Provider Requirements, Prior Authorization, and Documentation

Prior authorization is required for provider-administered interleukin and related biologic therapies (e.g., Cinqair, Fasenra, Nucala). Providers must submit complete clinical documentation to support the requested therapy. Incomplete or missing documentation may result in denial or delay.

• Document diagnosis, baseline peripheral blood eosinophil count (pre-treatment) and phenotype (e.g., eosinophilic phenotype defined in policy thresholds).
• Provide objective evidence of disease severity and/or uncontrolled disease (e.g., ACQ/ACT scores, number of exacerbations, OCS bursts, ED visits, hospitalizations, FEV1/FEV1-FVC data).
• For EGPA, submit documentation of relapsing or refractory disease and required clinical characteristics (history/presence of asthma plus ≥2 typical EGPA features such as eosinophilic vasculitis, perivascular eosinophilic infiltration, eosinophil-rich granulomatous inflammation, neuropathy, pulmonary infiltrates, sino-nasal abnormality, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity).
• For HES, submit baseline (pre-treatment) blood eosinophil ≥ 1000 cells/µL within past 4 weeks and documentation the patient is on a stable dose of background HES therapy (e.g., oral corticosteroid, immunosuppressive, or cytotoxic therapy) and history of ≥2 HES flares in prior 12 months.
• For CRSwNP, provide baseline documentation of inadequate response to nasal corticosteroids (≥8 weeks) and conservative therapies (e.g., saline irrigations, intranasal corticosteroids, antileukotriene agents), prior sinus surgery status (e.g., prior surgery within 10 years) or prior systemic corticosteroid use for CRSwNP in previous 2 years, nasal obstruction VAS and endoscopic/CT findings consistent with policy criteria.
• Confirm therapy will be used as add‑on maintenance and that standard/conservative therapies and other indicated treatments (intranasal/oral corticosteroids, surgery for nasal polyps, optimized inhaled controllers for asthma) have been trialed and failed as appropriate.
• If requesting Cinqair, document prior biologic therapy trials per step therapy requirement: history of failure to a 4‑month trial of Fasenra or Nucala or documented contraindication/intolerance to them, and history of failure to a 4‑month trial of Tezspire or contraindication/intolerance to Tezspire.
• Do not combine biologics for the same indication. Document the patient is not receiving concurrent biologic therapy from the prohibited lists (anti‑IL‑5/5R, anti‑IgE, anti‑IL‑4/13, anti‑TSLP agents).
• Dosing must follow FDA‑approved labeling and drug must be prescribed by an appropriate specialist (e.g., pulmonologist, allergist/immunologist, hematologist, cardiologist, or otolaryngologist depending on indication). Initial authorizations are limited to up to 12 months unless otherwise specified.
• Therapies used for unproven or not medically necessary indications (e.g., acute bronchospasm, status asthmaticus, Wegener's/granulomatosis with polyangiitis, microscopic polyangiitis, organ- or life‑threatening EGPA, other eosinophilic conditions, and COPD for certain agents) are subject to denial per policy.
• Check member‑specific benefit plan documents, federal/state mandates, and Medicare Advantage program rules (e.g., Medicare Part B Step Therapy) — benefit terms govern coverage and may impose additional requirements.
• Ensure medical records (chart notes, lab values, imaging, operative reports) supporting all criteria are submitted with the PA request; missing phenotype/severity documentation or insufficient EGPA documentation may trigger denial.

Denial Risk and Common Triggers

Prior authorization will be denied when clinical prerequisites are not met or when use is for unproven indications or in disallowed combinations. Common high‑risk denial triggers include missing eosinophilic phenotype or severity documentation, incomplete EGPA diagnostic features, concurrent use of another biologic for the same indication, non‑FDA dosing, and lack of required prior therapy trials (including step therapy for Cinqair).

• Missing pre‑treatment peripheral blood eosinophil documentation (policy thresholds vary by indication; e.g., ≥150 cells/µL for many severe eosinophilic asthma indications, ≥300 cells/µL for COPD, ≥1000 cells/µL for HES within prior 4 weeks) may result in denial.
• Insufficient documentation of relapsing/refractory EGPA (absence of required clinical characteristics or histopathology) may result in denial.
• Requests for therapy in combination with another biologic listed in policy for the same indication (e.g., anti‑IL‑5 with anti‑IL‑5, anti‑IgE, anti‑IL‑4/13, or anti‑TSLP agents) will be denied.
• Use for conditions listed as unproven/not medically necessary (e.g., acute bronchospasm, status asthmaticus, granulomatosis with polyangiitis, microscopic polyangiitis, organ/life‑threatening EGPA, certain other eosinophilic conditions; and COPD for some agents) will be denied.
• Cinqair-specific step therapy denials if there is no documentation of failure to a 4‑month trial of Fasenra or Nucala (or documented contraindication/intolerance), and no documentation of failure to a 4‑month trial of Tezspire (or documented contraindication/intolerance).
• Lack of documentation demonstrating trials of standard therapies prior to biologic (e.g., intranasal/oral corticosteroids, surgical history for CRSwNP; maximally dosed ICS/LABA and other controller therapies for asthma) may lead to denial.

Required Supporting Documentation and Plan Terms

Documentation and program rules required at the time of PA submission — these items support adjudication and compliance with benefit terms.

• Submit baseline labs (per‑indication eosinophil counts with collection date) and relevant imaging or endoscopy reports (e.g., nasal endoscopy or sinus CT for CRSwNP).
• For HES: submit baseline (pre‑treatment) blood eosinophil ≥ 1000 cells/µL within the past 4 weeks and documentation of stable background HES therapy.
• For CRSwNP: document ≥8 weeks of nasal corticosteroid use pre‑screening, symptom duration ≥12 weeks, endoscopic NPS or CT findings per policy, prior sinus surgery history (if applicable), nasal obstruction VAS scores, and trials of conservative therapies (e.g., saline irrigation, intranasal corticosteroids, antileukotriene agents).
• Include notation of prior standard therapy trials before biologic initiation (optimized inhaled controller therapy for asthma, systemic corticosteroid courses, and surgical interventions where indicated).
• Members on Medicare Advantage may be subject to Part B Step Therapy Programs and other Medicare-specific requirements; consult Medicare program materials and the member‑specific plan.
• Verify member‑specific benefit plan documents for coverage limits, exclusions, or state/federal mandates — plan terms govern and may supersede policy language.