Background

As-needed budesonide/formoterol is effective in patients with mild asthma for whom low-dose inhaled corticosteroid (ICS) maintenance therapy is appropriate. We assessed the cost-effectiveness of this regimen versus maintenance low-dose ICS plus as-needed short-acting β2-agonist (SABA).

Methods

A probabilistic Markov cohort model was developed that simulated time within/outside severe asthma exacerbations, conducted from a UK NHS perspective with a 70-year time horizon. Clinical efficacy inputs were derived from the SYGMA 2 trial. Patients with mild asthma eligible for low-dose maintenance ICS therapy received as-needed budesonide/formoterol 200/6 μg or twice-daily budesonide 200 μg maintenance therapy plus as-needed terbutaline 0.5 mg. A severe exacerbation was defined as worsening asthma requiring systemic corticosteroid use alone/in combination with an emergency department visit, or hospitalisation for acute asthma. Utility values were derived from SYGMA 2 EQ-5D-5L data, and all-cause- and asthma-related mortality, reduction in utility of an exacerbation, and costs were based on published data. The base-case analysis discount rate was 3.5%. Model robustness was evaluated with one-way sensitivity, probabilistic sensitivity, and two scenario analyses.

Results

On average, as-needed budesonide/formoterol was associated with a £292.99 cost saving and quality-adjusted life year (QALY) gains of 0.001 versus ICS + SABA. At a willingness-to-pay of £20,000/QALY, as-needed budesonide/formoterol had >85% probability of being cost-effective versus ICS + SABA. Key drivers were budesonide/formoterol and budesonide maintenance annual exacerbation rates, mean daily budesonide/formoterol inhalations, and costs and outcomes discount rates.

Conclusions

From a UK healthcare payer perspective, as-needed budesonide/formoterol is a cost-effective option for the treatment of mild asthma versus regular ICS.

中文翻译：

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在英国轻度哮喘患者中，按需使用布地奈德/福莫特罗与低剂量吸入糖皮质激素维持治疗的成本效益比较。

背景

必要的布地奈德/福莫特罗在轻度哮喘患者中有效，因此低剂量吸入皮质类固醇（ICS）维持疗法是合适的。我们评估了该方案相对于维持低剂量ICS加需要的短效β2-激动剂（SABA）的成本效益。

方法

建立了概率马尔可夫队列模型，该模型从英国NHS的角度出发，以70年的时间跨度模拟了严重哮喘加重前后的时间。临床功效输入来自SYGMA 2试验。有资格接受低剂量维持ICS治疗的轻度哮喘患者接受了按需使用的布地奈德/福莫特罗200/6μg或每日两次布地奈德200μg维持治疗加按需的特布他林0.5 mg。严重加重定义为哮喘加重，需要单独使用全身性糖皮质激素/结合急诊就诊或急性哮喘住院治疗。效用值是根据SYGMA 2 EQ-5D-5L数据得出的，所有原因和哮喘相关的死亡率，加重效用的降低以及成本均基于已发布的数据。基本案例分析的折现率为3.5％。使用单向敏感性，概率敏感性和两种方案分析来评估模型的鲁棒性。

结果

平均而言，与ICS + SABA相比，按需使用布地奈德/福莫特罗可节省292.99英镑的成本，并获得质量调整的生命年（QALY）0.001。愿意支付的费用为£20,000 / QALY，相对于ICS + SABA，所需的布地奈德/福莫特罗具有85％的成本效益可能性。关键驱动因素是布地奈德/福莫特罗和布地奈德维持率的年度恶化，平均每日布地奈德/福莫特罗吸入量以及成本和结果折现率。

结论

从英国医疗保健付款人的角度来看，与常规ICS相比，按需使用布地奈德/福莫特罗是治疗轻度哮喘的一种经济高效的选择。