Background: Deteriorating renal function in chronic kidney disease (CKD) patients is commonly associated with reduced haemoglobin levels, adding to the already considerable humanistic burden of CKD. This analysis evaluated the impact of anaemia on disease burden in patients with CKD stages 3-4, and in those on dialysis.Methods: This was a descriptive, cross-sectional analysis of European data from an Adelphi CKD Disease-Specific Programme. This programme collected data from patients and their treating nephrologists/endocrinologists; patient-and physician-reported data were matched for each patient. Health-related quality of life (HRQoL) data were obtained through patient completion of the EQ-5D, SF-12 and KDQOL-36. Additional information was obtained via physician reporting of patient symptoms, and patients' reports of impaired activity. Anaemia was defined by haemoglobin level and/or current use of erythropoiesis stimulating agents.
Introduction The aim of the current study is to estimate the cost-effectiveness of adjuvant treatment with nivolumab relative to clinically relevant comparators in adult patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection from a French societal perspective. Methods The comparators were observation, low-dose interferon and pembrolizumab. A subgroup analysis was carried out in patients with BRAF mutation, adding dabrafenib plus trametinib. A three-state partitioned survival model was developed to project costs and health benefits over a 20-year time horizon. Extrapolation for recurrence-free survival (RFS) and overall survival (OS) was carried out using spline-based models. Because of the immaturity of OS data in pivotal trials for nivolumab and pembrolizumab, a predictive model of OS treatment effect based on RFS effect was developed using a correlation equation. Health state utilities and adverse events disutilities were derived from the CheckMate 238 trial and literature. Costs were estimated in 2019 euros. The model’s primary outcome was efficiency frontier. Deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of results. Results Observation, low-dose interferon and nivolumab were on the efficiency frontier. The incremental cost–utility ratio of nivolumab versus low-dose interferon (closest therapy on the efficiency frontier) was €37,886/quality-adjusted life year (QALY). Probabilistic sensitivity analysis reported an 80% probability of nivolumab being a cost-effective strategy for a willingness-to-pay threshold of €52,000/QALY. In the subgroup with BRAF mutation, the efficiency frontier was not changed by the addition of dabrafenib plus trametinib. Conclusions Nivolumab is a cost-effective strategy as adjuvant treatment in adult patients with surgically resected melanoma in France. Electronic supplementary material The online version of this article (10.1007/s13555-020-00446-z) contains supplementary material, which is available to authorized users.
articles; corporate, foundation and government reports; and existing literature reviews. Results: Preliminary results demonstrate a growing recognition within the industry of the value of understanding patient experiences and perspectives. Patient involvement in research varies tremendously, from superficial and tokenistic to highly substantive (e.g., patient involvement in every stage of the research process, from framing research questions to dissemination of results). Research on the outcomes of patient involvement is largely qualitative, making it difficult to arrive at generalizable conclusions. Positive results often are assumed without being empirically demonstrated. That said, the literature suggests patient involvement can lead to benefits for all stakeholders, including increased legitimacy and transparency, better alignment of research agendas with outcomes that patients value, higher data quality and better communication of results to lay audiences. Other sources, however, highlight barriers to incorporating a patient-centered perspective, such as resistance to diverting research resources, defensiveness relating to researchers' expertise and traditional practices and the time and effort necessary to include patients in an already lengthy R&D process. ConClusions: While there is a growing literature on patient involvement in industry research, the current lack of robust evidence on the outcomes of patient involvement hinders effective inclusion of patients. Further development of a science of patient involvement is a necessary step for broadening and strengthening industry inclusion of patients in the drug development process.
Islamic Republic of)Objectives: Cancer is one of the major causes of mortality and represents a significant burden of disease. Due to the complexity of chemotherapy regimens, medication errors can occur at any point from prescribing to administration. Today, pharmacists play an important role in rationalizing consumption and prescription of medicines for patients undergoing chemotherapy. Intervention of the pharmacist, as one of the last members of the treatment team, can reduce adverse drug events (ADEs) and ultimately save costs. This study estimated the cost-benefit ratio of pharmacist interventions over a year in a chemotherapy preparation unit at a referral hospital in Iran in which annually about 10,000 cancer patients receive inpatient and outpatient care. Methods: Pharmacist intervention records from Sep 2017 to Aug 2018 collected in a standard checklist in Cancer Institute, Tehran University of Medical Sciences, Iran.The clinical significance of interventions was rated by one oncologist and one clinical pharmacist according to Common Terminology Criteria for Adverse Event (CTCAE). Benefit was estimated through both cost avoidance based on the potential to avoid an ADE and cost savings related to reducing discarded products. Cost was estimated from the pharmacists' salary corresponding to the time spent in reviewing chemotherapy prescriptions. Finally, the analysis was conducted by calculation of the cost-benefit ratio. Results: Among 18,450 cancer chemotherapy prescriptions, 559 interventions were applied. Most cases of interventions were related to dosage adjustment of the prescribed dosage (36.4%). 78% of the interventions were considered as clinically more than significant. The cost-benefit analysis showed a clear cost benefit with a cost-benefit ratio of 2.3-16.6 (depends on clinical significance):1. Conclusions: Positive impact of pharmacists' interventions on the clinical and economic outcomes of chemotherapy drugs was clearly demonstrated in this study. This service could reduce medication errors, preventable ADEs, as well as costs of both medications and potential ADEs.
Objectives: There is a paucity of UK-specific resource use data in unresectable HCC. Cost-effectiveness analyses have been based on surveys performed in 2007 and 2015, however clinicians have reported changes in resource utilisation, which could affect HCC-related health state (HS) costs. This study aimed to assess these changes for patients receiving selective internal radiation therapy (SIRT) and systemic therapy. Methods: Resource use was elicited via a questionnaire from experienced medical professionals involved in care. The questionnaire (including background information, medical staff contacts, monitoring, hospitalisations and social care) was developed based on previous examples, guidelines and was validated by a medical oncologist. Face-to-face or telephone interviews were conducted. Unit costs were obtained from publicly available databases. Mean 2018/19 HS costs were compared to 2007 and 2015 results. Results: Five interviews were conducted (two oncologists, one hepatologist, two specialist nurses). Pre-progression HS costs for SIRT and systemic therapy were £245.74 and £287.19/month respectively. One-off cost at progression was £207.79, and post-progression palliative care £499.37/month. Post-progression HS cost when on systemic therapy was same as pre-progression. Monthly costs were lower than in previous studies (by 55% and 80% pre-and post-progression respectively), mainly due to reduced hospitalisations and reduced use of funded social care. The main cost drivers pre-and post-progression were diagnostic procedures (53%) and medical staff contacts (45%) in the current study, and hospitalisations (41%) and social care (42%) in the 2007/2015 costs. Conclusions: Current results suggest important changes in clinical practice in HCC care since 2007, especially post-progression, due to increased familiarity with treatments and a shift from palliative care towards informal care. HS costs were also more dependent on patients receiving chemo-, radiation or palliative therapy, than on progression status, with costs doubling for palliative treatments. Further research would be beneficial using patient level information from large databases, registries.
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