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Objective: To provide a framework for addressing payers' criteria during the development of pharmaceuticals.Methods: A conceptual framework was presented to an international health economic expert panel for discussion. A structured literature search (from 2010 to May 2015), using the following databases in Ovid: Medline(®) and Medline(®) In-Process (PubMed), Embase (Ovid), EconLit (EBSCOhost) and the National Health Service Economic Evaluation Database (NHS EED), and a 'grey literature' search, were conducted to identify existing criteria from the payer perspective. The criteria assessed by existing frameworks and guidelines were collated; the most commonly reported criteria were considered for inclusion in the framework. A mnemonic was conceived as a memory aide to summarise these criteria.Results: Overall, 41 publications were identified as potentially relevant to the objective. Following further screening, 26 were excluded upon full-text review on the basis of no framework presented (n = 13), redundancy (n = 11) or abstract only (n = 2). Frameworks that captured criteria developed for or utilised by the pharmaceutical industry (n = 5) and reimbursement guidance (n = 10) were reviewed. The most commonly identified criteria-unmet need/patient burden, safety, efficacy, quality-of-life outcomes, environment, evidence quality, budget impact and comparator-were incorporated into the summary framework. For ease of communication, the following mnemonic was developed: BEACON (Burden/target population, Environment, Affordability/value, Comparator, Outcomes, Number of studies/quality of evidence).Conclusions: The BEACON framework aims to capture the 'essence' of payer requirements by addressing the most commonly described criteria requested by payers regarding the introduction of a new pharmaceutical. [ABSTRACT FROM AUTHOR]

Introduction: Pressurized metered-dose inhalers (pMDI) such as fluticasone propionate and salmeterol (FP/SAL) are commonly used for the treatment of asthma in the UK. Previously, a budget impact analysis demonstrated that use of FP and formoterol fumarate (FP/FORM) pMDI as an alternative to FP/SAL pMDI, would be a cost-saving option for the UK National Health Service (NHS). This budget impact analysis aimed to update the existing analysis with prescription volume data and real-world evidence since the introduction of FP/FORM to the UK market.Methods: Patient Data (IMS Information Solutions UK Ltd) moving annual total (MAT) August 2015 were used to ascertain the number of units of pMDI prescribed. Annual costs to the NHS in terms of drug, administration, monitoring and adverse event costs, were used to estimate the potential budget impact for FP/FORM and FP/SAL. Costs were calculated for current prescription volumes (12% FP/FORM, 88% FP/SAL), and for different prescription volume scenarios (FP/FORM at 0%, 25%, 50% and 100%). Real-world evidence and budget impact at a clinical commissioning group (CCG) level were also considered.Results: Total annual costs per person year were less with FP/FORM (£625) than with FP/SAL (£734). Annual costs to the NHS based on the current prescription volumes and clinical trial data were estimated at £210.0M, however, based on real-world evidence, costs were estimated at £179.8M. For all scenarios with increased FP/FORM prescription volumes, the annual total costs to the NHS decreased. This was reflected at a CCG level.Conclusion: The use of FP/FORM as an alternative to FP/SAL can result in cost savings for the NHS when assessing drug, administration, monitoring and adverse events costs. The inclusion of data released since the launch of FP/FORM within the budget impact analysis demonstrates that the potential cost savings to the NHS that were previously published are being translated to clinical practice.Funding: Mundipharma, UK. [ABSTRACT FROM AUTHOR]

Introduction: Asthma affects 30 million people in Western Europe, leading to substantial burden on healthcare systems and economies. REcognise Asthma and LInk to Symptoms and Experience (REALISE™) was a large European survey across 11 countries assessing patient attitudes and behaviors towards their asthma. The present study utilizes REALISE™ data to understand resource use and absenteeism in asthma. Methods: Data were collected on absenteeism and healthcare resource use from 8000 asthma patients (aged 18-50 years) across the 11 countries. All data were patient reported. Odds ratios (ORs) were calculated against the country with the lowest proportion of respondents for hospitalization (as a proxy for lowest resource use). Results: Patient characteristics were broadly similar across countries. However, self-reported asthma control status varied. More than 50% of respondents in most countries considered primary healthcare professionals (HCPs), i.e., general practitioners and nurses, the main HCP they see about their asthma. However, in some countries, specialists or nurses were considered the main HCP. Hospitalization was lowest amongst patients in the Netherlands. Resource use and productivity loss varied widely across the countries; ORs for hospitalization ranged from 1 in Sweden to 4 in Norway and for productivity loss from 0.6 in Sweden to 2.6 in Italy, compared with the Netherlands. Conclusion: This study quantified utilization of healthcare resources in asthma (number of visits of HCPs, hospitalization, and accident and emergency visits) as well as absenteeism and showed that differences exist across countries. The differences in primary care and specialist use suggest a possible difference in healthcare delivery across countries. Funding: Mundipharma International Limited, Cambridge, UK. [ABSTRACT FROM AUTHOR]

Introduction: The economic burden of asthma on the UK National Health Service (NHS) is the largest among allergic diseases. Current asthma guidelines recommend adding a long acting β 2-agonist (LABA) to a low-dose inhaled corticosteroid (ICS) in patients who are on ICS monotherapy and have uncontrolled asthma. The fixed-dose combination of fluticasone propionate and salmeterol xinafoate (FP/SAL), available in a pressurized metered-dose inhaler (pMDI) device, is the most commonly prescribed ICS/LABA combination. An additional fixed-dose combination of fluticasone propionate and formoterol fumarate (FP/FORM) in pMDI is now available. In a 12-week non-inferiority study, FP/FORM demonstrated comparable efficacy to FP/SAL. The present analysis estimates the annual budget impact for the UK NHS using FP/FORM as an alternative to FP/SAL. Methods: Current pMDI prescribing data were from a real-world UK patient database (Cegedim Strategic Data). Annual costs to the NHS for drug acquisition, administration, and monitoring were estimated for FP/FORM and FP/SAL and used to assess the potential budget impact for the NHS for the use of FP/FORM instead of FP/SAL. Varying rates of uptake, adherence, adverse event-related costs, and resource use associated with switching treatment were assessed in scenario analyses. Results: Assuming similar levels of ICS use with both regimens, annual drug acquisition costs per person were lower with FP/FORM (£412) than with FP/SAL (£509). The difference in acquisition costs and otherwise comparable input costs between the treatments, results in potential annual savings of £15,110,279 to the NHS, assuming uptake of FP/FORM over FP/SAL in 50% of existing patients. The introduction of FP/FORM results in cost savings for the NHS in all of the assessed scenario analyses. Conclusions: The comparable efficacy and lower acquisition costs of FP/FORM compared with FP/SAL make it a cost-saving option for the UK NHS for the treatment of asthma patients requiring combination maintenance therapy using a pMDI. [ABSTRACT FROM AUTHOR]

Introduction: Nearly every individual with schizophrenia is affected by cognitive decline. The aim of this literature review was to: (a) describe the humanistic burden of cognitive impairment associated with schizophrenia (CIAS); (b) develop a conceptual model that depicts the signs and symptoms of CIAS along with key concepts important to patients; and (c) consider the adequacy of potential patient-reported outcome (PRO) instruments for assessing future treatments. Methods: The following electronic databases were searched for articles published between January 1999 and November 2009 related to CIAS and PROs, or cost of illness: Medline; Embase; PsycINFO; the Health Economic Evaluation Database; and the National Health Service Economic Evaluation Database and Health Technology Assessment databases at the Centre for Reviews and Dissemination, University of York. Results: The literature search revealed 3950 abstracts, of which 101 articles were reviewed in detail. Cognitive functions affected include memory, attention/concentration, problem solving, learning, executive function, processing speed, and social cognition. Cognitive impairment impacts the ability of individuals to carry out activities of daily living, work productively, function socially, and adhere to treatment. These effects have economic ramifications through increased direct and indirect costs associated with the treatment of schizophrenia. The literature revealed 39 PRO instruments that have been used to assess functioning. However, no single instrument captures all key concepts of importance to patients with schizophrenia. Conclusion: The significant burden from CIAS for patients and society has implications for designing future treatments and health strategies to improve functional outcomes. [ABSTRACT FROM AUTHOR]