Omalizumab (CPB 0670, reviewed 2026-06-05)

REQUIREMENTS: By June 5, 2026 (Policy Effective Date): - Billing team must implement precertification requirements for ALL omalizumab products (Xolair and Omlyclo). Update billing software to automatically route omalizumab claims to specialty pharmacy precertification at (866) 752-7021 or fax (888) 267-3277. - Configure system to require Statement of Medical Necessity (SMN) precertification forms for all omalizumab requests in applicable plan designs. - Update prior authorization workflows to validate prescriber specialty matches the approved indication: allergist/immunologist or pulmonologist (asthma), allergist/immunologist or otolaryngologist (CRSwNP), allergist/immunologist or dermatologist (urticaria), allergist/immunologist (food allergy), dermatologist/hematologist/oncologist (checkpoint inhibitor toxicity), or allergist/immunologist/dermatologist/hematologist/oncologist (systemic mastocytosis). - For asthma and urticaria cases, update authorization forms to require documentation of baseline serum IgE ≥30 IU/mL (asthma) or up-dosed H1 antihistamine trial ≥2 weeks (urticaria) BEFORE omalizumab approval. - For CRSwNP, configure system to verify member has nasal polyp documentation (endoscopy, rhinoscopy, or CT showing polyps below middle turbinate) plus Meltzer score ≥2 or NPS ≥5 with min 2 per nostril before authorizing. - For food allergy, ensure claims documentation includes allergen-specific IgE or skin-prick test confirmation plus either positive oral food challenge or systemic reaction history. - Ensure all authorization denials cite specific unmet criteria (e.g., "Member age <6 years" for asthma, "Inadequate prior biologic trial" for continuation therapy). - Claims submitted without precertification or with incomplete medical necessity documentation will be DENIED. - Billing team should flag to providers that prior biologic therapy (Nucala, Cinqair, Dupixent as applicable per indication) within past 12 months provides expedited pathway to omalizumab approval. - Front desk staff must update patient financial counseling to include precertification timeline (allow 2-3 business days minimum).