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Per governare i tempi di attesa delle prestazioni è imprescindibile utilizzare i dati amministrativi nella pianificazione dell'offerta e nel governo della domanda di servizi. L'articolo illustra l'esperienza della ricerca-intervento realizzata dall'Azienda Sanitaria dell'Alto Adige per la stima dei fabbisogni futuri e l'analisi retrospettiva dei consumi della specialistica ambulatoriale. Viene presentato il modello quantitativo predittivo sviluppato dall'azienda per la definizione del fabbisogno di prestazioni con dettaglio per singola prestazione, e vengono esposte le scelte strategiche aziendali per ridurre i tempi di attesa. Rispetto ad alcune prestazioni di particolare rilevanza sono invece proposte analisi retrospettive per verificare l'appropriatezza dei consumi, con particolare riferimento agli indici di consumo per area di residenza, MMG, o fasce di età; alla mobilità intraprovinciale; alle modalità di accesso alle prestazioni; ai codici di priorità. Tale approccio si presta a esser facilmente applicabile ad altre aziende sul territorio italiano data la semplicità dello strumento e la crescente disponibilità e granularità di dati sul consumo di prestazioni sanitarie a disposizione delle aziende.

Resource modeling aims to explicitly quantify the effects of adopting new health care technologies in settings with capacity-related constraints. The aim of this analysis was to use resource modeling to explore the effects of the uptake of first-line treatment with daratumumab on wait lists and wait times in patients with untreated multiple myeloma. Two formulations were compared: the standard IV formulation (DARA-IV) and a recently approved SC formulation (DARA-SC).First, semi-structured interviews at six oncologic centers were used to retrieve data on the management of patients given a DARA-IV regimen. Second, a discrete event simulation (DES) model was built to estimate the effects on resource consumption, wait lists, and wait times in scenarios with different incident numbers of patients treated with either DARA-IV or DARA-SC.In all of the simulated scenarios with more incident patients initiated on first-line treatment with DARA-IV, the actual capacity of infusion chairs was not enough to meet the demand, leading to increases in wait times and wait lists. In the highest-demand scenario, 17 more infusion chairs per center would be required to avoid such increases. Treatment with DARA-SC would allow centers to meet the demand with their actual capacity.DES modeling can effectively be used to formally explore the effects of different formulations on the use of limited resources, wait lists, and wait times at the facility level. Based on the findings from this analysis, DARA-SC may free up resources and prevent short- and long-term costs to infusion centers.

The blended learning (BL) approach to training health care professionals is increasingly adopted in many countries because of high costs and disruption to service delivery in the light of severe human resource shortage in low resource settings. The Covid-19 pandemic increased the urgency to identify alternatives to traditional face-to-face (f2f) education approach. A four-day f2f antenatal care (ANC) and postnatal care (PNC) continuous professional development course (CPD) was repackaged into a 3-part BL course; 1) self-directed learning (16 hours) 2) facilitated virtual sessions (2.5 hours over 3 days) and 3) 2-day f2f sessions. This study assessed the feasibility, change in healthcare providers’ knowledge and costs of the BL package in Nigeria, Tanzania, and Kenya. A mixed methods design was used. A total of 89 healthcare professionals, were purposively selected. Quantitative data was collected through an online questionnaire and skills assessments, analyzed using STATA 12 software. Qualitative data was collected through key informant interviews and focus group discussions, analysed using thematic analysis.Majority of participants (86%) accessed the online sessions using a mobile phone from home and health facilities. The median (IQR) time of completing the self-directed component was 16 hours, IQR (8, 30). A multi-disciplinary team comprising of 42% nurse-midwives, 28% doctors, 20% clinical officers and 10% other healthcare professionals completed the BL course. Participants liked the BL approach due to its flexibility in learning, highly educative/relevant content, mixing of health worker cadres and CPD points. Aspects that were noted as challenging were related to personal log-in details and network connectivity issues during the self-directed learning and facilitated virtual sessions respectively. The blended learning approach to ANC-PNC in-service training was found to be feasible, cost saving compared to the face-to-face approach and acceptable to health care professionals in LMICs.

By using a case-study on a fall-prediction device for elderly patients with orthostatic hypotension we aim to demonstrate how the MAFEIP tool, developed as part of the European Innovation Programme on Active and Healthy Ageing (EIP on AHA), can be used to inform manufacturers on their product development based on a cost-effectiveness criterion. Secondly, we critically appraise the tool and suggest further improvements that may be needed for a larger-scale adoption of MAFEIP within and beside the EIP on AHA initiative. The model was implemented using the MAFEIP tool. Within the tool one way sensitivity analyses were performed to assess the robustness of the model against the relative effectiveness of the fall-prevention device at different price levels. The MAFEIP tool was applied to a novel fall-prediction device and used to estimate the expected cost-effectiveness and perform threshold analysis. In our case study, the device produced estimated gains of 0.035 QALYs per patient and incremental costs of £ 518 (incremental cost-effectiveness ratio £14,719). Based on the one-way sensitivity analysis, the maximum achievable price at a willingness to pay threshold of £20,000 per QALY is estimated close to £900. The MAFEIP allows to quickly create early economic models, and to explore model uncertainty by performing deterministic sensitivity analysis for single parameters. However, the integration within the MAFEIP of common analytical tools such as probabilistic sensitivity analysis and Value of information would greatly contribute to its relevance for evaluating innovative technologies within and beside the EIP on AHA initiative.

Objectives A recent debate in health economics and outcomes research community identified option value as one of the elements warranting consideration in the assessment of medical technologies. To conduct a scoping review of contributions on option value in the healthcare sector and identify relevant conceptual aspects and methods used to incorporate it in standard economic evaluations. Methods A systematic search was conducted up to July 2020 to identify contributions from electronic bibliographic database and gray literature. Data on the proposed definitions of option value, theoretical implications of its use in economic evaluations, and methods used to estimate it were extracted and analyzed. Results We found 57 eligible studies. Three different definitions emerged: insurance value, real option value, and option value of survival. Focusing on the latter (24 studies), we analyzed in depth 8 empirical applications across 7 therapeutic areas. The most relevant methodological challenges were on the perspective used in economic evaluations and how to robustly manage forecasting uncertainty, update cost-effectiveness thresholds, and avoid double-counting issues. For empirical studies assessing the total value of the technology, including option value, estimates ranged from +7% to +469% of its conventional value. Conclusions This review synthesizes theoretical and empirical aspects on option value of healthcare technologies and proposes a terminology to distinguish 3 different concepts identified. Future work should focus primarily on agreeing on whether option value should be included in economic evaluations and, if so, on developing and validating reliable methods for its ex-ante estimation.

Objectives Medical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization. Methods We conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years. Results We identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion. Conclusions CED programmes for devices with different characteristics exist in Europe. Decision-makers’ perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.

Differing contexts have greatly influenced HTA development in various countries, with considerable effort recently made by international HTA networks (e.g., EUnetHTA) and the European Union (EU) to make HTA a more coherent, equal, and efficient process. Medical devices (MDs) present particular challenges for HTA because of frequent, rapid innovation, outcomes influenced by end-user competence, dynamic pricing and often low-quality scientific evidence. Our objective is to describe the development, structure and governance of a National HTA Program for MDs (PNHTADM) in Italy, a highly participatory, stakeholder-engaged, evidence-based process to reform a fragmented system of appraisal and approval. Based largely on EUnetHTA methods, the resulting process delineates a standardized system for proposing MDs by any stakeholders, accrediting HTA producers, setting criteria for prioritization and appraisals, and innovatively linking recommendations with coverage, reimbursement and procurement of MDs. Expected benefits include reduced disparities in pricing and reimbursement policies and improved access to new technologies across 21 regional healthcare systems in Italy's decentralized, universal system, complete with provisions to require additional evidence collection and centrally monitor diffusion. Though devised for Italy, the design, resources and underlying analysis provide a framework for other nations seeking to consolidate HTA initiatives, particularly in light of new EU regulation.

INTRODUCTION: Performance-based risk-sharing agreements (PBRSAs), between payers, health care providers, and technology manufacturers can be useful when there is uncertainty about the (cost-) effectiveness of a new technology or service. However, they can be challenging to design and implement. AREAS COVERED: A total of 18 performance-based agreements were identified through a literature review. All but two of the agreements identified were pay-for-performance schemes, agreed between providers and payers at the national level. No examples were found of agreements between health care providers and manufacturers at the local level. The potential for these local agreements was illustrated by hypothetical case studies of water quality management and an integrated chronic kidney disease program. EXPERT OPINION: Performance-based risk-sharing agreements can work to the advantage of patients, health care providers, payers, and technology manufacturers, particularly if they facilitate the introduction of technologies or systems of care that might not have been introduced otherwise. However, the design, conduct, and implementation of PBRSAs in renal care pose a number of challenges. Efforts should be made to overcome these challenges so that more renal care patients can benefit from technological advances and new models of care.

Early Feasibility Studies (EFS) are among the pre-market clinical investigations allowed by the International Standard for Clinical investigation of medical devices (MD) for human subjects. The Food and Drug Administration (FDA) introduced an EFS program in the US in 2013. The European Union (EU) MD Regulation, that entered into force in May 2021, opened the possibility of EFS in the EU. However, European countries at present have no standardized procedural framework for EFS. In this paper, we address the desirability of a European EFS program.Characteristics of EFS conducted so far are reviewed, and perceptions of an expert, multidisciplinary panel of key stakeholders are explored regarding desirability and feasibility of a European EFS program and critical factors favoring or hampering its implementation.Implementing an EFS program in the EU would contribute to creating a favorable environment for early-stage clinical investigations, with positive effects on the quality and timeliness of clinical evidence for novel MDs, and attractiveness of the European system for pre- and post-market clinical research. Based on discussion with experts, also leveraging on the US experience, three dimensions should be considered for effective design and implementation: process, resources, and ethical issues.

In the drive towards faster patient access to treatments, health technology assessment (HTA) agencies are increasingly faced with reliance on evidence from surrogate endpoints, leading to increased decision uncertainty. This study undertook an updated survey of methodological guidance for using surrogate endpoints across international HTA agencies. We reviewed HTA and economic evaluation methods guidance from European, Australian and Canadian HTA agencies. We considered how guidelines addressed the methods for handling surrogate endpoints, including (1) level of evidence, (2) methods of validation, and (3) thresholds of acceptability. Across the 73 HTA agencies surveyed, 29 (40%) had methodological guidelines that made specific reference to consideration of surrogate outcomes. Of the 45 methods documents analysed, the majority [27 (60%)] were non-technology specific, 15 (33%) focused on pharmaceuticals and three (7%) on medical devices. The principles of the European network for Health Technology Assessment (EUnetHTA) guidelines published in 2015 on the handling of surrogate endpoints appear to have been adopted by many European HTA agencies, i.e. preference for final patient-relevant outcomes and reliance on surrogate endpoints with biological plausibility and epidemiological evidence of the association between the surrogate and final endpoint. Only a small number of HTA agencies (UK National Institute for Care and Excellence; the German Institute for Medical Documentation and Information and Institute for Quality and Efficiency in Health Care; the Australian Pharmaceutical Benefits Advisory Committee; and the Canadian Agency for Drugs and Technologies in Health) have developed more detailed prescriptive criteria for the acceptance of surrogate endpoints, e.g. meta-analyses of randomised controlled trials showing strong association between the treatment effect on the surrogate and final outcomes. As the decision uncertainty associated with reliance on surrogate endpoints carries a risk to patients and society, there is a need for HTA agencies to develop more detailed methodological guidance for consistent selection and evaluation of health technologies that lack definitive final patient-relevant outcome evidence at the time of the assessment.

In this viewpoint, we discuss the approach promoted by the Italian Drug Agency (AIFA) to the assessment of the value of new pharmaceuticals in the Italian Healthcare Service. On top of traditionally acknowledged components, such as quality adjusted life years gained and net costs, the overall value framework might include other elements such as productivity and adherence, equity, severity of disease, reduction in uncertainty, spillover effects. There is a residual dimension in the value framework that may capture the option value or reduction in fear of contagion for infectious disease treatments. We debate measurement issues on these elements of value and discuss open issues from a methodological and policy standpoint.

Payers and manufacturers can disagree on the appropriate level of evidence that is required for new medical devices, resulting in high societal costs due to decisions taken with sub‐optimal information. A cost‐effectiveness model of a hypothetical total artificial heart was built using data from the literature and the (simulated) results of a pivotal study. The expected value of perfect information (EVPI) was calculated from both the payer and manufacturer perspectives, using net monetary benefit and the company's return on investment respectively. A function was also defined, linking effectiveness to market shares. Additional constraints such as a minimum clinical difference or maximum budget impact were introduced into the company's decisions to simulate additional barriers to adoption. The difference in the EVPI between manufacturers and payers varied greatly depending on the underlying decision rules and constraints. The manufacturer's EVPI depends on the probability of being reimbursed, the uncertainty on the (cost‐)effectiveness of the technology, as well as other parameters relating to initial investments, operating costs and market dynamics. The use of Value of information for both perspectives can outline potential misalignments and can be particularly useful to inform early dialogs between manufacturers and payers, or negotiations on conditional reimbursement schemes.

Health economic modeling of novel technology at the early stages of a product lifecycle has been used to identify technologies that are likely to be cost-effective. Such early assessments are challenging due to the potentially limited amount of data. Modelers typically conduct uncertainty analyses to evaluate their effect on decision-relevant outcomes. Current approaches, however, are limited in their scope of application and imposes an unverifiable assumption, i.e., uncertainty can be precisely represented by a probability distribution. In the absence of reliable data, an approach that uses the fewest number of assumptions is desirable. This study introduces a generalized approach for quantifying parameter uncertainty, i.e., probability bound analysis (PBA), that does not require a precise specification of a probability distribution in the context of early-stage health economic modeling. We introduce the concept of a probability box (p-box) as a measure of uncertainty without necessitating a precise probability distribution. We provide formulas for a p-box given data on summary statistics of a parameter. We describe an approach to propagate p-boxes into a model and provide step-by-step guidance on how to implement PBA. We conduct a case and examine the differences between the status-quo and PBA approaches and their potential implications on decision-making.

IntroductionAn iterative, life-cycle approach to the evaluation of healthcare technologies requires that clinical and economic evidence is collected since the initial stages of diffusion. Nevertheless, early cost-effectiveness models are challenging mainly due to the difficulties in estimating model parameters and faithfully characterizing parameter uncertainty. This is especially true with AI-based diagnostics, where attribution of effects on costs and patient-relevant outcomes is more challenging. Empirical applications of early-models are useful to identify the main challenges of iterative modelling and provide recommendations on best-practices. Here, we reported on a case study on a machine learning-derived hypotension predictive index (HPI), that predicts the onset of intraoperative hypotension and trigger corrective measures.MethodsA hybrid decision-tree/Markov model was developed comparing an HPI-based intervention protocol to standard-of-care intervention protocol during gynecological procedures. A short-term component of the model was populated using data from individual patients collected at one hospital in Italy. An historical control group was also defined using propensity score matching. Long-term costs and consequences of HPI were modelled using secondary data. A probabilistic version of the headroom approach was used to determine the maximum achievable price of HPI based on available evidence. Value of Information analysis was also conducted to identify the parameters that contribute the most to the overall uncertainty, and to identify optimal future study designs. Extensive deterministic and probabilistic sensitivity analyses were conducted to characterize the uncertainty over the cost-effectiveness of HPI.ResultsThe preliminary results of the analysis suggest that HPI has potential to improve patients’ outcomes and generate efficiency gains by reducing hypotension events and permanent complications, such as acute kidney injury. The link between reduction in hypotension and the rate of complications, or the long-term effects on healthcare costs and patients’ quality of life are the parameters that contribute the most to model uncertainty.ConclusionsEarly cost-effectiveness models are a valuable tool to inform further product development and evidence requirements, but characterization of uncertainty and transparency in modelling assumptions are key.

Patient-reported outcomes (PROs) are any report of the status of a patient's health condition that comes directly from the patient (or in some cases from a caregiver or surrogate responder), without interpretation by a practitioner or anyone else. PROs are increasingly used as a valuable source of data in different domains of health care, including research, clinical practice, health care management, and decision making on the regulation, coverage, and reimbursement of new technologies. Several factors must be considered when selecting which PRO measure to use to ensure their appropriate use and interpretation as well as their relevance for decision makers. The increasing availability of PRO data, its integration with other data sources, and the improvements in data analytics offer a valuable opportunity to place the patient at the center of any health care process. However, several issues need to be addressed, including interoperability, data governance, security, privacy, and ethics, to realize an effective, integrated, standardized, real-time assessment of PROs in the health care systems.

Purpose Electrochemotherapy is increasingly entering into national and international guidelines, requiring formal evaluation of treatment costs and cost-effectiveness to ensure that its uptake provides value to budget-constrained health care systems. This study analyzed the early cost-effectiveness of electrochemotherapy in patients with Stage IIIc/IV skin melanoma in clinical practice in Slovenia. The costs of electrochemotherapy were compared to those of the standard of care, consisting of palliative treatment and therapy for symptoms. Methods wThe study enrolled 23 patients treated with electrochemotherapy at the Institute of Oncology (Ljubljana, Slovenia). The mean cost of electrochemotherapy was estimated using patient-specific cost data on electrochemotherapy procedures and subsequent follow-up. Quality-adjusted life-years (QALYs) were estimated by collecting EQ-5D-3L questionnaires at baseline, after complete or partial response following the treatment, and after a relapse of skin lesions. A discrete-time Markov model was built to estimate the lifetime costs and consequences of using electrochemotherapy compared to standard of care, from the perspective of the Slovenian health care system. The analysis was conducted separately in the whole patient sample and in the subset of patients with bleeding lesions. Deterministic and probabilistic sensitivity analyses were conducted to test model assumptions and to characterize the uncertainty around model parameters. Findings In the whole patient population, electrochemotherapy for skin melanoma Stage IIIc/IV was expected to increase QALYs by 0.29 (95% credible interval [CrI], 0.10–0.50), at the higher cost of 6568 EUR (95% CrI, 4593–8928) in comparison to the standard of care. At the cost-effectiveness threshold of 20,000 EUR/QALY, the estimated probabilities of electrochemotherapy being cost-effective compared to standard of care were 0.30 and 0.91 in the whole patient sample and in patients with bleeding lesions, respectively. In the whole sample population, a 50% reduction in the price of the electrodes was expected to increase the probability of electrochemotherapy being cost-effective from 0.30 to ~0.64. Implications The findings from this cost-effectiveness analysis of data from clinical practice were based on a small sample size (ie, 23 patents), which made the subgroup of patients with bleeding lesions very small. Therefore, the findings in this patient population should be carefully interpreted.

ObjectivesTo explore treatment behaviours in a cohort of Italian patients with hereditary angioedema due to complement C1-inhibitor deficiency (C1-INH-HAE), and to estimate how effects and costs of treating attacks in routine practice differed across available on-demand treatments.DesignCost analyses and survival analyses using attack-level data collected prospectively for 1 year.SettingNational reference centre for C1-INH-HAE.Participants167 patients with proved diagnosis of C1-INH-HAE, who reported data on angioedema attacks, including severity, localisation and duration, treatment received, and use of other healthcare services.InterventionsAttacks were treated with either icatibant, plasma-derived C1-INH (pdC1-INH) or just supportive care.Main outcome measuresTreatment efficacy in reducing attack duration and the direct costs of acute attacks.ResultsOverall, 133 of 167 patients (79.6%) reported 1508 attacks during the study period, with mean incidence of 11 attacks per patient per year. Only 78.9% of attacks were treated in contrast to current guidelines. Both icatibant and pdC1-INH significantly reduced attack duration compared with no treatment (median times from onset 7, 10 and 47 hours, respectively), but remission rates with icatibant were 31% faster compared with pdC1-INH (HR 1.31, 95% CI 1.14 to 1.51). However, observed treatment behaviours suggest patterns of suboptimal dosing for pdC1-INH. The average cost per attack was €1183 (SD €789) resulting in €1.58 million healthcare costs during the observation period (€11 912 per patient per year). Icatibant was 54% more expensive than pdC1-INH, whereas age, sex and prophylactic treatment were not associated to higher or lower costs.ConclusionsBoth icatibant and pdC1-INH significantly reduced attack duration compared with no treatment, however, icatibant was more effective but also more expensive. Treatment behaviours and suboptimal dosing of pdC1-INH may account for the differences, but further research is needed to define their role.

Background Unhealthy diet is a risk factor for adverse health outcomes. Reformulation of processed foods has the potential to improve population diet, but evidence of its impact is limited. The purpose of this review was to explore the impact of reformulation on nutrient intakes, health outcomes and quality of life; and to evaluate the quality of modelling studies on reformulation interventions. Methods A systematic review of peer-reviewed articles published between January 2000 and December 2017 was performed using MEDLINE, ScienceDirect, Embase, Scopus, Cochrane, and the Centre for Reviews and Dissemination of the University of York. Additional studies were identified through informal searches on Google and specialized websites. Only simulation studies modelling the impact of food reformulation on nutrient intakes and health outcomes were included. Included articles were independently extracted by 2 reviewers using a standardized, pre-piloted data form, including a self-developed tool to assess study quality. Results A total of 33 studies met the selected inclusion criteria, with 20, 5 and 3 studies addressing sodium, sugar and fats reformulation respectively, and 5 studies addressing multiple nutrients. Evidence on the positive effects of reformulation on consumption and health was stronger for sodium interventions, less conclusive for sugar and fats. Study features were highly heterogeneous including differences in methods, the type of policy implemented, the extent of the reformulation, and the spectrum of targeted foods and nutrients. Nonetheless, partial between-study comparisons show a consistent relationship between percentages reformulated and reductions in individual consumption. Positive results are also shown for health outcomes and quality of life measures, although comparisons across studies are limited by the heterogeneity in model features and reporting. Study quality was often compromised by short time-horizons, disregard of uncertainty and time dependencies, and lack of model validation. Conclusions Reformulation models highlight relevant improvements in diets and population health. While models are valuable tools to evaluate reformulation interventions, comparisons are limited by non-homogeneous designs and assumptions. The use of validated models and extensive scenario analyses would improve models’ credibility, providing useful insights for policy-makers. Review Registration A research protocol was registered within the PROSPERO database (ID number CRD42017057341). Electronic supplementary material The online version of this article (10.1186/s40795-018-0263-6) contains supplementary material, which is available to authorized users.

In this work we report a pre-restoration spectroscopic study by a multi-technique approach on the green pigment and the binder used in illuminations in a codex of the late 15th century. Our analysis aimed to characterize the badly deteriorated parts of the codex, mainly the green parts, by electron paramagnetic resonance (EPR), X-ray diffraction (XRD), X-ray fluorescence (XRF) and infrared spectroscopy (ATR-IR). We will show that a combined study by EPR and IR spectroscopies on model systems allowed us to refine the general information obtained with the other techniques and to identify the binding media surrounding the chromophore Cu(II) ion.

INTRODUCTION:The evaluation of orphan drugs raises both positive and normative issues. Due to the rarity of the disease, higher drug costs and greater uncertainty on effectiveness often result in incremental cost-effectiveness ratios (ICER) far beyond the usually accepted thresholds for reimbursement. However, decision makers may need to consider other criteria to assess the social value of orphan drugs such as equity, the rule of rescue, and the perceived need in the community. Hereditary Angioedema (HAE) is a rare congenital deficiency resulting in recurrent attacks of angioedema in affected patients. These episodes cause extreme pain and distress, and may even be fatal when air pathways are involved. In Italy, icantibant or C1-Esterase-Inhibitors (C1-INH) are the indicated treatments for acute attacks. Although more expensive, icantibant may reduce time to symptom-relief and the need for further treatments. Nonetheless, evidence on its social value is missing. The present study aims at evaluating the cost-effectiveness of icantibant and providing new insights on other potentially relevant criteria for decision making on HAE treatments.METHODS:A cost-effectiveness model of icantibant versus C1-INH (Berinert) was developed. Using a two-part bayesian model, costs were estimated from real-world data of an unpublished national registry. Efficacy data were synthesized from both the registry and an indirect comparison of existing trials, whereas utilities were derived from the literature.RESULTS:In our Italian registry, respectively 98 percent and 60 percent of patients self-administered icatibant or Berinert at home in absence of medical personnel. On average, per treatment costs were 60 percent higher and attack duration 25 percent shorter with icantibant compared to Berinert. The resulting ICER greatly exceeded the considered threshold of EUR30,000.CONCLUSIONS:On cost-effectiveness grounds icantibant did not demonstrate good value for money compared to Berinert. However, further considerations are needed on whether standard health-related quality of life measures are able to truly reflect societal preferences for HAE treatments.The use of real-world data for the economic evaluation of orphan drugs can support decision making when evidence from clinical studies is too sparse.

The NMR-MOUSE is a mobile sensor for single-sided NMR inspection of organic materials which takes advantage of the principles of magnetic resonance and inside-out-NMR. Historical books dating from the 17th century were measured at different points by positioning the NMR-MOUSE on the paper. Different degrees of paper degradation can be discriminated from the regularized inverse Laplace transform of the envelope of the acquired echo signals. For the first time the degradation of historical paper was characterized entirely nondestructively by NMR. As a contribution to current preservation efforts, NMR shows great promise for future use in damage assessment of historical documents.

Correspondence to: G. Righini Studies on the deterioration of medieval paper, in particular on the widespread foxing and discoloration which affects sheets, have attributed the origin of these phenomena to trace elements within the paper itself and/or to the action of external agents. This investigation was carried on the possible correlation between the process of manufacturing and paper deterioration. Attention was focused particularly on the chemical nature of the sizing, such as animal gelatin, vegetal polysaccharides, such as starch, and on the procedure itself used for the sizing. Since sizing is a technique which affects mostly the surface of a sheet, we used X-ray photoelectron spectroscopy as this is an extremely sensitive method for studying surface phenomena. X-ray photoelectron spectroscopy is an ideal analytic tool for measuring the chemical composition of the first few layers of all solid materials. This paper proposes the use of this technique to estimate the effect of sizing on the preservation of paper sheets produced in Europe between the 15th and the 18th centuries. Introduction

Agati Maria Luisa, Canart Paul, Federici Carlo. Giovanni Onorio da Maglie, « instaurator librorum graecorum» à la fin du Moyen Âge. In: Scriptorium, Tome 50 n°2, 1996. pp. 363-369.

Electron paramagnetic resonance spectroscopy is used to detect paramagnetic impurities in differently degraded antique sheets of unprinted paper. Impurities consist primarily of transition metal ions (Fe3+, Mn2+, Cu2+) present in different environments and symmetries. Organic radicals, common in modern, wood pulp paper, are absent in these antique samples made from rags. Fe3+ is the largest impurity (from 300 to 700 ppm). Mn2+ is also present but its concentration does not exceed 50ppm. Cu2+ has been detected in about one-third of the samples. Coupled with nuclear magnetic resonance data, these results describe degradation as an hydrolytic process leading to a net increase of amorphous cellulose and to a decrease of bound water. Copper and rhombic iron appear to act as efficient degradation catalysts, whereas the presence of octahedral iron is almost irrelevant.

Federici Carlo. Enseigner la conservation : Pourquoi ? Comment ?. In: Gazette du livre médiéval, n°26. Printemps 1995. pp. 27-35.

A cineritic level, which appears very interesting from a chronostratigraphic point of view because it is found throughout the eastern Mediterranean Sea, has been related to the « Cetara — Serrara Fontana » tuff formation (Ischia Island, Italy) by previous authors who estimated the age of this cineritic level to be about 25,000 years.

Di Majo Anna, Federici Carlo, Palma Marco. Indagine sulla pergamena insulare (secoli VI-XVI). In: Scriptorium, Tome 42 n°2, 1988. pp. 131-139.

Canart Paul, Federici Carlo. Les lampes à rayons ultra-violets. In: Gazette du livre médiéval, n°6. Printemps 1985. pp. 22-24.

Hace unos meses el actual Presidente de la República, en discurso ante la Asamblea General de las Naciones Unidas, afirmó que las teorías eran biodegradables. Se trataba de una alusión lateral, tal vez no muy afortunada, al servicio de la propuesta de paz del Grupo de Contadora. Abordaremos el problema del cientificismo en el terreno de la educación con la seguridad de que lo que aquí, en este país, se ha presentado no en sino la expresión —a veces grotesca y caricatural— de tendencias universales. Nos proponemos avanzar algunas reflexiones que, al mismo tiempo que muestran la relevancia de la epistemología para enfrentar cierto tipo de fenómenos culturales ligados a la creciente importancia económica y social de las ciencias, pretenden tener un interés universal.

Health Technology Assessment (HTA) has been defined as a ‘multidisciplinary approach studying the clinical, economic, social and ethical implications of development, diffusion and use of health technology’. While the general definition of HTA is widely accepted and its role in policy making is increasingly established in EU countries, the currently adopted methodological framework for HTA does not fully encounter the challenges rising from different types of health technologies, such as medical devices. This paper provides i) an introduction to the HTA methodology, highlight on ii) specific challenges medical devices pose in addition to other health technologies (i.e. short lifecycle and rapid changes, clinical outcomes often depend on training and experience of operator, dynamic pricing), iii) current HTA practices for medical devices and iv) the results of a FP7 funded project, “Methods for Health Technology Assessment of Medical Devices: a European Perspective” (MedTecHTA n. 305694) completed in December 2015. The general objective of MedtecHTA was to enhance HTA methods for medical devices that would acknowledge complexities rising from their integration into clinical practice and to develop recommendations for a wide range of stakeholders in the field. Overall, this paper provides a summary of the current and expected future trends in the assessment of medical devices technology to inform coverage and reimbursement decisions in healthcare within Europe and beyond.