quantity limits (details in subsequent sections)

Approvals provided for 1 year.

Reliever (as‑needed) quantity override

Override for reliever use

As-needed ICS/formoterol reliever override: An override to quantity limits is provided for patients using the product 'as needed', providing an extra inhaler (2 inhalers at retail or 4 inhalers at home delivery).max 54 mcg formoterol/day when used as-needed per GINA guidance

Symbicort (budesonide/formoterol) is the studied ICS/formoterol in this setting; other products are not FDA‑approved as relievers.

Budesonide/formoterol reliever override

Exceptions to quantity limits are covered as medically necessary when the following product-specific conditions are met:

Budesonide/formoterol (Symbicort, generic [including Breyna]) reliever override: If the patient has asthma and is using budesonide/formoterol as a reliever therapy, approve 2 inhalers per dispensing at retail or 4 inhalers per dispensing at home delivery.

Reflects GINA recommendation for ICS/formoterol reliever; product not FDA-approved as reliever

Dulera reliever override

Dulera reliever override: If the patient has asthma and is using Dulera as a reliever therapy, approve 2 inhalers per dispensing at retail or 4 inhalers per dispensing at home delivery.

Off-label reliever use allowance added to policy

No overrides for other products

Other corticosteroid/LABA combinations: All other corticosteroid/long-acting beta2-agonist combination inhalers: No overrides recommended.

Standard per-Rx quantity limits apply; exceptions limited to items listed above

Claims must be submitted with the covered diagnosis and/or procedure code(s) required by the applicable benefit plan. Providers must bill using the most appropriate codes as of the date of submission. Claims submitted without the covered diagnosis or procedure code(s) will be denied as not covered.

Exceptions to the quantity limits listed in this policy are explicitly defined in the Criteria section. Any exception not listed in the specified criteria is considered not medically necessary.

Only the product-specific reliever overrides detailed in the Criteria (for example, budesonide/formoterol and Dulera when used as reliever therapy) are considered medically necessary exceptions to quantity limits. Exceptions other than the product-specific reliever overrides are not medically necessary.

Listed Medications, Strengths, and Coding

Listed medications and strengthsmixed

Advair Diskus (fluticasone propionate/salmeterol) strengths 100/50, 250/50, 500/50	Listed with package sizes and retail/home delivery max quantities
Advair HFA (fluticasone propionate/salmeterol) strengths 45/21, 115/21, 230/21	Listed with package sizes and retail/home delivery max quantities; authorized generic included
AirDuo Digihaler / RespiClick (fluticasone/salmeterol) strengths 55/14, 113/14, 232/14	Listed with package sizes and retail/home delivery max quantities
Breo Ellipta (fluticasone furoate/vilanterol) strengths 50/25, 100/25, 200/25	Listed with package sizes and retail/home delivery max quantities
Dulera (mometasone/formoterol) strengths 50/5, 100/5, 200/5	Listed with package sizes and retail/home delivery max quantities; overrides specified for reliever use
Symbicort (budesonide/formoterol) strengths 80/4.5, 160/4.5	Listed with package sizes and retail/home delivery max quantities; overrides specified for reliever use; generics including Breyna included

inv-10: Formoterol maximum dose for as-needed use — 54 mcg of formoterol per day

Formoterol maximum daily dose (as‑needed reliever use)54 mcg of formoterol per day

ContextMaximum applies when ICS/formoterol is used as needed for asthma symptoms per GINA guidance

Applies toICS/formoterol products used as reliever or maintenance-and-reliever regimens (Symbicort noted as the studied product)

Provider Actions, Billing, and Approval Details

Note

Approval duration and quantity rule

This Drug Quantity Management program prevents stockpiling, misuse, and/or overuse of corticosteroid/long-acting beta2-agonist combination inhalers. If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the criteria below. All approvals are provided for 1 year in duration.

Approvals provided for 1 year
Coverage determined when quantity rule not met at point of service

Billing Rule

Drug quantity enforcement

Drug quantity limits are enforced at the point of service. The plan applies per-prescription maximum quantities for retail and home delivery fills (typically 1 inhaler at retail; up to 3 inhalers for home delivery, unless otherwise specified for a specific product). Exceptions to these per-Rx quantity limits are only provided as specified in this policy (for example, the as‑needed reliever override below).

Definitions

inv-20: ICS — Inhaled corticosteroid definition

TermInhaled corticosteroid (ICS)

DefinitionA corticosteroid medication delivered by inhalation to reduce airway inflammation; listed among combination products in Table 1

Example in policyICS component of ICS/LABA combination inhalers (see Table 1 dosing and availability)

inv-21: LABA — Long-acting beta2-agonist definition

TermLong-acting beta2-agonist (LABA)

DefinitionA bronchodilator with prolonged duration of action included in combination inhalers to relax airway smooth muscle

Example in policy

Background

Inhaled corticosteroid/long‑acting beta2‑agonist (ICS/LABA) combination inhalers are used primarily for asthma management; several products in this class are also approved for maintenance treatment of COPD and reduction of COPD exacerbations. This policy implements a Drug Quantity Management program to prevent stockpiling, misuse, and overuse of ICS/LABA inhalers and enforces per‑prescription quantity limits at the point of service. Approvals for requests that meet policy criteria are provided for 1 year.

Per current evidence and guideline guidance (GINA), an ICS/formoterol product may be used as an as‑needed reliever; the policy provides a limited quantity override for reliever use for specific products (see Criteria). When used as reliever therapy, the policy permits additional inhalers (for example, 2 inhalers per dispensing at retail or 4 inhalers per dispensing for home delivery) for budesonide/formoterol products and Dulera, reflecting allowance for maintenance‑and‑reliever or reliever use despite those products not being FDA‑labeled as relievers.

Policy Summary

PayerCigna

PolicyInhalers Drug Quantity Management Policy - Per Rx (Pulmonary)

Policy CodePolicy N/A

Change TypeMaterial updates to generics and reliever overrides (adds Dulera overrideAdvair HFA generic addedSymbicort generic changes)

Effective DateN/A

Next Review DateJan 9, 2026

Key ActionWhen requesting an override for reliever use, document reliever therapy and request approval for up to 2 inhalers (retail) or 4 inhalers (home delivery).

SourceLink

On This Page

Per-Rx quantity limits enforced at point of service
Retail maximum quantity per Rx typically = 1 inhaler
Home delivery maximum quantity per Rx typically = 3 inhalers
Exceptions only as specified in this policy

Prior Authorization

Quantity override for as‑needed reliever use

An override to quantity limits is available for patients using an ICS/formoterol product as an as‑needed reliever. For patients using the product 'as needed', an extra inhaler will be allowed (e.g., 2 inhalers at retail or 4 inhalers at home delivery) to accommodate increased dosing when used as reliever therapy. Documentation supporting reliever (as‑needed) use should be provided when requesting or processing these overrides.

Override provided for ICS/formoterol used as reliever (extra inhaler allowed)
Example: 2 inhalers at retail or 4 inhalers at home delivery for as‑needed use
Documentation should support reliever use when requesting overrides

Billing Rule

Billing and documentation

Providers must bill using the most appropriate codes as of the date of service and supply documentation consistent with the member's benefit plan. Claims submitted without covered diagnosis/procedure codes or lacking required documentation may be denied. Where applicable, include documentation that supports medical necessity and any requested quantity overrides.

Bill using appropriate codes as of the submission date
Supply documentation consistent with the benefit plan
Provide documentation supporting medical necessity and quantity overrides

Denial Risk

Point-of-service quantity rule noncompliance

If the Drug Quantity Management rule is not met at the point of service, the plan will determine coverage in accordance with the policy criteria. Providers should be aware that point-of-service noncompliance with quantity limits places coverage contingent on plan review and may require additional documentation or prior authorization.

Point-of-service quantity rule noncompliance leads to plan coverage determination
Coverage contingent on meeting quantity management rule at point of service
Additional documentation or prior authorization may be required

LABA component of ICS/LABA combination inhalers listed in Table 1

inv-22: DPI — Dry-powder inhaler definition

TermDry-powder inhaler (DPI)

DefinitionAn inhaler device that delivers medication as a dry powder formulation (see Table 1 product listings)

Example in policySeveral ICS/LABA products in Table 1 are listed as DPI formulations

inv-23: pMDI — Pressurized metered-dose inhaler definition

TermPressurized metered‑dose inhaler (pMDI)

DefinitionAn inhaler device that delivers a specific number of metered aerosolized doses per actuation (see Symbicort pMDI in Table 1)

Example in policySymbicort (budesonide/formoterol) is listed in Table 1 as a pMDI formulation

inv-24: Reliever therapy — use of an ICS/formoterol product as as-needed medication to relieve acute asthma symptoms

TermReliever therapy

DefinitionUse of an ICS/formoterol product as an as‑needed medication to relieve acute asthma symptoms

Policy noteGINA recommends ICS/formoterol as preferred initial reliever; Symbicort is the studied product; neither Symbicort nor Dulera are FDA‑approved as relievers

inv-25: Maintenance-and-reliever therapy — regimen where same product used regularly and as needed

TermMaintenance-and-reliever therapy

DefinitionA regimen where the same ICS/formoterol product is used regularly for maintenance and also as needed for symptom relief

Policy noteGINA supports using ICS/formoterol as maintenance-and-reliever when appropriate; maximum as‑needed formoterol dosing remains 54 mcg/day