Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
Hospital Seri Manjung, Ministry of Health Malaysia, Seri Manjung, Perak, Malaysia.
PLoS One. 2024 Aug 23;19(8):e0305257. doi: 10.1371/journal.pone.0305257. eCollection 2024.
Empagliflozin demonstrates promising clinical benefits in patients with heart failure (HF). While an early study demonstrates that empagliflozin is cost-effective for treating HF patients with reduced ejection fraction (HFrEF) in Malaysia, its cost-effectiveness for HF with ejection fraction (EF)>40% remains unclear. Therefore, the current study aimed to assess the cost-effectiveness of adding empagliflozin to the standard of care (SoC) for HF patients with EF>40% from the perspective of Malaysian healthcare system. Subsequently, the results were consolidated with the findings for HFrEF to evaluate the cost-effectiveness of empagliflozin when used for all HF patients in Malaysia, irrespective of EF.
A cost-utility analysis was performed using a validated Markov model, which modelled a cohort of adult patients through health states related to symptom severity and functional impairment, to estimate costs and quality-adjusted life-years (QALYs). The influence of model inputs and assumptions, sensitivity, scenario, and subgroup analyses were explored. All costs were expressed in 2022 Malaysian ringgits (RM). Costs and QALYs were discounted at an annual rate of 3.0% as per local pharmacoeconomic guideline.
The base-case incremental cost-effectiveness ratio (ICER) for HF patients with EF>40% was RM 40,454 per QALY gained. At a cost-effectiveness threshold of RM 47,439/QALY gained, empagliflozin was cost-effective in 57% of replications. The model outcomes were sensitive to inputs related to the treatment effect of empagliflozin in reducing HF-related hospitalisation and cardiovascular mortality, and empagliflozin cost. For the overall HF population, the ICER was RM 29,463/QALY gained.
The findings suggest that empagliflozin is a cost-effective treatment option for the Malaysian HF population, including those with EF>40%. As such, the intervention warrants consideration by the Malaysian healthcare provider to mitigate the burden of HF and address the unmet needs of the EF>40% population.
恩格列净在心力衰竭（HF）患者中显示出有前景的临床获益。虽然早期的一项研究表明，在马来西亚，恩格列净对于治疗射血分数降低的心力衰竭（HFrEF）患者具有成本效益，但对于射血分数（EF）>40%的心力衰竭患者的成本效益仍不清楚。因此，本研究旨在从马来西亚医疗保健系统的角度评估将恩格列净添加到标准治疗（SoC）中治疗 EF>40%的心力衰竭患者的成本效益。随后，将结果与 HFrEF 的研究结果合并，以评估恩格列净在马来西亚所有心力衰竭患者中的成本效益，无论 EF 如何。
使用经过验证的马尔可夫模型进行成本效用分析，该模型通过与症状严重程度和功能障碍相关的健康状态对成年患者队列进行建模，以估计成本和质量调整生命年（QALYs）。探讨了模型输入和假设、敏感性、情景和亚组分析的影响。所有成本均以 2022 年马来西亚林吉特（RM）表示。根据当地药物经济学指南，成本和 QALYs 以每年 3.0%的贴现率贴现。
EF>40%的心力衰竭患者的基础病例增量成本效益比（ICER）为每获得 1 个 QALY 需花费 40454 林吉特。在成本效益阈值为 47439 林吉特/QALY 时，恩格列净在 57%的复制中具有成本效益。模型结果对与恩格列净降低心力衰竭相关住院和心血管死亡率以及恩格列净成本相关的治疗效果输入敏感。对于整个 HF 人群，ICER 为每获得 1 个 QALY 需花费 29463 林吉特。
研究结果表明，恩格列净是马来西亚 HF 人群的一种具有成本效益的治疗选择，包括 EF>40%的人群。因此，该干预措施值得马来西亚医疗保健提供者考虑，以减轻 HF 的负担，并解决 EF>40%人群的未满足需求。
