Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic idiopathic urticaria.
Treatment: Xolair dosed 300mg (milligrams) every 14 days
The insurer denied Xolair dosed 300mg every 14 days.
The denial is overturned.

The patient is an adult female. The request is for Xolair for CIU (chronic idiopathic urticarial) dosed with 300 mg (milligrams) every 14 days. She has improved with therapy, but a higher dose is requested.

The health plan should not cover the requested health service.

The maximum dose for Xolair is 300 mg (milligrams) every four weeks per the FDA (United States Food and Drug Administration) indication.

There is no robust support for the use of Xolair at higher doses or increased frequency intervals per the medical literature. 

Metz M et al (2014) performed a retrospective clinical analysis to assess responder rates, optimal dosage, response to up-/downdosing, time to relief of symptoms, rates of return and time of relapse after omalizumab administration, and safety in 51 CU (chronic urticarial) patients. The authors noted that the optimum interval between doses was 4 weeks in 15 patients while the interval could be extended to 68 weeks in 4 patients but in 1 patient it had to be shortened to two weeks because of the reappearance of symptoms. Of 15 patients with a starting dose of 150 mg (milligrams) every 4 weeks, only 2 required up-dosing to achieve complete remission. In a further 5 patients, the minimum effective dose of omalizumab was 300 mg (milligrams) given every 3 or 4 weeks. However, this study is limited by its retrospective nature.

Groffik A et al (2011) treated 9 patients with Xolair. Of the 9 patients, 3 required doses of 300 mg (milligrams) twice monthly. However, this study is limited by a small number of patients.

A small phase II study evaluated omalizumab in patients aged 12 to 75 years in the United States and 18 to 75 years in Germany with a UAS (urticaria activity score) over 7 days (UAS7) of 12 or greater despite antihistamine therapy. Patients were randomized 1:1:1:1 to receive a single subcutaneous dose of 75, 300, or 600 mg (milligrams) of omalizumab or placebo added to a stable dose of H(1)-antihistamine. Ninety patients from the United States or Germany were enrolled. Both the 300-mg (milligrams) omalizumab group (-19.9 vs -6.9, P < .001) and the 600-mg (milligrams) omalizumab group (-14.6 vs -6.9, P = .047) showed greater improvement versus the placebo group in UAS7 (7-day urticaria activity score). No meaningful difference was observed for the 75-mg (milligrams) omalizumab group. Similar results were seen for key secondary endpoints of weekly hive and itch scores. The onset of the effect occurred after 1 to 2 weeks. Omalizumab was well tolerated, and the incidence of adverse events was similar across treatment groups. The authors concluded that this study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU (chronic idiopathic urticarial) in patients who are symptomatic despite treatment with H(1)-antihistamines. However, the frequency of this study was every 4-week dosing and it was a small study.

Tonnacci et al performed a systematic review of the literature to identify studies that evaluated the efficacy of omalizumab for the treatment of chronic idiopathic urticaria, in both controlled and real-world settings, to assess its potential role as a preferred therapy. The search was limited to articles published in peer-reviewed journals in the English language, and 29 studies were included in this review. Omalizumab 300 mg (milligrams) administered every 4 weeks appears to be the most effective and safe dosage, with a rapid response time, for the treatment of chronic idiopathic urticaria, with few minor adverse effects.

Therefore, the current evidence-based literature does not support the use of Xolair 300 mg (milligrams) every 2 weeks for the treatment of CIU (chronic idiopathic urticarial).