Cost Minimization Analysis of Bont-As in the Treatment of Upper Limb Spasticity and Cervical Dystonia

Abstract

of total costs. In the base scenario (no peginterferon beta-1a) the total cost to treat Italian RRMS patients was estimated to be approximately € 321.5, € 339.7 and € 357.8 million in years 1, 2, and 3, respectively. In the alterna- tive scenario (adoption of peginterferon beta-1a), the same costs resulted in about € 321.1, € 338.6 and € 356.2 million, respectively. The cumulative budget impact over the three year period resulted in an approximate cost saving of € 3.1 million (about 0.3%). The sensitivity analysis confirmed the robustness and reliability of the base-case results. Conclusions: Peginterferon beta-1a showed a favourable pharmaco-eco- nomic profile versus the first line injectable therapies for the treatment of RRMS, being both cost-effective and financially sustainable, and thus repre- sents an efficient treatment option for RRMS patients in Italy. Italy). Introduction: Multiple sclerosis (MS) is a condition with a significant eco- nomic and social burden that affects young adults in their active working phase. The most recent evaluations show an annual average social cost of €38,000–39,000 per patient. Peginterferon beta-1a, injected every two weeks, is the first approved pegylated interferon beta-1a for the treatment of relapsing remitting multiple sclerosis (RRMS), the most common form of MS. The efficacy and safety of peginterferon beta-1a was demonstrated in the placebo-controlled ADVANCE trial. Objective: The objective of this study was the cost-effectiveness and the budget impact analysis of peginterferon beta-1a as compared to injectable first-line treatments for RRMS in Italy. Methods : The cost-effectiveness analysis was developed through a Markov model with lifetime simulation in the perspective of the Italian National Healthcare Service (NHS). An additional scenario analysis was developed to take into account the Italian societal perspective. Outcomes were measured in terms of life years (LYs), quality adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness One-way probabilis- sensitivity cost-effectiveness acceptability budget impact three- support of a simple decision-analytic model years of of a reduction of relapse one-way sensitivity tiveness and meta-analysis matology to 15% in adult rheumatology). Similarly, the economic analysis showed that also average monthly costs vary from €1,054 in dermatology (highest monthly cost) to € 729 in adult rheumatology (lowest monthly cost). Finally the economic analysis showed that in general the highest costs were observed achieved in the maintenance group. Conclusions: The analysis shows high variability across different areas and indications. This is mainly due to patients’ characteristics, type of disease, available treatments and their mix. The huge heterogeneity in monthly costs is due to the fact that costs are collected from a real world administrative database, therefore the annual costs depend on real patients’ exposure time to treatments. In fact it is important to address this issue in order to correctly assess results of the data analysis, providing evidence based data to appro-priately support policy and decision makers choices. of EQ-5D, EQ-5D-VAS and SF-6D in patients with chronic widespread pain. Methods: Data comes from a previous randomized controlled trial, including patients with chronic widespread pain. Anchor based methods were applied to estimate MCID: Global Change Impression (GCI), patient self-reported statement of improvement and a disease specific scale and Chronic Pain Grade (CPG), were utilized as anchors. The selection of anchors was based on Spearman’s correlation coefficient and ANOVA analysis. MCID estimates were computed by means of regression analysis and ROC curves. Moreover, several non-analytical methods were also applied. Co- herent with existing literature, triangulation was used to provide a range of MCID estimates for each HR-QoL measure. Results: For EQ-5D index, MCID was 0.10 [0.03-0.16]. These estimates were robust with respect to the anchor utilized in the analysis; self-reported im- provement and CPG yielded a MCID estimate of 0.09 [0.03-0.13]and 0.10 [0.01-0.14], respectively. For EQ-5D-VAS score, MCID was 9.56 [0.16-13.51] using GCI as an anchor and 6.48 [2.76-16.09] and 9.37 [9.16-13.81] with self-reported improvement and CPG, respectively. However, in EQ-5D-VAS score analysis CPG was a weak anchor and gave raise to not statistically significant estimates when applying regression analysis. Finally for SF-6D score, MCID was 0.06 [0.03-0.09]. Estimates were most ro- bust for SF-6D score, for which sensitivity analysis gave 0.06 [0.03-0.08] and 0.05 [0.02-0.09], with self-reported improvement and CPG, respectively. Conclusions: Overall, MCID estimates for SF-6D were lower than those obtained for EQ-5D index and EQ-5D-VAS. support: None. Conflict of interest: None. Introduction: Botulinum toxin type A (BoNT-A) injections are recommend- ed for the management of upper limb spasticity (ULS) and cervical dystonia (CD). Objective: The main aim of this cost minimization analysis (CMA) was to compare the annual cost per patient for three BoNT-As (Botox®, Dysport® and Xeomin®) in the treatment of ULS or CD in Italy. A budget impact analysis (BIA) was also conducted. Methods: The CMA was conducted from the perspective of the Italian Na- tional Health Service. Only direct medical costs (BoNT-A and standard therapy) were considered. By using a Delphi panel of twelve Italian Experts in the treatment of ULS and CD, data was collected about BoNT-As (dose, number of administrations and acquisition prices) and standard therapy (concomi- tant medications, visits, Day-Hospital, hospitalizations, etc.). Costs were assessed in Euros 2014. A BIA was conducted to evaluate the pharmaceutical expenditure for the three BoNT-As on a five-year time horizon. A sensitivity analysis was also conducted. Results: The mean annual cost per patient with ULS was €1,840.20 with Dysport®, €2,067.12 with Botox® and €2,171.05 with Xeomin®. The mean annual cost per patient with CD was €1,353.79 with Dysport®, €1,433.12 with Botox® and €1,503.60 with Xeomin®. In the time horizon considered, the substitution process of Botox® and Xeomin® by Dysport® would result in a total saving of €620,000 when treating ULS and a total saving of €481,000 in the case of CD. Sensitivity and probabilistic analyses showed the robustness of results. Conclusions: From the Italian National Health Service perspective, Dysport® appears to be the cost-saving therapeutic option compared with Botox® and Xeomin® in the treatment of ULS or CD. and a descriptive analysis of divided into different therapeutic indications and patient groups (naive, switch and maintenance) in to a real picture of use and costs of anti TNF alpha therapies A real-world, retrospective, observational study based on data performed through administrative database analysis of Messina Hospi- tal on a cohort of 906 patients diagnosed with chronic inflammatory diseases treated and Both a pooled analysis and a specific analysis for each indication and disease area (adult rheumatology, rheumatology, gastroenterology, pediatric gas- troenterology and dermatology) performed. addition, also an economic analysis on treatment drug costs across was carried Introduction: In the clinical management of HIV infection, CD4 cell counts and HIV-RNA copies counts have proved to be the best predictors of disease progression and combined antiretroviral therapy (cART) efficacy. However, several studies have recently shown that in patients on cART with CD4 >200 cell/mm 3 and HIV-RNA <50 copies/mL frequent (generally quar- terly) CD4 cell count monitoring results in limited (or null) clinical relevance. Objective: The study, based on data referring to all HIV-infected patients > 18 years being treated at two infectious diseases units located in the metropoli-tan area of Genoa, is intended to investigate whether performing quarterly CD4 cell counts in stable patients is worthwhile and provides a forecast of the cost saving that could be achieved by reducing CD4 monitoring. Methods: Patients with HIV-RNA <50 copies/mL and CD4 >500 cell/mm 3 throughout 2011 were enrolled and defined as “stable patients”. The set of stable patients was observed during a one-year time period, from January to December 2012. The probability of CD4 cell count dropping below the threshold value of 350 cells/mm 3 was assessed using confidence intervals and Kaplan-Meier survival estimates. Multivariate Cox analysis and logistic regression were implement-ed in order to identify factors associated with CD4 cell count fall below the threshold value. The economic consequences of less frequent CD4 cell counts in stable pa- tients were estimated assuming two alternative scenarios: in the first it was assumed that all stable patients were monitored once per year, while in the second scenario stable patients were divided on the basis of the results of the econometric analysis and it was hypothesized CD4 cell counts twice a year for patients characterized by higher risk and CD4 cell counts once a year for the group of “safe” patients. Results: The results of the statistical analysis indicate that among stable patients the probability of maintaining CD4 >350 cell/mm 3 is more than 98%. Econometric models reveal that HCV co-infection is associated with CD4 fall below 350 cells/mm 3 . Economic evaluation suggests that if all stable patients are monitored once per year the total expenditure would be reduced by 63%, whereas it would be decreased by 50% by monitoring once annually stable patients without HCV and twice a year those patients with HCV co-infection (in the Italian con- text cost saving is estimated in the range from about € 400,000 to € 500,000 per year). Moreover, during the period of observation none of the patients have reached the critical value of 200 cells/mm 3 (which is usually considered as the threshold under which