Nucala — United Healthcare

Initial criteria

• One of the following: (1) Established on therapy with Nucala under an active UnitedHealthcare medical benefit prior authorization for CRSwNP, documentation of positive clinical response, continued use as add-on maintenance therapy in combination with intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone), not used in combination with anti-interleukin-5, anti-IgE, anti-interleukin-4, or TSLP inhibitors, and prescribed by Allergist, Immunologist, Otolaryngologist, or Pulmonologist
• OR (2) Diagnosis of CRSwNP defined by all of the following: (a) two or more symptoms for >12 weeks (nasal mucopurulent discharge, nasal obstruction, facial pain/pressure/fullness, reduction or loss of smell); (b) one nasal endoscopy or CT finding (purulent mucus or edema, nasal polyps, or mucosal thickening/opacification); (c) bilateral nasal polyposis or prior surgical removal of bilateral nasal polyps; (d) prior sinus surgery OR systemic corticosteroid requirement within 2 years OR lack of relief after trial of two of the following: nasal saline irrigations, intranasal corticosteroids, antileukotriene agents; AND will receive Nucala as add-on maintenance therapy with intranasal corticosteroids; AND not receiving in combination with anti-IL-5, anti-IgE, anti-IL-4, or TSLP inhibitors; AND prescribed by Allergist, Immunologist, Otolaryngologist, or Pulmonologist

Reauthorization criteria

• Documentation of positive clinical response to Nucala therapy
• Continued use as add-on maintenance therapy in combination with intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone)
• Patient is not receiving Nucala in combination with anti-interleukin-5 therapy [e.g., Cinqair (resilizumab), Fasenra (benralizumab)], anti-IgE therapy [e.g., Xolair (omalizumab)], anti-interleukin-4 therapy [e.g., Dupixent (dupilumab)], or thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]

Approval duration

12 months