CurrentHealth NetPolicy CP.PHAR.212

Clinical Policy: Dornase Alfa (Pulmozyme)

Covers medical necessity criteria, dosing, and coverage rules for dornase alfa (Pulmozyme) for members across Commercial, HIM, and Medicaid lines of business; applies to providers requesting authorization for therapy for cystic fibrosis and other uses referenced in policy.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Dornase Alfa (Pulmozyme)

Policy CodePolicy CP.PHAR.212

Change TypeNo material changes

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 mg/daydocumented maximum daily dose

12 monthscontinued therapy approval duration

J7639billing code referenced

2.5 mg ampulesproduct availability

Medicaid notedMedicaid precedence

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Coverage Criteria for Dornase Alfa (Pulmozyme)

Initial Approval — Cystic Fibrosis

Covered when ALL of the following are met

Initial CF criteria: 1) Diagnosis of cystic fibrosis; 2) Prescribed by or in consultation with a pulmonologist or an expert in treatment of cystic fibrosis; 3) Therapeutic plan includes concomitant use of standard CF therapies (e.g., antimicrobials, bronchodilators, mucolytics, chest physiotherapy); 4) Dose does not exceed both of the following: a) 5 mg per day; and b) 2 ampules per day.dose limits: 5 mg/day and 2 ampules/day

Initial approval requires all conditions

Continued Therapy — Cystic Fibrosis

Covered when ALL of the following are met

Continued therapy CF: 1) Member meets one of the following: a) currently receiving medication via the Centene benefit or previously met initial approval criteria; or b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed both of the following: a) 5 mg per day; and b) 2 ampules per day.dose limits: 5 mg/day and 2 ampules/day

Approval duration: 12 months

Other Diagnoses / Indications

Other uses — follow formulary/off-label pathways

Other indications routing: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190, HIM.PA.103, CP.PMN.16). 2) If the requested use (diagnosis, age, dosing) is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).N/A

Policy routes other indications to referenced formulary/off-label policies

Non‑FDA approved indications that are not specifically addressed in this policy are generally not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage decisions are guided by this clinical policy but remain subject to the terms, conditions, exclusions, and limitations contained in the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract). This policy does not guarantee payment and does not override applicable state or federal requirements or Health Plan‑level administrative procedures.

Requests for use of dornase alfa for non‑FDA approved indications that lack sufficient supporting documentation per the off‑label use policy may be considered not medically necessary and therefore may be denied.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Requests for Pulmozyme (dornase alfa) must be prior authorized and meet the applicable initial or continued therapy criteria for cystic fibrosis.

Affected policy: CP.PHAR.212 (Dornase alfa)
Approval duration for continued therapy: 12 months
Dose limits: ≤ 5 mg per day and ≤ 2 ampules per day

Documentation Required

Required Documentation

Provider must submit documentation supporting that the member has met all approval criteria. Acceptable documentation includes office chart notes, laboratory results, and other relevant clinical information. Failure to provide sufficient documentation may result in denial.

Include documentation of diagnosis of cystic fibrosis
Include documentation of prescribing clinician specialty (pulmonologist or CF expert) or consultation notes
Include treatment plan showing concomitant standard CF therapies and evidence of positive response for continuation requests

Step Therapy

Step Therapy / Formulary Routing

Step therapy / formulary routing: No specific step therapy is stated in this policy. When the drug is non‑formulary for the applicable line of business, follow the non‑formulary or off‑label use policies referenced by the Health Plan.

Refer to formulary/non‑formulary policies for the relevant line of business when applicable
Off‑label uses require adherence to the off‑label use policy and sufficient evidence of efficacy/safety

Note

Coverage and Contract Compliance

Coverage decisions are subject to the member's evidence of coverage, contract terms, and applicable state/federal regulations. This clinical policy is a guide to medical necessity and does not guarantee payment. Providers must follow all applicable Health Plan policies and regulatory requirements when submitting prior authorization requests.

Coverage subject to terms, conditions, exclusions, and limitations of member coverage documents
Health Plan may change or withdraw this clinical policy; legal/regulatory requirements govern if discrepancies exist

Denial Risk

Non‑FDA Indications

Non‑FDA indications not addressed in this policy may be denied unless adequate clinical evidence is provided per the Health Plan's off‑label use policies.

Requests for non‑FDA approved indications must include sufficient documentation of efficacy and safety in accordance with off‑label use policies
When in doubt, reference the applicable off‑label policy for the line of business

OpenPayer

Clinical Policy: Dornase Alfa (Pulmozyme)

Coverage Criteria for Dornase Alfa (Pulmozyme)

Coding and Dosing Information

Provider Actions, Authorization & Documentation

Background

Definitions