CurrentCignaPolicy N/A

Drug Quantity Management Policy — Budesonide (Pulmicort Respules) — Per Rx

Defines per-prescription quantity limits and authorization criteria for budesonide inhalation suspension (Pulmicort Respules and generics) for Cigna-administered health benefit plans. Affects prescribers, pharmacists, and utilization reviewers processing retail and home-delivery dispensing.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Budesonide (Pulmicort Respules) — Per Rx

Policy CodePolicy N/A

Change TypeMaterial revisions: approval duration shortenedadded/confirmed home delivery limitscriteria wording updates

Effective DateN/A

Next Review DateFeb 10, 2025

Key ActionEnsure requested per‑Rx quantity does not exceed the listed retail or home‑delivery limits or document an allowed exception to obtain approval.

SourceLink

POLICY UPDATE CHANGES

Approval duration was changed from 3 years to 1 year; one-time approvals are provided for 30 days.

Quantity limits when product is obtained via home delivery were added/confirmed (higher maximums for home delivery vs retail).

Criteria for 1 mg/2 mL respules for eosinophilic esophagitis updated to remove the phrase 'the requested quantity, not to exceed.'

0.25/0.5/1 mgavailable respule strengths

Retail: 60 / 30max per Rx (retail)

Home: 180 / 90max per Rx (home delivery)

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Budesonide (Pulmicort Respules) — Per Rx

Policy CodePolicy N/A

Change TypeMaterial revisions: approval duration shortenedadded/confirmed home delivery limitscriteria wording updates

Effective DateN/A

Next Review DateFeb 10, 2025

Key ActionEnsure requested per‑Rx quantity does not exceed the listed retail or home‑delivery limits or document an allowed exception to obtain approval.

SourceLink

On This Page

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authorization duration

Coverage and Exception Criteria

Quantity Limits and Exception Criteria

Covered when the per-Rx quantity limit for the requested strength and dispensing channel is not exceeded, or when specific exception criteria below are met.

Standard quantity limits by strength and dispensing method: For Pulmicort Respules (budesonide inhalation suspension) 0.25 mg/2 mL and 0.5 mg/2 mL: Retail maximum per Rx = 120 mL (60 respules); Home delivery maximum per Rx = 360 mL (180 respules). For Pulmicort Respules 1 mg/2 mL: Retail maximum per Rx = 60 mL (30 respules); Home delivery maximum per Rx = 180 mL (90 respules).see values

Default per‑Rx quantity limits; any other exception is considered not medically necessary.

Exception - esophageal eosinophilia / eosinophilic esophagitis (1 mg/2 mL): If the 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.not specified

Applies only to 1 mg/2 mL respules.

Exception - pediatric/adolescent higher dosing (1 mg/2 mL): If the patient is ≥ 11 years of age and the prescriber documents the patient requires a dose > 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.>=11 years

Prescriber justification required for dosing >1 mg/day.

Exception - COPD exacerbation (1 mg/2 mL): If the 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.>=18 years

One-time override; approval duration for one-time approvals is 30 days per policy.

Coverage is limited to the specific exceptions listed in the criteria. Any exception not specifically listed in the criteria is considered not medically necessary. Reviewers should apply the listed exception criteria (for example, eosinophilic esophagitis, pediatric/adolescent higher dosing, or COPD exacerbation) and may not approve other, unstated exceptions.

Per-prescription drug quantity limits are enforced. Requests that exceed the specified maximum per‑Rx quantities for the requested strength and dispensing channel without meeting an allowed exception are not medically necessary. The policy’s quantity limits (retail vs home delivery and by respule strength) must be used to determine coverage unless one of the enumerated exceptions applies.

Prescriber, Pharmacist and Reviewer Actions

Prior Authorization

Quantity limits and approval duration

Quantity limits are enforced per prescription at point of sale. Approvals (when criteria are met) are provided for 1 year (standard). One-time approvals are provided for 30 days.

Retail maximums per Rx: 0.25 mg/2 mL and 0.5 mg/2 mL — 120 mL (60 respules). 1 mg/2 mL — 60 mL (30 respules).
Home delivery maximums per Rx: 0.25 mg/2 mL and 0.5 mg/2 mL — 360 mL (180 respules). 1 mg/2 mL — 180 mL (90 respules).

Denial Risk

Denial triggers

If the Quantity Management rule is not met at point of service, coverage will be determined by the policy criteria below. Denials may result when requested quantities exceed the specified per‑Rx maximums and no qualifying clinical exception is documented. Exceptions described in the criteria (e.g., eosinophilic esophagitis, age‑based higher dosing, COPD exacerbation one‑time override) must be clearly documented by the prescriber to avoid denial. For one‑time emergency or acute exacerbation overrides, limit approvals to the one‑time durations and quantities specified in the criteria.

Clinical and Product Background

Budesonide inhalation suspension (Pulmicort Respules) is an inhaled corticosteroid supplied as single‑dose nebulizer ampules (respules) in strengths of 0.25 mg/2 mL, 0.5 mg/2 mL, and 1 mg/2 mL. It is indicated for maintenance treatment of asthma and prophylactic therapy in young children (FDA‑labeled for ages 12 months to 8 years), with additional off‑label uses described in the criteria (including nebulized delivery in older patients and treatment of eosinophilic esophagitis). Quantity limits apply per Rx and vary by strength and dispensing channel (retail vs home delivery).

Definitions and Abbreviations

respules

DefinitionRespules: single‑dose nebulizer ampules supplied in sealed aluminum envelopes containing a plastic strip of five single‑dose respules.

Packaging per carton30 respules per carton.

Abbreviations

QDOnce daily.

BIDTwice daily.

ICSInhaled corticosteroids.

Per-Prescription Quantity Limits by Strength and Channel

Pulmicort Respules 0.25 mg/2 mL — Retail

Retail quantity (mL)120 mL per Rx.

Retail quantity (respules)60 respules per Rx.

Strength / formPulmicort Respules 0.25 mg/2 mL respules.

Pulmicort Respules 0.25 mg/2 mL — Home delivery

Home delivery quantity (mL)360 mL per Rx.

Home delivery quantity (respules)180 respules per Rx.

Strength / formPulmicort Respules 0.25 mg/2 mL respules.

If Drug Quantity Management rule not met at POS → coverage evaluated per criteria; absence of qualifying criteria → deny.
Document clinical exception and prescriber rationale to support override.
One‑time overrides: 30‑day approval; chronic exceptions: 1‑year approval.

Documentation Required

Documentation and review expectations

Coverage determinations require consideration of the applicable benefit plan terms, any relevant laws/regulations, and collateral materials (including this policy). Reviewers should assess the specific facts of each request, verify prescriber documentation for any exceptions, and apply clinical judgment. Medical Directors may exercise discretion in individual determinations.

Verify benefit plan language for member-specific exclusions or differing limits.
Confirm documentation supports criteria used for approval (diagnosis, age, prescriber rationale).
Record duration of approval (1 year or one‑time 30 days) in the authorization notes.

Note

Provider action: document clinical justification when requesting overrides

Prescriber action: when requesting quantities above the standard per‑Rx maximums, include the clinical diagnosis and supporting rationale (e.g., eosinophilic esophagitis, indication that patient ≥11 years requires >1 mg/day, or COPD exacerbation justification for a one‑time higher quantity). Pharmacists: verify authorization duration and that quantity dispensed does not exceed approved per‑Rx limits. Reviewers: apply the policy criteria exactly as written and document the basis for any exception or denial.

For 1 mg/2 mL respules — to approve above standard limits for eosinophilic esophagitis: prescriber must document diagnosis.
For age‑based approvals (≥11 years requiring >1 mg/day): prescriber must document required dose; do not exceed 240 mL (120 respules) retail or 720 mL (360 respules) home delivery.
For COPD exacerbation in ≥18 years: authorize one‑time override up to 480 mL (240 respules).

Pulmicort Respules 0.5 mg/2 mL — Retail

Retail quantity (mL)120 mL per Rx.

Retail quantity (respules)60 respules per Rx.

Strength / formPulmicort Respules 0.5 mg/2 mL respules.

Pulmicort Respules 0.5 mg/2 mL — Home delivery

Home delivery quantity (mL)360 mL per Rx.

Home delivery quantity (respules)180 respules per Rx.

Strength / formPulmicort Respules 0.5 mg/2 mL respules.

Pulmicort Respules 1 mg/2 mL — Retail

Retail quantity (mL)60 mL per Rx.

Retail quantity (respules)30 respules per Rx.

Strength / formPulmicort Respules 1 mg/2 mL respules.

Pulmicort Respules 1 mg/2 mL — Home delivery

Home delivery quantity (mL)180 mL per Rx.

Home delivery quantity (respules)90 respules per Rx.

Strength / formPulmicort Respules 1 mg/2 mL respules.