Anthony Russell Villanueva

Chronic kidney disease (CKD) affects a significant proportion of the population leading to a substantial economic burden on healthcare systems and societies. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have been shown to slow CKD progression and reduce cardiovascular risks in patients regardless of their diabetes status, leading to cost-savings and health benefits for patients with CKD. Currently, published cost-effectiveness studies in the UK and Southeast Asia demonstrate a significantly high value of adding empagliflozin in CKD management. This study aims to simulate a CKD progression model to assess the cost-effectiveness of adding empagliflozin to the standard of care (SoC) compared to SoC alone for CKD management in the Philippines. We conducted an individual microsimulation model of CKD progression and its related complications using annual cycles from a healthcare perspective. The simulation incorporated local costs, life tables, and utility values derived from local and best available evidence from published CKD literature. The addition of empagliflozin to the SoC leads to significant lifetime cost-savings per patient of PHP 8,360,571.52 (USD 146,986.14) for the full cohort of the CKD population, PHP 7,944,677.72 (USD 139,674.36) for the diabetic cohort, and PHP 9,339,394.50 (USD 164,194.70) for the non-diabetic cohort. Patients on empagliflozin also experienced higher quality-adjusted life years (QALYs) of 0.84, 0.90, and 0.78 for the full, diabetic, and non-diabetic cohorts, respectively. Adding empagliflozin to the SoC is economically dominant across willingness-to-pay (WTP) thresholds ranging from 0.5 to 1 times the Philippine gross domestic product (GDP) per capita of 2024. Sensitivity analyses confirmed these findings, demonstrating consistency across varied input parameters. Empagliflozin is cost-saving and provides utility benefits when added to SoC among patients with CKD. This finding holds significant value for patients with CKD, regardless of diabetes status.

Heart Failure (HF) poses significant clinical and economic burden globally. Due to its progressive and chronic nature, HF requires both continuous medical management and acute care related to hospitalization. This study aimed to estimate the economic burden of HF in the Philippines, covering both outpatient care and inpatient management. The study utilized a bottom-up micro-costing approach to determine the economic burden of heart failure with mildly reduced ejection fraction (HFmrEF)/heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) across all NYHA classifications using a societal perspective. Price data were gathered from clinical experts, public and private hospitals, while quantity and probability assumptions were derived from published literature, subsequently validated through clinical expert consensus. In 2022, an estimated 914,892 individuals were diagnosed with HF in the Philippines, based on a prevalence rate of 0.82%. This equates to a total economic burden of PHP 80.9B (USD 1.5B). Direct costs accounted for 90% of the total burden at PHP 72.8B (USD 1.3B). Hospital and medication expenses represented 61% of the total cost-of-illness, amounting to PHP 49.2B (USD 887.6M). HF management poses significant burden-of-disease for Filipinos. The annual societal costs of HF management potentially expose Filipinos to catastrophic health spending and impoverishment, especially in a system where a substantial portion of healthcare expenses are paid out-of-pocket. These findings highlight the urgent need to prioritize preventive public health interventions and enhance financial risk protection for HF patients.

Empagliflozin confers cardioprotective benefits among patients with heart failure, across the range of ejection fraction (EF), regardless of type 2 diabetes status. The long-term cost-effectiveness of empagliflozin for the treatment of heart failure (HF) in the Philippines remains unclear. This study aims to determine the economic benefit of adding empagliflozin to the standard of care (SoC) vs the SoC alone for HF in the Philippines. Using a Markov model, we predicted lifetime costs and clinical outcomes associated with treating HF in the Philippine setting. We used estimates of treatment efficacy, event probabilities, and derivations of utilities from the EMPEROR trials. Costs were derived from hospital tariffs and expert consensus. Separate analyses were performed for patients with left ventricular EF >40%, categorized under mid-range ejection fraction or preserved ejection fraction (HFmrEF/HFpEF), and patients with left EF ≤ 40%, categorized under HF with reduced ejection fraction (HFrEF). Our model predicted an average of 0.09 quality-adjusted life year (QALY) gains among HFmrEF/HFpEF patients and HFrEF patients when empagliflozin was compared to SoC. The addition of empagliflozin in the treatment results in a discounted incremental lifetime cost of PHP 62,692 (USD 1,129.99) and PHP 17,215 (USD 308.67) for HFmrEF/HFpEF and HFrEF, respectively. The incremental cost-effectiveness ratio (ICER) of empagliflozin is PHP 198,270 (USD 3,570.72)/QALY and PHP 742,604 (USD 13,385.08)/QALY for HFrEF and HFmrEF/HFpEF, respectively. This study employed parameters derived from short-term clinical trial data, alongside metrics representative of Asian populations, which are not specific to the Philippine cohort. Adding empagliflozin to the SoC in comparison to the SoC is associated with improved clinical outcomes and quality of life, at additional costs for both HFrEF and HFmrEF/HFpEF.

Background: IgA nephropathy is the most common primary GN. Clinical features of IgA nephropathy include proteinuria, which is the strongest known surrogate of progression to kidney failure. Complement pathway activation is a critical driver of inflammation and tissue injury in IgA nephropathy. Cemdisiran is an investigational RNA interference therapeutic that suppresses hepatic production of complement component 5 (C5), thereby potentially reducing proteinuria in IgA nephropathy. We evaluated the efficacy and safety of cemdisiran in adult patients with IgA nephropathy at high risk of kidney disease progression. Methods: In this phase 2, 36-week, double-blind study, adult patients with IgA nephropathy and urine protein ≥1 g/24 hours were randomized (2:1) to subcutaneous cemdisiran 600 mg or placebo every 4 weeks in combination with the standard of care. The primary end point was percentage change from baseline at week 32 in urine protein-to-creatinine ratio (UPCR) measured by 24-hour urine collection. Additional end points included change from baseline in UPCR measured by spot urine, serum C5 level, and safety assessments. Results: Thirty-one patients were randomized (cemdisiran, N =22; placebo, N =9). Cemdisiran-treated patients had a placebo-adjusted geometric mean change in 24-hour UPCR of –37.4% (cemdisiran-adjusted geometric mean ratio to baseline [SEM], 0.69 [0.10]) at week 32. Spot UPCR was consistent with 24-hour UPCR placebo-adjusted change of –45.8% (cemdisiran-adjusted geometric mean ratio to baseline [SEM], 0.73 [0.11]). Mean (SD) change in serum C5 level from baseline at week 32 was –98.7% (1.2) with cemdisiran and 25.2% (57.7) with placebo. Over 36 weeks, most adverse events were mild or moderate and transient; the most common adverse event after cemdisiran treatment was injection-site reaction (41%). Conclusions: These findings indicate that treatment with cemdisiran resulted in a reduction of proteinuria at week 32 and was well tolerated.