Choo Coleen Siew Bee, Yong Yee Vern, Chandriah Haarathi, Ahmad Nur Sufiza
Pharmaceutical Services Programme, Ministry of Health MalaysiaPetaling Jaya, Malaysia.
Dato' Keramat Primary Healthcare Clinic, Ministry of Health MalaysiaKuala Lumpur, Malaysia.
Int J Technol Assess Health Care. 2024 Dec 5;40(1):e69. doi: 10.1017/S0266462324000643.
Ministry of Health (MOH) Malaysia stakeholders seek primary care access to sodium-glucose cotransporter 2 inhibitor (SGLT2i). Addressing this required a complex decision, selecting among three SGLT2i for two different indications and two practice settings. The options include expanding the existing SGLT2i (empagliflozin) in the MOH Medicines Formulary to primary care and/or having dapagliflozin and/or luseogliflozin as alternatives. This study aimed to conduct a multiple health technology assessment (HTA) to determine the SGLT2i of choice for the MOH setting.
The clinical benefits of SGLT2i were assessed through a systematic literature review and affordability was assessed through the development of three budget impact analysis models simulating seventy scenarios. Each model varied by prescribing indications, restrictions, and SGLT2i involved (M1: glycemic control, HbA1c between 6.5 percent and 10 percent, empagliflozin-dapagliflozin-luseogliflozin; M2: cardiovascular benefits, HbA1c less than 10 percent, empagliflozin-dapagliflozin; M3: a composite of M1 and M2). The outcome of the HTA was presented to the MOH decision-makers.
Although there was no significant difference in glycemic control between the SGLT2i, differences exist in cardiovascular benefits conferred. Despite having scenarios with lower net budget impact (NBI) in the M1, M2, and M3 models, decision-makers decided to expand empagliflozin use to primary care setting and add dapagliflozin for hospital-only setting for both indications [NBI of $4.38 mil] due to empagliflozin's advantage in reducing risk for cardiovascular death and prior experience of its use in MOH.
The multiple HTA approach guided the complex decision-making process by providing a holistic understanding of the decision's impact.
马来西亚卫生部的利益相关者寻求在初级保健中使用钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）。要解决这个问题需要做出复杂的决策，要在三种SGLT2i中为两种不同适应症和两种实践环境进行选择。这些选择包括将卫生部药品处方集里现有的SGLT2i（恩格列净）扩展到初级保健领域，和/或使用达格列净和/或鲁格列净作为替代方案。本研究旨在进行多项卫生技术评估（HTA），以确定卫生部环境下的首选SGLT2i。
通过系统的文献综述评估SGLT2i的临床益处，并通过开发三个预算影响分析模型模拟70种情况来评估可承受性。每个模型因处方适应症、限制条件和所涉及的SGLT2i而有所不同（模型1：血糖控制，糖化血红蛋白在6.5%至10%之间，恩格列净-达格列净-鲁格列净；模型2：心血管益处，糖化血红蛋白低于10%，恩格列净-达格列净；模型3：模型1和模型2的综合）。HTA的结果提交给了卫生部决策者。
虽然SGLT2i之间在血糖控制方面没有显著差异，但在心血管益处方面存在差异。尽管在模型1、模型2和模型3中存在净预算影响（NBI）较低的情况，但决策者决定将恩格列净的使用扩展到初级保健环境，并在两种适应症的仅医院环境中添加达格列净（NBI为438万美元），因为恩格列净在降低心血管死亡风险方面具有优势，且卫生部此前有其使用经验。
多项HTA方法通过提供对决策影响的全面理解，指导了复杂的决策过程。
