Dupixent (dupilumab) prior authorization for allergic fungal rhinosinusitis
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Defines prior authorization requirements for Dupixent (dupilumab) when prescribed for allergic fungal rhinosinusitis (AFRS) for Mississippi Division of Medicaid members age 6 and older; applies to providers requesting coverage for this indication.
No material clinical or coverage changes in this revision.
Coverage Criteria for Dupixent (dupilumab) — Allergic Fungal Rhinosinusitis (AFRS)
Initial Authorization
Covered when ALL of the following are met for initial authorization:
Initial approval duration 6 months
Re-Authorization
Covered when ALL of the following are met for re-authorization:
Re-authorization duration 12 months
These criteria apply only to use of Dupixent (dupilumab) for allergic fungal rhinosinusitis (AFRS). Therapy for indications other than AFRS is not addressed by this policy; prior authorization requests for other diagnoses should be evaluated under the applicable coverage rules or excluded from consideration under these AFRS-specific criteria.
Drug Formulations and Dosing Limits
| dupilumab 300 mg/2 mL | Single-Dose Pre-Filled Syringe with Needle Shield: 300 mg/2 mL injection (formulation referenced) |
| dupilumab 200 mg/1.14 mL | Single-Dose Pre-Filled Syringe with Needle Shield: 200 mg/1.14 mL injection (formulation referenced) |
Provider Submission, Authorization Durations, and Preconditions
Initial authorization — 6 months
Initial prior authorization approvals are granted for 6 months when all initial criteria are met, including age ≥6 years, diagnosis of AFRS, documented history of sinonasal surgery related to AFRS, prescribing or consultation by an ENT/allergist/immunologist, trial/intolerance/contraindication to standard therapy, and dose ≤300 mg every other week.
- Initial approval duration: 6 months
Re-authorization — 12 months
Re-authorization approvals are granted for 12 months when the patient continues to meet the initial authorization criteria, the prescribed dose does not exceed 300 mg every other week, and there is documented positive clinical response to therapy (e.g., improved sinonasal symptoms, reduced inflammatory burden on endoscopy/imaging, decreased systemic steroid need, or improved quality of life).
- Re-authorization duration: 12 months
Step therapy / prior therapy requirement
The patient must have had an inadequate response, intolerance, or contraindication to standard therapies (unless contraindicated) such as intranasal corticosteroids, systemic corticosteroids, antifungal therapy if clinically appropriate, or saline irrigations before Dupixent will be authorized.
- Document the specific prior therapies tried and the nature of inadequate response, intolerance, or contraindication.
Required documentation for PA submission
Submit the Mississippi Universal PA Form and supporting clinical documentation, including the diagnosis of AFRS, documentation of prior sinonasal surgery related to AFRS (e.g., functional endoscopic sinus surgery), history of prior therapies (response/intolerance/contraindication), and prescriber specialty or consultation (ENT, allergist, or immunologist).
- Include operative or procedural notes confirming sinonasal surgery when available.
- Include clinical notes documenting prior therapy trials and outcomes.
PA submission requirements and potential denial triggers
Prior authorization is required and may be denied if supporting documentation is not provided showing the AFRS diagnosis, history of sinonasal surgery, prescriber specialty/consultation, required prior therapy trial or documented contraindication/intolerance, or if the prescribed dose exceeds 300 mg every other week.
- Failure to submit the Universal PA Form plus supporting clinical documentation may result in denial.
- Dose above 300 mg every other week is a potential denial trigger.
Background
Allergic fungal rhinosinusitis (AFRS) is a form of chronic rhinosinusitis in which patients demonstrate an eosinophilic inflammatory response to fungal elements and commonly require prior sinonasal (e.g., functional endoscopic sinus) surgery. Dupilumab is indicated for treatment of patients aged 6 years and older with AFRS who have a history of sino-nasal surgery; prior authorization is required and approval is contingent on meeting the policy’s clinical criteria (including documented surgery, specialty prescriber involvement, prior standard therapy trial or documented contraindication/intolerance, and dose limits).
Definitions
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