Analysis of the long‐term economic burden of omalizumab on patients with chronic spontaneous urticaria

Abstract

Omalizumab (OMA) is highly effective for refractory chronic spontaneous urticaria (CSU), but its high cost exerts a great economic burden on patients and society. Current knowledge is lacking regarding the economic impact of long-term administration of OMA on patients with CSU in the real-world setting. We retrospectively investigated drug costs relevant to CSU treatment during the period before through to 12 months after starting OMA in actual clinical practice. This study involved 32 patients who received at least two injections of OMA (300 mg/ 4 weeks) and achieved good responses of urticaria control test score of 12 or more and/or weekly urticaria activity score of 6 or less within 12 weeks. Median drug costs of the overall patient cohort increased from ¥14 496/ month to ¥104 522 after starting OMA, but reduced to ¥48 810 in 12 months along with reduced amount of OMA administration and concomitant medication use. In patients pretreated with antihistamine alone or plus alternative medicines such as H 2 blocker and antileukotriene prior to OMA, the increased drug costs by adding OMA decreased to approximately 30% in 12 months mainly due to the OMA dose reduction and interval extension of OMA. The drug cost reduction was also observed in patients pretreated with intensive multi-agents, due to discontinuation of expensive immunosuppressants. In conclusion, the introduction of OMA significantly increased the total drug costs relevant to CSU management, but the costs decreased to half in 12 months, along with dosereduced and interval-extended OMA and discontinued concomitant drugs in patients with CSU who responded well to OMA.

Basophils activation of patients with chronic spontaneous urticaria in response to C5a despite failure to respond to IgE-mediated stimuli

“…Furthermore, basophils migrate from blood vessels into the skin during wheal formation, and are suggested to contribute to the persistence of wheals in CSU ( 4 ). Rapid effect of omalizumab, an anti-IgE monoclonal antibody for the treatment of CSU also shows the importance of FcϵRI-dependent activation of basophils rather than mast cells ( 5 ). However, the number of peripheral blood basophils and the histamine releasing activities of peripheral basophils of healthy donors and patients with CSU in response to anti-IgE antibody (anti-IgE), an activator of the IgE-FcϵRI pathway, are significantly decreased (non- or low-responder) ( 6 ) ( 7 ).…”

Efficacy and safety of Tripterygium glycosides as an add-on treatment in adults with chronic urticaria: a systematic review and meta-analysis

“… 2021 ), the high cost of omalizumab and adverse effects of cyclosporin, including nephrotoxicity and elevated blood pressure, may limit their long-term use for the treatment of CU (Matsubara et al. 2021 ; Zuberbier et al. 2022 ).…”

Efficacy and safety of Runzao Zhiyang capsule for chronic urticaria: a systematic review and meta-analysis of randomized controlled trials

“…Other drugs, such as cyclosporine and systemic corticosteroids, can also be applied in cases resistant to H1 antihistamines and omalizumab (He et al, 2021). However, cyclosporine is not recommended as a standard treatment because of its systemic adverse effects, such as gastrointestinal symptoms, headache, nephrotoxicity, and elevated blood pressure (Matsubara et al, 2021;Zuberbier et al, 2022). The adverse effect of corticosteroids, such as infection, also limits their clinical application (Yao et al, 2015).…”