S De Portu

The psoriatic arthritis cost evaluation study: a cost-of-illness study on tumour necrosis factor inhibitors in psoriatic arthritis patients with inadequate response to conventional therapy

Objective. To evaluate costs, benefits and cost–effectiveness of anti-TNF agents in PsA patients with inadequate response to conventional treatment. Methods. A total of 107 patients, from nine Italian rheumatology centres, with different forms of PsA were given anti-TNF treatment, mainly etanercept (87%). Information on resource use, health-related quality of life, disease activity, function and laboratory values were collected at baseline and through out the 12 months of therapy. Cost (expressed in euro 2007) and utility (measured by EuroQol) before and after anti-TNF therapy initiation were compared in order to estimate the incremental cost per quality-adjusted life year (QALY) gained, and cost–effectiveness acceptability curve was calculated. Results. At the end of 12 months, there was a significant increase in direct cost due to an increase of drug cost caused by TNF inhibitors that was only partially offset by the decrease in indirect cost. In the last 6 months of therapy, the direct cost increased by €5052, the cost for the National Health System (NHS) by €5044 and the social cost by €4638. However, a gain of 0.12 QALY resulted in a cost per QALY gained of €40 876 for the NHS and of €37 591 for the society. The acceptability curve showed that there would be a 97% likelihood that anti-TNF therapy would be considered cost-effective at willingness-to-pay threshold of €60 000 per QALY gained. Conclusion. Cost–effectiveness ratios are within the commonly accepted willingness-to-pay threshold. These results need to be confirmed in larger samples of patients.

Autoantibody profile during short‐term infliximab treatment for Crohn's disease: a prospective cohort study

Background : The potential clinical implications of autoimmunity during treatment with infliximab are unclear.

Health-economic analysis of real-time continuous glucose monitoring in people with Type 1 diabetes

To evaluate the clinical benefits and cost‐effectiveness of the sensor‐augmented pump compared with self–monitoring of plasma glucose plus continuous subcutaneous insulin infusion in people with Type 1 diabetes.

Cost-effectiveness of continuous subcutaneous insulin infusion versus multiple daily injections of insulin in Type 1 diabetes: a systematic review

Continuous subcutaneous insulin infusion (CSII) is increasingly used in clinical practice for the management of selected patients with Type 1 diabetes. Several cost‐effectiveness studies comparing CSII vs. multiple insulin injections (MDI) have been reported. The aim was systematically to review these analyses and test the hypothesis that CSII is a cost‐effective use of healthcare resources across settings.

Cost Analysis of Capecitabine vs 5-Fluorouracil-Based Treatment for Metastatic Colorectal Cancer Patients

Abstract The aim was to evaluate the cost of capecitabine vs conventional combination chemotherapics such as 5-fluorouracil (5-FU) for the treatment of metastatic colorectal cancer (MCRC) in Italy. The study was a multicenter, retrospective longitudinal treatment-cost analysis. Patient solder than 18 years, diagnosis of MCRC and at least 3 completed cycles of chemotherapy with oral capecitabine or 5-FU also in association with other chemotherapic agents were enrolled. Direct healthcare resources attributable to MCRC treatment were quantified using 2007prices and tariffs. The analysis was conducted from the National Health Service perspective with a 6-month time horizon. A total of 231 patients affected by MCRC (55% males; mean age 63.7±10.31 yrs) were studied. Total direct costs per patient per month in capecitabine and 5-FU groups were €1,001.66 ± €434.93 and € 3,172.81 ± € 1,232.37 respectively (p<0.0001). Oral capecitabine therapy cost the health service less than intravenous therapies.

Factors affecting the benefit of insulin dose intensification in people with Type 2 diabetes: an analysis from the OpT2mise randomized trial

The recent OpT2mise randomized trial compared the efficacy of insulin pump therapy and multiple daily injections (MDI) in people with Type 2 diabetes and HbA1c levels that remained ≥64 mmol/mol (8.0%) despite insulin dose optimization [1,2]. During the initial 6-month randomized phase of the study, pump therapy was shown to produce a significant improvement in glycaemic control and a 20% reduction in total daily insulin dose, compared with MDI therapy [1], and these benefits were sustained during the subsequent 6-month extension phase during which all participants received pump therapy [2]. According to the study protocol, screened participants with an HbA1c level between 64 mmol/mol (8.0%) and 108 mmol/mol (12.0%) entered an 8-week run-in period prior to randomization, during which oral antihyperglycaemic agents were withdrawn, except for metformin, which was maintained at the maximum tolerated dose, and insulin therapy was intensified to reach a dose between 0.7 and 1.8 U/kg/day (or ≤220 U/day) [2]. MDI insulin doses were titrated to achieve a preprandial glucose range of 3.9– 7.2 mmol/l and postprandial glucose <10.0 mmol/l [2]. At the end of this run-in period, participants in whom HbA1c remained ≥64 mmol/mol (8.0%) were randomized to receive pump therapy or MDI therapy at the optimized dosage. An HbA1c ≥64 mmol/mol (8.0%) at the end of the run-in period was considered to indicate failure of dose optimization. Because identification of factors influencing the outcome of insulin treatment intensification during the run-in period could be useful in informing management decisions, differences in baseline characteristics between randomized and non-randomized participants were analysed using twosample t-tests for continuous variables and Fisher’s exact test for categorical variables. Multivariate logistic regression analysis, including factors that were significant (a level = 0.20) in univariate analysis, was also performed to assess associations between baseline demographic and clinical factors and the likelihood of randomization. Sensitivity and specificity were calculated for several values of initial HbA1c to assess its predictive value in distinguishing between participants in whom MDI dose optimization was beneficial or not. Statistical analyses were performed using SAS version 9.3 software (SAS Institute, Cary, NC, USA) and the R package rpart version 4.1–10, and P values <0.05 were taken to indicate statistical significance. Of 495 participants who entered the run-in phase, 164 were not subsequently randomized to pump therapy or MDI. Of these, 134 participants were not randomized because their HbA1c had decreased to <64 mmol/mol (8.0%) after insulin dose optimization, 26 were withdrawn by the investigators, two were lost to follow-up, one withdrew because of adverse events, and one withdrew for other reasons [1]. On multivariate analysis, the only factor associated with randomization was HbA1c at the beginning of the run-in period. Two HbA1c cut-off values were identified: a baseline HbA1c of 68 mmol/mol (8.4%) was found to give optimum sensitivity and specificity for the prediction of dose optimization success or failure, while a value >75 mmol/mol (>9.0%) was considered on clinical grounds to indicate a low likelihood of achieving glycaemic goals with MDI alone. The overall rate of MDI dose optimization failure was 79.9%, and the failure rate increased markedly when the initial HbA1c level was ≥68 mmol/mol (≥8.4%). Overall, 336 of 395 participants with initial HbA1c ≥68 mmol/mol (≥8.4%) did not achieve a level <64 mmol/mol (<8.0%) at the end of the run-in period, resulting in a dose optimization failure rate of 85%; by contrast, only 38/73 participants (52%) with baseline HbA1c <68 mmol/mol (<8.4%) did not achieve HbA1c <64 mmol/ mol (<8.0%) at the end of the run-in phase. At a cut-off initial HbA1c level of 68 mmol/mol (8.4%), it was possible to predict failure of dose intensification with a sensitivity of 90% and a specificity of 37%, and positive and negative predictive values of 85 and 48%, respectively. In participants with initial HbA1c >75 mmol/mol (>9.0%) the failure rate was 91% (231/254), compared with 67% (143/214) in participants with initial HbA1c ≤75 mmol/mol (<9.0%); sensitivity and specificity were 62 and 76%, respectively, and positive and negative predictive values were 91 and 33%, respectively. Participants who were randomized to the control arm, and therefore continued to receive MDI therapy with ongoing dose intensification, showed only a further 4.4mmol/mol (0.4%) decrease in HbA1c. These data show that extending the duration of MDI dose intensification is unlikely to result in a relevant further decrease in HbA1c with MDI therapy. A limitation of the present analysis is its post hoc nature; however, the MDI dose optimization was performed according to the study protocol, and the 64–108 mmol/mol (8– 12%) HbA1c range for dose optimization was prespecified in the protocol. In conclusion, MDI dose intensification is unlikely to be beneficial in an individual with baseline HbA1c > 75 mmol/

Cost-effectiveness of continuous subcutaneous insulin infusion in people with type 2 diabetes in the Netherlands

Abstract Aims: Up to 30% of insulin-treated type 2 diabetes patients are unable to achieve HbA1c targets despite optimization of insulin multiple daily injections (MDI). For these patients the use of continuous subcutaneous insulin infusion (CSII) represents a useful but under-utilized alternative. The aim of the present analysis was to examine the cost-effectiveness of initiating CSII in type 2 diabetes patients failing to achieve good glycemic control on MDI in the Netherlands. Methods: Long-term projections were made using the IMS CORE Diabetes Model. Clinical input data were sourced from the OpT2mise trial. The analysis was performed over a lifetime time horizon. The discount rates applied to future costs and clinical outcomes were 4% and 1.5% per annum, respectively. Results: CSII was associated with improved quality-adjusted life expectancy compared with MDI (9.38 quality-adjusted life years [QALYs] vs 8.95 QALYs, respectively). The breakdown of costs indicated that ∼50% of costs were attributable to diabetes-related complications. Higher acquisition costs of CSII vs MDI were partially offset by the reduction in complications. The ICER was estimated at EUR 62,895 per QALY gained and EUR 60,474 per QALY gained when indirect costs were included. Conclusions: In the Netherlands, CSII represents a cost-effective option in patients with type 2 diabetes who continue to have poorly-controlled HbA1c despite optimization of MDI. Since the ICER falls below the willingness-to-pay threshold of EUR 80,000 per QALY gained, CSII is likely to represent good-value for money in the treatment of poorly-controlled T2D patients compared with MDI.

Long Term Costs and Outcomes in Psoriatic Arthritis Patients Not Responding to Conventional Therapy Treated with Tumor Necrosis Factor Inhibitors: The Extension of Psoriatic Arthritis Cost Evaluation (PACE) Study

OBJECTIVES Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs). METHODS Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared. RESULTS The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years. CONCLUSIONS The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.

PSN19 QUALITY OF LIFE OF PAEDIATRIC PATIENTS WITH ATOPIC ECZEMAANDTHEIR FAMILIES

OBJECTIVE: To assess feasibility, convergent validity and reliability of the Italian version of the Infants’ Dermatitis Quality Of Life Index (IDQOL) and the Family Dermatitis Index (FDI). METHODS: Parents of 21 children with atopic dermatitis were enrolled at the Policlinico Hospital in Modena and interviewed on two separate occasions (6/7 days between the interviews). Feasibility was tested by computing the number of missing answers; convergent validity was tested by testing correlation between the scores; reliability was tested in terms of internal consistency and test-retest reproducibility. RESULTS: all the interviewed persons answered to every question. The median severity score was 1.00 (0–3), with no significant differences between the two interviews and good level of agreement (weighted kappa = 0.604). The IDQOL median score was 9.00 (from 7 to 17, in the first, to 16 in the second interview), with no significant differences between the two interviews; Cronbach’s alpha >0.7; Intraclass Correlation Coefficient (ICC) between the first and second assessment =0.95; presence of biases excluded (Bland & Altman method); the coefficient of agreement for each IDQOL item ranged from 0.632 (‘mealtimes’) to 1.000 (‘play’, “family activities”). The median DFI score was 5 (from 0 to 19, in the first, to 18, in the second interview), with no significant differences between the two interviews, Cronbach’s alpha >0.9, ICC between the first and second assessment =0.99, the presence of biases excluded; coefficients of agreement computed for each item ranged from 0.638 (‘feeding’) to 0.908 (‘expenditure’). The convergent validity between these instruments was satisfactory, with high and statistically significant correlation coefficients. CONCLUSIONS: The Italian version of IDQOL and DFI is feasible, valid and reliable. These instruments can be used to evaluate QOL of young patients with atopic dermatitis and their families and can be used to assist decisions on treatment and health-care resource allocation.

Reduction of Complications and Associated Costs for Type 2 Diabetic Patients Using Continuous Subcutaneous Insulin Infusion In The Uk.

The CDM is a peer-reviewed, validated model, which employs standard Markov techniques to describe the long-term incidence and progression of diabetes-related complications. A complete description of the CORE Diabetes Model, including validations, can be found in the literature1,2. The cohort characteristics was based on the Opt2mise3 study for age, diabetes duration, gender proportion and HbA1c (Table 1).