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Gore M.E.,Royal Marsden Hospital | Bellmunt J.,University of the Sea | Eisen T.,University of Cambridge | Escudier B.,Institute Gustave Roussy | And 9 more authors.
European Journal of Cancer | Year: 2014

The appropriateness of the numerous therapeutic options available for patients with advanced or metastatic renal cell carcinoma (RCC) was evaluated in 2011, using the RAND/University of California, Los Angeles (UCLA) appropriateness methodology to match treatment suitability to a range of patient scenarios. However, the RCC therapeutic area evolves rapidly and a body of new clinical data has accrued in the intervening years; as a result the exercise was repeated in 2013 using the same methodology, expert panel and patient scenarios. The aim of the updated assessment was to update the guidance to clinicians and use it to develop an interactive web-based application, the Renal Cell Carcinoma Appropriateness-based Treatment Toolkit (ReCATT). This round of assessment achieved greater concordance concerning the appropriateness of treatments/interventions for the clinical scenarios tested; this higher level of agreement is likely to reflect the body of scientific evidence accrued since the previous assessment exercise. Many of the areas of disagreement in 2011 related to the suitability of pazopanib or sunitinib treatment; in the 2013 assessment both agents were considered appropriate treatment options for many of the clinical scenarios assessed. Uncertain scenarios often are related to the optimal management of metastatic RCC with clear cell histology. The use of the RAND/UCLA RCC assessment findings to develop the ReCATT support tool will help to disseminate expert opinion concerning best treatment practice and guide the clinical management of RCC patients treated in the community setting. © 2014 Published by Elsevier Ltd. Source


Gore M.E.,Royal Marsden Hospital | Bellmunt J.,University of the Sea | Eisen T.,University of Cambridge | Escudier B.,Institute Gustave Roussy | And 10 more authors.
European Journal of Cancer | Year: 2012

A diverse range of treatment options and interventions are available for the management of renal cell carcinoma (RCC), allowing clinicians to tailor therapy to best meet their patient's needs and situation. However, choosing from the plethora of options can be problematic. RCC treatment guidelines advise on the most efficacious agents based upon specific clinical trial populations, but these do not always take into account all the patient factors that influence the suitability of treatment options for individual patients. This study used the validated RAND/UCLA (RAND corporation/University of California, Los Angeles) 'appropriateness methodology' to integrate clinical efficacy data with expert opinion concerning the use of specific RCC treatment options for particular patient scenarios, in an attempt to facilitate the widespread implementation of patient-focussed treatment choices. Use of the methodology has allowed us to develop treatment algorithms for patients with locally-advanced RCC and for those with metastatic disease post-nephrectomy or with primary tumour in situ. The algorithms take into account patient-specific characteristics such as tumour histology, prior treatment and known risk factors to advise whether a particular treatment intervention is appropriate, not appropriate or of uncertain appropriateness. Use of this methodology aims to develop a formalised process by which expert opinion can be integrated with clinical data and used as an additional source of information that can provide further guidance concerning difficult treatment decisions when data are absent or sparse. © 2012 Elsevier Ltd. All rights reserved. Source


Alberti A.,Istituto Clinico santAmbrogio | Giudice P.,University of Salerno | Gelera A.,Boston Scientific Inc. | Stefanini L.,Boston Scientific Inc. | And 4 more authors.
European Journal of Health Economics | Year: 2016

Aims: To examine the cost-effectiveness of intravascular ultrasound (IVUS) use during percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in treating coronary artery disease (CAD). Methods and results: A Markov model was constructed with a lifetime horizon to compare costs and health outcomes between IVUS-guided PCI and PCI guided solely by angiography from an Italian healthcare payer perspective. The population examined included CAD patients undergoing PCI with DES. From a healthcare payer perspective, the resulting incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year was negative in the base-case scenario (i.e., IVUS benefit assumed to persist beyond the first year). When IVUS benefit was assumed to be limited to the first year, the ICER increased to €9,624. This conclusion remained consistent even when scenarios varied regarding the duration of the device’s effect. Furthermore, benefits of using IVUS were greater for patients with acute coronary syndrome, renal insufficiency, and diabetes. Conclusions: Using IVUS with angiography is a dominant strategy in Italy, and results demonstrate that it is desirable to target those at a greater risk of restenosis (i.e., patients with diabetes, chronic kidney disease, and acute coronary syndrome), who tend to benefit more from accurate stent implantation. Further information is necessary regarding the long-term benefits of IVUS, however sensitivity analysis presented in this research demonstrates a strong argument supporting the cost-effectiveness of IVUS. © 2015, Springer-Verlag Berlin Heidelberg. Source


Punekar Y.S.,Glaxosmithkline | Roberts G.,Double Helix Consulting | Ismaila A.,Glaxosmithkline | Ismaila A.,McMaster University | O'Leary M.,Double Helix Consulting
Cost Effectiveness and Resource Allocation | Year: 2015

Background: The cost-effectiveness of umeclidinium bromide-vilanterol (UMEC/VI) versus tiotropium monotherapy in the UK was assessed using a UMEC/VI treatment-specific economic model based on a chronic obstructive pulmonary disease (COPD) disease-progression model. Methods: The model was implemented as a linked-equation model to estimate COPD progression and associated health service costs, and its impact on quality-adjusted life years (QALYs) and survival. Statistical risk equations for clinical endpoints and resource use were derived from the ECLIPSE and TORCH studies, respectively. For the selected timeframe (1-40 years) and probabilistic analysis, model outputs included disaggregated costs, total costs, exacerbations, life-years and QALYs gained, and incremental cost-effectiveness ratios (ICERs). Results: Random-effects meta-analysis of tiotropium comparator trials estimated treatment effect of UMEC/VI as 92.17 mL (95 % confidence interval: 61.52, 122.82) in forced expiratory volume in 1 s. With this benefit, UMEC/VI resulted in an estimated annual exacerbation reduction of 0.04 exacerbations/patient and 0.36 life years gained compared to tiotropium over patient lifetime. With an additional 0.18 QALYs/patient and an additional lifetime cost of £372/patient at price parity, the incremental cost effectiveness ratio (ICER) of UMEC/VI compared to tiotropium was £2088/QALY. This ICER increased to £17,541/QALY when price of UMEC/VI was increased to that of indacaterol plus tiotropium in separate inhalers. The ICER improved when model duration was reduced from patient lifetime to 1 or 5 years, or when treatment effect was assumed to last for 12 months following treatment initiation. Conclusion: UMEC/VI can be considered a cost-effective alternative to tiotropium at a certain price. © 2015 Punekar et al. Source


Kardos P.,Gemeinschaftspraxis und Zentrum fur Allergologie | Bechtel B.,Glaxosmithkline | Palovis L.,Glaxosmithkline | Hagedorn C.,Glaxosmithkline | Latif F.,Double Helix Consulting
Pneumologie | Year: 2012

Background: Guidelines recommend the addition of a long-acting βagonist (LABA) for patients whose asthma is uncontrolled on inhaled corticosteroid (ICS) monotherapy. For COPD patients the addition of an ICS to a long-acting bronchodilator is recommended for symptomatic patients at high risk of exacerbations. We examined whether in real-life practice guideline recommendations may delay optimal timing for initiation of combination treatment. Methods: A modified Delphi process was undertaken with a panel of physicians, including six GPs and four pulmonologists, in practice in Germany. The first round comprised a semi-structured questionnaire, the second stage was an online discussion to reach consensus on 25 statements concerning the use of ICS/LABA in patients with asthma or COPD. Results: Consensus was achieved on 24 of 25 prepared statements for early initiation of fixed ICS/LABA combination treatment. The panel agreed that a meaningful share of their asthma patients on ICS monotherapy experienced symptoms and exacerbations that should lead to addition of LABAs and that timely initiation of ICS/LABA therapy in asthma patients could improve asthma control, and prevent a significant number of emergency room visits, hospitalisations or additional specialist visits. The panel agreed that symptomatic patients with moderate to severe COPD, and frequent exacerbations should receive ICS without any delay in addition to their bronchodilator maintenance therapy. These patients could benefit from fewer exacerbations and a reduction in symptoms. The panel reached a consensus that fixed-dose ICS/LABA could have a positive effect on adherence, compared with separate inhalers for ICS and LABA, which may impact treatment outcomes. Conclusion: A panel of ten physicians working in primary and secondary care agreed on 24 out of 25 statements that supported the early initiation of fixed combination treatment, if indicated in a meaningful number of their asthma and COPD patients. © Georg Thieme Verlag KG Stuttgart New York. Source

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