Actionable Real-World Evidence to Improve Health Outcomes and Reduce Medical Spending Among Risk-Stratified Patients with Diabetes

Garry, Elizabeth M.; Schneeweiß, Sebastian; Eapen, Sara; Petruski‐Ivleva, Natalia; Cheever, E. V.; Murk, William; Rajan, Aditya; Rassen, Jeremy A.; Gambino, David; Jang, Hannah; Rubin, Elizabeth; Jan, Saira

doi:10.18553/jmcp.2019.25.12.1442

Cited by 13 publications

(20 citation statements)

References 33 publications

(34 reference statements)

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“…A CVD event is a major cause of elevated medical cost for patients with DM. Garry et al reported that among patients with high CVD risk, the total cost of care was higher for DPP-4i users than for dapagliflozin users [29], and our study also found that the difference in cost was higher among patients with underlying CVD. Thus, dapagliflozin may have maximal economic value when administered in patients with a high risk of a CVD event.…”

Section: Discussionsupporting

confidence: 77%

“…Further, Garry et al analyzed the medical costs between patients who used SGLT-2i and patients who used DPP-4i as second-line therapy using insurance claims data in the US and reported that the annual total cost of care was $3419 (95% CI − $11,264 to − $4426) lower among patients in the CVD high risk group who used SGLT-2i [29]. The patients were classified according to the first drug used in the second-line therapy, and a pairwise comparison was performed between the SGLT-2i and DPP-4i groups using adjusted deciles of propensity score and Cox proportional hazards regression model, with treatment costs compared without any simulation.…”

Section: Discussionmentioning

confidence: 99%

“…Economical evaluation of DPP-4i and SGLT-2i, including dapagliflozin, as a second-line therapy for DM in the UK and US has shown that SGLT-2i is cost-effective and reduces the medical costs [27][28][29]. However, the results of pharmaco-economical evaluations vary according to the health insurance or healthcare service systems across countries, so it is difficult to directly cite the results reported in other countries.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of heart failure risk and medical costs between patients with type 2 diabetes mellitus treated with dapagliflozin and dipeptidyl peptidase-4 inhibitors: a nationwide population-based cohort study

Seong

Kim

et al. 2020

Cardiovasc Diabetol

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Background: Dapagliflozin is one of the novel glucose-lowering agents, which has recently been reported to reduce the risk of hospitalization for heart failure (hHF). The present study aimed to compare the differences between the risk of hHF after using dapagliflozin and dipeptidyl peptidase-4 inhibitors (DPP-4i) as second-line drugs for the treatment of type 2 diabetes mellitus using the latest nationwide population data in Korea. Additionally, we aimed to examine the impact of clinical outcomes on direct medical costs in the two groups. Methods: The present population-based, retrospective cohort study was conducted using the nationwide claims data between September 01, 2014 and June 30, 2018. New users of dapagliflozin and DPP-4i were identified from the database and the differences in patients' characteristics between the two groups were analyzed using propensity score-weighted analysis. Cox proportional hazards regression analysis was used to estimate the risk of hHF. A simple model was used for the estimation of direct medical costs for 3 years. Results: In total, 23,147 patients in the dapagliflozin group and 237,187 patients in the DPP-4i group were selected for the analysis. The incidence rates of hHF were 3.86 and 6.79 per 1000 person-years in the dapagliflozin and DPP-4i groups, respectively. In the entire study population, the hazard ratio for hHF in the dapagliflozin group compared to the DPP-4i group was 0.58 (95% confidence interval 0.46-0.74), with 0.55 (95% confidence interval 0.41-0.74) among patients with underlying cardiovascular disease and 0.66 (95% confidence interval 0.46-0.95) among patients without underlying cardiovascular disease. The direct medical costs were $57,787 lower in the dapagliflozin group than in the DPP-4i group for 3 years. Conclusions: This study showed that dapagliflozin lowers the risk for hHF and subsequently reduces direct medical costs compared to DPP-4i. The protective effect against hHF was more evident among patients with underlying cardiovascular disease.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of heart failure risk and medical costs between patients with type 2 diabetes mellitus treated with dapagliflozin and dipeptidyl peptidase-4 inhibitors: a nationwide population-based cohort study

Seong

Kim

et al. 2020

Cardiovasc Diabetol

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“…The sponsor wishes to expand the indicated patient population or broaden the labeled benefits, often from a surrogate endpoint to a clinical endpoint ( 39 ). A frequent use case for payer organizations is establishing the comparative effectiveness in clinical practice of multiple alternative treatment options ( 40 ).…”

Section: Rwe and Regulatory Decision Makingmentioning

confidence: 99%

Conducting Real-world Evidence Studies on the Clinical Outcomes of Diabetes Treatments

Schneeweiß

Patorno

2021

Endocrine Reviews

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Real-world Evidence (RWE), the understanding of treatment effectiveness in clinical practice generated from longitudinal patient-level data from the routine operation of the healthcare system, is thought to complement evidence on the efficacy of medications from RCTs. RWE studies follow a structured approach: (1) A design layer decides on the study design, which is driven by the study question and refined by a medically informed target population, patient-informed outcomes, and biologically informed effect windows. Imagining the randomized trial we would ideally perform before designing an RWE study in its likeness reduces bias; the new-user active comparator cohort design has proven useful in many RWE studies of diabetes treatments. (2) A measurement layer transforms the longitudinal patient-level data stream into variables that identify the study population, the pre-exposure patient characteristics, the treatment, and the treatment-emergent outcomes. Working with secondary data increases the measurement complexity compared to primary data collection that we find in most RCTs. (3) An analysis layer focuses on the causal treatment effect estimation. Propensity score analyses have gained in popularity to minimize confounding in healthcare database analyses. Well-understood investigator errors, like immortal time bias, adjustment for causal intermediates, or reverse causation, should be avoided. To increase reproducibility of RWE findings, studies require full implementation transparency. This article integrates state-of-the-art knowledge on how to conduct and review RWE studies on diabetes treatments to maximize study validity and ultimately increased confidence in RWE-based decision making.

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“…67 Real-world data (RWD) and real-world evidence (RWE) are becoming increasingly important in healthcare, across a broad range of different areas including regulatory submissions for medication label expansions and discussions around pricing and the budgetary impact of medications. [67][68][69][70][71][72][73][74][75][76][77] RWD and RWE have been utilized for many decades to evaluate the effects of poor adherence (or conversely the benefits of improving adherence) with medications used to manage NCDs. 33,[36][37][38]78 During 2020, RWD and RWE have been at the forefront of the efforts to address the healthcare challenges of the COVID-19 pandemic.…”

Section: The Use Of Rwd and Rwe And Applying Digital Technology To Study And Improve Adherencementioning

confidence: 99%

New Strategies to Improve Patient Adherence to Medications for Noncommunicable Diseases During and After the COVID-19 Era Identified via a Literature Review

Hassan¹,

Sáenz²,

Dučinskienė³

et al. 2021

JMDH

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Noncommunicable diseases (NCDs) place a huge burden on healthcare systems and society as a whole. Relatively early in the coronavirus disease 2019 (COVID-19) pandemic, clinicians became aware that in individuals infected with COVID-19, those with preexisting NCDs such as diabetes mellitus and cardiovascular disease (CVD) were at a greater risk of poor outcomes and mortality than those without. The importance of adherence to medications and lifestyle changes to control and prevent NCDs has been a major focus for many years, but with limited success -the proportion of patients adherent and persistent to their medications remains very low. There are many facets to adherence and persistence. Recent evidence suggests that a patient-centric approach is important, and ensuring that a patient is both motivated and empowered is critical to improving adherence/persistence. The COVID-19 pandemic has brought many changes to the way in which patients with NCDs are managed, with telemedicine and ehealth becoming more common. Changes have also occurred in the way in which patients can gain access to medications during the pandemic. The potential for these changes forms the basis of improving the management of patients with NCDs both during and after the pandemic. Over the coming months, a huge amount of work will be put into initiatives to promote adherence to COVID-19 vaccination programs. Those at highest risk of severe COVID-19, such as people aged 80 years and older, are likely to receive the vaccine first in some parts of world. Finally, social determinants of health are critical elements that can impact not just the likelihood of having an NCD or becoming infected with COVID-19, but also access to healthcare, and a patient's adherence and persistence with their treatments.

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Actionable Real-World Evidence to Improve Health Outcomes and Reduce Medical Spending Among Risk-Stratified Patients with Diabetes

Cited by 13 publications

References 33 publications

Comparison of heart failure risk and medical costs between patients with type 2 diabetes mellitus treated with dapagliflozin and dipeptidyl peptidase-4 inhibitors: a nationwide population-based cohort study

Comparison of heart failure risk and medical costs between patients with type 2 diabetes mellitus treated with dapagliflozin and dipeptidyl peptidase-4 inhibitors: a nationwide population-based cohort study

Conducting Real-world Evidence Studies on the Clinical Outcomes of Diabetes Treatments

New Strategies to Improve Patient Adherence to Medications for Noncommunicable Diseases During and After the COVID-19 Era Identified via a Literature Review

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