Diagnosis: Chronic rhinosinusitis (CRS)
Treatment: Formulary Exception for Dupixent Syn 300
The insurer denied coverage for Formulary Exception for Dupixent Syn 300
The denial is overturned.

This patient has a complex medical history which includes hemophilia and multiple sinus surgeries for CRS, Samter's Triad or Aspirin Sensitive Asthma, a chronic medical condition that consists of asthma, recurrent sinus disease with nasal polyps, and a sensitivity to aspirin and other non-steroidal anti-inflammatory drugs and an encephalocele for which he underwent two craniotomies for repair.

The patient has been seen twice by an otolaryngologist. On both of these occasions he was diagnosed with nasal polyps documented twice from direct observation through nasal endoscopy and with the accompanying symptoms of anosmia, nasal obstruction, facial pressure pain and significant drainage.

The information provided noted that he has had several courses of steroids to control his CRS and nasal polyps. The treating otolaryngologist prescribed the use of Dupixent Syn 300 to treat his CRS and nasal polyps. The use of Dupixent in the care of CRS and nasal polyps has been approved by the Food and Drug Administration (FDA).

There is extensive documentation in the peer-reviewed literature [2-18] of the efficacy of Dupixent for the care of CRS and nasal polyps.

The plan criteria for the use of Dupixent in the treatment of CRS and nasal polyps are:

"That all of the following criteria are met:

1. Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 2 months unless contraindicated or not tolerated; and

2. The member has chronic rhinosinusitis with nasal polyps (CRSwNP) despite one of the following:
i. Prior sino-nasal surgery; or
ii. Prior treatment with systemic corticosteroids within the last two years was ineffective, unless contraindicated or not tolerated; and

3. Member has one of the following:
i. A bilateral nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril
ii. Meltzer Clinical Score of 2 or higher in both nostrils
iii. A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril

4. Member has nasal blockage plus one additional symptom:
i. Rhinorrhea (anterior/posterior); or
ii. Reduction or loss of smell; or
iii. Facial pain or pressure

5. Member will continue to use a daily intranasal corticosteroid while being treated with Dupixent, unless contraindicated or not tolerated." [1]

The patient fulfills all of these criteria in that he has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 2 months. He has CRSwNP despite all of the following: prior sino-nasal surgery; prior treatment with systemic corticosteroids within the last two years was ineffective.

His available (CT) showed almost total obliteration of the sinus cavities which would fulfill the plan criteria. He has all three of the additional symptoms of rhinorrhea, anterior/posterior; reduction or loss of smell; facial pain or pressure. The use of a intranasal corticosteroids has failed and is not indicated.

The denial should be overturned as the patient met both the FDA and plan criteria for use.

The formulary drugs are not expected to cause adverse effects. The requested drug is more effective, as no formulary alternative was offered.

The carrier's denial of Request for Formulary Exception for Dupixent Syn 300 to treat chronic rhinosinusitis with nasal polyposis is overturned.