Aims: To evaluate the cost-effectiveness of standard-of-care treatment (SoC) to SoC in combination with omalizumab (OML + Soc) in patients with severe asthma using real-world prospective clinical data from four major medical centers in Turkey.
Materials and methods: Between February 2018 and November 2019, a total of 206 patients with severe asthma, including 126 of whom were in the OML + SoC group and 80 in the SoC group, were followed for 12 months to evaluate their asthma status and quality of life. Cost data for this patient-level economic evaluation were sourced from the MEDULA database of the hospitals and expressed in Turkish Lira (₺). Efficacy data were obtained by means of Turkish versions of the Asthma Control Test for asthma status, the 5-level EQ-5D-5L version (EQ-5D-5L), and the Asthma Quality of Life Scale for quality of life. A Markov model with 2-week cycles was specified, comparing costs and treatment effects of SoC vs. OML + SoC over a lifetime from the Turkish payer perspective.
Results: Per-patient costs were ₺23,607.08 in the SoC arm and ₺425,329.81 in the OML + Soc arm, for a difference of ₺401,722.74. Life years (LY) and quality-adjusted life years (QALY) were 13.60 and 10.08, respectively, in the SoC group; and 21.26 and 13.35, respectively, in the OML + SoC group, for differences of 7.66 LYs and 3.27 QALYs. This yielded an incremental cost-effectiveness ratio of an additional ₺52,427.04 to gain 1 LY and an incremental cost-utility ratio of an incremental ₺122,675.57 to gain 1 QALY; the latter being below the ₺156,948 willingness-to-pay threshold for Turkey referenced by WHO. One-way and multivariate sensitivity analyses confirmed the base-case results.
Conclusion: Whereas most economic evaluations are based on aggregate data, this independent cost-effectiveness analysis using prospective real-world patient-level data suggests that omalizumab in combination with standard of care is cost-effective for severe asthma from the Turkish public payer perspective.
Keywords: C1; C15; I; I1; I19; Severe asthma; cost-effectiveness analysis; omalizumab; quality of life; real-world data.
What is the context? Severe asthma, a subset of difficult-to-treat asthma, refers to asthma that cannot be controlled despite adherence to optimized maximal therapy and treatment of contributing factors, or asthma that worsens when high-dose therapy is reduced.Omalizumab is the first biologic therapy approved for the treatment of allergic asthma. Its main role is to prevent the release of various inflammation factors that cause severe asthma episodes.Cost-effectiveness analysis is an economic method of determining how much more a new and better treatment costs relative to the current treatment in terms of how many life years (LY) and how many quality-adjusted life years (QALY) are gained with the new treatment. Cost-effectiveness results tell us how much more money is needed over the cost of the current treatment to achieve one additional LY, regardless of the quality of life, or one additional LY with good quality of life.No cost-effectiveness data obtained from actual clinical patient data are available for Turkey. What is new? Our study found that the addition of omalizumab to the current standard of care for severe asthma increases costs but also increases life years and quality-adjusted life years. The additional cost was less than what the World Health Organization assumes is reasonable for Turkey.This study used actual clinical patient data and noted that asthma patients in the omalizumab group used fewer health services, had a better clinical course, had a better quality of life, and lived longer with their disease under control.What is the impact? In severe asthmatic patients, adding omalizumab to standard-of-care, while more costly, yields better outcomes and is therefore cost-effective.The cost-effectiveness estimates fall within the margins of being cost-responsible. The Turkish public payer should strongly consider making omalizumab available to all eligible patients. This will enable working-age patients to work, and contribute to their families, while also strengthening the Turkish economy.