Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Nasal Polyps
Treatment: Xolair (J2357) x (times) 181
The insurer denied Xolair (J2357) x 181.
The denial is overturned.

The patient is an adult male with a history of mast cell activation syndrome (MCAS) and chronic rhinosinusitis with nasal polyps (CRSwNP). With respect to the nasal symptoms, he has bilateral nasal congestion. He has a history of neurofibromatosis affecting the upper and lower extremities. The patient also has a history of asthma, chronic migraine, cervical dystonia, and orofacial dystonia. He has a history of functional rhinoplasty. The reports indicate the patient has a history of multiple recurrent nasal polyposis. He has trialed cromolyn but did not see a difference in symptoms. He has also trailed Singulair, inhaled steroids, and oral steroids. Omalizumab injections (Xolair) were recommended. The patient had one dose and reported improvement in the nasal congestion. These were denied on account of medical necessity was not demonstrated related to the absence of polyps below the lower border of the middle turbinate or beyond in each nostril, or having a Meltzer clinical score of 2 plus (+) in both nostrils, or endoscopic nasal polyp score of at least five with a minimum score of two for each nostril.

The requested health service is medically necessary.

Omalizumab, commonly known as Xolair, is primarily used for severe asthma and chronic idiopathic urticaria but has off-label applications in other conditions such as chronic rhinosinusitis with nasal polyps (CRSwNP). The patient has a complex medical history including mast cell activation syndrome (MCAS), chronic rhinosinusitis with nasal polyps, neurofibromatosis, asthma, chronic migraine, cervical dystonia, and orofacial dystonia. Chronic rhinosinusitis with nasal polyps can cause significant nasal congestion, impacting quality of life. The history of functional rhinoplasty and recurrent nasal polyposis suggests a persistent, severe form of chronic rhinosinusitis with nasal polyps. The patient has trialed cromolyn, Singulair, inhaled steroids, and oral steroids without significant improvement. XOLAIR (omalizumab) has demonstrated efficacy in treating nasal polyps, particularly in patients with chronic rhinosinusitis with nasal polyps who have not responded adequately to intranasal corticosteroids. This was shown in two randomized phase 3 trials, POLYP 1 and POLYP 2, where omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes. The initial dose of omalizumab led to reported improvement in nasal congestion, indicating a positive response. The denial of further omalizumab injections was based on the absence of polyps below the lower border of the middle turbinate or an endoscopic nasal polyp score not meeting the threshold. These criteria, while standard, may not encompass all clinical scenarios where omalizumab could be beneficial, especially in complex cases like this where multiple comorbidities exist. Omalizumab effectiveness in this case is evidenced by reported symptom improvement. Given the refractory nature of the patient's chronic rhinosinusitis with nasal polyps to standard treatments, omalizumab injections are considered a medically necessary next step, especially in the context of improving quality of life and managing symptoms more effectively. While omalizumab's use in chronic rhinosinusitis with nasal polyps is off-label, its application should be considered based on the patient's unique clinical scenario and response to other treatments. The patient's complex medical history, inadequate response to conventional therapies, and initial positive response to omalizumab suggest that these injections are medically necessary in this specific case. It would be prudent to consider a tailored approach, taking into account the patient's overall medical condition and the potential for significant symptomatic relief with omalizumab therapy.