CurrentCignaPolicy N/A

Corticosteroids (Nebulized) - Budesonide Drug Quantity Management Policy - Pulmicort Respules (budesonide inhalation suspension)

Defines quantity limits, exceptions, and approval criteria for budesonide inhalation suspension (Pulmicort Respules and generics) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyBudesonide inhalation suspension (Pulmicort Respules) drug quantity management

Policy CodePolicy N/A

Change TypeCriteria revisedclarification added

Effective DateN/A

Next Review DateN/A

Key ActionSubmit appropriate diagnosis/procedure codes and documentation to support medical necessity; approvals are generally for 1 year with one-time approvals for 30 days.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for esophageal eosinophilia/eosinophilic esophagitis to remove 'the requested quantity, not to exceed.'

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

0.25/0.5/1 mgavailable respule strengths

120 mLretail max (0.25/0.5)

360 mLhome delivery max (0.25/0.5)

60 mLretail max (1 mg)

1 yr / 30 days

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Coverage Criteria

inv-01: Drug Quantity Limits and Exceptions

Quantity limits apply; exceptions considered medically necessary only when listed criteria are met.

Default quantity limits for 0.25 mg and 0.5 mg respules: For 0.25 mg and 0.5 mg respules: Retail maximum 120 mL (60 respules) per Rx; Home delivery maximum 360 mL (180 respules) per Rx.as stated

No overrides recommended for these strengths.

Default quantity limits for 1 mg respules: For 1 mg respules: Retail maximum 60 mL (30 respules) per Rx; Home delivery maximum 180 mL (90 respules) per Rx.as stated

Exceptions possible as listed below.

Exceptions for 1 mg respules

Esophageal eosinophilia/eosinophilic esophagitis: Patient has esophageal eosinophilia/eosinophilic esophagitis; approve 120 mL (60 respules) per dispensing at retail or 360 mL (180 respules) per dispensing at home delivery.
Prescriber requires ≥11 years of age: Patient is ≥ 11 years of age and the prescriber requires a dose greater than 1 mg per day; approve the requested quantity up to 240 mL (120 respules) per dispensing at retail or 720 mL (360 respules) per dispensing at home delivery.
COPD exacerbation (adult): Patient is ≥ 18 years of age and is experiencing a chronic obstructive pulmonary disease (COPD) exacerbation; approve a one-time override for the requested quantity up to 480 mL (240 respules) at retail or home delivery.
One-time approvals for COPD exacerbation are 30 days in duration.

ref

inv-01

Exceptions to the quantity limits listed in this policy are covered as medically necessary only when the specific criteria in the policy are met. Any exception that does not meet those specified criteria is considered not medically necessary.

Any request for an exception to the stated quantity limits that fails to satisfy the policy’s exception criteria will be considered not medically necessary and will not be approved.

Coding and Dose Information

Coding informationmixed

No codes listed

The document provides no explicit CPT/HCPCS/ICD-10/NDC codes.

Maximum daily budesonide dose (off‑label adult COPD)

Reported maximum daily dose (off-label adult COPD)4–8 mg/day reported

Dose examples for COPD exacerbationNebulized budesonide 1–2 mg every 6 hours commonly used

Higher pediatric/off-label dosingFor patients ≥11 years, doses of 1–2 mg twice daily (max 4 mg/day) have been used

Provider Actions and Billing Guidance

Prior Authorization

Quantity management and approval duration

Coverage is determined by the Drug Quantity Management rules. All standard approvals are provided for 1 year in duration. One-time approvals (e.g., for acute/short-term needs) are provided for 30 days.

Standard approvals: 1 year
One-time approvals: 30 days

Documentation Required

Documentation and coding

Provider must submit appropriate procedure and diagnosis codes and supporting documentation to demonstrate medical necessity. Claims submitted without covered diagnosis or procedure codes referenced in the applicable coverage policy will be denied as not covered. When billing, use the most appropriate codes in effect on the date of service.

Submit supporting clinical documentation with prior authorization requests or claims
Use most appropriate procedure/diagnosis codes as of date of service

Definitions

Respules (single‑dose nebulizer ampules)

DefinitionSingle‑dose nebulizer ampules of budesonide inhalation suspension supplied in sealed aluminum envelopes

Available strengths0.25 mg/2 mL; 0.5 mg/2 mL; 1 mg/2 mL

Brand examplePulmicort Respules (budesonide inhalation suspension) and generics

Background

Budesonide inhalation suspension (Pulmicort Respules and generics) are single‑dose nebulizer ampules used for maintenance treatment of asthma and prophylactic therapy in young children; they are also used off‑label via nebulizer in older children and adults for conditions such as chronic obstructive pulmonary disease exacerbations and eosinophilic esophagitis. Available respule strengths include 0.25 mg/2 mL, 0.5 mg/2 mL, and 1 mg/2 mL; quantity limits and any approved exceptions vary by strength as described in the criteria (for example, no overrides are recommended for 0.25 mg/2 mL and 0.5 mg/2 mL, and specified exception criteria apply for the 1 mg/2 mL strength).