Dataset Information

Cost-Effectiveness Analysis of Linagliptin in Japan Based on Results from the Asian Subpopulation in the CARMELINA^® Trial.

ABSTRACT:

Introduction

We evaluated the cost-effectiveness of linagliptin in Japan by estimating the lifetime outcome based on clinical event rates from the Asian subpopulation of the CARMELINA trial. In CARMELINA, linagliptin added to standard of care (SoC) versus SoC demonstrated noninferiority with regard to risk of composite cardiovascular (CV) outcome in patients with type 2 diabetes at high risk of CV and kidney events. Issues resulting from conducting a cost-effectiveness analysis using data from a clinical noninferiority study were also investigated.

Methods

A microsimulation model was used to evaluate linagliptin/SoC versus SoC in terms of direct costs and quality-adjusted life years (QALYs) from a Japanese public healthcare payer's perspective. Cost data were obtained from recent Japanese publications. The time horizon was defined as lifetime, and the discount rate for costs and effectiveness was 2% per year. One-way and probabilistic sensitivity analyses were performed.

Results

In the base case analysis, and taking medical history into account, the incremental effectiveness of linagliptin/SoC versus SoC was 1.34 QALYs, and the incremental cost for linagliptin was - 545,319 yen. In the one-way sensitivity analysis, the parameter which most affected the results was the hazard ratio for renal failure of linagliptin/SoC compared with SoC. The probabilistic sensitivity analysis showed that the probability of reduced costs and increased effectiveness (dominant) was 48%. Assuming an incremental cost-effectiveness ratio (ICER) threshold of 5 million yen, the probability that the ICER was below the threshold was 89% for linagliptin/SoC compared with SoC.

Conclusions

This evaluation, using Asian subpopulation data from the CARMELINA trial, suggested that the cost-effectiveness of linagliptin for a lifetime outcome was favourable in Japan. However, the results must be interpreted cautiously because of the noninferiority trial data source, which might cause ICER variations for each parameter.

SUBMITTER: Watada H

PROVIDER: S-EPMC7376765 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundGene expression profiling tests can predict the risk of disease recurrence and select patients who are expected to benefit from therapy, while allowing other patients to forgo therapy. For breast cancers, these tests were initially designed to tailor chemotherapy decisions, but recent evidence suggests that they may also guide the use of endocrine therapy. This study evaluated the cost effectiveness of a prognostic test, MammaPrint®, to guide the use of adjuvant endocrine therapy in patients eligible according to Dutch treatment guidelines.MethodsWe constructed a Markov decision model to calculate the lifetime costs (in 2020 Euros) and effects (survival and quality-adjusted life-years) of MammaPrint® testing versus usual care (endocrine therapy for all patients) in a simulated cohort of patients. The population of interest includes patients for whom MammaPrint® testing is currently not indicated, but for whom it may be possible to safely omit endocrine therapy. We applied both a health care perspective and a societal perspective and discounted costs (4%) and effects (1.5%). Model inputs were obtained from published research (including randomized controlled trials), nationwide cancer registry data, cohort data and publicly available data sources. Scenario and sensitivity analyses were conducted to explore the impact of uncertainty around input parameters. Additionally, threshold analyses were performed to identify under which circumstances MammaPrint® testing would be cost effective.ResultsAdjuvant endocrine therapy guided by MammaPrint® resulted in fewer side effects, more (quality-adjusted) life-years (0.10 and 0.07 incremental QALYS and LYs, respectively) and higher costs (€18,323 incremental costs) compared with the usual care strategy in which all patients receive endocrine therapy. While costs for hospital visits, medication costs and productivity costs were somewhat higher in the usual care strategy, these did not outweigh costs of testing in the MammaPrint® strategy. The incremental cost-effectiveness ratio was €185,644 per QALY gained from a healthcare perspective and €180,617 from a societal perspective. Sensitivity and scenario analyses showed that the conclusions remained the same under changed input parameters and assumptions. Our results show that MammaPrint® can become a cost-effective strategy when either the price of the test is reduced (> 50%), or the proportion of patients for which treatment is altered (i.e. those with ultra-low risk) increases to > 26%.ConclusionStandard MammaPrint® testing to guide the use of endocrine therapy in our simulated patient population appears not to be a cost-effective strategy compared with usual care. The cost effectiveness of the test can be improved by reducing the price or preselecting a population more likely to benefit from the test.

Project description:ImportancePrevious studies have reported an association between hypoglycemia and cardiovascular (CV) events in people with type 2 diabetes (T2D), but it is unclear if this association is causal or identifies a high-risk patient phenotype.ObjectiveTo evaluate the associations between hypoglycemia and CV outcomes.Design, setting, and participantsThis secondary analysis was a post hoc assessment of the multinational, double-blind CARMELINA (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin; 2013-2016) and CAROLINA (Cardiovascular Outcome Trial of Linagliptin vs Glimepiride in Type 2 Diabetes; 2010-2018) randomized clinical trials of the antihyperglycemic drug, linagliptin, a dipeptidyl peptidase 4 inhibitor. Participants were adults with T2D at high CV risk with or without high kidney risk. By design, participants in the CARMELINA trial had longer duration of T2D and had a higher CV risk than participants in the CAROLINA trial. Data analyses were conducted between June 2021 and June 2023.InterventionLinagliptin or placebo in the CARMELINA trial, and linagliptin or glimepiride in the CAROLINA trial.Main outcomes and measuresThe primary outcome for both trials was CV death, myocardial infarction (MI), or stroke (3-point major adverse CV events [3P-MACE]). For the present analyses, hospitalization for heart failure (HF) was added. Hypoglycemia was defined as plasma glucose less than 54 mg/dL or severe hypoglycemia (episodes requiring the assistance of another person). Associations between the first hypoglycemic episode and subsequent CV events and between nonfatal CV events (MI, stroke, hospitalization for HF) and subsequent hypoglycemic episodes were assessed using multivariable Cox proportional hazards regression models. Sensitivity analyses explored the risk of CV events within 60 days after each hypoglycemic episode.ResultsIn the CARMELINA trial (6979 patients; 4390 males [62.9%]; mean [SD] age, 65.9 [9.1] years), there was an association between hypoglycemia and subsequent 3P-MACE plus hospitalization for HF (hazard ratio [HR], 1.23; 95% CI, 1.04-1.46) as well as between nonfatal CV events and subsequent hypoglycemia (HR, 1.39; 95% CI, 1.06-1.83). In the CAROLINA trial (6033 patients; 3619 males (60.0%); mean [SD] age, 64.0 [9.5] years), there was no association between hypoglycemia and subsequent 3P-MACE plus hospitalization for HF (HR, 1.00; 95% CI, 0.76-1.32) and between nonfatal CV events and subsequent hypoglycemia (HR, 1.44; 95% CI, 0.96-2.16). In analyses of CV events occurring within 60 days after hypoglycemia, there was either no association or too few events to analyze.Conclusions and relevanceThis study found bidirectional associations between hypoglycemia and CV outcomes in the CARMELINA trial but no associations in either direction in the CAROLINA trial, challenging the notion that hypoglycemia causes adverse CV events. The findings from the CARMELINA trial suggest that both hypoglycemia and CV events more likely identify patients at high risk for both.Trial registrationClinicalTrials.gov Identifier: NCT01897532 (CARMELINA) and NCT01243424 (CAROLINA).

Project description:Background: There is little experience in the economic evaluation of pharmacy/primary care collaborative health interventions using interprofessional technology-driven communication under real-world conditions. This study aimed to conduct cost-effectiveness and cost-utility analyses of a collaborative care intervention in hypertension and hyperlipidemia management between pharmacies and primary care versus usual (fragmented) care alongside a trial. Methods: An economic evaluation was conducted alongside a 6-month pragmatic quasi-experimental controlled trial. Data sources included primary care clinical software; pharmacy dispensing software; patient telephone surveys; and published literature. The target population was adult patients on hypertension and/or lipid-lowering medication. The perspective was societal. We collected patient-level data on resource use to estimate trial costs. Effect outcomes included blood pressure (BP) and quality-adjusted life years (QALYs). Bootstrapping was used to estimate uncertainty around the incremental cost-effectiveness and cost-utility ratios. Cost-effectiveness planes and acceptability curves were estimated. Results: The intervention was not shown to have reasonable levels of cost-effectiveness or cost-utility when compared to usual care as denoted by the levels of uncertainty expressed in wide confidence intervals. The probability of the intervention being cost-effective is 28% at the threshold of €20,000 per QALY gained and 57% at the threshold of €500 per mmHg systolic BP decrease. Conclusion: Considering the limitations of the trial which affected effectiveness and economic outcomes, our results are not generalizable for community pharmacy and primary care in Portugal. This research offers, however, valuable lessons on methods and strategies that can be used in future economic evaluations of collaborative public health interventions with the potential for reimbursement. Clinical trial registration: https://www.isrctn.com/ISRCTN13410498, identifier ISRCTN13410498.

Project description:ContextCardiovascular disease (CVD) costs the economy €210 billion per year in Europe. There is an association between low-density lipoprotein cholesterol (LDL-C) and CVD risk.ObjectiveTo evaluate the cost and effectiveness of LopiGLIK® (LOPI) in lowering LDL-C and CVD risk.DesignSingle blind multicenter randomized controlled trial; patients were divided into two groups, subjected to centralized randomization.SettingFour Italian regions.ParticipantsThirty-one physicians enrolled 573 adult patients with mild hypercholesterolemia between January 2016 and January 2018.InterventionPatients were treated for 16 weeks either with LOPI (intervention) or Armolipid Plus® (AP; control).Outcome measuresPrimary outcome: percentage of patients who achieved LDL-C <130 mg/dL. Secondary outcomes: reduction of HbA1c, survival analysis and HR linked to 38.67 mg/dL reduction of LDL-C and 1% reduction of HbA1c. Costs were assessed per unit and cure.ResultsThree hundred and seventy patients treated with LOPI and 203 treated with AP were randomized and completed the study. At baseline 8.9% (n=18) patients treated with AP and 9.5% (n=35) treated with LOPI had LDL-C levels <130 mg/dL (P=0.815). At the 16-week follow-up, 41.4% (n=84) of patients treated with AP and 67.6% (n=250) with LOPI achieved LDL-C levels <130 mg/dL (P<0.001). LOPI patients were three times more likely to achieve LDL-C levels <130 mg/dL; adjusted OR 2.97 (95% CI; 2.08-4.24; P<0.001), number needed to treat was four (95% CI; 5.60-2.90; P<0.001). Survival analysis demonstrated the superiority of LOPI vs AP relative to 38.67 mg/dL LDL-C reduction (P<0.002); HR was 0.761 (95% CI; 0.62-0.94; P<0.001). Both products reduced the HbA1c without a significant difference between them (P=0.156). Survival analysis and HR (0.91; 95% CI; 0.70-1.18) estimated for 1% HbA1c reduction, showed differences between LOPI and AP, which were not significant (P=0.411; P=0.464). The cost of LOPI was €2.11 (unit), €211 (cure), and AP €3.77 and €377, respectively.ConclusionLOPI appeared more effective and less expensive than AP in lowering LDL-C and CVD risk.Trial registrationNCT02898805, September 8, 2016.

Project description:IntroductionFrequent glucose monitoring is essential to obtain glucose control. This is done by periodic self-monitoring of blood glucose (SMBG) using finger-prick testing, or by using continuous glucose monitoring devices, wherein a sensor records interstitial glucose data automatically. This study assessed the cost-effectiveness of using the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) compared to SMBG in individuals with type 2 diabetes (T2D) treated with insulin from a Swedish societal perspective.MethodsCost-effectiveness analysis was conducted using the IQVIA Core Diabetes model v9.5, with demographic and clinical inputs from a real-world study using Swedish National Diabetes Register data. Two cohorts of individuals with T2D were considered based on baseline HbA1C (HbA1c: 8-9% [64-75 mmol/mol]; HbA1c: 9-12% [75-108 mmol/mol]). HbA1c reductions with FSL were - 0.41% (- 4 mmol/mol; SD: 0.94%-10 mmol/mol) and - 1.30% (- 14 mmol/mol; SD: 1.40%-15 mmol/mol) for the two cohorts, respectively. Utilities, treatment costs and diabetes-related complication costs were obtained from published sources. Analyses were conducted over a lifetime horizon, applying annual discounting of 3% on costs and effects. Scenario analyses and probabilistic sensitivity analyses were performed.ResultsIndividuals with T2D who had a baseline HbA1c of 8-9% (64-75 mmol/mol) and 9-12% (75-108 mmol/mol) and used FSL gained 0.50 and 0.57 quality-adjusted life-years (QALYs), respectively, at an incremental cost of SEK109,957 and SEK82,170 compared to SMBG, generating an incremental cost-utility ratio of SEK219,127 and SEK144,412 per QALY gained. Assuming a willingness-to-pay threshold of SEK300,000 per QALY gained, FSL use was considered cost-effective compared to SMBG for the majority of the individuals in both the lower and higher HbA1c cohorts. The key driver identified was the additional quality-of-life benefit that applied to FSL use.ConclusionThe FreeStyle Libre Flash Continuous Glucose Monitoring System is a cost-effective glucose monitoring alternative to SMBG for individuals with T2D in Sweden who are treated with insulin but are not reaching their glycaemic goals.

Dataset Information

Cost-Effectiveness Analysis of Linagliptin in Japan Based on Results from the Asian Subpopulation in the CARMELINA^® Trial.

Introduction

Methods

Results

Conclusions

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Dataset Information

Cost-Effectiveness Analysis of Linagliptin in Japan Based on Results from the Asian Subpopulation in the CARMELINA® Trial.

Introduction

Methods

Results

Conclusions

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Cost-Effectiveness Analysis of Linagliptin in Japan Based on Results from the Asian Subpopulation in the CARMELINA^® Trial.