BACKGROUND: Reimbursement process of oncology drugs in Europe occurs within a complex decision-making process that varies between Member States. Distinctions between the States trigger societal debates since it is necessary to balance access to medicines and health systems sustainability.
OBJECTIVE: We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe.
METHODS: A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs.
RESULTS: Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01).
CONCLUSIONS: There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.

Wild-caught fish from coral reefs, one of the most threatened ecosystems on the planet, continue to supply the marine aquarium trade. Despite customs and veterinary checks during imports, comprehensive data on this global industry remain scarce. This study provides consolidated data on the largest import market by value, the European Union (EU): a 24-million-euro annual trade value, detailing the main exporting and importing countries, as well as the species and families of the 26 million specimens imported between 2014 and 2021. A watchlist alert system based on the number of specimens traded, import trends, and vulnerability index according to FishBase and the IUCN Red List conservation status is presented, providing key information on which species should require closer scrutiny by authorities. While the European TRAde Control and Expert System (TRACES) electronically monitors the movement of live animals to respond quickly to biosecurity risks, one-third of marine ornamental fish imported lack species-level information. With minor adjustments, TRACES holds the potential to significantly enhance data granularity and the monitoring of wildlife trade, with marine ornamental fish being an interesting case study to validate this approach.

OBJECTIVE: This narrative review aims to present the concept of value in imaging and explore why we conduct low-value procedures, how to reduce this wasteful use, and what we could gain from reducing low-value imaging.
RESULTS: Imaging of low value to the patient contributes to thousands of metric tons of CO2 emissions, costing several billion US dollars annually. With a 20% reduction in low-value imaging, we would reduce the waste of resources related to 7.2 million procedures and, at the same time, reduce the risk of incidentalomas, overdiagnosis, and overtreatment and reduce wait times for patients in need of imaging services of high value. Multi-component initiatives targeting barriers in all levels of society and healthcare are needed to reduce low-value imaging. Radiographers are key actors in medical imaging and can make substantial contributions to this effort by, together with the radiologists, referrers, and managers, ensuring that all imaging procedures conducted are sustainable along four dimensions of sustainability: value, cost, risk, and environment.
CONCLUSIONS: Efforts to secure sustainable imaging considering the four crucial dimensions (value, cost, radiation, and environment) should be made at all levels of society and healthcare, from governmental management to the individual healthcare worker. Radiographers are vital in obtaining sustainability to ensure only sustainable imaging procedures are conducted.
CONCLUSIONS: When assessing the appropriateness of imaging procedures, we need to consider the environment, safety, effectiveness, and efficiency. To obtain this, we need a collective and coordinated effort locally, nationally, and internationally to deliver sustainable imaging services.

Mohs Micrographic Surgery (MMS) for treatment of melanoma offers several advantages over wide local excision (WLE), including complete histologic margin evaluation, same-day resection and closure, and sparing of healthy tissue in critical anatomic sites. Recently, a large volume of clinical data demonstrating efficacy in MMS treatment of melanoma was published, leading to emerging patient safety considerations of incurred treatment costs, risk of tumor upstaging, and failure of care coordination for sentinel lymph node biopsy (SLNB). MMS offers a safe, effective, and value-based treatment for both melanoma in situ (MIS) and invasive melanoma (IM), particularly with immunohistochemistry use on frozen sections. Compared to wide local excision, MMS treatment demonstrates similar or improved outcomes for local tumor recurrence, melanoma-specific survival, and overall survival at long-term follow-up. Tumor upstaging risk is low, and if present, alteration to clinical management is minimal. Discussion of SLNB for eligible head and neck IM cases should be done prior to MMS. Though challenging, successful multidisciplinary coordination of SLNB with MMS has been demonstrated. Herein, we provide a detailed clinical review of evidence for MMS treatment of cutaneous melanoma and offer recommendations to address current controversies surrounding the evolving paradigm of surgical management for both MIS and invasive melanoma (IM).

UNASSIGNED: While the value of individual biosimilars is evident, little is known about the value of a biosimilar portfolio beyond the cost savings between biosimilars and originators. Stakeholders may consider the value of a manufacturer\'s biosimilar portfolio, especially when negotiating portfolio-based contracts or other rebate programs. However, little is known about what other types of value, in addition to financial benefits, decision-makers perceive regarding a manufacturer with a biosimilar portfolio compared to those without one. The objective of this integrative literature review was to describe a conceptual framework consisting of themes that may help define the value of a biosimilar portfolio.
UNASSIGNED: An integrative literature review was conducted using Excerpta Medica Database (Embase) and Medical Literature Analysis and Retrieval System Online (MEDLINE). Grey literature searches of search engines, journals not indexed in Embase or MEDLINE, healthcare payers, health technology assessment bodies, value frameworks, and non-pharmaceutical industry analogs were also conducted. Eligible studies reported on the value of a biosimilar portfolio in decision-making by stakeholders. Apart from the literature, insights were gained from clinical experience and observation.
UNASSIGNED: No studies investigating biosimilar portfolio value were identified; however, several themes were identified that may help define the value of a biosimilar portfolio: Manufacturing; procurement, inventory, and storage; administration; education; and transaction costs. Several non-pharmaceutical industry analogs were identified: Product line length and single-supplier versus multiple-supplier procurement. Several themes were identified through other sources: Science credibility and research. Based on these themes, we developed a conceptual framework for biosimilar portfolio value.
UNASSIGNED: To our knowledge, this is the first study to systematically assess and create a framework for biosimilar portfolio value. The conceptual framework described here could be tested to quantify the clinical and economic value associated with a biosimilar portfolio.
Though the value of single biosimilars is evident, little is known about the value of a biosimilar portfolio beyond the cost savings incurred between biosimilars and originators.We identified seven themes that may help to define the value of a biosimilar portfolio: Manufacturing; procurement, inventory, and storage; administration; education; transaction costs; science credibility; and research.These themes may be integrated into a conceptual framework that may form a basis to help quantify the clinical and economic benefit of a biosimilar portfolio to stakeholders.

UNASSIGNED: As a result of an increasing focus on patient-centered care within oncology and more pressure on the sustainability of health-care systems, the discussion on what exactly constitutes value re-appears. Policymakers seek to improve patient values; however, funding all values is not sustainable.
UNASSIGNED: We collect available evidence from scientific literature and reflect on the concept of value, the possible incorporation of a wide spectrum of values in reimbursement decisions, and alternative strategies to increase value in oncological care.
UNASSIGNED: We state that value holds many different aspects. For reimbursement decisions, we argue that it is simply not feasible to incorporate all patient values because of the need for efficient resource allocation. We argue that we should shift the value debate from the individual perspective of patients to creating value for the cancer population at large. The different strategies we address are as follows: (1) shared decision-making; (2) biomarkers and molecular diagnostics; (3) appropriate evaluation, payment and use of drugs; (4) supportive care; (5) cancer prevention and screening; (6) monitoring late effect; (7) concentration of care and oncological networking; and (8) management of comorbidities. Important preconditions to support these strategies are strategic planning, consistent cancer policies and data availability.

Evidence on the potential for value-based payment models to improve quality of care and ensure more efficient outcomes is limited and mixed. We aim to identify the factors that enhance or inhibit the design, implementation, and application of these models through a systematic literature review. We used the PRISMA guidelines. The facilitating and inhibiting factors were divided into subcategories according to a theoretical framework. We included 143 publications, each reporting multiple factors. Facilitators on objectives and strategies, such as realistic/achievable targets, are reported in 56 studies. Barriers regarding dedicated time and resources (e.g., an excessive amount of time for improvements to manifest) are reported in 25 studies. Consensus within the network regarding objectives and strategies, trust, and good coordination is essential. Health care staff needs to be kept motivated, well-informed, and actively involved. In addition, stakeholders should manage expectations regarding when results are expected to be achieved.

OBJECTIVE: Understanding approaches to sustainability in cataract surgery and their risks and benefits.
CONCLUSIONS: In the United States, health care is responsible for approximately 8.5% of greenhouse gas (GHG), and cataract surgery is one of the most commonly performed surgical procedures. Ophthalmologists can contribute to reducing GHG emissions, which lead to a steadily increasing list of health concerns ranging from trauma to food instability.
METHODS: We conducted a literature review to identify the benefits and risks of sustainability interventions. We then organized these interventions into a decision tree for use by individual surgeons.
RESULTS: Identified sustainability interventions fall into the domains of advocacy and education, pharmaceuticals, process, and supplies and waste. Existing literature shows certain interventions may be safe, cost-effective, and environmentally friendly. These include dispensing medications at home to patients after surgery, multi-dosing appropriate medications, training staff to properly sort medical waste, reducing the number of supplies used during surgery, and implementing immediate sequential bilateral cataract surgery where clinically appropriate. The literature was lacking on the benefits or risks for some interventions, such as switching specific single-use supplies to reusables or implementing a hub-and-spoke-style operating room setup. Many of the advocacy and education interventions have inadequate literature specific to ophthalmology but are likely to have minimal risks.
CONCLUSIONS: Ophthalmologists can engage in a variety of safe and effective approaches to reduce or eliminate dangerous GHG emissions associated with cataract surgery.
BACKGROUND: Proprietary or commercial disclosure may be found after the references.

SARS-CoV-2 vaccination has been the most effective tool to prevent COVID-19, significantly reducing deaths and hospitalizations worldwide. Vaccination has played a huge role in bringing the COVID-19 pandemic under control, even as the inequitable distribution of vaccines still leaves several countries vulnerable. Therefore, organizing a mass vaccination campaign on a global scale is a priority to contain the virus spread. The aim of this systematic review was to assess whether COVID-19 vaccination campaigns are cost-effective with respect to no vaccination. A systematic literature search was conducted in the WHO COVID-19 Global literature database, PubMed, Web of Science, Embase, and Scopus from 2020 to 2022. Studies assessing the COVID-19 vaccination campaign cost-effectiveness over no vaccination were deemed eligible. The \"Drummond\'s checklist\" was adopted for quality assessment. A synthesis of the studies was performed through the \"dominance ranking matrix tool\". Overall, 10 studies were considered. COVID-19 vaccination was deemed cost-effective in each of them, and vaccination campaigns were found to be sustainable public health approaches to fight the health emergency. Providing economic evaluation data for mass vaccination is needed to support decision makers to make value-based and evidence-based decisions to ensure equitable access to vaccination and reduce the COVID-19 burden worldwide.

BACKGROUND: Insight into the relationship between concepts that matter to the people affected by Alzheimer\'s disease (AD) and the clinical outcome assessments (COAs) commonly used in AD clinical studies is limited. Phases 1 and 2 of the What Matters Most (WMM) study series identified and quantitatively confirmed 42 treatment-related outcomes that are important to people affected by AD.
METHODS: We compared WMM concepts rated as \"very important\" or higher to items included in COAs used commonly in AD studies.
RESULTS: Twenty COAs designed to assess signs, symptoms, and impacts across the spectrum of AD were selected for review. Among these 20 COAs, only 5 reflected 12 or more WMM concepts [Integrated Alzheimer\'s Disease Rating Scale (iADRS), Alzheimer\'s Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), Alzheimer\'s Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment (ADCS-ADL-MCI), Alzheimer\'s Disease Composite Scores (ADCOMS), and Clinical Dementia Rating; Clinical Dementia Rating-Sum of Boxes (CDR/CDR-SB)]. Multiple symptoms and impacts of AD identified as important and meaningful in the WMM studies map only indirectly at best to 7 of the 20 most widely used COAs.
CONCLUSIONS: While many frequently used COAs in AD capture some concepts identified as important to AD populations and their care partners, overlap between any single measure and the concepts that matter to people affected by AD is limited. The highest singly matched COA reflects fewer than half (45%) of WMM concepts. Use of multiple COAs expands coverage of meaningful concepts. Future research should explore the content validity of AD COAs planned for AD trials based on further confirmation of the ecological validity of the WMM items. This research should inform development and use of core outcome sets that capture WMM items and selection or development of new companion tools to fully demonstrate clinically meaningful outcomes spanning WMM.