Cost and Outcome Assessment of a Pharmaceutical Care Service for Cancer Patients treated with Capecitabine

Objective: The present study aimed at evaluating the costs and benefits of a pharmaceutical care (PC) service delivered to cancer patients treated with capecitabine compared to standard care (SC) from a health insurance perspective. Methods: An open, prospective, multi-centred cohort study with a preceding control group was chosen as the study design. Colorectal and breast cancer patients treated with capecitabine were included in the study. For a study period of six months control patients received SC whereas intervention patients received intensified PC. Endpoints among others were direct disease-related outpatient and inpatient costs and quality adjusted life years (QALYs). Utility scores were derived from the EQ-5D questionnaire. A cost-utility analysis was conducted with data from retrospectively matched patient pairs. Matching parameters were tumor entity, therapy setting (neoadjuvant, adjuvant or palliative), therapy regimen at time of inclusion and type of health insurance. Results: Thirty patients were analysed in the control group (CG) and 46 patients in the intervention group (IG). The retrospective finding of matched-pairs yielded eleven patient pairs. Costs for antineoplastic therapy played a dominant role in both patient groups (CG: 59 %, IG: 71 % of total direct costs), followed by costs for inpatient stays (CG: 19 %, IG: 14 % of total direct costs). PC was associated with a gain in mean QALYs compared to SC (0.40, SD: 0.14 versus 0.32, SD: 0.19), at lower mean costs (€ 15606, SD: 13816 versus € 16080, SD: 11308), demonstrating dominance of the PC service. The bootstrapping showed that in 87 % of all replications the PC service was associated with a gain in QALYs. According to the cost-effectiveness acceptability curve the probability that PC was a cost-effective strategy was 43 % at a WTP for an additional QALY of € 0, reaching 62 % probability at a WTP of € 29000 per additional QALY, which is about the implicit NICE cost-effectiveness threshold ratio. Conclusion: In terms of common understanding of cost-effectiveness the PC service was a cost-effective service in the studied patient population. The very small sample size of 22 patients included in the analysis limits the validity of the observed positive result. Further studies with a higher sample size are needed to confirm these findings

Bending radius limits of different coated REBCO conductor tapes - an experimental investigation with regard to HTS undulators

Compact FELs require short-period, high-field undulators in combination with compact accelerator structures to produce coherent light up to X-rays. Likewise, for the production of low emittance positron beams for future lepton colliders, like CLIC or FCC-ee, high-field damping wigglers are required. Applying high-temperature superconductors (HTS) in form of coated REBCO tape conductors allows reaching higher magnetic fields and larger operating margins as compared to low-temperature superconductors (LTS) like Nb-Ti or Nb~3~Sn. However, short undulator periods like 13 mm may require bending radii of the conductor smaller than 5 mm which induce significant bending strain on the superconducting layer and may harm its conducting properties. In this contribution, we present our designed bending rig and experimental results for coated REBCO tape conductors from various manufacturers and with different properties. Investigated bending radii reach from 20 mm down to 1 mm and optionally include half of a helical twist. To represent magnet winding procedures, the samples were bent at room temperature and then cooled down to T = 77 K in the bent state to test for potential degradation of the superconducting properties

Evaluation of patient-reported severity of hand–foot syndrome under capecitabine using a Markov modeling approach

Purpose!#!The inclusion of the patient's perspective has become increasingly important when reporting adverse events and may assist in management of toxicity. The relationship between drug exposure and toxicity can be quantified by combining Markov elements with pharmacometric models. A minimal continuous-time Markov model (mCTMM) was applied to patient-reported outcomes using hand-foot syndrome (HFS) induced by capecitabine anti-cancer therapy as an example.!##!Methods!#!Patient-reported HFS grades over time of 150 patients from two observational studies treated with oral capecitabine were analyzed using a mCTMM approach. Grading of HFS severity was based on the Common Terminology Criteria for Adverse Events. The model was evaluated by visual predictive checks (VPC). Furthermore, a simulation study of the probability of HFS severity over time was performed in which the standard dosing regimen and dose adjustments according to HFS severity were investigated.!##!Results!#!The VPC of the developed dose-toxicity model indicated an accurate description of HFS severity over time. Individual absolute daily dose was found to be a predictor for HFS. The simulation study demonstrated a reduction of severe HFS using the recommended dose adjustment strategy.!##!Conclusion!#!A minimal continuous-time Markov model was developed based on patient-reported severity of hand-foot syndrome under capecitabine. Thus, a modeling framework for patient-reported outcomes was created which may assist in the optimization of dosage regimens and adjustment strategies aiming at minimizing symptom burden during anti-cancer drug therapy