MO876ESTIMATING THE BUDGET IMPACT OF DAPAGLIFLOZIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE FROM A UK PAYER PERSPECTIVE*

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Oliver Darlington ◽  
Phil McEwan ◽  
Rebecca Boyce ◽  
Gengshi Chen ◽  
Becky Martin ◽  
...  

Abstract Background and Aims Chronic kidney disease (CKD) is a chronic and progressive disease which imposes a significant burden on patients and healthcare systems as the disease progresses, particularly in patients who reach end-stage kidney disease (ESKD). Dapagliflozin was established to be an efficacious treatment for CKD in the DAPA-CKD study, where it was associated with a significant reduction in the incidence of CKD progression, ESKD, hospitalization for heart failure (HHF) and death in comparison with standard care alone. A vital component of a new treatment's health economic evaluation is to assess its potential budget impact, particularly in conditions with high prevalence in the general population such as CKD. As such, this study's objective was to estimate the budget impact of introducing dapagliflozin for the treatment of CKD in the UK from an NHS perspective. Method A model was developed to estimate the three-year budget impact of the introduction of dapagliflozin in addition to standard care (angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers) vs. standard care alone for the treatment of CKD in the UK. The size of the eligible patient population was estimated based on overall CKD prevalence, and the proportion of all CKD patients who would have been eligible for inclusion in DAPA-CKD. In total, 929,000 patients were estimated to be eligible for treatment with dapagliflozin in the UK. The analysis assumed that 5% of CKD patients would receive treatment with dapagliflozin in the first year, increasing to 15% in the second year and 20% in the third year. The relative market share of individual components of background standard care was assumed to remain constant over time, with the distribution informed by the baseline characteristics from DAPA-CKD. Event rates from DAPA-CKD were used to predict the incidence of CKD progression (≥50% decline in estimated glomerular filtration rate), ESKD, HHF, acute kidney injury, hyperkalaemia and death to estimate cost-offsets associated with reduced event incidence. Published event and drug acquisition costs were applied to the incidence of modelled events. Results The introduction of dapagliflozin was estimated to reduce total three-year costs associated with CKD management by £114.0M, from £6.6B to £6.5B in the patient population eligible for treatment with dapagliflozin. Cost-savings were driven by a reduction in the incidence of CKD progression events (122.7K vs. 130.5K with and without the introduction of dapagliflozin, respectively), ESKD (99.2K vs. 103.8K) and HHF (44.2K vs. 41.3K) over a three-year time horizon. Cumulative three-year drug acquisition costs were estimated to increase by £177.4M following the introduction of dapagliflozin when used in addition to standard care. However, the cumulative cost-offsets associated with reduced incidence of clinical events was £291.3M over the three-year model time horizon, with reduced incidence of ESKD resulting in the largest cost-saving (£4.8B vs. £5.0B). Conclusion The introduction of dapagliflozin for the treatment of CKD is estimated to be cost-saving over a three-year horizon in comparison with standard care, even when considering additional drug acquisition costs. Dapagliflozin has the potential to significantly ameliorate the clinical and economic burden imposed by CKD on patients and the NHS.

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Ting-Ting Chung ◽  
Kuang-Hui Yu ◽  
Chang-Fu Kuo ◽  
Shue-Fen Luo ◽  
Meng-Jiun Chiou ◽  
...  

Abstract Background This study investigates the association between exposure to urate-lowering drugs (ULDs) and progression and recovery from chronic kidney disease (CKD). Methods We identified 5860 incident gout patients at Chang Gung Memorial Hospital from 2012 to 2015. Propensity score (PS)-weighted Cox proportional hazards model was used to estimate hazard ratios (HRs) for CKD progression and improvement. A separate analysis was conducted to assess the HR for CKD progression and CKD recovery among those with worsening CKD. Results The incidence of CKD progression among allopurinol, febuxostat and uricosuric agent users were 1.98, 1.88 and 1.64 per 1000 person-days. Compared with allopurinol users, the PS-weighted HR (95% confidence intervals [CIs]) was 1.77 (0.85–1.76) for febuxostat users and 1.37 (0.71–1.37) for uricosuric agent users for CKD progression and 1.43 (1.26–1.62) for febuxostat users and 1.00 (0.88–1.14) for uricosuric agent users for CKD improvement. Compared to allopurinol users, the HRs for CKD progression were 1.14 (0.80–1.66) for febuxostat users and 0.92 (0.67–1.31) for uricosuric agent users. Among 741 patients who had CKD progression, the incidence of CKD recovery was 1.33, 6.21 and 3.53 per 1000 person-days for allopurinol, febuxostat and uricosuric agent users. The HRs (95% CIs) for recovery in febuxostat and uricosuric agent users were 2.17 (1.40–3.47) and 1.80 (1.20–2.83) compared to allopurinol users. Conclusions CKD progression and recovery are common in gout patients using ULDs. Febuxostat and benzbromarone were associated with a similar risk of CKD progression with allopurinol, which has a poorer recovery compared with other ULDs.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Angela Rivera ◽  
Angelito Bernardo ◽  
Jasmin Vesga ◽  
Izcay Ronderos ◽  
Mauricio Sanabria

Abstract Background and Aims Chronic kidney disease (CKD) is a syndrome that today has important implications for the health of populations and the economic sustainability of health systems around the world, therefore strategies to slow disease progression are necessary. Aims: To estimate the incidence of renal replacement therapy (RRT) in a cohort of patients included in a CKD secondary prevention program and to describe the decrease of the estimated glomerular filtration rate (eGFR). Method This is a historical, multicenter, observational cohort study in a prevention program between January 1, 2010, and December 31, 2017, with follow-up until December 31, 2018, at the Renal Care Services (RCS) network. Socio-demographic and clinical characteristics of all patients were summarized descriptively. We estimated the incidence of RRT rate with Kaplan Meier analysis. Progression rate to RRT was analyzed by mixed-effects model adjusted for the eGFR reduction rate at 180 days; the model considered the diagnosis of diabetes. Results 7131 patients met the inclusion criteria for data analysis. The mean age was 65 years, 50.5% were female, (Table 1). There were 577 events of RRT with a rate of 2.02 events of RRT per 100 patients-year [95% CI,1.86 to 2.19], characteristics at the RRT initiation are presented in Table 2. At the beginning of the program the eGFR was 45.3 ml / min / 1.73m2 in non-diabetics, and 40.9 3 ml / min / 1.73m2 in diabetics. The CKD progression was - 0.48 ml / min / 1.73m2 per 180 days in diabetics and - 0.20 ml / min / 1.73m2 per 180 days in non-diabetics. The final events of the cohort are presented in Figure 1; the mortality rate was 0.89 events per 100 patients-year [95% CI, 0,79 to 1,01]. Conclusion This population of patients in a CKD prevention program presented a low rate of initiation of dialysis therapy and a slight decrease of eGFR; the diabetic status influences the CKD progression.


2021 ◽  
Vol 32 ◽  
pp. 100739
Author(s):  
Claire A Lawson ◽  
Samuel Seidu ◽  
Francesco Zaccardi ◽  
Gerry McCann ◽  
Umesh T Kadam ◽  
...  

2018 ◽  
Vol 19 (2) ◽  
pp. 190-207 ◽  
Author(s):  
Udo Klotzki ◽  
Alexander Bohnert ◽  
Nadine Gatzert ◽  
Ulrike Vogelgesang

Purpose Due to the continuing low interest rate environment as well as the increase in acquisition costs, price transparency, cost transparency and competition with banks, the cost of life insurance becomes increasingly important for customers, insurers and shareholders. Against this background, the purpose of this paper is to study the development of insurers’ economies of scale in regard to administrative costs for four of the largest European life insurance markets. Design/methodology/approach The analysis on economies of scale is based on a comprehensive set of 477 life insurers in Germany, Italy, Spain and the UK, yearly data between 2000 and 2014, and regression calculations that are based on 4,855 observations. Findings The results show that economies of scale exist for all considered markets and for most of the considered years. However, the extent of economies of scale varies considerably across countries. Originality/value Overall, the existing academic literature on costs and corresponding economies of scale in life insurance primarily deals with analyses of total costs instead of administrative costs, a single year or a single market. This paper contributes to the existing literature by conducting an analysis of recent market dynamics and economies of scale in regard to administrative costs for the period from 2000 and 2014 for four of the largest European life insurance markets for which the respective data were available (Germany, Italy, Spain and the UK) and 477 life insurers in total. This is done by means of a log-log transformation of premiums and costs and a fixed effects model based on these transformed figures for 4,855 observations. In addition, for each market, the authors analyze the development of administrative costs for a total of 477 insurers.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Ilter Bozaci ◽  
Ali Nazmi Can Doğan ◽  
Merve Aktar ◽  
Alev Mahşer ◽  
Gizem Yıldırım ◽  
...  

AbstractObjectivesMetabolic acidosis is a common disorder seen in course of chronic kidney disease (CKD). In this study, we aimed to investigate the association of Base excess (BE), Anion gap (AG) and Delta Ratio with progression of CKD, renal replacement therapy (RRT) requirement and mortality in patients with stage 3–5 CKD.MethodsA total of 212 patients with stage 3–5 CKD were included in this study. Patients were divided into two groups according to the baseline BE level. Patients were also grouped according to the delta ratio such as non- AG, High AG and mixed type.ResultsMean BE level was significantly lower (−4.7 ± 4.0 vs. −3.3 ± 4.3; p=0.02) in patients with CKD progression. The patients in group 1 (n: 130) (Be<−2.5) revealed more CKD progression (%53 vs. %32; p=0.002), and RRT requirement (%35 vs. %15; p=0.001). Baseline BE <−2.5 (odds ratio, 0.38; 95% CI, 0.16 to 0.91; p<0.05) and baseline GFR (odds ratio, 0.94; 95% CI, 0.90 to 0.97; p<0.001) were independently related to RRT requirement. Delta BE was independently associated with mortality (odds ratio, 0.90; 95% CI, 0.85–0.96; p<0.01).ConclusionsLow BE levels were associated with CKD progression and RRT requirement. BE change is associated with mortality during the follow-up of those patients.


2022 ◽  
pp. ASN.2021060757
Author(s):  
Sherry Mansour ◽  
Pavan Bhatraju ◽  
Steven Coca ◽  
Wassim Obeid ◽  
Francis Wilson ◽  
...  

Background The mechanisms underlying long-term sequelae following acute kidney injury (AKI) remain unclear. Vessel instability, an early response to endothelial injury, may reflect a shared mechanism and early trigger for chronic kidney disease (CKD) and heart failure. Methods To investigate whether plasma angiopoietins, markers of vessel homeostasis, are associated with CKD progression and heart failure admissions after hospitalization in patients with and without AKI, we conducted a prospective cohort study to analyze the balance between angiopoietin-1 (Angpt-1), which maintains vessel stability, and angiopoietin-2 (Angpt-2), which increases vessel destabilization. Three months after discharge, we evaluated the associations between angiopoietins and development of the primary outcomes of CKD progression and heart failure, as well as the secondary outcome of all-cause mortality 3 months after discharge or later. Results Median age for the 1503 participants was 65.8 years; 746 (50%) had AKI. Compared with the lowest quartile, the highest quartile of the Angpt-1:Angpt-2 ratio was associated with 72% lower risk of CKD progression (adjusted hazard ratio [aHR], 0.28; 95% confidence interval [95% CI], 0.15 to 0.51), 94% lower risk of heart failure (aHR, 0.06; 95% CI, 0.02 to 0.15), and 82% lower risk of mortality (aHR, 0.18; 95% CI, 0.09 to 0.35) for those with AKI. Among those without AKI, the highest quartile of Angpt-1:Angpt-2 ratio was associated with 71% lower risk of heart failure (aHR, 0.29; 95% CI, 0.12 to 0.69) and 68% less mortality (aHR, 0.32; 95% CI, 0.15 to 0.68). There were no associations with CKD progression. Conclusions A higher Angpt-1:Angpt-2 ratio was strongly associated with less CKD progression, heart failure, and mortality in the setting of AKI.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18820-e18820
Author(s):  
Elizabeth James ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Stephen Thompson

e18820 Background: Rituximab-abbs is an anti-CD20 monoclonal antibody and an important immuno-oncology agent for the treatment of B-cell malignancies NHL (diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]) and CLL. It is also indicated for patients with RA, GPA, and MPA. Rituximab-abbs was the first rituximab biosimilar approved in the US and is expected to reduce drug acquisition costs. This budget impact model (BIM) estimated the impact of replacing a share of originator rituximab (IV-R-REF) use with rituximab-abbs (IV-R-BIOSIM) for NHL (DLBCL and FL), CLL, RA, GPA, and MPA. The objective was to project incremental annual cost differences between IV-R-BIOSIM and IV-R-REF for a hypothetical 1-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated changes in 1-year drug and administration costs for an increased IV-R-BIOSIM uptake from 17.5% to 22.0%. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Dosing was based on a mean patient body surface area of 1.8 m2. Annual dose counts per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL, and 4 for RA, GPA, or MPA. All treatments were assumed to infuse over 3 hours. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drug products. Univariate sensitivity analyses were conducted. A scenario analysis was performed to project 2-year costs for extended FL maintenance treatment. Results: Estimated total annual plan incremental savings for a 1-million-member payer after the utilization shift were $312,379, equating to $0.31 per enrolled member per year (PMPY). Per-patient incremental drug cost savings with IV-R-BIOSIM for 1-year were $5,474–$12,924 (Table). The model was most sensitive to IV-R-REF cost and proportion of patients with RA. Conclusions: This analysis estimated annual savings of over $310,000 ($0.31 PMPY) for a 1-million-member US payer following a 4.5% utilization shift from IV-R-REF to IV-R-BIOSIM, demonstrating that IV-R-BIOSIM may confer considerable economic benefits vs originator rituximab.[Table: see text]


Author(s):  
Simon Correa ◽  
Xavier E. Guerra-Torres ◽  
Sushrut S. Waikar ◽  
Finnian R. Mc Causland

Magnesium is involved in the regulation of blood pressure (BP). Abnormalities in serum magnesium are common in chronic kidney disease (CKD), yet its association with the development of hypertension and CKD progression in patients with CKD is unclear. We analyzed data from 3866 participants from the CRIC Study (Chronic Renal Insufficiency Cohort). Linear regression assessed the association of serum magnesium with baseline systolic BP (SBP) and diastolic BP (DBP). Logistic regression explored the association of serum magnesium with various definitions of hypertension. Cox proportional hazards models explored assessed the risk of incident hypertension and CKD progression. Mean serum magnesium was 2.0 mEq/L (±0.3 mEq/L). Higher magnesium was associated with lower SBP (−3.4 mm Hg [95% CI, −5.8 to −1.0 per 1 mEq/L]) and lower DBP (−2.9 mm Hg [95% CI, −4.3 to −1.5 per 1 mEq/L]). Higher magnesium was associated with a lower risk of American Heart Association–defined hypertension (SBP≥130 mm Hg or DBP≥80 mm Hg) at baseline (adjusted hazard ratio, 0.65 [95% CI, 0.49–0.86 per 1 mEq/L]), a lower risk of suboptimally controlled BP (SBP≥120 mm Hg or DBP≥80 mm Hg; adjusted odds ratio, 0.58 [95% CI, 0.43–0.78 per 1 mEq/L]). In time-to-event analyses, higher baseline serum magnesium was associated with a nominally lower risk of incident CRIC-defined hypertension (adjusted hazard ratio, 0.77 [95% CI, 0.46–1.31 per 1 mEq/L]). Higher magnesium was associated with a significantly lower risk of CKD progression (adjusted hazard ratio, 0.68 [95% CI, 0.54–0.86 per 1 mEq/L]). In patients with CKD, higher serum magnesium is associated with lower SBP and DBP, and with a lower risk of hypertension and CKD progression. In patients with CKD, whether magnesium supplementation could optimize BP control and prevent disease progression deserves further investigation.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Takeshi Hasegawa ◽  
Hiroki Nihiwaki ◽  
Erika Ota ◽  
William Levack ◽  
Hisashi Noma

Abstract Background and Aims Patients with chronic kidney disease (CKD) undergoing dialysis are at a particularly high risk of cardiovascular mortality and morbidity. This systematic review and meta-analysis aimed to evaluate the benefits and harms of aldosterone antagonists, both non-selective (spironolactone) and selective (eplerenone), in comparison to control (placebo or standard care) in patients with CKD requiring haemodialysis or peritoneal dialysis. Method We searched the Cochrane Kidney and Transplant Register of Studies up to 29 July 2019 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register Search Portal and ClinicalTrials.gov. We included individual and cluster randomised controlled trials (RCTs), cross-over trials, and quasi-RCTs that compared aldosterone antagonists with placebo or standard care in patients with CKD requiring dialysis. We used a random-effects model meta-analysis to perform a quantitative synthesis of the data. We used the I2 statistic to measure heterogeneity among the trials in each analysis. We indicated summary estimates as a risk ratio (RR) for dichotomous outcomes with their 95% confidence interval (CI). We assessed the certainty of the evidence for each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Results We included 16 trials (14 parallel RCTs and two cross-over trials) involving a total of 1,446 patients. Among included studies, 13 trials compared spironolactone to placebo or standard care and one trial compared eplerenone to a placebo. Most studies had an unclear or high risk of bias. Compared to control, aldosterone antagonists reduced the risk of all-cause death for patients with CKD requiring dialysis (9 trials, 1,119 patients: RR 0.45, 95% CI 0.30 to 0.67; moderate certainty of evidence). Aldosterone antagonist also decreased the risk of death due to cardiovascular disease (6 trials, 908 patients: RR 0.37, 95% CI 0.22 to 0.64; moderate certainty of evidence) and cardiovascular and cerebrovascular morbidity (3 trials, 328 patients: RR 0.38, 95% CI 0.18 to 0.76; moderate certainty of evidence). While aldosterone antagonists had an apparent increased risk of gynaecomastia compared with control (4 trials, 768 patients: RR 5.95, 95% CI 1.93 to 18.3; moderate certainty of evidence), the elevated risk of hyperkalaemia due to aldosterone antagonists was uncertain (9 trials, 981 patients: RR 1.41, 95% CI 0.72 to 2.78; low certainty of evidence). Conclusion Based on moderate certainty of the evidence, aldosterone antagonists could reduce the risk of all-cause and cardiovascular death and morbidity due to cardiovascular and cerebrovascular disease but increase the risk of gynaecomastia in patients with CKD requiring dialysis.


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