Forecasting pharmaceutical expenditure in Europe : adjusting for the impact of rebates and discounts

European healthcare systems are under constant pressure to contain healthcare expenditure. Understanding future drug expenditure is an important consideration for payers when formulating policies. QuintileIMS publishes European forecasts that are underpinned by its audited volume data and publicly available list prices. With increasing price pressures, list to net price divergence is growing, although some of this information is commercially sensitive and thus not publicly available. The objective of this study was to further develop an established forecast to account for this divergence and explore its impact

Resultados de los potenciales evocados miogénicos vestibulares en el vértigo posicional paroxístico benigno

Objective: Benign paroxysmal positional vertigo (BPPV) seems to occur because of otoconia migration into the semicircular canals or their adherence to the cupula. Although the origin of these otoconia lies in the macula of the utricle, vestibular evoked myogenic potentials (VEMPs) can be used assess saccular function. The aim of this study is to assess the saccular function in patients diagnosed with BPPV. Patients and method: Nineteen patients diagnosed with BPPV of the posterior semicircular canal were included in this study. Their auditory function and their caloric, rotatory chair, and VEMP responses were tested. Ipsilateral and contralateral VEMP thresholds, ipsilateral and contralateral p13 and n23 latencies at 100 dB, inter-peak amplitude and the interaural amplitude difference were determined. Results: We found a lack of VEMP response in 52 % of the ears with BPPV. When adjusted for bilateral absence, VEMP response was absent in 20.3 % of ears. Conclusions: Some patients with idiopathic BPPV show a degree of saccular dysfunction

Does the use of health technology assessment have an impact on the utilisation of health care resources? Evidence from two European countries

Objectives: A centralised approach to health technology assessment (HTA) may facilitate optimal use of HTA resources. A regional approach may increase the chances of local implementation of recommendations. This study aimed to compare assessment procedures in England (centralised HTA approach) with Spain (regional HTA approach) discussing key challenges and opportunities from both approaches. Methods: We compared technology assessments of anticancer medicines in the two jurisdictions from 2008 to 2015. In order to assess the implementation of HTA recommendations, we assessed trends in medicine usage using regression methods. We used IQVIA data, from 2011 to 2016, for a sample of 11 medicines. We used CatSalut data from Catalonia to assess the implementation of local recommendations. Results: In England 66 assessments were undertaken by the National Institute for Health and Care Excellence (NICE), using a standardised methodology. In Spain there were 79 reports undertaken by a range of bodies using a shared process and coordinated through the GENESIS collaboration; the assessment methods used varied substantially. Overall, the recommendations in the two jurisdictions were similar. Regression analyses indicate that where there is a positive recommendation by HTA bodies, the usage of the medicine responds most strongly (p<0.001) in Catalonia (=4.892), followed by England ( =3.120) and Spain ( =1.693). Conclusions: This study suggests that medicine utilisation does respond to the positive recommendations of HTA bodies. However, if HTA capacity is organised primarily regionally, considerable effort may be required in coordination, in order to ensure consistent and rigorous assessments and adequate implementation of HTA findings

Freshness and Reactivity Analysis in Globally Asynchronous Locally Time-Triggered Systems

International audienceCritical embedded systems are often designed as a set of real-time tasks, running on shared computing modules, and communicating through networks. Because of their critical nature, such systems have to meet timing properties. To help the designers to prove the correctness of their system, the real-time systems community has developed numerous approaches for analyzing the worst case times either on the processors (e.g. worst case execution time of a task) or on the networks (e.g. worst case traversal time of a message). However, there is a growing need to consider the complete system and to be able to determine end-to-end properties. Such properties apply to a functional chain which describes the behavior of a sequence of functions, not necessarily hosted on a shared module, from an input until the production of an output. This paper explores two end-to-end properties: freshness and reactivity, and presents an analysis method based on Mixed Integer Linear Programming (MILP). This work is supported by the French National Research Agency within the Satrimmap project

Endomembranes promote chromosome missegregation by ensheathing misaligned chromosomes

Errors in mitosis that cause chromosome missegregation lead to aneuploidy and micronucleus formation, which are associated with cancer. Accurate segregation requires the alignment of all chromosomes by the mitotic spindle at the metaphase plate, and any misalignment must be corrected before anaphase is triggered. The spindle is situated in a membrane-free “exclusion zone”; beyond this zone, endomembranes (mainly endoplasmic reticulum) are densely packed. We investigated what happens to misaligned chromosomes localized beyond the exclusion zone. Here we show that such chromosomes become ensheathed in multiple layers of endomembranes. Chromosome ensheathing delays mitosis and increases the frequency of chromosome missegregation and micronucleus formation. We use an induced organelle relocalization strategy in live cells to show that clearance of endomembranes allows for the rescue of chromosomes that were destined for missegregation. Our findings indicate that endomembranes promote the missegregation of misaligned chromosomes that are outside the exclusion zone and therefore constitute a risk factor for aneuploidy

Does NICE influence the adoption and uptake of generics in the UK?

The aim of this paper is to examine generic competition in the UK, with a special focus on the role of Health Technology Assessment (HTA) on generic market entry and diffusion. In the UK, where no direct price regulation on pharmaceuticals exists, HTA has a leading role for recommending the use of medicines providing a non-regulatory aspect that may influence the dynamics in the generic market. The paper focuses on the role of Technology Appraisals issued by the National Institute for Health and Care Excellence (NICE). We follow a two-step approach. First, we examine the probability of generic entry. Second, conditional on generic entry, we examine the determinants of generic market share. We use data from IQVIA British Pharmaceutical Index (BPI) for the primary care market for 60 products that lost patent between 2003 and 2012. Our results suggest that market size remains one of the main drivers of generic entry. After controlling for market size, intermolecular substitution and difficulty of manufacturing increase the likelihood of generic entry. After generic entry, our estimates suggest that generic market share is highly state dependent. Our findings also suggest that while NICE recommendations do influence generic uptake, there is only marginal evidence they affect generic entry

Hybrid fly ash-based geopolymeric foams: Microstructural, thermal and mechanical properties

This research investigates the preparation and characterization of new organic-inorganic geopolymeric foams obtained by simultaneously reacting coal fly ash and an alkali silicate solution with polysiloxane oligomers. Foaming was realized in situ using Si0 as a blowing agent. Samples with density ranging from0.3 to 0.7 g/cm3 that show good mechanical properties (with compressive strength up to ≈5 MPa for a density of 0.7 g/cm3) along with thermal performances (λ = 0.145 ± 0.001 W/m·K for the foamed sample with density 0.330 g/cm3) comparable to commercial lightweight materials used in the field of thermal insulation were prepared. Since these foams were obtained by valorizing waste byproducts, they could be considered as low environmental impact materials and, hence, with promising perspectives towards the circular economy

Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate‐to‐severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2)

SummaryBackground Apremilast, an oral phosphodiesterase 4 inhibitor, regulates immune responses associated with psoriasis. Objectives ESTEEM 2 evaluated the efficacy and safety of apremilast 30 mg twice daily for moderate-to-severe plaque psoriasis. Methods This phase III, double-blind, placebo-controlled trial randomized adults to apremilast or placebo (2 : 1). At week 16, placebo patients switched to apremilast. At week 32, apremilast patients achieving ≥ 50% reduction in Psoriasis Area and Severity Index (PASI 50) were rerandomized (1 : 1) to continue apremilast or receive placebo. Upon loss of 50% of PASI improvement obtained at week 32, patients rerandomized to placebo resumed apremilast. Results The modified intention-to-treat population (full analysis set) included 137 placebo and 274 apremilast patients. At week 16, significantly more apremilast patients achieved PASI 75 (28·8%), PASI 50 (55·5%) and static Physician's Global Assessment score of 0 or 1 (20·4%) vs. placebo (5·8%, 19·7%, 4·4%, respectively; P < 0·001). Most patients rerandomized to apremilast at week 32 had a PASI 50 response at week 52 (80%). Patients treated with apremilast showed significant improvements in quality of life (as assessed by the Dermatology Life Quality Index) and pruritus at week 16 compared with placebo (P < 0·001). The exposure-adjusted incidence of adverse events did not increase with continued apremilast treatment for up to 52 weeks. The most common adverse events were nausea, diarrhoea, nasopharyngitis and upper respiratory tract infection. Conclusions Apremilast was effective in the treatment of moderate-to-severe plaque psoriasis over 52 weeks

Policy instruments (‎non-price)‎ for medical innovation

Innovation policy instruments are policy interventions with a specific mechanism of action that influences the innovation process. This Oslo Medicines Initiative technical report presents a broad range of such instruments available to national policy-makers in support of innovation for new medicines (excluding those focused on price, which are covered elsewhere in the report series). This report explores various types of policy instruments, based on reviews of the literature on policies for innovation in the medical and other sectors. For each type identified, the report explores the mechanisms of action, the effects these have and where they occur, and the extent to which these instruments have been implemented globally. It also sets out considerations for their effective implementation. The report demonstrates that the long-established push/pull (supply/ demand) framing that dominates discourse around medical innovation can be broadened, providing policy-makers with instruments to supplement push/pull approaches, by emphasizing the role of communication, collaboration and coordination in supporting the emergence of medicines to address societal needs