Cost-effectiveness of Ingenol Mebutate Gel for the Treatment of Actinic Keratosis in Greece

Purpose: The present study aimed to perform a cost-effectiveness analysis of ingenol mebutate (IM) versus other topical alternatives for the treatment of actinic keratosis (AK). Methods: The analysis used a decision tree to calculate the clinical effects and costs of AK first-line treatments, IM (2-3 days), diclofenac 3% (for 8 or 12 weeks), imiquimod 5% (for 4 or 8 weeks), during a 24 month horizon, using discrete intervals of 6 months. A hypothetical cohort of immunocompetent adult patients with clinically confirmed AK on the face and scalp or trunk and extremities was considered. Clinical data on the relative efficacy were obtained from a network meta-analysis. Inputs concerning resource use derived from an expert panel. All costs were calculated from a Greek third-party payer perspective. Findings: IM 0.015% and 0.05% were both cost-effective compared with diclofenac and below a willingness-to-pay threshold of (sic)30,000 per quality adjusted life-year (QALY) (sic)199 and (sic)167 per QALY, respectively). Comparing IM on the face and scalp AK lesions for 3 days versus imiquimod for 4 weeks resulted in an incremental cost-effectiveness ratio of (sic)10,868 per QALY. IM was dominant during the 8-week imiquimod period. IM use on the trunk and extremities compared with diclofenac (8 or 12 weeks) led to incremental cost-effectiveness ratios estimated at (sic)1584 and (sic)1316 per QALY accordingly. Results remained robust to deterministic and probabilistic sensitivity analyses. (C) 2017 Elsevier HS Journals, Inc. All rights reserved

Methodological Aspects in the Assessment of Treatment Effects in Observational Health Outcomes Studies

Prospective observational studies, which provide information on the effectiveness of interventions in natural settings, may complement results from randomised clinical trials in the evaluation of health technologies. However, observational studies are subject to a number of potential methodological weaknesses, mainly selection and observer bias. This paper reviews and applies various methods to control for selection bias in the estimation of treatment effects and proposes novel ways to assess the presence of observer bias. We also address the issues of estimation and inference in a multilevel setting. We describe and compare the use of regression methods, propensity score matching, fixed-effects models incorporating investigator characteristics, and a multilevel, hierarchical model using Bayesian estimation techniques in the control of selection bias. We also propose to assess the existence of observer bias in observational studies by comparing patient- and investigator-reported outcomes. To illustrate these methods, we have used data from the SOHO (Schizophrenia Outpatient Health Outcomes) study, a large, prospective, observational study of health outcomes associated with the treatment of schizophrenia. The methods used to adjust for differences between treatment groups that could cause selection bias yielded comparable results, reinforcing the validity of the findings. Also, the assessment of observer bias did not show that it existed in the SOHO study. Observational studies, when properly conducted and when using adequate statistical methods, can provide valid information on the evaluation of health technologies.Bayesian-analysis, Clinical-trial-design, Statistics

Burden of Atopic Dermatitis in Adults in Greece: Results from a Nationwide Survey

The objective was to describe the AD burden in terms of quality of life (QoL), sleep, social life, work productivity, and resource utilization in Greece and assess the impact of disease severity. A nationwide cross-sectional survey was conducted. The questionnaire consisted of socioeconomic factors, medical history, AD screening, AD severity, QoL, sleep difficulties, social activities, and work productivity questions. AD was defined using the UK Working Party criteria (UKWP cohort) and a patient-reported AD diagnosis from a physician (Expert Diagnosis cohort). Self-reported moderate/severe AD was estimated using the Patient-Oriented Eczema Measure (POEM). In the UKWP cohort, the AD effect on QoL was moderate/extremely large in 84.3% of moderate/severe AD (vs. 55.7% in mild; p = 0.016), while in the Expert Diagnosis cohort, it was 72.2% (vs. 22.8%; p p < 0.001). The AD burden in Greece is significant, especially for those in moderate/severe AD stages. Acknowledging this burden is the first step toward applying healthcare decisions that will benefit patients and the community

Cost-Utility Analysis of Treatment with Olanzapine Compared with Other Antipsychotic Treatments in Patients with Schizophrenia in the Pan-European SOHO Study

Objective: To determine the cost utility of treating schizophrenic patients with olanzapine compared with other antipsychotics in a naturalistic outpatient setting. Methods: The pan-European SOHO study is a 3-year, prospective, outpatient, observational study of outcomes associated with antipsychotic treatment, focusing on olanzapine, in ten European countries. For the cost-utility analysis, healthcare resource use (inpatient care, day care, outpatient psychiatric consultations and antipsychotic and concomitant medication use) and EQ-5D data were collected at baseline and at 3, 6 and 12 months. The perspective was that of the health service payer. UK healthcare unit costs (year 2004 values) were applied to the resource use data for the ten countries. UK population tariffs were applied to the EQ-5D data to determine utility values. An Epoch analysis was used to analyze the longitudinal data. Multivariate regression analyses that adjusted for baseline covariates were used to estimate the incremental cost and utility gains for patients treated with olanzapine compared with each of the other antipsychotics (risperidone, quetiapine, amisulpride, clozapine and oral or depot typical antipsychotics). Results: A total of 10_972 patients were enrolled at baseline, of which 9107 completed the 12-month study period. Treatment with olanzapine was more effective in terms of QALYs gained than all of the other antipsychotic treatments. Treatment with olanzapine dominated quetiapine and amisulpride. The incremental cost for olanzapine compared with risperidone was Lstg 226 per patient over 12 months and the incremental cost per QALY gained was Lstg 5156, with bootstrap analyses showing 100% of the replications falling below a Lstg 30_000 per QALY gained threshold. Compared with treatment with clozapine, olanzapine was found to be marginally more effective, at an additional cost of Lstg 13 per patient over 12 months and to have an incremental cost per QALY gained of Lstg 775. Bootstrap analyses showed that 81% of replications fell below a Lstg 30_000 per QALY gained threshold. Comparing olanzapine with oral and depot typical antipsychotics, the incremental cost was Lstg 849 and Lstg 1106 per patient over 12 months and the incremental cost per QALY gained was Lstg 15_696 and Lstg 23_331, respectively. Bootstrap analyses showed that 98% of the replications fell below a Lstg 30_000 per QALY gained threshold for the comparison with oral typical antipsychotics, and 79% of replications for the comparison with depot preparations. Conclusions: Among SOHO patients, if a funding threshold of Lstg 30_000 per QALY gained is assumed, this analysis suggests that olanzapine has a high probability of being the most cost-effective treatment compared with other antipsychotic treatments. However, comparison of olanzapine with clozapine and typical depot antipsychotics should be viewed with caution because clozapine is a second-line treatment and depot treatment is used for patients who do not adhere to their oral medication.Amisulpride, Antipsychotics, Clozapine, Cost-utility, Olanzapine, Quetiapine, Risperidone, Schizophrenia