R Brett McQueen1, Marc D Breton2, Markus Ott3, Helena Koa3, Bruce Beamer3, Jonathan D Campbell4. 1. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA Robert.mcqueen@ucdenver.edu. 2. Center for Diabetes Technology, University of Virginia Health System, Charlottesville, VA, USA. 3. Bayer HealthCare, Bayer Inc, Germany and Canada. 4. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Abstract
OBJECTIVE: The objective was to simulate and compare clinical and economic outcomes of self-monitoring of blood glucose (SMBG) devices along error ranges and strip price. METHODS: We programmed a type 1 diabetes natural history and treatment cost-effectiveness model. In phase 1, using past evidence from in silico modeling validated by the Food and Drug Administration, we associated changes in SMBG error to changes in hemoglobin A1c (HbA1c) and separately, changes in severe hypoglycemia requiring an inpatient stay. In phase 2, using Markov cohort simulation modeling, we estimated clinical and economic outcomes from the Canadian payer perspective. The primary comparison was a SMBG device with strip price $0.73 Canadian dollars (CAD) and 10% error (exceeding accuracy requirements by International Organization for Standardization (ISO) 15197:2013) versus a SMBG device with strip price $0.60 CAD and 15% error (accuracy meeting ISO 15197:2013). Outcomes for the average patient, were quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and budget impact. RESULTS: Assuming benefits translate into HbA1c improvements only, the ICER with 10% error versus 15% was $11 500 CAD per QALY. Assuming the benefits translate into reduced severe hypoglycemia requiring an inpatient stay only, an SMBG device with 10% error dominated (ie, less costly, more effective) an SMBG device with 15% error. The 3-year budget impact findings ranged from $0.004 CAD per member per month for HbA1c improvements to cost-savings for severe hypoglycemia reductions. CONCLUSIONS: From efficiency (cost-effectiveness) and affordability (budget impact) payer perspectives, investing in devices with improved accuracy (less error) appears to be an efficient and affordable strategy.
OBJECTIVE: The objective was to simulate and compare clinical and economic outcomes of self-monitoring of blood glucose (SMBG) devices along error ranges and strip price. METHODS: We programmed a type 1 diabetes natural history and treatment cost-effectiveness model. In phase 1, using past evidence from in silico modeling validated by the Food and Drug Administration, we associated changes in SMBG error to changes in hemoglobin A1c (HbA1c) and separately, changes in severe hypoglycemia requiring an inpatient stay. In phase 2, using Markov cohort simulation modeling, we estimated clinical and economic outcomes from the Canadian payer perspective. The primary comparison was a SMBG device with strip price $0.73 Canadian dollars (CAD) and 10% error (exceeding accuracy requirements by International Organization for Standardization (ISO) 15197:2013) versus a SMBG device with strip price $0.60 CAD and 15% error (accuracy meeting ISO 15197:2013). Outcomes for the average patient, were quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and budget impact. RESULTS: Assuming benefits translate into HbA1c improvements only, the ICER with 10% error versus 15% was $11 500 CAD per QALY. Assuming the benefits translate into reduced severe hypoglycemia requiring an inpatient stay only, an SMBG device with 10% error dominated (ie, less costly, more effective) an SMBG device with 15% error. The 3-year budget impact findings ranged from $0.004 CAD per member per month for HbA1c improvements to cost-savings for severe hypoglycemia reductions. CONCLUSIONS: From efficiency (cost-effectiveness) and affordability (budget impact) payer perspectives, investing in devices with improved accuracy (less error) appears to be an efficient and affordable strategy.
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