Diagnosis: Chronic rhinosinusitis with nasal polyps.

Treatment: Dupixent (dupilumab) subcutaneous injections for the treatment of rhinosinusitis with nasal polyps.

The insurer denied coverage for Dupixent (dupilumab) subcutaneous injections for the treatment of rhinosinusitis with nasal polyps.

The denial is overturned.

This is a female patient with a medical diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP). The patient has a septal perforation due to inflammation, and she has underlying eczema and asthma which are poorly controlled with medical therapy. The patient's skin reactivity has caused such inflammation that she developed a septal perforation. The patient also has postnasal drip, sinus congestion and a history of an acute sinus infection. The patient was previously using intranasal steroids, Astelin, Pulmicort and Flonase, but her symptoms persisted. The patient's treating otolaryngologist prescribed Dupixent for the treatment of chronic rhinosinusitis with nasal polyps.

As per Laidlaw et al. (2019), CRSwNP "is a predominantly type 2 mediated inflammatory disease associated with a high symptom burden and poor health-related quality of life...Dupilumab is approved by the US [United States] Food and Drug Administration for the treatment of adults with moderate-to-severe [atopic dermatitis (AD)] whose disease is inadequately controlled with topical prescription therapies or for whom those therapies are not advisable, and can be used with or without topical corticosteroids, and by the European Medicines Agency for use in adults with moderate-to-severe AD who are candidates for systemic therapy. Dupilumab is also approved by the US Food and Drug Administration as an add-on maintenance treatment in patients [above a certain age] with moderate-to severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma, and has demonstrated positive results in proof-of-concept studies for patients with eosinophilic esophagitis." As per Laidlaw et al. (2019), "Bachert et al. have described a phase 2a dupilumab trial in patients with CRSwNP refractory to intranasal corticosteroids. In this proof-of-concept study (ClinicalTrials.gov Identifier: NCT01920893), dupilumab in conjunction with mometasone furoate nasal spray significantly improved endoscopic, radiographic, clinical, and patient-reported outcomes in these patients, many of whom had comorbid conditions. Patients with CRSwNP with comorbid aspirin-exacerbated respiratory disease (AERD), also referred to as nonsteroidal anti-inflammatory drug-exacerbated respiratory disease, are among the most severe and difficult to treat. An estimated 8% to 26% of patients with CRSwNP are reported to have comorbid AERD."

As per literature review, Dupixent (dupilumab) via subcutaneous injections for the treatment of rhinosinusitis with nasal polyps is considered medically necessary for this patient. The patient has a history of chronic rhinosinusitis with nasal polyps (CRSwNP), and has failed the long term use of nasal steroid and antihistamine spray, oral antihistamine, oral steroid, as well as Pulmicort rinses. Nasal endoscopy showed nasal polyps below the inferior border of the middle turbinate bilaterally. The plan criteria are not aligned with the Food and Drug Administration and other criteria for Dupixent use. The patient has failed nasal steroid spray/antihistamine spray/oral antihistamine/oral prednisone/Pulmicort rinses. The next step in this patient's medical management would be the use of Dupixent.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Dupixent (dupilumab) subcutaneous injections for the treatment of rhinosinusitis with nasal polyps should be overturned. The medical necessity is substantiated.