Cost-Effectiveness Analysis of Flash Glucose Monitoring System for People with Type 2 Diabetes Receiving Intensive Insulin Treatment.

AIMS: For people with type 2 diabetes (T2D) on intensive insulin therapy, the use of flash continuous glucose monitoring ("flash monitoring") is associated with improved average glucose control and/or reduced hypoglycemic exposure. This study assessed the cost-effectiveness of flash monitoring versus traditional blood glucose monitoring (BGM) in people with T2D using intensive insulin in the United Kingdom (UK). METHODS: The IQVIA CORE Diabetes Model (IQVIA CDM; v9.0) was used to analyze the impact of flash monitoring versus BGM over a 40-year time horizon from the UK payer perspective. Model inputs included baseline characteristics, intervention effects, resource utilization, costs, and utilities, based on recently published literature and national databases. UK National Health Service reimbursed costs of flash monitoring and BGM were used. An intervention-related health utility was obtained from a time trade-off study. Alternative scenarios were explored to assess the impact of key assumptions on base case results. RESULTS: In base-case analysis, flash monitoring compared with BGM resulted in an incremental cost of £5781 and an additional 0.47 quality-adjusted life years (QALYs). This provides an incremental cost-effectiveness ratio (ICER) of £12,309/QALY. HbA1c and the intervention-related health utility were the key drivers of differentiation. All scenario analyses, including different discount rates, time horizons, effects on HbA1c and on the intervention-related health utility, as well as glycemic emergencies, generated ICERs of less than £20,000 per QALY. CONCLUSIONS: The consistent results across base case and a range of scenario analyses indicate that long-term flash glucose monitoring use is cost-effective compared with BGM in a UK population of T2D on intensive insulin therapy based on updated clinical effects and a cost-effectiveness threshold of £20,000-30,000 per QALY.

Budget Impact of the Flash Continuous Glucose Monitoring System in Medicaid Diabetes Beneficiaries Treated with Intensive Insulin Therapy.

Objective: We assessed the economic impact of using the newest flash continuous glucose monitoring (CGM) among Medicaid beneficiaries with diabetes treated with intensive insulin therapy (IIT). Research Design and Methods: A budget impact analysis was created to assess the impact of increasing the proportion of Medicaid beneficiaries with diabetes on IIT, who use flash CGM by 10%. The analysis included glucose monitoring device costs, cost savings due to reductions in glycated hemoglobin, severe hypoglycemia events, and hyperglycemic emergencies such as diabetic ketoacidosis. The net change in costs per person to adopt flash CGM for three populations treated with IIT (adults with type 1 diabetes [T1D] or type 2 diabetes [T2D], and children and adolescents with T1D or T2D) was calculated; these costs were used to estimate the impact of increasing flash CGM use by 10% to the U.S. Medicaid budget over 1-3 years. Results: The analysis found that flash CGM demonstrated cost savings in all populations on a per patient basis. Increasing use of flash CGM by 10% was associated with a $19.4 million overall decrease in costs over the year and continued to reduce costs by $25.3 million in years 2 and 3. Conclusions: Our results suggest that the new flash CGM system can offer cost savings compared to blood glucose monitoring in Medicaid beneficiaries treated with IIT, especially T1D adults, and children and adolescents. These findings support expanding access to CGM by Medicaid plans.

Analysis Estimating the Potential Cost Impact of Utilizing Flash Glucose Monitoring with Optional Alarms in Swedish Adults with Diabetes with Impaired Awareness of Hypoglycaemia, Using Intensive Insulin.

INTRODUCTION: The objective of this analysis was to estimate the costs associated with using flash glucose monitoring with optional alarms as a replacement for either traditional continuous glucose monitoring (CGM) or routine self-monitoring of blood glucose (SMBG) in adults with diabetes and impaired awareness of hypoglycaemia (IAH) who use intensified insulin therapy, from a Swedish payer perspective, applying assumptions to simulate hypothetical scenarios. METHODS: A simple two-state cohort Markov model was used to calculate the cost per patient treated over a 3-year period, capturing the risk of severe hypoglycaemic events requiring medical assistance and non-adherence using quarterly Markov cycles. The costs considered were those for glucose monitoring and resource use to treat severe hypoglycaemic events. Cost inputs were sourced from Swedish price lists, manufacturer data and resource use reported in the control arm of the HypoDE study. Targeted literature searches were run in PubMed to source the clinical inputs. Uncertainty in the model was considered through one-way sensitivity analysis and scenario analysis. RESULTS: Over 3 years, flash monitoring with optional alarms resulted in potential cost-savings of Swedish krona (SEK) 7708 and SEK 69,908 per patient when compared to routine SMBG or CGM respectively. Sensitivity and scenario analyses were largely supportive of this conclusion with respect to SMBG, and large cost-savings were consistent across all sensitivity and scenario analyses with respect to CGM. CONCLUSION: Utilizing flash monitoring with optional alarms is potentially a cost-saving treatment strategy compared to routine SMBG or traditional CGM in adults with diabetes using intensive insulin and IAH from a Swedish payer perspective. Future studies in the IAH population will help to assess more precisely the relative cost impact of flash glucose monitoring with optional alarms compared with SMBG and traditional CGM.

Cost-effectiveness Analysis of a Flash Glucose Monitoring System for Patients with Type 1 Diabetes Receiving Intensive Insulin Treatment in Sweden.

Flash glucose monitoring - an alternative to traditional self-monitoring of blood glucose (SMBG) - prevents hypoglycaemic events without impacting glycated haemoglobin (HbA1c).21 Given the potential benefits, this study assessed the cost-effectiveness of using flash monitoring versus SMBG alone in patients with type 1 diabetes (T1D) receiving intensive insulin treatment in Sweden. Methods: This study used the IQVIA CORE Diabetes Model (IQVIA CDM, v9.0) to simulate the impact of flash monitoring versus SMBG over 50 years from the Swedish societal perspective. Trial data informed cohort data, intervention effects, and resource utilisation; literature and Tåndvards-Läkemedelförmånsverket (TLV) sources informed utilities and costs. Scenario analyses explored the effect of key base case assumptions. Results: In base case analysis, direct medical costs for flash monitor use were SEK1,222,333 versus SEK989,051 for SMBG use. Flash monitoring led to 0.80 additional quality-adjusted life years (QALYs; 13.26 versus 12.46 SMBG) for an incremental cost effectiveness ratio (ICER) of SEK291,130/QALY. ICERs for all scenarios remained under SEK400,000/QALY. Conclusion: Hypoglycaemia and health utility benefits due to flash glucose monitoring may translate into economic value compared to SMBG. With robust results across scenario analyses, flash monitoring may be considered cost-effective in a Swedish population of T1D intensive insulin users.

The Cost-effectiveness of a Flash Glucose Monitoring System for Management of Patients with Type 2 Diabetes Receiving Intensive Insulin Treatment in Sweden.

Flash glucose monitoring, an alternative to traditional self-monitoring of blood glucose (SMBG), prevents hypoglycaemic events without impacting glycated haemoglobin (REPLACE trial). Given the potential benefits, this study assessed the cost-effectiveness of using flash monitoring versus SMBG alone in patients with type 2 diabetes (T2D) receiving intensive insulin treatment in Sweden.Methods: This study used the IQVIA CORE Diabetes Model (IQVIA CDM, v8.5) to simulate the impact of flash monitoring versus SMBG over 40 years from the Swedish societal perspective. Baseline characteristics, intervention effects, and resource utilisation were derived from REPLACE; literature and Tandvårds-Läkemedelförmånsverket (TLV) sources informed utilities and costs. Scenario analyses explored the effect of key base case assumptions. Results: In base case analysis, direct medical costs for flash monitoring use were SEK1,630,586 (€158,523) versus SEK1,459,394 (€141,902) for SMBG use. Flash monitoring led to 0.56 additional quality-adjusted life years (QALYs; 6.21 versus 5.65 SMBG) for an incremental cost-effectiveness ratio (ICER) of SEK306,082/QALY (€29,762/QALY). ICERs for all scenarios remained under SEK400,000/QALY (€38,894/QALY). Conclusions: Hypoglycaemia and health utility benefits due to flash glucose monitoring may translate into economic value compared to SMBG. With robust results across scenario analyses, flash monitoring may be considered cost-effective in a Swedish population of T2D intensive insulin users.

Cost Calculation for a Flash Glucose Monitoring System for Adults with Type 2 Diabetes Mellitus Using Intensive Insulin - a UK Perspective.

Aims: Estimate the costs associated with flash glucose monitoring as a replacement for routine self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes mellitus (T2DM) using intensive insulin, from a UK National Health Service (NHS) perspective. Methods: The base-case cost calculation used the frequency of SMBG and healthcare resource use observed in the REPLACE trial. Scenario analyses considered SMBG at the flash monitoring frequencies observed in the REPLACE trial (8.3 tests per day) and a real-world analysis (16 tests per day). Results: Compared with 3 SMBG tests per day, flash monitoring would cost an additional £585 per patient per year, offset by a £776 reduction in healthcare resource use, based on reductions in emergency room visits (41%), ambulance call-outs (66%) and hospital admissions (77%) observed in the REPLACE trial. Per patient, the estimated total annual cost for flash monitoring was £191 (13.4%) lower than for SMBG. In the scenarios based on acquisition cost alone, flash monitoring was cost-neutral versus 8.3 SMBG tests per day (5% decrease) and cost-saving at higher testing frequencies. Conclusion: From a UK NHS perspective, for patients with T2DM using intensive insulin, flash monitoring is potentially cost-saving compared with routine SMBG irrespective of testing frequency.

Cost calculation for a flash glucose monitoring system for UK adults with type 1 diabetes mellitus receiving intensive insulin treatment.

AIMS: To estimate the costs associated with a flash glucose monitoring system as a replacement for routine self-monitoring of blood glucose (SMBG) in patients with type 1 diabetes mellitus (T1DM) using intensive insulin, from a UK National Health Service (NHS) perspective. METHODS: The base-case cost calculation was created using the maximum frequency of glucose monitoring recommended by the 2015 National Institute for Health and Care Excellence guidelines (4-10 tests per day). Scenario analyses considered SMBG at the frequency observed in the IMPACT clinical trial (5.6 tests per day) and at the frequency of flash monitoring observed in a real-world analysis (16 tests per day). A further scenario included potential costs associated with severe hypoglycaemia. RESULTS: In the base case, the annual cost per patient using flash monitoring was £234 (19%) lower compared with routine SMBG (10 tests per day). In scenario analyses, the annual cost per patient of flash monitoring compared with 5.6 and 16 SMBG tests per day was £296 higher and £957 lower, respectively. The annual cost of severe hypoglycaemia for flash monitoring users was estimated to be £221 per patient, compared with £428 for routine SMBG users (based on 5.6 tests/day), corresponding to a reduction in costs of £207. CONCLUSIONS: The flash monitoring system has a modest impact on glucose monitoring costs for the UK NHS for patients with T1DM using intensive insulin. For people requiring frequent tests, flash monitoring may be cost saving, especially when taking into account potential reductions in the rate of severe hypoglycaemia.

Health State Utilities Associated with Glucose Monitoring Devices.

BACKGROUND: Glucose monitoring is important for patients with diabetes treated with insulin. Conventional glucose monitoring requires a blood sample, typically obtained by pricking the finger. A new sensor-based system called "flash glucose monitoring" monitors glucose levels with a sensor worn on the arm, without requiring blood samples. OBJECTIVES: To estimate the utility difference between these two glucose monitoring approaches for use in cost-utility models. METHODS: In time trade-off interviews, general population participants in the United Kingdom (London and Edinburgh) valued health states that were drafted and refined on the basis of literature, clinician input, and a pilot study. The health states had identical descriptions of diabetes and insulin treatment, differing only in glucose monitoring approach. RESULTS: A total of 209 participants completed the interviews (51.7% women; mean age = 42.1 years). Mean utilities were 0.851 ± 0.140 for conventional monitoring and 0.882 ± 0.121 for flash monitoring (significant difference between the mean utilities; t = 8.3; P < 0.0001). Of the 209 participants, 78 (37.3%) had a higher utility for flash monitoring, 2 (1.0%) had a higher utility for conventional monitoring, and 129 (61.7%) had the same utility for both health states. CONCLUSIONS: The flash glucose monitoring system was associated with a significantly greater utility than the conventional monitoring system. This difference may be useful in cost-utility models comparing the value of glucose monitoring devices for patients with diabetes. This study adds to the literature on treatment process utilities, suggesting that time trade-off methods may be used to quantify preferences among medical devices.

Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses.

Non-steroidal anti-inflammatory drugs (NSAIDs), such as non-selective NSAIDs (nsNSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors, are commonly prescribed for arthritic pain relief in patients with osteoarthritis (OA), rheumatoid arthritis (RA), or ankylosing spondylitis (AS). Treatment guidelines for chronic NSAID therapy include the consideration for gastroprotection for those at risk of gastric ulcers (GUs) associated with the chronic NSAID therapy. The United States Food and Drug Administration has approved naproxen/esomeprazole magnesium tablets for the relief of signs and symptoms of OA, RA, and AS, and to decrease the risk of developing GUs in patients at risk of developing NSAID-associated GUs. The European Medical Association has approved this therapy for the symptomatic treatment of OA, RA, and AS in patients who are at risk of developing NSAID-associated GUs and/or duodenal ulcers, for whom treatment with lower doses of naproxen or other NSAIDs is not considered sufficient. Naproxen/esomeprazole magnesium tablets have been compared with naproxen and celecoxib for these indications in head-to-head trials. This systematic literature review and network meta-analyses of data from randomized controlled trials was performed to compare naproxen/esomeprazole magnesium tablets with a number of additional relevant comparators. For this study, an original review examined MEDLINE®, Embase®, and the Cochrane Controlled Trials Register from database start to April 14, 2009. Using the same methodology, a review update was conducted to December 21, 2009. The systematic review and network analyses showed naproxen/esomeprazole magnesium tablets have an improved upper gastrointestinal tolerability profile (dyspepsia and gastric or gastroduodenal ulcers) over several active comparators (naproxen, ibuprofen, diclofenac, ketoprofen, etoricoxib, and fixed-dose diclofenac sodium plus misoprostol), and are equally effective as all active comparators in treating arthritic symptoms in patients with OA, RA, and AS. Naproxen/esomeprazole magnesium tablets are therefore a valuable option for treating arthritic symptoms in eligible patients with OA, RA, and AS.

A rationale for the reinitiation of adjuvant tamoxifen therapy in women receiving fewer than 5 years of therapy.

The overview analysis of adjuvant therapy trials in early-stage breast cancer by the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) compared 1, 2, and 5 years of adjuvant therapy. The optimal benefit to patients in terms of reduced risk of recurrence and death was clearly conferred by 5 years of therapy with tamoxifen compared to shorter durations of therapy. Many women with early-stage breast cancer treated in the past received a recommendation for shorter durations of tamoxifen therapy. The obvious question is whether reinitiating tamoxifen to complete a full 5-year course would further reduce the risk of recurrence and death. In an attempt to explore this issue, we have analyzed recurrence rates in women who received different durations of tamoxifen therapy in the adjuvant setting. The data used for this analysis are directly from the EBCTCG. Our analysis suggests that women who received 1-2 years of adjuvant tamoxifen therapy may benefit from reinitiation of tamoxifen to complete a 5-year course.