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  • 1
    In: Gesundheits- und Sozialpolitik, Nomos Verlag, Vol. 63, No. 5 ( 2009), p. 38-47
    Type of Medium: Online Resource
    ISSN: 1611-5821
    URL: Issue
    RVK:
    Language: Unknown
    Publisher: Nomos Verlag
    Publication Date: 2009
    detail.hit.zdb_id: 2103330-4
    detail.hit.zdb_id: 2708766-9
    SSG: 3,4
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  • 2
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: Introduction: Self-Monitoring of Blood Glucose (SMBG) uses capillary blood glucose to measure glycemia in diabetic patients. Recently FDA-approved Flash Continuous Glucose Monitoring (F-CGM) reveals glucose levels when scanned by the reading device. The Centers for Medicare and Medicaid Services (CMS) have announced to reimburse F-CGM at the same level as CGM devices. Aim: This analysis’ objective was to quantify the CMS budget impact (BI) of F-CGM reimbursement in patients with type 2 diabetes (T2DM) on intensified insulin therapy (IIT), and compare it to the BI of conventional SMBG via cost-related break-even metrics. These were chosen because - in the absence of RCT-based, primary endpoint-driven clinical superiority evidence of F-CGM over SMBG for this population (REPLACE study) - they are well-suited to inform budget allocation decisions. Methods: An economic model was developed in Excel. CMS reimbursement/patient co-insurance levels for SMBG and F-CGM were used; data on morbidity, treatment and usage patterns were sourced from the literature and official websites. Different scenarios were simulated to elicit break-even points between F-CGM and SMBG. Results: The annual cost of SMBG with 3.7 tests per day (see REPLACE) is $180 per patient, compared to $2,156 incurred per F-CGM patient, representing a cost difference of $1,976/year or $5.41/day. This implies a budget break-even ratio of 1:12 patients (F-CGM:SMBG). Both technologies would break even at a consumption of 44 test strips per day. A year’s SMBG budget would last only 30 days if spent on F-CGM. Conclusion: With diabetes budgets under pressure, thoughtful spending policies are needed. It is recommended to analyze in detail which T2DM subgroups will benefit most from F-CGM, focusing reimbursement to the latter. SMBG, being an established technology, represents - at current reimbursement levels - an attractive spending option to budget holders. Disclosure M. Stueve: Employee; Self; JnJ GmbH Life Scan. Y.F. Zoellner: Research Support; Self; J & J Medical GmbH, LifeScan.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
    detail.hit.zdb_id: 1501252-9
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  • 3
    In: Heart and Vessels, Springer Science and Business Media LLC, Vol. 38, No. 8 ( 2023-08), p. 1009-1018
    Abstract: Randomized trials suggest benefits for fractional flow reserve (FFR)-guided vs. angiography-guided treatment strategies in well-defined and selected patient cohorts with acute coronary syndromes (ACS). The long-term prognostic value of FFR measurement in unselected all-comer ACS patients, however, remains unknown. This subanalysis of the Fractional FLOw Reserve In cardiovascular DiseAses (FLORIDA) study sought to investigate the long-term effects of FFR in the management of lesions in patients with acute coronary syndrome (ACS). FLORIDA was an observational all-comer cohort study performed in Germany, that was population-based and unselected. Patients enrolled into the anonymized InGef Research Database presenting with ACS and undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Patients were stratified into either the FFR-guided or the angiography-guided treatment arm, based on the treatment received. A matched cohort study design was used. The primary endpoint was all-cause mortality. The secondary endpoint was major adverse cardiovascular events (MACE), a composite of death, non-fatal myocardial infarction (MI), and repeat revascularization. Follow-up time was 3 years. Rates of 3-year mortality were 10.2 and 14.0% in the FFR-guided and the angiography-guided treatment arms ( p  = 0.04), corresponding to a 27% relative risk reduction for FFR in ACS patients. Rates of MACE were similar in both arms (47.7 vs. 51.5%, p  = 0.14), including similar rates of non-fatal MI (27.7 vs. 25.4%, p  = 0.47) and revascularization (9.9 vs. 12.1%, p  = 0.17). In this large, all-comer observational study of ACS patients, FFR-guided revascularization was associated with a lower mortality at 3 years. This finding encourages the routine use of FFR to guide lesion revascularization in patients presenting with ACS.
    Type of Medium: Online Resource
    ISSN: 0910-8327 , 1615-2573
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 1481441-9
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  • 4
    Online Resource
    Online Resource
    SAGE Publications ; 2019
    In:  Journal of Diabetes Science and Technology Vol. 13, No. 3 ( 2019-05), p. 584-591
    In: Journal of Diabetes Science and Technology, SAGE Publications, Vol. 13, No. 3 ( 2019-05), p. 584-591
    Abstract: Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations. Objectives: The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice. Methods: A literature review was conducted using online HTA resources. Results: Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands). Conclusion: HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.
    Type of Medium: Online Resource
    ISSN: 1932-2968 , 1932-2968
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2467312-2
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  • 5
    In: Journal of Diabetes Science and Technology, SAGE Publications, Vol. 10, No. 5 ( 2016-09), p. 1142-1148
    Abstract: Most patients with type 1 diabetes (T1D) administer insulin by multiple daily injections (MDI). However, continuous subcutaneous insulin infusion (CSII) therapy has been shown to improve glycemic control compared with MDI. Objective: The objective was to determine the key medical event and cost offsets generated over a 4-year period by introducing CSII to T1D patients who have inadequately controlled glucose metabolism on MDI in Germany. Methods: A decision-analytic budget impact model, simulating a treatment switch scenario, was developed. In the base case, all T1D patients received MDI, while in the switch scenario, 20% of the eligible T1D population, randomly selected, moved to CSII. The model focused on 2 medical endpoints and their corresponding cost offsets: severe hypoglycemic events requiring hospitalization (SHEH) and complication-borne diabetic events (CDEs) avoided. Event rates and costs were taken from the literature and official sources, adopting a health insurance perspective. Results: Compared with the base case, treating 20% of patients with CSII in the switch scenario resulted in 47 864 fewer SHEH and 5543 fewer CDEs. This led to total cost offsets of €183 085 281 within the 4-year time horizon. Of these, 92% were driven by avoided SHEH. Compared to an expected budget impact (cost increase) of 83%, only treatment costs considered, the total impact of the switch scenario amounted merely to a 24.5% increase in costs (reduction by 58.5% points; a factor of 3.4). Conclusion: The use of CSII resulted in fewer SHEH and CDEs compared to MDI. The incurred CSII implementation costs are hence offset to a substantial degree by cost savings in complication treatment.
    Type of Medium: Online Resource
    ISSN: 1932-2968 , 1932-2968
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
    detail.hit.zdb_id: 2467312-2
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  • 6
    Online Resource
    Online Resource
    Nomos Verlag ; 2008
    In:  Gesundheits- und Sozialpolitik Vol. 62, No. 2 ( 2008), p. 10-26
    In: Gesundheits- und Sozialpolitik, Nomos Verlag, Vol. 62, No. 2 ( 2008), p. 10-26
    Type of Medium: Online Resource
    ISSN: 1611-5821
    URL: Issue
    RVK:
    Language: Unknown
    Publisher: Nomos Verlag
    Publication Date: 2008
    detail.hit.zdb_id: 2103330-4
    detail.hit.zdb_id: 2708766-9
    SSG: 3,4
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