Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Rhinosinusitis.

Treatment: Xhance (fluticasone propionate 93 micrograms [mcg]/actuation) nasal spray.

The insurer denied coverage for Xhance (fluticasone propionate 93 micrograms [mcg]/actuation) nasal spray.

The denial is overturned.

According to the medical records, the patient presented with chronic rhinosinusitis with polyposis. The patient has previously had a bilateral Functional endoscopic sinus surgery (FESS) with septoplasty and turbinate reduction. Since that time, the patient has been monitored for polyp recurrence. The patient has trialed multiple types of nasal steroids and medications without benefit. The request is to determine if Xhance is medically necessary.

Xhance is medically necessary for the patient. The claimant has failed extensive medical therapy including multiple types of the listed nasal steroids. This medication is indicated for refractory sinusitis with polyposis:

According to Wu et al (2022), "Of the initial 108 abstracts reviewed, 4 full-text articles were included. The 22-item sinonasal outcome test scores were significantly decreased in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) after receiving exhalation delivery system with fluticasone (EDS-FLU) twice a day (93, 186, or 372 g) for 16 weeks when compared with exhalation delivery system (EDS)-placebo (all P < .001). Patients with CRSwNP reported significant improvement of smell after receiving twice daily EDS-FLU twice a day (93, or 372 g) for 4 weeks when compared with EDS-placebo (all P < .05). The proportions of patients achieving >=1-point improvement in total polyp grade were significantly higher in EDS-FLU group and dose-dependent, with the highest rates in the 372-g group. The proportions of patients achieving polyp elimination were significantly higher in EDS-FLU group with the highest rates in the 372-g group."

According to Sindwani et al (2019), "All EDS-FLU doses produced significant improvement in both coprimary endpoints ( P < .05) and in Sino-Nasal Outcome Test (SNOT-22) total score ( P <= .005). EDS-FLU significantly improved all 4 cardinal symptoms of nasal polyps (NP) ( P < .05), including congestion/obstruction, facial pain/pressure, rhinorrhea/post-nasal drip, and hyposmia/anosmia. Approximately 80% of subjects reported improvement with EDS-FLU, with 65% reporting "much" or "very much" improvement by week 16. Adverse events were generally local in nature and similar to other intranasal steroids studied for similar durations in similar populations, with the most common being epistaxis."

According to Ow et al (2023), "Patients with prior ESS (exhalation delivery system-placebo [n = 53], EDS-FLU 186 g [n = 52], and EDS-FLU 372 g [n = 49]) and unoperated patients (exhalation delivery system-placebo [n = 108], EDS-FLU 186 g [n = 108], and EDS-FLU 372 g [n = 111]) treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptom and quality-of-life/functioning outcomes (congestion score, 22-Item Sinonasal Outcomes Test [SNOT-22], Rhinosinusitis Disability Index [RSDI], Patient Global Impression of Change) and by nasal polyp grade. In previously operated patients, unlike surgery-naive patients, multiple outcomes (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose."                                                         

Based on the above, the insurer's denial must be reversed. 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 Xhance (fluticasone propionate 93 micrograms [mcg]/actuation) nasal spray is substantiated.