CurrentCignaPolicy N/A

Cystic Fibrosis - Pulmozyme Prior Authorization Policy

Cigna prior authorization policy for Pulmozyme (dornase alfa inhalation solution) specifying coverage for cystic fibrosis, required prescriber specialty, duration of approval, and noncovered/not medically necessary uses.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Pulmozyme Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual review — no criteria changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (approvals provided for 1 year) and ensure Pulmozyme is prescribed by or in consultation with a pulmonologist or cystic fibrosis specialist.

POLICY UPDATE CHANGES

Annual revisions noted with 'No criteria changes' for prior reviews; most recent review date 05/07/2025.

1Covered Indication(s)

2Not Covered Example Indications Listed

Coverage Summary & Criteria

Applicable Codes

Drug (not specified in document)NDC

No codes listed

Authorization, Documentation, and Denial Risk

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Pulmozyme. All approvals are provided for a duration of 1 year when the coverage criteria are met.

Documentation Required

Prescriber specialty requirement

Pulmozyme must be prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis; this specialty requirement is part of the approval criteria.

Denial Risk

Denial for noncovered indications

Claims for Pulmozyme for indications other than cystic fibrosis are considered not medically necessary and may be denied. Examples of noncovered indications include asthma and idiopathic (non–cystic fibrosis) bronchiectasis.

Evidence & References

Evidence includes: Pulmozyme prescribing information (Genentech/Roche; February 2024); Cystic Fibrosis Foundation Patient Registry: 2023 Annual Data Report; and randomized trial data in idiopathic bronchiectasis (n = 349) showing worsened lung function and more frequent pulmonary exacerbations with Pulmozyme versus placebo.

Clinical guidance: Pulmozyme is indicated as an adjunctive therapy to improve pulmonary function in patients with cystic fibrosis. Guidelines recommend use in patients aged ≥6 years, with separate guidance supporting individualized use in younger children. Safety and tolerability have been established in patients as young as 3 months, although efficacy data are lacking in patients 5 years of age.

Background & Definitions

Pulmozyme (dornase alfa) is a recombinant human deoxyribonuclease I indicated, in conjunction with standard therapies, for the management of patients with cystic fibrosis to improve pulmonary function. Prior authorization is recommended and approvals are provided for 1 year; prescribing or consultation by a pulmonologist or physician who specializes in cystic fibrosis is required for approval.

Definition: Pulmozyme = Dornase alfa inhalation solution, recombinant human deoxyribonuclease I.

Policy Revision History

2025-05-07reviewLatest

Annual revisions noted with No criteria changes; most recent review 05/07/2025.

2024-05-15review

Annual Revision, Summary of Changes = No criteria changes.

2023-05-17review