CurrentCignaPolicy IP0483

Cystic Fibrosis - Pulmozyme

Defines Cigna's prior authorization and coverage criteria for Pulmozyme (dornase alfa inhalation solution) for patients with cystic fibrosis and states conditions considered not medically necessary. Applies to health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Pulmozyme

Policy CodePolicy IP0483

Change TypeTitle and criteria revisions

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization; approve for 1 year when prescribed by or in consultation with a pulmonologist or physician who specializes in cystic fibrosis.

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from Dornase Alfa to Cystic Fibrosis - Pulmozyme and removed criterion 'used to improve pulmonary function in cystic fibrosis (CF).' and removed criteria for treatment of complicated pleural effusions.

Prior Authauthorization requirement

1 yearapproval length

Cystic FibrosisFDA-approved use

Asthma, Bronchiectasisexplicit non-covered

≥6 yrsage guidance

Coverage Criteria for Pulmozyme (dornase alfa)

Initial approval - Cystic Fibrosis

Covered when ALL of the following are met

FDA-approved Cystic Fibrosis indication: Medication is prescribed for cystic fibrosis

Pulmozyme is indicated as adjunctive therapy to improve pulmonary function in cystic fibrosis; approval duration 1 year

Prescriber requirement: Prescribed by or in consultation with a pulmonologist or physician who specializes in treatment of cystic fibrosis

Required for approval; prior authorization is required

Use of Pulmozyme (dornase alfa) for any indication other than cystic fibrosis is considered not medically necessary. The policy explicitly lists non-covered examples including asthma and idiopathic/non-CF bronchiectasis, and notes the list may not be all inclusive and will be updated as new published data become available.

Pulmozyme is considered not medically necessary for asthma because efficacy outside of cystic fibrosis has not been established; a pilot study in patients with severe acute asthma (n = 50) showed no significant difference in FEV1 versus placebo. Pulmozyme is also not medically necessary for idiopathic bronchiectasis; a multicenter randomized placebo-controlled 24-week trial (n = 349) demonstrated worsened lung function and more frequent pulmonary exacerbations with Pulmozyme compared with placebo, leading authors to advise against its use in that population.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Pulmozyme

Policy CodePolicy IP0483

Change TypeTitle and criteria revisions

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization; approve for 1 year when prescribed by or in consultation with a pulmonologist or physician who specializes in cystic fibrosis.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Pulmozyme. Approvals are provided for the duration noted below. Because of the specialized skills required for evaluation and diagnosis of patients treated with Pulmozyme as well as the monitoring required for adverse events and long‑term efficacy, approval requires Pulmozyme to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approve for 1 year when prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Documentation Required

Prescriber and Documentation Requirements

Pulmozyme requires prior authorization. Approval requires prescription by or in consultation with a physician who specializes in the treatment of cystic fibrosis. Ensure documentation supports the FDA‑approved indication and that the prescribing relationship (specialist or consult) is clearly recorded in the medical record.

Prescriber must be a pulmonologist or physician who specializes in cystic fibrosis, or the request must document consultation with such a specialist.
Include clinical documentation supporting the diagnosis of cystic fibrosis and medical necessity for Pulmozyme.
Approval duration: 1 year (subject to reauthorization with updated documentation).

Denial Risk

Denial Triggers

Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

Submit claims with the most appropriate and current diagnosis and procedure codes that correspond to the covered indication.
Services billed for conditions or diagnoses not covered under this policy will be denied.

Note

Provider Action

Placeholder: Follow the above prior authorization, prescriber, documentation, and coding requirements. If additional plan‑specific instructions apply, follow the applicable benefit plan document or contact Cigna for utilization review guidance.

OpenPayer

Cystic Fibrosis - Pulmozyme

Coverage Criteria for Pulmozyme (dornase alfa)

Coding and Age Guidance

Provider Requirements and Prior Authorization

Background

Definitions