Dataset Information

Economic Evaluation of Dulaglutide vs Traditional Therapies: Implications of the Outcomes of the Rewind Study.

ABSTRACT: Background:Diabetes represents a relevant public health problem worldwide due to its growing prevalence and socioeconomic burden, principally due to the development of macrovascular and microvascular complications as well as to the continuous launch of new and even more expensive drugs. The aim of our study is to evaluate the economic impact of dulaglutide, a weekly GLP-1 receptor agonist, on the treatment of diabetic patients as an alternative to both high dose sulphonylureas and insulin basalization at the failure of oral therapies alone. We carried out a cost-effectiveness analysis developed considering the economic implications of recent clinical studies regarding cardiovascular risk drug effects and especially of REWIND studies outcomes, focusing on the impact of weight changes on HRQoL. Material and Method:In our analysis, we have applied the cost-utility technique to the above reported clinical outcomes and compared the global costs of dulaglutide versus sulfonylurea or basal insulin, all in add-on with metformin. We have chosen gliclazide, as a sulfonylurea and Abasaglar®, the less expensive among basal insulin analogues. Abasaglar was titrated to 20 IU, corresponding to the mean dosage used in the treatment of type II diabetic patients. The model aims to estimate total direct costs related to the above-reported treatments and find out the real gap in costs between dulaglutide, the apparently cheaper gliclazide and basal insulin glargine (IGlargine) based on the Italian National Healthcare System (INHS). Results:The total cost of dulaglutide has resulted in €859.66 higher than gliclazide (€1,579.73 vs €720.07) and basal insulin, although less significantly, reporting a difference of €396.54 (€1,579.73 vs 1,183.19). Except for the purchase cost, dulaglutide has reported reduced costs compared to insulin IGlargine and gliclazide. Dulaglutide showed lower self-monitoring blood glucose and hypoglycaemia costs, a significant reduction in costs related to cardiovascular complications, as well as savings in costs in other drugs. Dulaglutide can be considered a cost-effective antidiabetic therapy, due to the positive impact on the quality of life induced by weight reduction, despite the higher annual cost per patient, mainly influenced by drug purchase cost. Discussion and Conclusion:In this cost-utility analysis, dulaglutide has shown to be a cost-effective treatment option from the Italian healthcare system perspective as add-on therapy to metformin in patients with inadequately controlled type 2 diabetes mellitus. Study findings can provide stakeholders valuable evidence to support the adoption of this cost-effective second- or third-line therapy compared to gliclazide or basal insulin glargine. Dulaglutide cost-effectiveness has been particularly evident in the comparison with basal insulin glargine, indicating that, in patients who have treatment indication, this therapy may be preferred to basalization avoiding related complications and costs.

SUBMITTER: Torre E

PROVIDER: S-EPMC7152542 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Economic Evaluation of Dulaglutide vs Traditional Therapies: Implications of the Outcomes of the Rewind Study.

Torre Enrico E Bruno Giacomo M GM Di Matteo Sergio S Martinotti Chiara C Valentino Maria Chiara MC Bottaro Luigi C LC Colombo Giorgio L GL

ClinicoEconomics and outcomes research : CEOR 20200408

<h4>Background</h4>Diabetes represents a relevant public health problem worldwide due to its growing prevalence and socioeconomic burden, principally due to the development of macrovascular and microvascular complications as well as to the continuous launch of new and even more expensive drugs. The aim of our study is to evaluate the economic impact of dulaglutide, a weekly GLP-1 receptor agonist, on the treatment of diabetic patients as an alternative to both high dose sulphonylureas and insuli ...[more]

PMID: 32308446

Similar Datasets

Project description:BackgroundThe REWIND trial demonstrated cardiovascular (CV) benefits to patients with type 2 diabetes and multiple CV risk factors or established CV disease. This exploratory analysis evaluated the degree to which the effect of dulaglutide on CV risk factors could statistically account for its effects on major adverse cardiovascular events (MACE) in the REWIND trial.MethodsPotential mediators of established CV risk factors that were significantly reduced by dulaglutide were assessed in a post hoc analysis using repeated measures mixed models and included glycated hemoglobin (HbA1c), body weight, waist-to-hip ratio, systolic blood pressure, low-density lipoprotein (LDL), and urine albumin/creatinine ratio (UACR). These factors, for which the change in level during follow-up was significantly associated with incident MACE, were identified using Cox regression modeling. Each identified variable was then included as a covariate in the Cox model assessing the effect of dulaglutide on MACE to estimate the degree to which the hazard ratio of dulaglutide vs placebo was attenuated. The combined effect of the variables associated with attenuation was assessed by including all variables in an additional Cox model.ResultsAlthough all evaluated variables were significantly improved by treatment, only changes in HbA1c and UACR were associated with MACE and a reduction in the effect of dulaglutide on this outcome was observed. The observed hazard ratio for MACE for dulaglutide vs placebo reduced by 36.1% by the updated mean HbA1c, and by 28.5% by the updated mean UACR. A similar pattern was observed for change from baseline in HbA1c and UACR and a reduction of 16.7% and 25.4%, respectively in the hazard ratio for MACE with dulaglutide vs placebo was observed. When HbA1c and UACR were both included, the observed hazard ratio reduced by 65.4% for the updated mean and 41.7% for the change from baseline with no HbA1c-UACR interaction (P interaction = 0.75 and 0.15, respectively).ConclusionsTreatment-induced improvement in HbA1c and UACR, but not changes in weight, systolic blood pressure, or LDL cholesterol, appear to partly mediate the beneficial effects of dulaglutide on MACE outcomes. These observations suggest that the proven effects of dulaglutide on cardiovascular disease benefit are partially related to changes in glycemic control and albuminuria, with residual unexplained benefit. Clinicaltrials.gov; Trial registration number: NCT01394952. URL: https://clinicaltrials.gov/ct2/show/NCT01394952.

Project description:ImportanceProbation is a cornerstone of efforts to reduce mass incarceration. Although it is understudied, specialty probation could improve outcomes for the overrepresented group of people with mental illness.ObjectiveTo test whether specialty probation yields better public safety outcomes than traditional probation.Design, setting, and participantsA longitudinal observational study with group matching on age, sex, race/ethnicity, probation time, and offense at 2 urban agencies that exemplify specialty and traditional probation. Enrollment began October 19, 2005; follow-up data were complete January 26, 2013. Participants were 359 diverse probationers with serious mental health problems and functional impairment. Probationers and officers were assessed 3 times (for probationers, 6-month retention, 315 of 359 [88%]; 12-month retention 304 of 359 [85%]) and follow-up records were obtained. Machine learning algorithms were combined with a targeted maximum likelihood estimation, a double robust estimator that accounts for associations between confounders and both treatment assignment and outcomes. Statistical analysis was conducted from January 1, 2016 to May 5, 2017.InterventionsSpecialty probationers were assigned to small, homogeneous caseloads supervised by experts. Prior data indicate that specialty officers had better relationships with probationers, participated more in probationers' treatment, and relied more on positive compliance strategies than traditional officers.Main outcomes and measuresViolence during 1 year, determined by probationer report, officer report, and records, and rearrest during a period of 2 to 5 years, according to Federal Bureau of Investigation records.ResultsParticipants were 183 specialty (73.8% of 248 eligible) and 176 traditional (56.6% of 311 eligible) probationers (205 men and 154 women; mean [SD] age, 36.9 [10.6]). Although specialty probation had no significant effect on violence (odds ratio, 0.97; 95% CI, 0.69-1.36), the odds of rearrest were 2.68 times higher for traditional probationers than for specialty probationers (95% CI, 1.86-3.84; P?<?.001). At 2 years, estimated probabilities of rearrest were 28.6% for specialty probationers and 51.8% for traditional probationers. Survival analyses indicate that arrest effects endured up to 5 years.Conclusions and relevanceAlthough it did not specifically reduce violence, well-implemented specialty probation appears to be effective in reducing general recidivism. Reform efforts for people with mental illness could leverage probation-a ubiquitous and revitalized node of the justice system.

Project description:Medication complexity/burden can be associated with nonadherence in patients with type 2 diabetes mellitus (T2DM). Patients' satisfaction with their treatment is an important consideration for physicians. Strategies like using longer acting efficacious agents with less frequent dosing may help adherence.To explore the mode of administration of dulaglutide and its implications for treatment adherence in T2DM.PubMed search using the term "Dulaglutide" through October 31, 2015 was conducted. Published articles, press releases, and abstracts presented at national/international meetings were considered.Dulaglutide is a once-weekly glucagon like peptide-1 analog with a low intraindividual variability. Phase III trials demonstrated significant improvements in glycemia and weight, with a low hypoglycemia risk similar to liraglutide/exenatide, but with substantially fewer injections. A significant improvement was observed in the total Diabetes Treatment Satisfaction Questionnaire score, Impact of Weight on Self-Perception, and perceived frequency of hyperglycemia with dulaglutide when compared with placebo, exenatide, liraglutide, or metformin. Treatment satisfaction scores showed an improvement with dulaglutide (34%-39%) when compared with exenatide (31%). A positive experience with a high initial (97.2%) and final (99.1%) injection success rate along with a significant reduction in patients' fear of self-injecting, as measured by the modified self-injecting subscale of the Diabetes Fear of Injecting and Self-Testing Questionnaire and Medication Delivery Device Assessment Battery, was found. Its acceptance was high (>96%) among a variety of patients including patients who fear injections and injection-naïve users. Dulaglutide is available as a single-dose automatic self-injecting device, which has a low volume, does not need reconstitution, and avoids patient handling of the needle. Dose adjustment based on weight, sex, age, race, ethnicity, or injection-site is not necessary. In chronic diseases like diabetes where patients need lifelong medications, the efficacy, safety, and convenience of a once-weekly, easy-to-use, self-injecting device should encourage patient adherence to dulaglutide therapy.

Project description:Background:Botulinum neurotoxins type A (BoNT-As) are commonly used treatments for cervical dystonia (CD). Clinical trials have demonstrated the benefits of them in these patients, but data from real-life clinical practice as well as comparative data on the cost and outcome of different BoNT-A formulations are limited. The aim of this study was to compare abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) on their clinical outcomes and drug costs in real-life clinical practice. Methods:This analysis included 356 adult patients with idiopathic CD treated with aboBoNT-A (n?=?253) or onaBoNT-A (n?=?103) from 38 centres across Europe and Australia (NCT00833196). The clinical outcome measures were treatment responses, changes in TWSTRS scores and changes in health utility scores from baseline to study visit 2 and 3. Health utility score was mapped from the TWSTRS total scale, using a previous publication. Costs included drug cost for France. Results:The aboBoNT-A treated group had 2.06 (95% CI: 1.15 to 3.69) times higher odds of achieving treatment response than the onaBoNT-A treated group. The adjusted mean change in TWSTRS total score from baseline to visit 3 were?-?6.42 (95% CI: -?7.52 to -?5.33) for aboBoNT-A and?-?3.94 (95% CI: -?5.68 to -?2.2) for onaBoNT-A, with a difference of -?2.48 (95% CI: -?4.57 to -?0.39). The corresponding difference in the adjusted mean change for health utility score was 0.008 (95% CI: 0.001 to 0.014). Mean treatment costs for aboBoNT-A and onaBoNT-A were 314.1 (95% CI: 299.1 to 329.0) and 346.6 (95% CI: 322.9 to 370.4) Euros, respectively. Conclusions:This comparative analysis indicated that treatment with aboBoNT-A may be less costly and lead to improved clinical outcomes when compared with onaBoNT-A, from a French healthcare system perspective. Additional comparative clinical data from larger patient cohorts, as well as more information about cost consequences of an improvement in clinical outcome would be of value to further confirm the findings.

Project description:ImportancePlatform trial design allows the introduction of new interventions after the trial is initiated and offers efficiencies to clinical research. However, limited guidance exists on the economic resources required to establish and maintain platform trials.ObjectiveTo compare cost (US dollars) and time requirements of conducting a platform trial vs a series of conventional (nonplatform) trials using a real-life example.Design, setting, and participantsFor this economic evaluation, an online survey was administered to a group of international experts (146 participants) with publication records of platform trials to elicit their opinions on cost and time to set up and conduct platform, multigroup, and 2-group trials. Using the reported entry dates of 10 interventions into Systemic Therapy in Advancing Metastatic Prostate Cancer: Evaluation of Drug Efficacy, the longest ongoing platform trial, 3 scenarios were designed involving a single platform trial (scenario 1), 1 multigroup followed by 5 2-group trials (scenario 2), and a series of 10 2-group trials (scenario 3). All scenarios started with 5 interventions, then 5 more interventions were either added to the platform or evaluated independently. Simulations with the survey results as inputs were used to compare the platform vs conventional trial designs. Data were analyzed from July to September 2021.ExposurePlatform trial design.Main outcomes and measuresTotal trial setup and conduct cost and cumulative duration.ResultsAlthough setup time and cost requirements of a single trial were highest for the platform trial, cumulative requirements of setting up a series of multiple trials in scenarios 2 and 3 were larger. Compared with the platform trial, there was a median (IQR) increase of 216.7% (202.2%-242.5%) in cumulative setup costs for scenario 2 and 391.1% (365.3%-437.9%) for scenario 3. In terms of total cost, there was a median (IQR) increase of 17.4% (12.1%-22.5%) for scenario 2 and 57.5% (43.1%-69.9%) for scenario 3. There was a median (IQR) increase in cumulative trial duration of 171.1% (158.3%-184.3%) for scenario 2 and 311.9% (282.0%-349.1%) for scenario 3. Cost and time reductions in the platform trial were observed in both the initial and subsequently evaluated interventions.Conclusions and relevanceAlthough setting up platform trials can take longer and be costly, the findings of this study suggest that having a single infrastructure can improve efficiencies with respect to costs and efforts.

Dataset Information

Economic Evaluation of Dulaglutide vs Traditional Therapies: Implications of the Outcomes of the Rewind Study.

Publications

Economic Evaluation of Dulaglutide vs Traditional Therapies: Implications of the Outcomes of the Rewind Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets