Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic rhinosinusitis with polyposis

Treatment: Dupixent syringe 300 milligram (mg) / 2 milliliter (ml) syringe

The insurer denied coverage for Dupixent syringe 300 milligram (mg) / 2 milliliter (ml) syringe

The denial is overturned.

 
The medical records indicate the patient presented with chronic rhinosinusitis with polyposis. The patient has a history of significant nasal congestion with recurrent infections and is documented to have a loss of taste and smell. He demonstrated a history of polyps on examination. The patient underwent nasal polypectomy five (5) or six (6) years ago. He tried Xhance for three (3) months, without lasting benefit. The patient is reported to have "responded to all prior oral steroids"; however, he was said to have a return of his symptoms after a few months of discontinuation of those medications. 

The patient is currently being treated with Dupixent along with Mometasone and has shown clinical stability with an improvement in nasal congestion as well as a return of his taste and smell. 

The patient has seen a relief in his negative symptoms with the use of Dupixent in conjunction with Mometasone. He is said to have had a decrease in nasal congestion and an increase in his taste and smell. As such, the request for continuation of therapy with Dupixent is medically necessary and supported by current medical literature. 

"Among adults with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids, the addition of subcutaneous dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced endoscopic nasal polyp burden after 16 weeks." (Bachert, C., et al., 2016).

According to the Food and Drug Administration (FDA) Prescribing Label For Dupixent, "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Chronic Rhinosinusitis with Nasal Polyposis - as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)"

"Chronic rhinosinusitis (CRS) refractory to medical and surgical treatment is challenging. It impacts patients' quality of life significantly. The pathophysiology of CRS has some similarities to allergic asthma and allergic rhinitis (AR) and includes eosinophilia, T-helper cell 2 cytokines, and local immunoglobulin E formation. Monoclonal antibody therapy has been used successfully in asthma and AR and more recently in CRS. Our was aim to systematically review the literature and identify the role of monoclonal antibodies (MAbs) in the treatment of CRS with polyps (CRSwNP) and without polyps (CRSsNP), especially with regard to comparability with current medical treatment, efficacy, and risk of complications. In addition, the role of surgery and biologics was evaluated..Dupilumab treatment resulted in a 70% (percent) reduction in EPS compared with 20% in the placebo group." (Iqbal, I. Z., Kao, S. S., & Ooi, E. H.(2020).


Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Dupixent syringe 300 milligram (mg) / 2 milliliter (ml) syringe is substantiated.