Health economic comparison between continuous subcutaneous insulin infusion and multiple daily injections of insulin for the treatment of adult type 1 diabetes in Canada.

BACKGROUND: Patients with type 1 diabetes mellitus (DM) may be treated with insulin via multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). OBJECTIVE: The purpose of this study was to evaluate the projected long-term cost-effectiveness of CSII compared with MDI by modeling a simulated sample of adult patients with type 1 DM in Canada. METHODS: A health economic model was used to determine the incremental cost-effectiveness ratio (ICER) of CSII compared with MDI from the perspective of a Canadian provincial government. The primary input variable was change in glycosylated hemoglobin (HbA(1c)). A series of Markov constructs also simulated the progression of disease-related complications. Annual acquisition costs for CSII and MDI were year-2006 Can $6347.18 and Can $4649.69, respectively. A 60-year time horizon and a discount rate of 5.0% per annum on costs and clinical outcomes were used. RESULTS: Mean direct lifetime costs were Can $15,591 higher with CSII treatment than MDI. Treatment with CSII was associated with an improvement in discounted life expectancy of 0.655 quality-adjusted life-years (QALYs) over a 60-year time horizon, compared with MDI (mean [SD], 10.029 [0.133] vs 9.374 [0.076] QALYs). ICERs were Can $27,264 per life-year gained and Can $23,797 per QALY for CSII compared with MDI. The results were most sensitive to HbA(1c) assumptions. CONCLUSION: Based on this analysis, CSII may be a cost-effective treatment option when compared with MDI in adult patients with type 1 DM in Canada.

A cost-effectiveness analysis of continuous subcutaneous insulin injection versus multiple daily injections in type 1 diabetes patients: a third-party US payer perspective.

OBJECTIVE: To estimate the long-term cost-effectiveness of using continuous subcutaneous insulin infusion (CSII) compared with multiple daily injections (MDI) of insulin in adult and child/young adult type 1 diabetes mellitus (T1DM) patients from a third-party payer perspective in the United States. METHOD: A previously validated health economic model was used to determine the incremental cost-effectiveness ratio (ICER) of CSII compared with MDI using published clinical and cost data. The primary input variable was change in HbA(1c), and was assumed to be an improvement of -0.9% to -1.2% for CSII compared with MDI for child/young adult and adults, respectively. A series of Markov constructs simulated the progression of diabetes-related complications. RESULTS: CSII was associated with an improvement in quality-adjusted life-years (QALYs) gained of 1.061 versus MDI for adults and 0.799 versus MDI for children/young adults. ICERs were $16,992 and $27,195 per QALY gained for CSII versus MDI in adults and children/young adults, respectively. Improved glycemic control from CSII led to a lower incidence of diabetes complications, with the most significant reduction in proliferative diabetic retinopathy (PDR), end stage renal disease (ESRD), and peripheral vascular disease (PVD). The number needed to treat (NNT) for PDR was nine patients, suggesting that only nine patients need to be treated with CSII to avoid one case of PDR. The NNT for ESRD and PVD was 19 and 41, respectively. CONCLUSIONS: Setting the willingness to pay at $50,000/QALY, the analysis demonstrated that CSII is a cost-effective option for patients with T1DM in the United States.

Webinar Training: an acceptable, feasible and effective approach for multi-site medical record abstraction: the BOWII experience.

BACKGROUND: Abstractor training is a key element in creating valid and reliable data collection procedures. The choice between in-person vs. remote or simultaneous vs. sequential abstractor training has considerable consequences for time and resource utilization. We conducted a web-based (webinar) abstractor training session to standardize training across six individual Cancer Research Network (CRN) sites for a study of breast cancer treatment effects in older women (BOWII). The goals of this manuscript are to describe the training session, its participants and participants' evaluation of webinar technology for abstraction training. FINDINGS: A webinar was held for all six sites with the primary purpose of simultaneously training staff and ensuring consistent abstraction across sites. The training session involved sequential review of over 600 data elements outlined in the coding manual in conjunction with the display of data entry fields in the study's electronic data collection system. Post-training evaluation was conducted via Survey Monkey©. Inter-rater reliability measures for abstractors within each site were conducted three months after the commencement of data collection.Ten of the 16 people who participated in the training completed the online survey. Almost all (90%) of the 10 trainees had previous medical record abstraction experience and nearly two-thirds reported over 10 years of experience. Half of the respondents had previously participated in a webinar, among which three had participated in a webinar for training purposes. All rated the knowledge and information delivered through the webinar as useful and reported it adequately prepared them for data collection. Moreover, all participants would recommend this platform for multi-site abstraction training. Consistent with participant-reported training effectiveness, results of data collection inter-rater agreement within sites ranged from 89 to 98%, with a weighted average of 95% agreement across sites. CONCLUSIONS: Conducting training via web-based technology was an acceptable and effective approach to standardizing medical record review across multiple sites for this group of experienced abstractors. Given the substantial time and cost savings achieved with the webinar, coupled with participants' positive evaluation of the training session, researchers should consider this instructional method as part of training efforts to ensure high quality data collection in multi-site studies.

Cost-effectiveness of combination fluticasone propionate-salmeterol 250/50 microg versus salmeterol in severe COPD patients.

OBJECTIVE: To estimate the cost-effectiveness of fluticasone propionate-salmeterol combination (FSC) compared to salmeterol for maintenance therapy in severe chronic obstructive pulmonary disease (COPD). STUDY DESIGN: Pooled economic analysis. METHODS: We performed an economic analysis of pooled data from two randomized clinical trials (combined N = 1554) that evaluated the effect of maintenance therapy with FSC (250/50 microg twice daily) or salmeterol (50 microg twice daily) on exacerbation rates in patients with severe COPD. We calculated exacerbation rates and applied standardized costs to exacerbation-related health care utilization reported in the trials (office, urgent care, and emergency department visits; hospitalizations; and oral corticosteroids and antibiotics) to determine cost differences between FSC and salmeterol treatment outcomes. RESULTS: Annual rates of any exacerbation and moderate/severe exacerbation were lower in the FSC group than the salmeterol group (4.91 vs 5.78 and 1.32 vs 2.00 respectively, both P < 0.05). Total adjusted annual COPD related exacerbation and therapeutic costs were $4,842 (95% CI; $4,731-$4,952) in the FSC group and $5,066 (95% CI; $4,937-$5,195) in the salmeterol group. CONCLUSIONS: FSC combination therapy is associated with reduced risk of any exacerbation and moderate/severe exacerbation, and incurs lower annual COPD-related health care costs compared to treatment with salmeterol. This analysis demonstrates that FSC therapy may be advantageous from both a clinical and cost-benefit standpoint for patients with severe COPD.

Gastroenterologists' prescribing of infliximab for Crohn's disease: a national survey.

BACKGROUND: Practice guidelines suggest that immunomodulators (IMs) be given prior to infliximab (IFX) in patients with Crohn's disease (CD). The package insert for IFX recommends that maintenance therapy be prescribed for patients who respond to induction therapy. Our aim was to determine the extent to which gastroenterologists (GIs) are utilizing IM prior to IFX and prescribing maintenance IFX when treating patients with CD. METHODS: An 18-item questionnaire was developed and validated. The survey was sent to 4515 GIs who are members of the American Gastroenterology Association. Bivariate and multivariate analyses were performed. RESULTS: In all, 305 GIs responded; 70% use an IM prior to IFX, 86% prescribe maintenance IFX, and 62% reported both use of IM prior to IFX and use of maintenance IFX. Academic GIs, Midwest GIs, and GIs prescribing IFX a few times per year were more likely to report both use of an IM prior to IFX and use of maintenance IFX (odds ratio [OR] = 4.56, 2.18, and 2.25, respectively). GIs demonstrated awareness of the risk of reactivation of tuberculosis when initiating IFX and appropriately manage infusion reactions. GIs were unable to rank serious adverse reactions associated with IFX. CONCLUSIONS: A total of 38% of GIs did not report the use of IM prior to IFX and/or did not use maintenance IFX. GIs practicing outside the Midwest and those in nonacademic settings may need additional training regarding prescribing IFX.

A cost-effectiveness analysis of pioglitazone plus metformin compared with rosiglitazone plus metformin from a third-party payer perspective in the US.

OBJECTIVE: The long-term cost-effectiveness of using pioglitazone plus metformin (Actoplusmet dagger) compared with rosiglitazone plus metformin (Avandamet double dagger) in treating type 2 diabetes (T2DM) was assessed from a US third-party payer perspective. RESEARCH DESIGN AND METHODS: Clinical efficacy (change in HbA(1c) and lipids) and baseline cohort parameters were extracted from a 12-month, randomized clinical trial (Derosa et al., 2006) evaluating the efficacy and tolerability of pioglitazone versus rosiglitazone, both in addition to metformin, in adult T2DM patients with insufficient glucose control (n = 96). A Markov-based model was used to project clinical and economic outcomes over 35 years, discounted at 3% per annum. Costs for complications were taken from published sources. Base-case assumptions were assessed through several sensitivity analyses. MAIN OUTCOME MEASURES: Outcomes included incremental life-years, quality-adjusted life-years (QALYs), total direct medical costs, cumulative incidence of complications and associated costs, and incremental cost-effectiveness ratios (ICERs). RESULTS: Compared to rosiglitazone plus metformin, pioglitazone plus metformin was projected to result in a modest improvement in 0.187 quality-adjusted life-years. Over patients' lifetimes, total direct medical costs were projected to be marginally lower with pioglitazone plus metformin (difference -$526.), largely due to reduced CVD complication costs. While costs were higher among renal, ulcer/amputation/neuropathy, and eye complications in the pioglitazone plus metformin group, the cost savings for CVD complications outweighed their economic impact. Pioglitazone plus metformin was found to be a dominant long-term treatment strategy in the US compared to rosiglitazone plus metformin. Sensitivity analyses showed findings to be robust under almost all scenarios, including short-term time horizons, 6% discounting, removal of individual lipid parameters, and modifications of patient cohort to more closely represent a US T2DM population. Pioglitazone plus metformin was no longer dominant with 0% discounting, with 25% reduction in its HbA(1c) effects, or with a 15% increase in its acquisition price. CONCLUSIONS: Under a range of assumptions and study limitations around cohorts, clinical effects, and treatment patterns, this long-term analysis showed that pioglitazone plus metformin, when compared to rosiglitazone plus metformin, was a dominant treatment strategy within the US payer setting. Results were driven by the combination of modest differences in QALYs and modest savings in total complication costs over 35 years.

Pioglitazone versus rosiglitazone treatment in patients with type 2 diabetes and dyslipidemia: cost-effectiveness in the US.

OBJECTIVES: Pioglitazone hydrochloride (Actos † ) and rosiglitazone maleate (Avandia ‡ ) are members of the thiazolidinedione (TZD) class of oral anti-diabetic drugs (OADs) and are used to treat type 2 diabetes mellitus (T2DM). Greater beneficial effects on lipids have been demonstrated with pioglitazone, however. Study objectives were to evaluate the long-term cost-effectiveness of pioglitazone compared to rosiglitazone in treating patients with T2DM and dyslipidemia, and determine the extent to which reported beneficial lipid effects of pioglitazone would improve clinical and economic outcomes through reduced macrovascular complications. † Actos is a trade name of Takeda Pharmaceuticals Co. Ltd., Deerfield, IL, US ‡ Avandia is a trade name of GlaxoSmithKline, Research Triangle, NC, US. RESEARCH DESIGN AND METHODS: The validated CORE Diabetes Model (CDM) was used to simulate changes in glycosylated hemoglobin (HbA(1c)), complications, and direct medical costs. Baseline parameters came from a multi-center, double-blind trial comparing lipid and glycemic effects of pioglitazone (n = 400) and rosiglitazone (n = 402) among individuals with T2DM and untreated dyslipidemia. Sensitivity analyses examined the impact of cohort, clinical, and cost inputs on incremental cost effectiveness ratios (ICERs). RESULTS: In the base case, pioglitazone was associated with mean (standard deviation [SD]) quality-adjusted life years (QALYs) of 7.476 (0.123) vs. 7.326 (0.128) for rosiglitazone. Pioglitazone had $3038 higher total direct costs, but $580 lower complication costs. Risks of four cardiovascular complications were reduced with pioglitazone (relative risks 0.860-0.942), while risks of 17 other complications were slightly higher (relative risks 1.001-1.056). The ICER for pioglitazone treatment was $20 171/QALY. Results were most sensitive to the effects of HbA(1c), high-density lipoprotein-cholesterol, overall lipid effects, and pioglitazone acquisition costs. CONCLUSIONS: Study limitations include issues of generalizability of the trial patient population, as well as inability to capture non-adherence and variation in 'real-world' treatment patterns. Nevertheless, pioglitazone (when compared to rosiglitazone) was found to have long-term value as a treatment option for T2DM patients with dyslipidemia treated within the US payer setting.