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A special issue of International Journal of Environmental Research and Public Health (ISSN 1660-4601). This special issue belongs to the section "Health Communication and Informatics".

Deadline for manuscript submissions: closed (1 October 2020) | Viewed by 22786

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Special Issue Editors

Dr. Marco Marchetti

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Guest Editor

National Centre for Health Technology Assessment, Istituto Superiore di Sanità (Italian National Institute of Health), 00161 Rome, Italy
Interests: hospital management; quality assurance; risk management; HTA; drug epidemiology; evidence-based medicine; digital medicine impact evaluation

Prof. Dr. Matteo Ruggeri

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Guest Editor

National Centre for Health Technology Assessment, Italian National Institute of Health, 00161 Roma RM, Italy
Interests: cost effectiveness analysis; Bayesian decision modeling; experimental economics; risk and uncertainty analysis and quantitative methods in the field of Pharmacoeconomics; HTA; healthcare policy; health outcomes research and emergency management
Special Issues, Collections and Topics in MDPI journals

Dr. Chiara Cadeddu

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Guest Editor

1. National Centre for Health Technology Assessment, Istituto Superiore di Sanità (Italian National Institute of Health), Rome, Italy
2. Università Cattolica del Sacro Cuore, Rome, Italy
Interests: health technology assessment; public health; health prevention and promotion; health management; digital health
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

A Special Issue on the topic of Health Technology Assessment in the International Journal of Environmental Research and Public Health is being organized. For detailed information on the journal, I refer you to https://0-www-mdpi-com.brum.beds.ac.uk/journal/ijerph.

Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, and robust manner. A health technology is defined by the WHO as “the application of organized knowledge and skills in the form of medicines, medical devices, vaccines, procedures and systems developed to solve a health problem and improve quality of life”. (EunetHTA.2016; WHO 2007).

HTA aims to inform policy in order to improve the performance of health systems using robust evidence-based approaches to make clear, consistent recommendations about which health technologies to use and for which patients. This supports quality improvement and efficiency throughout healthcare services (EUPATI, 2016).

The role of HTA is presently becoming more and more important in helping to prioritize the need for the sustainability of health systems and for the assessment of innovative medical technologies like telemedicine or gene therapy.

This Special Issue deals with the topic of HTA and its applications.

The keywords listed below provide an outline of some of the possible areas of interest.

Dr. Marco Marchetti
Dr. Matteo Ruggeri
Dr. Chiara Cadeddu
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Environmental Research and Public Health is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2500 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

Health technology assessment
Multidisciplinary
Evidence-based
Innovation
Recommendations
Policy
Decision-making
Prioritization
Disinvestment
Sustainability
Equity
Efficacy, effectiveness, and safety
Patient involvement
Real world data
Transferability
Social and ethical issues

Published Papers (7 papers)

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Research

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17 pages, 358 KiB

Open AccessArticle

HTA and HIV: The Case of Dual NRTI Backbones in the Italian Setting

by Elisabetta Garagiola, Emanuela Foglia, Lucrezia Ferrario, Giovanni Cenderello, Antonio Di Biagio, Barbara Menzaghi, Giuliano Rizzardini and Davide Croce

Int. J. Environ. Res. Public Health 2020, 17(23), 9010; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17239010 - 03 Dec 2020

Cited by 1 | Viewed by 1629

Abstract

The aim of this study is to analyze the potential advantages of emtricitabine/tenofovir alafenamide (FTC/TAF) introduction, creating evidence-based information to orient strategies to reduce costs, thus preserving effectiveness and appropriateness. An Health Technology Assessment (HTA) was implemented in the years 2017–2018 comparing the dual backbones available in the Italian market: FTC/TAF, FTC/TDF (tenofovir disoproxil fumarate/emtricitabine) and ABC/3TC (abacavir/lamivudine). From an efficacy point of view, FTC/TAF ensured a higher percentage of virologic control and a better safety impact than FTC/TDF (improving the renal and bone safety profile, as well as the lipid picture). From an economic point of view, the results revealed a 4% cost saving for the Italian National Healthcare Service NHS with FTC/TAF introduction compared with the baseline scenario. Qualitative perceptions’ results showed that FTC/TAF would decrease the burden of adverse events management, increasing the accessibility of patients to healthcare providers (FTC/TAF: 0.95, FTC/TDF: 0.10, ABC/3TC: 0.28; p-value: 0.016) and social costs (FTC/TDF: −0.23, FTC/TAF: 1.04, ABC/3TC: 0.23; p-value < 0.001), improving patient quality of life (FTC/TDF: 0.31, FTC/TAF: 1.85, ABC/3TC: 0.38; p-value < 0.001). Healthcare services may consider the evidence provided by the present study as an opportunity to include HIV patients in a more adequate antiretroviral treatment arm, guaranteeing a personalized clinical pathway, thus becoming more efficient and effective over time. Full article

(This article belongs to the Special Issue Health Technology Assessment)

20 pages, 707 KiB

Open AccessArticle

Application of Managed Entry Agreements for Innovative Therapies in Different Settings and Combinations: A Feasibility Analysis

by Rick A Vreman, Thomas F Broekhoff, Hubert GM Leufkens, Aukje K Mantel-Teeuwisse and Wim G Goettsch

Int. J. Environ. Res. Public Health 2020, 17(22), 8309; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17228309 - 10 Nov 2020

Cited by 22 | Viewed by 4181

Abstract

The reimbursement of expensive, innovative therapies poses a challenge to healthcare systems. This study investigated the feasibility of managed entry agreements (MEAs) for innovative therapies in different settings and combinations. First, a systematic literature review included studies describing used or conceptual agreements between payers and manufacturers (i.e., MEAs). Identical and similar MEAs were clustered and data were extracted on their benefits and limitations. A feasibility assessment was performed for each individual MEA based on how it could be applied (financial/outcome-based), on what level (individual patients/target population), in which payment setting (centralized pricing and reimbursement authority yes/no), for what type of therapies (one-time/chronic), within what payment structures, and whether combinations with other MEAs were feasible. The literature search ultimately included 82 papers describing 117 MEAs. After clustering, 15 unique MEAs remained, each describing one or multiple similar agreements. Four of those entailed payment structures, while eleven entailed agreements between payers and manufacturers regarding price, usage, and/or evidence generation. The feasibility assessment indicated that most agreements could be applied throughout the different settings that were assessed and could be applied in different payment structures and in combination with multiple other agreements. The potential to combine multiple agreements leads to a multitude of different reimbursement mechanisms that may manage the price, usage, payment structure, and additional conditions for an innovative therapy. This overview of the feasibility of combinations of MEAs can help decision-makers construct a reimbursement mechanism most suited to their preferences, the type of therapy under evaluation, and the applicable healthcare system. Full article

(This article belongs to the Special Issue Health Technology Assessment)

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14 pages, 337 KiB

Open AccessArticle

The Determinants of Out-of-Pocket Expenditure in IBD Italian Patients. Results from the AMICI Survey

by Matteo Ruggeri, Carlo Drago, Chiara Cadeddu, Alessandro Armuzzi, Salvo Leone and Marco Marchetti

Int. J. Environ. Res. Public Health 2020, 17(21), 8156; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17218156 - 04 Nov 2020

Cited by 4 | Viewed by 2200

Abstract

Decision makers are used to consider Out-of-Pocket Expenditure (OOPE) within a health technology assessment framework in order to account for an indicator relying on the level of fairness and on the quality of care of a health system. In this paper, we provide estimates on the determinants of OOPE in Italy by using data coming from an observational cross-sectional study that enrolled a sample of 2526 patients suffering from inflammatory bowel diseases. We explore the association between OOPE and: (1) geographical location; (2) income effects; (3) performances in delivering healthcare. A regression model was used. Individuals’ age were in the range of 18–88 (mean 44 ± 14.55). Forty-six percent were females, 54% were married and 19% held a bachelor degree. Ninety-six percent of respondents declared an OOPE >0 whose mean value was €960 ± €950. Individuals belonging to low-income and low-performance regions were more likely to declare an OOPE >0 (99%). Regression findings suggest that increases in OOPE could be considered as a response from patients aiming to compensate for lacks and inefficiencies in the public healthcare offers. Policymakers should consider increases in OOPE in patients with Inflammatory Bowel Diseases (IBDs) as an indicator of poor quality of care and poor fairness. Full article

(This article belongs to the Special Issue Health Technology Assessment)

9 pages, 581 KiB

Open AccessArticle

Multi–Criteria–Decision–Analysis (MCDA) for the Horizon Scanning of Health Innovations an Application to COVID 19 Emergency

by Matteo Ruggeri, Chiara Cadeddu, Paolo Roazzi, Donatella Mandolini, Mauro Grigioni and Marco Marchetti

Int. J. Environ. Res. Public Health 2020, 17(21), 7823; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17217823 - 26 Oct 2020

Cited by 11 | Viewed by 3272

Abstract

Aim: In this article, we aim to present a tool for the early assessment of medical technologies. This evaluation system was designed and implemented by the National Centre for HTA and the National Centre for Innovative Technologies of the Istituto Superiore di Sanita, Italy, in order to respond to an institutional commitment within the “Health Technologies Assessment Team” that was established to face the huge demand for the evaluation of Health Technologies during the pandemic event caused by COVID-19, with a smart and easy-to-use framework. Methods: Horizon scanning was conducted through a brief assessment carried out according to the multicriteria decision analysis methodology. Each HTA domain was attributed a score according to a pros/cons and opportunities/threats system, derived from evidence in the literature. Scores were weighted according to different perspectives. Scores were presented in a Cartesian graph showing the positioning according to the potential value and the perceived risk associated with the technology. Results: Two case studies regarding the early assessment were reported, concerning two specific technologies: an individual protection device and a contact tracking system. Full article

(This article belongs to the Special Issue Health Technology Assessment)

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Review

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16 pages, 1855 KiB

Open AccessReview

Towards a New System for the Assessment of the Quality in Care Pathways: An Overview of Systematic Reviews

by Roberto Latina, Katia Salomone, Daniela D’Angelo, Daniela Coclite, Greta Castellini, Silvia Gianola, Alice Fauci, Antonello Napoletano, Laura Iacorossi and Primiano Iannone

Int. J. Environ. Res. Public Health 2020, 17(22), 8634; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17228634 - 20 Nov 2020

Cited by 5 | Viewed by 2762

Abstract

Clinical or care pathways are developed by a multidisciplinary team of healthcare practitioners, based on clinical evidence, and standardized processes. The evaluation of their framework/content quality is unclear. The aim of this study was to describe which tools and domains are able to critically evaluate the quality of clinical/care pathways. An overview of systematic reviews was conducted, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, using Medline, Embase, Science Citation Index, PsychInfo, CINAHL, and Cochrane Library, from 2015 to 2020, and with snowballing methods. The quality of the reviews was assessed with Assessment the Methodology of Systematic Review (AMSTAR-2) and categorized with The Leuven Clinical Pathway Compass for the definition of the five domains: processes, service, clinical, team, and financial. We found nine reviews. Three achieved a high level of quality with AMSTAR-2. The areas classified according to The Leuven Clinical Pathway Compass were: 9.7% team multidisciplinary involvement, 13.2% clinical (morbidity/mortality), 44.3% process (continuity-clinical integration, transitional), 5.6% financial (length of stay), and 27.0% service (patient-/family-centered care). Overall, none of the 300 instruments retrieved could be considered a gold standard mainly because they did not cover all the critical pathway domains outlined by Leuven and Health Technology Assessment. This overview shows important insights for the definition of a multiprinciple framework of core domains for assessing the quality of pathways. The core domains should consider general critical aspects common to all pathways, but it is necessary to define specific domains for specific diseases, fast pathways, and adapting the tool to the cultural and organizational characteristics of the health system of each country. Full article

(This article belongs to the Special Issue Health Technology Assessment)

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21 pages, 1309 KiB

Open AccessReview

A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies

by Ilda Hoxhaj, Laurenz Govaerts, Steven Simoens, Walter Van Dyck, Isabelle Huys, Iñaki Gutiérrez-Ibarluzea and Stefania Boccia

Int. J. Environ. Res. Public Health 2020, 17(21), 8001; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17218001 - 30 Oct 2020

Cited by 5 | Viewed by 4328

Abstract

Background: Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. Methods: PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies’ repositories, we retrieved the published reports on the practical use of these frameworks. Results: Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. Conclusions: A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects. Full article

(This article belongs to the Special Issue Health Technology Assessment)

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17 pages, 767 KiB

Open AccessReview

Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy

by Carlo Efisio Marras, Gabriella Colicchio, Luca De Palma, Alessandro De Benedictis, Giancarlo Di Gennaro, Marilou Cavaliere, Elisabetta Cesaroni, Alessandro Consales, Sofia Asioli, Massimo Caulo, Flavio Villani and Nelia Zamponi

Int. J. Environ. Res. Public Health 2020, 17(17), 6150; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176150 - 24 Aug 2020

Cited by 6 | Viewed by 2841

Abstract

Background: Vagus nerve stimulation (VNS) is a palliative treatment for medical intractable epileptic syndromes not eligible for resective surgery. Health technology assessment (HTA) represents a modern approach to the analysis of technologies used for healthcare. The purpose of this study is to assess the clinical, organizational, financial, and economic impact of VNS therapy in drug-resistant epilepsies and to establish the congruity between costs incurred and health service reimbursement. Methods: The present study used an HTA approach. It is based on an extensive detailed bibliographic search on databases (Medline, Pubmed, Embase and Cochrane, sites of scientific societies and institutional sites). The HTA study includes the following issues: (a) social impact and costs of the disease; (b) VNS eligibility and clinical results; (c) quality of life (QoL) after VNS therapy; (d) economic impact and productivity regained after VNS; and (e) costs of VNS. Results: Literature data indicate VNS as an effective treatment with a potential positive impact on social aspects and on quality of life. The diagnosis-related group (DRG) financing, both on national and regional levels, does not cover the cost of the medical device. There was an evident insufficient coverage of the DRG compared to the full cost of implanting the device. Conclusions: VNS is a palliative treatment for reducing seizure frequency and intensity. Despite its economic cost, VNS should improve patients’ quality of life and reduce care needs. Full article

(This article belongs to the Special Issue Health Technology Assessment)

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