Cost-Utility and Budget Impact Analysis of Adding SGLT-2 Inhibitors to Standard Treatment in Type 2 Diabetes Patients with Heart Failure: Utilizing National Database Insights from Thailand.

BACKGROUND: Heart failure (HF) in type 2 diabetes (T2D) patients poses a significant clinical and financial burden. While sodium-glucose cotransporter-2 inhibitors (SGLT2i) have shown cardiovascular benefits in trials, they are not included in Thailand's National List of Essential Medicines (NLEM), and their value-for-money remains unassessed. OBJECTIVE: This study aims to evaluate the cost-utility of adding SGLT2i to the standard treatment for T2D-HF patients in Thailand. METHODS: A Markov model with 3-month cycles and a lifetime horizon was conducted from a societal perspective. Efficacy data came from a systematic review and meta-analysis. Transition probabilities and direct medical costs were derived from the National Health Security Office database, while direct non-medical costs and utility were collected through patient interviews at Siriraj hospital to reflect Thailand's context. The main outcomes were incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). A sensitivity and budget impact analysis were also performed. RESULTS: Canagliflozin led to the highest increase in QALYs, at 1.21 years, followed by dapagliflozin (0.54 years) and empagliflozin (0.06 years). Collectively, SGLT2i yielded an increase of 0.41 QALYs. Canagliflozin incurred the highest additional treatment cost at United States dollars (US$)5600, followed by dapagliflozin (US$3547) and empagliflozin (US$2694). The ICERs for canagliflozin, dapagliflozin, empagliflozin, and overall SGLT2i were US$4632, US$6430, US$48,952, and US$8480 per QALY gained, respectively. SGLT2i were not cost-effective compared with Thailand's willingness-to-pay threshold of US$4564 per QALY gained. However, threshold analysis indicates that the costs of canagliflozin, dapagliflozin, empagliflozin, and overall SGLT-2i should be reduced by 2.3%, 38.2%, 90.2%, and 55.6%, respectively, to be cost-effective. Budget impact analysis revealed that the total budget for treating T2D patients with HF over 5 years is US$15.6 million. CONCLUSIONS: Adding SGLT2i to standard treatment reduced HF hospitalization and mortality rates and improved QALYs in T2D-HF patients. Nevertheless, they would not be cost-effective at current prices in Thailand.

Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials.

Background: In patients with type 2 diabetes (T2D) and a history of heart failure (HF), sodium-glucose cotransporter-2 inhibitors (SGLT2is) have demonstrated cardiovascular (CV) benefits. However, the comparative efficacy of individual SGLT2is remains uncertain. This network meta-analysis (NMA) compared the efficacy and safety of five SGLT2is (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin) on CV outcomes in these patients. Materials and methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched up to September 23, 2022, to identify all randomized controlled trials (RCTs) comparing SGLT2is to placebo in T2D patients with HF. The main outcomes included composite CV death/heart failure hospitalization (HFH), HFH, CV death, all-cause mortality, and adverse events. Pairwise and NMA approaches were applied. Results: Our analysis included 11 RCTs with a total of 20,438 patients with T2D and HF. All SGLT2is significantly reduced HFH compared to standard of care (SoC) alone. "Add-on" SGLT2is, except ertugliflozin, significantly reduced composite CV death/HFH relative to SoC alone. Moreover, canagliflozin had lower composite CV death/HFH compared to dapagliflozin. Based on the surface under the cumulative ranking curve (SUCRA), the top-ranked SGLT2is for reducing HFH were canagliflozin (95.5%), sotagliflozin (66.0%), and empagliflozin (57.2%). Head-to-head comparisons found no significant differences between individual SGLT2is in reducing CV death. "Add-on" SGLT2is reduced all-cause mortality compared with SoC alone, although only dapagliflozin was statistically significant. No SGLT2is were significantly associated with serious adverse events. A sensitivity analysis focusing on HF-specific trials found that dapagliflozin, empagliflozin, and sotagliflozin significantly reduced composite CV death/HFH, consistent with the main analysis. However, no significant differences were identified from their head-to-head comparisons in the NMA. The SUCRA indicated that sotagliflozin had the highest probability of reducing composite CV death/HFH (97.6%), followed by empagliflozin (58.4%) and dapagliflozin (44.0%). Conclusion: SGLT2is significantly reduce the composite CV death/HFH outcome. Among them, canagliflozin may be considered the preferred treatment for patients with diabetes and a history of heart failure, but it may also be associated with an increased risk of any adverse events compared to other SGLT2is. However, a sensitivity analysis focusing on HF-specific trials identified sotagliflozin as the most likely agent to reduce CV death/HFH, followed by empagliflozin and dapagliflozin. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022353754.

Selecting topic areas for developing quality standards in a resource-limited setting.

Variation in practices of and access to health promotion and disease prevention (P&P) across geographical areas have been studied in Thailand as well as other healthcare settings. The implementation of quality standards (QS)-a concise set of evidence-informed quality statements designed to drive and measure priority quality improvements-can be an option to solve the problem. This paper aims to provide an overview of the priority setting process of topic areas for developing QS and describes the criteria used. Topic selection consisted of an iterative process involving several steps and relevant stakeholders. Review of existing documents on the principles and criteria used for prioritising health technology assessment topics were performed. Problems with healthcare services were reviewed, and stakeholder consultation meetings were conducted to discuss current problems and comment on the proposed prioritisation criteria. Topics were then prioritised based on both empirical evidence derived from literature review and stakeholders' experiences through a deliberative process. Preterm birth, pre-eclampsia and postpartum haemorrhage were selected. The three health problems had significant disease burden; were prevalent among pregnant women in Thailand; led to high mortality and morbidity in mothers and children and caused variation in the practices and service uptake at health facilities. Having agreed-on criteria is one of the important elements of the priority setting process. The criteria should be discussed and refined with various stakeholders. Moreover, key stakeholders, especially the implementers of QS initiative, should be engaged in a constructive way and should be encouraged to actively participate and contribute significantly in the process.