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  1. Book ; Online: Chapter Patient-generated evidence in Epidermolysis Bullosa (EB): Development of a questionnaire to assess the Quality of Life

    Pilo, Cinzia / Benedan, Laura / El Hachem, May / Galeone, Carlotta / Mariani, Paolo / Tadini, Gianluca

    (Proceedings e report)

    2021  

    Series title Proceedings e report
    Keywords Social research & statistics ; Epidermolysis Bullosa ; Patient-centered approach ; Quality of Life ; Pseudo-Delphi
    Language 0|e
    Size 1 electronic resource (5 pages)
    Publisher Firenze University Press
    Publishing place Florence
    Document type Book ; Online
    Note English ; Open Access
    HBZ-ID HT021616611
    ISBN 9788855184618 ; 885518461X
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  2. Book ; Online: Chapter Development of an innovative methodology to define patient-designed quality of life: a new version of a wellknown concept in healthcare

    Bertoldi, Serena / Sofia, Francesca / Bartolini, Barbara / Benedan, Laura / Galeone, Carlotta / Mariani, Paolo / Zenga, Mariangela

    (Proceedings e report)

    2021  

    Series title Proceedings e report
    Keywords Social research & statistics ; Quality of Life ; QoL ; Pseudo Delphi ; Methodology ; Patient awareness ; Patient experience
    Language 0|e
    Size 1 electronic resource (5 pages)
    Publisher Firenze University Press
    Publishing place Florence
    Document type Book ; Online
    Note English ; Open Access
    HBZ-ID HT021616617
    ISBN 9788855184618 ; 885518461X
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  3. Article ; Online: The Evaluation of Drug Innovativeness in Italy: Key Determinants and Internal Consistency.

    Jommi, Claudio / Galeone, Carlotta

    PharmacoEconomics - open

    2023  Volume 7, Issue 3, Page(s) 373–381

    Abstract: Background: Innovative medicines are provided with dedicated funds and immediate market access in Italy. Innovativeness evaluation considers unmet need, added therapeutic value, and quality of the evidence.: Objective: We aimed to evaluate the ... ...

    Abstract Background: Innovative medicines are provided with dedicated funds and immediate market access in Italy. Innovativeness evaluation considers unmet need, added therapeutic value, and quality of the evidence.
    Objective: We aimed to evaluate the internal consistency and drivers of the innovativeness appraisal process.
    Methods: Appraisal reports on innovativeness refer to 1997-2021. We used both a descriptive approach and probabilistic multivariate analysis, using logistic regression models to compute odds ratios and 95% confidence intervals. The dependent variable is innovativeness status (innovative vs. non-innovative; full innovativeness vs. conditional innovativeness). Explanatory variables, besides the three above-mentioned domains, are the year of evaluation, drug type, target disease and population, and the number and type of available studies.
    Results: Among the 141 medicines scrutinized, 31.9%, 29.8%, and 38.3% were evaluated as fully innovative, conditionally innovative, and non-innovative, respectively. Added therapeutic value and the quality of the evidence were associated with the odds of receiving innovative status, and full compared with conditional innovativeness; unmet need was not a predictive variable. Other factors played a minor role: medicines for both solid tumours and rare diseases are more likely to be judged innovative; conditional innovativeness is more probable for medicines for rare diseases.
    Conclusions: Innovativeness status is driven by the added therapeutic value and quality of evidence. The appraisal process is internally consistent and predictable. This provides industry with a clear indication of what is needed to ensure that access to their medicines is prioritized.
    Language English
    Publishing date 2023-02-10
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2874287-4
    ISSN 2509-4254 ; 2509-4262
    ISSN (online) 2509-4254
    ISSN 2509-4262
    DOI 10.1007/s41669-023-00393-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: From Indication-Based Pricing to Blended Approach: Evidence on the Price and Reimbursement Negotiation in Italy.

    Rossini, Elvio Emanuele / Galeone, Carlotta / Lucchetti, Chiara / Jommi, Claudio

    PharmacoEconomics - open

    2024  Volume 8, Issue 2, Page(s) 251–261

    Abstract: Background: New indications for existing medicines are increasing over time. In most countries, drug pricing and reimbursement conditions are renegotiated every time a new indication is approved. There is a growing interest in the price negotiation ... ...

    Abstract Background: New indications for existing medicines are increasing over time. In most countries, drug pricing and reimbursement conditions are renegotiated every time a new indication is approved. There is a growing interest in the price negotiation model for new indications, specifically comparing an indication-based versus blended approach. However, little evidence currently exists regarding the complexity of these negotiations and their impact on actual prices. Italy has recently transitioned from an indication-based approach to a blended price model. This study aims to measure the impact of price and reimbursement negotiation of new indications on discounts (i.e. actual prices) and on the negotiation duration, used as a proxy of its complexity.
    Methods: We considered new indications approved through a European centralized procedure from January 2013 to March 2022 for which the price and reimbursement status was approved in Italy between January 2015 and March 2022, amounting to 52 new indications. Data on the timeframe of the Italian price and reimbursement process and its phases were obtained from publicly available sources. Discounts for the first indication and their subsequent increases for new indications were estimated by comparing ex-factory prices and tendered prices. To calculate p-values, we employed the Mann-Whitney test, and multiple regression models were utilized to examine correlations between negotiation time and the characteristics of the medicines.
    Results: The mean time to reimbursement was 603 days, in contrast to 583 days for the first launch. Price negotiation took longer for rare diseases, cancer drugs, and in case of therapies with minor added therapeutic value. On average, the additional discount (on top of discounts for prior indications) was 13%, significantly lower than the mean discount for the first indications approved (24.9%). The discounts increment was lower, but negotiation took longer if a Managed Entry Agreement accompanied the final agreement. Additionally, discounts have increased over the years.
    Conclusion: The negotiation for new indications takes longer than the first one, and provides, on average, an additional discount of 13%. While our findings bear the potential for significant policy implications, they necessitate prudent interpretation due to a limited number of observations. The increasing trend in additional discounts over time applied to all indications in recent negotiations, may suggest a descending trend of value for new indications and a shift from an indication-based pricing approach to a blended model. Otherwise, budget impact considerations might have outweighed a value-based approach in the recent negotiations. If so, two potential options for restoring a value-based approach are returning to an indication-based pricing or giving explicit and higher weight to value within a blended model.
    Language English
    Publishing date 2024-01-16
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2874287-4
    ISSN 2509-4254 ; 2509-4262
    ISSN (online) 2509-4254
    ISSN 2509-4262
    DOI 10.1007/s41669-023-00467-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Correction: From Indication-Based Pricing to Blended Approach: Evidence on the Price and Reimbursement Negotiation in Italy.

    Rossini, Elvio Emanuele / Galeone, Carlotta / Lucchetti, Chiara / Jommi, Claudio

    PharmacoEconomics - open

    2024  Volume 8, Issue 2, Page(s) 345

    Language English
    Publishing date 2024-02-12
    Publishing country Switzerland
    Document type Published Erratum
    ZDB-ID 2874287-4
    ISSN 2509-4254 ; 2509-4262
    ISSN (online) 2509-4254
    ISSN 2509-4262
    DOI 10.1007/s41669-024-00475-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Multi-dimensional evaluation of dupilumab efficacy in atopic dermatitis patients with a high disease burden.

    Fargnoli, Maria C / Amerio, Paolo / Galeone, Carlotta / Nicoli, Elena / Pedone, Maria P

    Italian journal of dermatology and venereology

    2024  Volume 159, Issue 1, Page(s) 63–64

    MeSH term(s) Humans ; Dermatitis, Atopic/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antibodies, Monoclonal/therapeutic use
    Chemical Substances dupilumab (420K487FSG) ; Antibodies, Monoclonal, Humanized ; Antibodies, Monoclonal
    Language English
    Publishing date 2024-02-12
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 3065415-4
    ISSN 2784-8450
    ISSN (online) 2784-8450
    DOI 10.23736/S2784-8671.23.07644-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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    ab Jg. 2022: Lesesaal (EG)

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  7. Article ; Online: [No title information]

    Marcellusi, Andrea / Raimondo, Paola / Galeone, Carlotta / Canonico, Pier Luigi

    Global & regional health technology assessment

    2023  Volume 10, Page(s) 79–88

    Title translation Time to market access in Italia: durata del processo di P&R per i farmaci per le malattie rare.
    Language Italian
    Publishing date 2023-10-31
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 2963961-X
    ISSN 2283-5733 ; 2284-2403
    ISSN (online) 2283-5733
    ISSN 2284-2403
    DOI 10.33393/grhta.2023.2610
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Adherence to European Association of Urology Guidelines and State of the Art of Glycosaminoglycan Therapy for the Management of Urinary Tract Infections: A Narrative Review and Expert Meeting Report.

    Bonkat, Gernot / Cai, Tommaso / Galeone, Carlotta / Koves, Bela / Bruyere, Franck

    European urology open science

    2022  Volume 44, Page(s) 37–45

    Abstract: Context: Urinary tract infections (UTIs) have a significant impact on patient's quality of life and society. Antibiotic therapy is the primary approach for the management of UTIs; however, it has major limits in the prevention of recurrent UTIs (rUTIs), ...

    Abstract Context: Urinary tract infections (UTIs) have a significant impact on patient's quality of life and society. Antibiotic therapy is the primary approach for the management of UTIs; however, it has major limits in the prevention of recurrent UTIs (rUTIs), also increasing the risk of development of multidrug-resistant micro-organisms.
    Objective: The aim of this paper is to discuss the European Association of Urology guidelines for the management of UTIs/rUTIs, the level of adherence to these recommendations, and the available evidence on the use of glycosaminoglycans (GAGs) as a possible alternative treatment to prevent rUTIs.
    Evidence acquisition: This narrative review and expert meeting report is based on a literature search concerning the currently available UTI guidelines, the results of a survey administered to 227 urologists, and the opinion of an expert panel in the field of UTIs.
    Evidence synthesis: Results obtained from the literature search showed that adherence to guidelines is not optimal. The survey demonstrated that antibiotics remain one of the treatments of UTIs. However, most of the urologists are aware of the problem caused by the resistance to antibiotics and prefer alternative methods for the prophylaxis of UTIs. Considering the alternative methods, the authors concluded that GAG therapy is highly effective in preventing rUTIs.
    Conclusions: Adherence to the international guidelines is important to align the clinical practice and avoid the spreading of antibiotic resistance. The survey outlines that the misuse and overuse of antibiotics are major problems; an analysis of clinical evidence confirms that GAG therapy is a valuable therapeutic approach to prevent the recurrence of episodes of UTIs and to limit the onset of antibiotic resistance.
    Patient summary: Although antibiotic therapy is primarily used for the management of urinary tract infections (UTIs), misuse and overuse of antibiotics are of concern. Adherence to the international guidelines is important to prevent the spreading of antibiotic resistance. Clinical evidence confirms that the use of glycosaminoglycans is a valuable therapeutic approach to prevent UTI recurrence and limit the onset of antibiotic resistance.
    Language English
    Publishing date 2022-08-23
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 3040546-4
    ISSN 2666-1683 ; 2058-4881
    ISSN (online) 2666-1683
    ISSN 2058-4881
    DOI 10.1016/j.euros.2022.07.009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Key drivers of innovativeness appraisal for medicines: the Italian experience after the adoption of the new ranking system.

    Galeone, Carlotta / Bruzzi, Paolo / Jommi, Claudio

    BMJ open

    2021  Volume 11, Issue 1, Page(s) e041259

    Abstract: Objective: In 2017, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) introduced a standardised process to appraise innovativeness of medicines. Innovative medicines are provided speeder market access and dedicated funds. Innovativeness ... ...

    Abstract Objective: In 2017, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) introduced a standardised process to appraise innovativeness of medicines. Innovative medicines are provided speeder market access and dedicated funds. Innovativeness criteria are: unmet therapeutic need, added therapeutic value and quality of the evidence (Grading of Recommendations Assessment, Development and Evaluation method). We investigated the role played by these three criteria on the final decision aimed to understand how the new Italian innovativeness appraisal framework was implemented.
    Design: A desk research gathered AIFA's appraisal reports on innovativeness and data analyses were conducted. No patients were directly involved in this study.
    Setting and participants: We scrutinised all 77 appraisal reports available on AIFA's website (2017-2020).
    Primary and secondary outcome measures: The impact of the three domains on final decision was investigated through a series of univariate analyses.
    Results: Among 77 appraisal reports on innovativeness available, 49 (64%) and 28 (36%) were for oncology and non-oncology medicines, respectively. The appraisals were equally distributed among 'fully innovative' (36%), 'conditionally innovative' (30%) and 'not innovative' (34%). Added therapeutic value was the most important driver on innovativeness decision, followed by quality of the evidence. Drugs for rare diseases and with paediatric/mixed indications were appraised 'innovative' by a larger proportion, but no statistical significance was found.
    Conclusions: Despite some limitations, including the moderate number of appraisals, this paper provides an insight into the determinants of innovativeness appraisals for medicines in Italy and the accuracy of the appraisal process. This has important implications in terms of transparency and accountability in the prioritisation process applied to innovative medicines.
    MeSH term(s) Child ; Drug Development ; Humans ; Italy ; Organizational Innovation
    Language English
    Publishing date 2021-01-13
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2020-041259
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Epidemiology, characteristics of disease and unmet needs of patients with generalized pustular psoriasis: a large Italian Delphi consensus.

    Prignano, Francesca / Atzori, Laura / Bellinato, Francesco / Damiani, Giovanni / Galeone, Carlotta / Mariani, Paolo / Potenza, Concetta / Scopinaro, Annalisa / Piaserico, Stefano / Fabbrocini, Gabriella

    Dermatology (Basel, Switzerland)

    2024  

    Abstract: Introduction: Generalized pustular psoriasis (GPP) is a rare and chronic, debilitating skin condition characterised, in its acute flare phase, by clinically severe and potentially life-threatening systemic manifestations. Data on GPP are still scanty, ... ...

    Abstract Introduction: Generalized pustular psoriasis (GPP) is a rare and chronic, debilitating skin condition characterised, in its acute flare phase, by clinically severe and potentially life-threatening systemic manifestations. Data on GPP are still scanty, particularly in Europe and at a national level. To provide expert indications on several disease-related and patient-related aspects of GPP, with specific focus to the Italian context.
    Methods: We conducted an iterative eDelphi study following the recommended criteria for reporting methods and results. After a thorough bibliographic review aimed to identify unknown or controversial issues in GPP, the following areas were investigated through a few specific questions/statements for each area: 1) disease epidemiology; 2) disease characteristics, with specific interest towards GPP flares; 3) diagnosis and diagnostic delay; 4) GPP treatment; 5) GPP patient journey and use of healthcare resources in Italy; 6) unmet needs and quality of life. An Executive Board of 9 principal investigators revised and approved the topics to be examined and overviewed the whole project. A total of 35 experts from different Italian areas, including 34 board-certified Italian dermatologists and one representative of patients' associations, took part in the study.
    Results: A high agreement in responses from Italian experts emerged during two eDelphi iterations on - among several other aspects - GPP prevalence and incidence in Italy, use of European Rare and Severe Psoriasis Expert Network diagnostic criteria, flare frequency and duration, best diagnostic and care pathway, and main unmet needs of Italian patients. On the other hand, a broad spectrum of treatments (of different drug classes) was reported both in the acute and chronic phases of GPP, and no consensus on the issue was thus achieved.
    Conclusions: Consensus findings from this Delphi study of GPP experts may be useful to fill gaps of knowledge and improve awareness of this rare disease, as well as to help clinical and public health management of GPP in Italy.
    Language English
    Publishing date 2024-03-17
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 1099692-8
    ISSN 1421-9832 ; 1018-8665
    ISSN (online) 1421-9832
    ISSN 1018-8665
    DOI 10.1159/000538072
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Ui VI Zs.35: Show issues Location:
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