Integrating environmental sustainability into health technology assessment: an international survey of HTA stakeholders.

Introduction: Health technologies play a relevant role in environmental sustainability (ES). However, limited evidence exists on approaches and methods to integrate ES into the Health Technology Assessment (HTA).

Objectives: The purpose of this study is: (i) to provide an overview of global HTA organizations' progression toward the integration of ES into HTA; (ii) to investigate various paths for this integration, highlighting obstacles, priorities, potential approaches, and methods.

Scaling up integrated care: Can community hospitals be an answer? A multiple-case study from the Emilia-Romagna region in Italy.

Integrated care is considered to be essential in improving care for people with chronic conditions who need continuous care. In 2022, the Italian Government asked all regions to build or renovate a massive number of community care facilities, employing European Next Generation funds, to be spent by 2026. Under the theoretical lens of the Structural Contingency Theory, the paper aims at aims at describing the contextual and organizational factors underlying the interconnection between integrated care and community hospitals.

Overcoming Barriers in Hospital-Based Health Technology Assessment (HB-HTA): International Expert Panel Consensus.

The purpose of this article is to investigate the common facilitators and barriers associated with the implementation of hospital-based health technology assessment (HB-HTA) across diverse hospital settings in seven countries. Through a two-round Delphi study, insights were gathered from a panel of 15 HTA specialists from France, Hungary, Italy, Kazakhstan, Poland, Switzerland, and Ukraine. Experts initially conducted a comprehensive review of the HB-HTA implementation in their respective countries, identifying the barriers and facilitators through descriptive analysis.

The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report.

Objectives: Digital health definitions are abundant, but often lack clarity and precision. We aimed to develop a minimum information framework to define patient-facing digital health interventions (DHIs) for outcomes research.

Methods: Definitions of digital-health-related terms (DHTs) were systematically reviewed, followed by a content analysis using frameworks, including PICOTS (population, intervention, comparator, outcome, timing, and setting), Shannon-Weaver Model of Communication, Agency for Healthcare Research and Quality Measures, and the World Health Organization's Classification of Digital Health Interventions.

The economic and fiscal impact of incremental use of cell-based quadrivalent influenza vaccine for the prevention of seasonal influenza among healthcare workers in Italy.

Background: Seasonal influenza has a significant impact on public health, generating substantial direct healthcare costs, production losses and fiscal effects. Understanding these consequences is crucial to effective decision-making and the development of preventive strategies. This study aimed to evaluate the economic and the fiscal impact of implementing an incremental strategy for seasonal influenza prevention using the cell-based quadrivalent influenza vaccine (QIVc) among healthcare workers (HCWs) in Italy.

Reducing the burden of travel and environmental impact through decentralization of cancer care.

Life expectancy, quality of life and satisfaction of oncologic patients highly depend on access to adequate specialized services, that consider their conditions in a holistic way. The present study aims to evaluate the introduction of oncology services in an outpatient setting in a mountain village in Northern Italy. The initiative is evaluated using the three pillars of sustainability (social, economic and environmental) as dimensions that are often overlooked by healthcare policy makers.

Intelligent digital tools for screening of brain connectivity and dementia risk estimation in people affected by mild cognitive impairment: the AI-Mind clinical study protocol.

More than 10 million Europeans show signs of mild cognitive impairment (MCI), a transitional stage between normal brain aging and dementia stage memory disorder. The path MCI takes can be divergent; while some maintain stability or even revert to cognitive norms, alarmingly, up to half of the cases progress to dementia within 5 years. Current diagnostic practice lacks the necessary screening tools to identify those at risk of progression.

Importance of aligning the implementation of new payment models for innovative pharmaceuticals in European countries.

Introduction: The uptake of complex technologies and platforms has resulted in several challenges in the pricing and reimbursement of innovative pharmaceuticals. To address these challenges, plenty of concepts have already been described in the scientific literature about innovative value judgment or payment models, which are either (1) remaining theoretical; or (2) applied only in pilots with limited impact on patient access; or (3) applied so heterogeneously in many different countries that it prevents the health care industry from meeting expectations of HTA bodies and health care payers in the evidence requirements or offerings in different jurisdictions.

Areas Covered: This paper provides perspectives on how to reduce the heterogeneity of pharmaceutical payment models across European countries in five areas, including 1) extended evaluation frameworks, 2) performance-based risk-sharing agreements, 3) pooled procurement for low volume or urgent technologies, 4) alternative access schemes, and 5) delayed payment models for technologies with high upfront costs.

Scoping Meta-Review of Methods Used to Assess Artificial Intelligence-Based Medical Devices for Heart Failure.

Artificial intelligence and machine learning (AI/ML) are playing increasingly important roles, permeating the field of medical devices (MDs). This rapid progress has not yet been matched by the Health Technology Assessment (HTA) process, which still needs to define a common methodology for assessing AI/ML-based MDs. To collect existing evidence from the literature about the methods used to assess AI-based MDs, with a specific focus on those used for the management of heart failure (HF), the International Federation of Medical and Biological Engineering (IFMBE) conducted a scoping meta-review.

Access and reimbursement pathways for digital health solutions and diagnostic devices: Current scenario and challenges.

Objectives: Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.

The added value of applying a disinvestment approach to the process of health technology assessment in Italy.

Objectives: The objective of the present policy analysis was to understand how a disinvestment approach to the process of health technology assessment (HTA), applied to the field of medical devices, might help Italian policymakers to properly spend the resources in healthcare.

Methods: Previous international and national experiences in disinvestment for medical devices were reviewed. Precious insights for the rational expenditure of the resources were derived by assessing the evidence available.

The Economic and Fiscal Impact of Influenza Vaccination for Health Care Workers in Italy.

Influenza has a significant impact on the health care system and also on production and economic systems. Vaccinated health care workers (HCWs) are more likely to have improved productivity compared to unvaccinated workers. The study aim was to estimate the economic and fiscal impact of an influenza vaccination program for HCWs in Italy.

Value assessment of medicinal products by the Italian Medicines Agency (AIFA) and French National Authority for Health (HAS): Similarities and discrepancies.

The evaluation of pharmaceutical innovation and therapeutic value is an increasingly complex exercise for which different approaches are adopted at the national level, despite the need for standardisation of processes and harmonisation of public health decisions. The objective of our analysis was to compare the approaches of the AIFA () and the HAS () in assessing the same medicinal products. In Italy, the 1525/2017 AIFA Deliberation introduces a transparent scheme for the evaluation of innovative status (innovative, conditional, not innovative) based on the therapeutic added value (TAV), therapeutic need, and quality of evidence.

Economic Aspects in the Management of Diabetic Macular Edema in Italy.

Background: Diabetic Macular Edema (DME) is the most common cause of vision loss in diabetic patients. Currently, the Vascular Endothelial Growth Factor inhibitors (anti-VEGFs) are used as the first line of DME treatment and corticosteroid implants are usually used as a second-line treatment. These implants are a safe and effective therapeutic option that can improve the quality of life of DME patients by reducing the intravitreal injections number.

A Proposal for Value-Based Managed Entry Agreements in an Environment of Technological Change and Economic Challenge for Publicly Funded Healthcare Systems.

Managed entry agreements (MEA) represent one of the main topics of discussion between the European National Payers Authorities. Several initiatives on the subject have been organized over the past few years and the scientific literature is full of publications on the subject. There is currently little international sharing of information between payers, mainly as a result of the confidentiality issues.

Incremental net benefit of whole genome sequencing for newborns and children with suspected genetic disorders: Systematic review and meta-analysis of cost-effectiveness evidence.

Background: The introduction of massive parallel sequencing has contributed to a decline in sequencing costs. In recent years, whole-exome sequencing (WES) and whole-genome sequencing (WGS) have been increasingly adopted for diagnostic purposes in individuals with suspected genetic diseases. However, a debate is still ongoing in the scientific community about the superiority of WGS over WES in terms of cost-effectiveness.

HPV Vaccination in Women Treated for Cervical Intraepithelial Neoplasia: A Budget Impact Analysis.

Human Papillomavirus (HPV) is the most common sexually transmitted infection. Its progression is related to the development of malignant lesions, particularly cervical intraepithelial neoplasias (CINs). CINs correlate with a higher risk of premature births, and their excisional and ablative treatment further increases this risk in pregnant women.

Dealing with COVID-19 Epidemic in Italy: Responses from Regional Organizational Models during the First Phase of the Epidemic.

As the COVID-19 outbreak traveled through various Italian regions, all national and local administrations issued measures to counter the spread of the contagion and organize healthcare. The Italian healthcare system is, indeed, a decentralized system with 21 regional health systems (RHSs), with different models of healthcare service delivery and organization. This study investigates whether a different organization of RHSs would have led to different management of the COVID-19 epidemic, and evaluates the effect of different approaches in epidemic management on the COVID-19 epidemiological trend.

Hospital contextual factors affecting the implementation of health technologies: a systematic review.

Background: To keep a high quality of assistance it is important for hospitals to invest in health technologies (HTs) that have the potential of improving health outcomes. Even though guidance exists on how HTs should be introduced, used and dismissed, there is a surprising gap in literature concerning the awareness of hospitals in the actual utilization of HTs.

Methods: We performed a systematic literature review of qualitative and quantitative studies aimed at investigating hospital contextual factors that influence the actual utilization of HTs.

Real-world data on patients with metastatic non-small-cell lung cancer treated with checkpoint inhibitors in an Italian Teaching Hospital in 2015-2018.

Background: Non-small-cell lung carcinoma (NSCLC) accounts for 85-90% of all forms of lung cancer. Immuno-oncology represents a valid new approach but the high cost requires a specific evaluation of the health outcomes. This study describes the real-world efficacy, safety and cost profiles of the new anti-PD-1 immune-checkpoint inhibitors nivolumab and pembrolizumab on a cohort of 56 selected patients with advanced NSCLC.

Economic evaluation of colorectal cancer screening programs: Affordability for the health service.

Objectives: To estimate the cost-effectiveness of the public colorectal cancer screening program in the Abruzzo region, Italy.

Methods: Cost-effectiveness was analysed using a two-armed Markov model comparing: (1) Abruzzo screening program based on biennial faecal immunochemical occult blood testing, with colonoscopy as second level test for individuals with positive results, with (2) Treatment of symptomatic patients according to the stage of the neoplasm. Transition probabilities were adjusted for accuracy of tests and incidence of colorectal cancer.