CurrentCignaPolicy IP0483

Cystic Fibrosis - Pulmozyme

Defines prior authorization and coverage criteria for Pulmozyme (dornase alfa inhalation solution) for treatment of cystic fibrosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Pulmozyme

Policy CodePolicy IP0483

Change TypeTitle revisionremoval of specific coverage criteria

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization documentation showing the medication is prescribed by or in consultation with a pulmonologist or cystic fibrosis specialist; approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from Dornase Alfa to Cystic Fibrosis - Pulmozyme and removed criteria 'used to improve pulmonary function in cystic fibrosis (CF)'.

Removed criteria for coverage of treatment of complicated pleural effusions.

1 yearstandard approval duration for FDA indication

Prior Authorizationauthorization requirement

≥3 monthssafety/tolerability established in patients as young as

Not coveredidiopathic bronchiectasis and asthma indications

Coverage Criteria for Pulmozyme (dornase alfa)

Initial/Standard Coverage

Covered when ALL of the following are met

FDA-Approved Indication for Cystic Fibrosis: Medication is prescribed for cystic fibrosis and is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosisapprove for 1 year

Prior authorization required

Pulmozyme (dornase alfa) is not medically necessary for any indication other than treatment of cystic fibrosis. This exclusion specifically includes use for asthma and idiopathic (non‑CF) bronchiectasis and applies to Cigna‑administered health benefit plans.

Use of Pulmozyme for asthma is considered not medically necessary because efficacy has not been established; randomized studies, including a pilot study of patients with severe acute asthma, did not demonstrate significant improvement in FEV1 compared with placebo. Use for idiopathic bronchiectasis is considered not medically necessary due to lack of demonstrated benefit and evidence of harm — a multicenter randomized trial showed worsened lung function and more frequent pulmonary exacerbations in patients treated with Pulmozyme versus placebo.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Pulmozyme

Policy CodePolicy IP0483

Change TypeTitle revisionremoval of specific coverage criteria

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization documentation showing the medication is prescribed by or in consultation with a pulmonologist or cystic fibrosis specialist; approvals are for 1 year.

SourceLink

On This Page

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Pulmozyme. Approvals will be provided for up to 1 year. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Pulmozyme, prior authorization must document that the medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Prior authorization required — approve for up to 1 year
Prescriber must be a pulmonologist or physician specializing in cystic fibrosis, or treatment must be in consultation with such a specialist
Documentation must support specialist involvement (prescription or consultation note)
Claims submitted without a covered diagnosis or procedure code will be denied as not covered

Documentation Required

Prescriber Specialty and Supporting Documentation

Prior authorization documentation must show the medication is prescribed by or that the treating provider consulted with a cystic fibrosis specialist/pulmonologist. Include specialty of prescriber and supporting documentation (e.g., consultation notes, prescription with specialist signature) with the authorization request.

Required documentation: prescription or consultation note demonstrating specialist involvement
If not prescribed directly by a specialist, include documentation of consultation with a pulmonologist or cystic fibrosis specialist

Denial Risk

Claim Coding and Coverage Risk

Claims submitted without a covered diagnosis or procedure code consistent with this policy will be denied as not covered. Ensure coding on the claim matches the approved indication and the supporting authorization.

Claims lacking covered diagnosis/procedure codes will be denied as not covered
Use the most appropriate and current diagnosis and procedure codes as of the date of service

OpenPayer

Cystic Fibrosis - Pulmozyme

Coverage Criteria for Pulmozyme (dornase alfa)

Coding and Approval Duration

Provider Actions and Authorization Requirements

Background

Definitions