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Introduction: The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies in Europe. This research aimed to assess the impact of the regulation on national HTAs, the strategic implications for health technology developers, and its influence on price and reimbursement negotiations. Methods: A scoping literature review encompassing peer-reviewed literature as well as grey literature was conducted. Between February and March 2023, semi-structured interviews (n = 20) were performed with stakeholders from Belgian governmental institutions, European institutions, advanced therapy medicinal product developers, academics, and sickness funds. The interviews were analyzed using the framework analysis method. Results: Numerous steps, such as the development of implementing acts and procedural guidelines remain to be taken. At member state level, national/regional HTA bodies and payers must act to adopt the new concepts of Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) within their national legislation, as well as revise their timelines and prepare for interactions at a European level. Compiling a harmonized PICO (Population, Intervention, Comparator, and Outcome), adapting local procedures, and increasing capacity to actively take part in the JSC and JCA are seen as primary barriers by several stakeholders. Training and education will help HTA bodies, payers, and health technology developers to participate in the European processes. Conclusion: While practical and legal challenges were identified, recommendations (such as actively preparing for the upcoming changes and increasing capacity while providing training) were provided to adapt national and European procedures to the needs of the HTA Regulation 2021/2282. The importance of fostering collaborations and aligning local HTA procedures with the new way of working set out by the Regulation was demonstrated with this study.

The Health Technology Assessment (HTA) of medicines is performed separately at the country level with some differences, but Italy, France, and Germany have implemented price and reimbursement systems strongly focused on the Added Therapeutic Value (ATV). This study investigates the level of agreement on ATV assessments by Agenzia Italiana del Farmaco (AIFA), Haute Autorité de Santé (HAS), and Gemeinsamer Bundesausschuss (G-BA). A database was created collecting all information about drugs with innovativeness status requests in Italy from July 2017 to December 2022 and populated with the corresponding HAS and G-BA ATV assessments. The primary comparative analysis was conducted by grouping the ATV ratings into \"higher added value\" and \"lower or no added value\", while a secondary analysis considered the Italian innovativeness status as a criterion to include the quality of evidence assessment. The concordance between ATV assessments was investigated through percentage agreement and unweighted Cohen k-value. 189 medicines/indications were included. The greatest agreement was found when comparing G-BA versus HAS (82 percent; k = 0.61, substantial agreement). Lower levels of agreements were observed for AIFA versus HAS and AIFA versus G-BA (respectively 52 percent; k = 0.17 and 57 percent; k = 0.25). The secondary analysis led to a reconciliation to moderate agreement for AIFA versus HAS (72 percent; k = 0.45) and AIFA versus G-BA (74 percent; k = 0.47). A high degree of concordance between HTA organizations is reached when considering jointly ATV and quality of evidence, suggesting that the system is extensively mature to make a Joint Clinical Assessment, avoiding duplications and reducing access inequalities.

The European Union Joint Clinical Assessment (JCA) process aligns with the regulatory process to promote faster patient access. The PICO (population, intervention, comparator, and outcome) scoping for the JCA must occur before the regulatory process concludes. The risk of indication change during this period is one of the concerns for the success of the JCA process. We investigated the frequency and type of changes that are made to proposed indications and examined how such changes could impact the PICO scoping for JCA. Twenty-seven recently approved oncology and 15 Advanced Therapy Medicinal Products (ATMP) products were included. Observed indication changes were categorized into editorial or population changes population changes were graded based on the anticipated impact on JCA scope depending on their nature. The majority of products had only editorial changes between proposed and approved indications (67 percent). Once amended, it was common for the indicated population to be narrowed, and rare for it to be broadened. The most common change observed was the shift to a later treatment line. The greatest risk for PICO rescoping would be when new populations would have been added, or new subpopulations or subgroups would have been omitted from the initial scope. The impact on JCA scope depends on the proposed indication wording and how the PICO scoping would have been conducted. Rescoping warrants a considered decision, and to mitigate the risk of delays, dialogue between the assessors and the developer is recommended for informed decision-making.

Introduction: The European regulatory landscape is undergoing a profound transformation with the entry into force of the new EU Regulation 2021/2282 on Health Technology Assessment (HTA), designed to harmonize HTA assessments and ensure equity of access to health technologies in different Member States. Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JCS), which allow developers to engage in prior discussion with the bodies responsible for HTA assessments, are key elements in this context where the need for collaborative and structured dialogue between companies and regulatory agencies is growing. The objective of the following work was to identify areas of improvement related to the dialogue between stakeholders and to find solutions for a more effective interaction.Methods: In the context of the Seventh Edition of “The Mogliano Veneto Seminars” held in Mogliano Veneto on September 26 and 27, 2024, a multidisciplinary Working Group composed of about 30 experts in different disciplines, including institutional and stakeholder subjects from different fields (Companies, clinicians, health economists, patients’ associations) discussed the interactions between AIFA and Companies.Conclusions: The key elements to be considered for a more effective interaction between the parties are timing, processes, and the tools to be used. According to what emerged during the discussion, three moments of interaction were identified (pre-submission to EMA, pre-submission to AIFA, and post-submission to AIFA), during which an active dialogue between Companies and AIFA should accelerate and streamline negotiations. The solutions proposed by the experts would bring tangible opportunities of improvement.

Objectives The reimbursement of, and subsequent patient access to, high-risk medical devices (MD) and in vitro diagnostics (IVD) across Europe often vary. The Health Technology Assessment Regulation (HTAR) aims to standardize clinical evaluations through Joint Clinical Assessments. Still, national differences in reimbursement frameworks and evidence integration for MD/IVD may impede the realization of HTAR’s expected benefits. This review aims to map existing reimbursement frameworks for high-risk MD/IVD, identify key oversight structures, and evaluate the use of comparative effectiveness and safety evidence in reimbursement decisions across the EU/EEA/UK. Methods A scoping review was conducted according to the registered protocol (osf.io/65bdk) and was reported following the PRISMA-ScR guidelines. Results were validated through direct engagement with national organizations. Results Reimbursement frameworks across the EU/EEA/UK for MD/IVD vary significantly. Of the thirty-four countries reviewed, twenty-three incorporate HTA for MD/IVD reimbursement decisions; of these, only eleven countries have a formal HTA process as part of reimbursement pathways. Eight countries have structured mechanisms to address safety and effectiveness evidence uncertainty. Furthermore, twelve countries have primarily centralized processes, while six rely on regional or local decision-making. Conclusions This review highlights the variations in how countries integrate HTA into reimbursement frameworks for MD/IVD, how the national decisions are implemented, and how the evidence uncertainty is assessed. Some countries have a well-established reimbursement framework with formal HTA components, whereas others rely on ad hoc HTA processes. Understanding these differences can help optimize the use of HTAR-generated evidence. Further research is needed to capture ongoing reforms in response to the HTAR.

[...]some of the experts note that the risk of losing country-specific expectations and specificities in appraisal criteria is the biggest obstacle. [...]they do not anticipate that this alliance will replace the country-level economic appraisal step, at least not in the near future. Polish HTA expert The added value and the drawbacks of the proposed EC pan-EU clinical assessment The HTA experts highlight that improved-quality joint clinical assessments can be produced by harmonization and consensus on methods from top experts leading to economies of scale and improved transparency. Particularly in rare diseases, given the novelty of orphan drugs and the absence of real world evidence, a joint clinical assessment produced by a collaboration of top EU experts could better assess the added value of the product and enable quicker access to these medicines (5). Given the country differences, trying to reach some form of alignment with mandatory participation and uptake is going to be unachievable in the short-to-medium term. [...]the first step toward a joint assessment could begin with voluntary participation and uptake to increase the number of countries participating in

Virtual and augmented reality (VAR) represents a combination of current state-of-the-art computer and imaging technologies and has the potential to be a revolutionary technology in many surgical fields. An increasing number of investigators have developed and applied VAR in hip-related surgery with the aim of using this technology to reduce hip surgery-related complications, improve surgical success rates, and reduce surgical risks. These technologies are beginning to be widely used in hip-related preoperative operation simulation and training, intraoperative navigation tools in the operating room, and postoperative rehabilitation. With the aim of reviewing the current status of virtual reality (VR) and augmented reality (AR) in hip-related surgery and summarizing its benefits, we discussed and briefly described the applicability, advantages, limitations, and future perspectives of VR and AR techniques in hip-related surgery, such as preoperative operation simulation and training; explored the possible future applications of AR in the operating room; and discussed the bright prospects of VR and AR technologies in postoperative rehabilitation after hip surgery. We searched the PubMed and Web of Science databases using the following key search terms: (\"virtual reality\" OR \"augmented reality\") AND (\"pelvis\" OR \"hip\"). The literature on basic and clinical research related to the aforementioned key search terms, that is, studies evaluating the key factors, challenges, or problems of using of VAR technology in hip-related surgery, was collected. A total of 40 studies and reports were included and classified into the following categories: total hip arthroplasty, hip resurfacing, femoral neck fracture, pelvic fracture, acetabular fracture, tumor, arthroscopy, and postoperative rehabilitation. Quality assessment could be performed in 30 studies. Among the clinical studies, there were 16 case series with an average score of 89 out of 100 points (89%) and 1 case report that scored 81 (SD 10.11) out of 100 points (81%) according to the Joanna Briggs Institute Critical Appraisal Checklist. Two cadaveric studies scored 85 of 100 points (85%) and 92 of 100 points (92%) according to the Quality Appraisal for Cadaveric Studies scale. VR and AR technologies hold great promise for hip-related surgeries, especially for preoperative operation simulation and training, feasibility applications in the operating room, and postoperative rehabilitation, and have the potential to assist orthopedic surgeons in operating more accurately and safely. More comparative studies are necessary, including studies focusing on clinical outcomes and cost-effectiveness.

There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.

Key Clinical PointsPostmenopausal OsteoporosisFragility fractures are very common among postmenopausal women and are associated with increased morbidity, mortality, and health care expenditures.Dual-energy x-ray absorptiometry (DXA) is recommended in postmenopausal women 65 years of age or older and postmenopausal women younger than 65 years of age who have risk factors.Osteoporosis is diagnosed on the basis of a fragility fracture or a DXA T score of −2.5 or less.Treatment of postmenopausal osteoporosis is recommended for patients who have any of the following findings: a fragility fracture (or fractures), particularly of the hip or spine, regardless of the patient’s bone mineral density; a T score of −2.5 or less at the lumbar spine, total hip, or femoral neck; or a high 10-year fracture risk (hip fracture risk of ≥3% or major osteoporotic fracture risk of ≥20%) according to the fracture risk assessment tool (FRAX).Evaluation should include risk stratification (based on the T score, presence of fractures, and FRAX score) to categorize candidates who meet treatment thresholds as “high risk” or “very high risk.”The selection of therapy must include consideration of coexisting conditions and contraindications, but anabolic agents are the preferred first line of treatment in women at very high risk.

Total joint replacements for end-stage osteoarthritis of the hip and knee are cost-effective and demonstrate significant clinical improvement. However, robust population based lifetime-risk data for implant revision are not available to aid patient decision making, which is a particular problem in young patient groups deciding on best-timing for surgery. We did implant survival analysis on all patients within the Clinical Practice Research Datalink who had undergone total hip replacement or total knee replacement. These data were adjusted for all-cause mortality with data from the Office for National Statistics and used to generate lifetime risks of revision surgery based on increasing age at the time of primary surgery. We identified 63 158 patients who had undergone total hip replacement and 54 276 who had total knee replacement between Jan 1, 1991, and Aug 10, 2011, and followed up these patients to a maximum of 20 years. For total hip replacement, 10-year implant survival rate was 95·6% (95% CI 95·3–95·9) and 20-year rate was 85·0% (83·2–86·6). For total knee replacement, 10-year implant survival rate was 96·1% (95·8–96·4), and 20-year implant survival rate was 89·7% (87·5–91·5). The lifetime risk of requiring revision surgery in patients who had total hip replacement or total knee replacement over the age of 70 years was about 5% with no difference between sexes. For those who had surgery younger than 70 years, however, the lifetime risk of revision increased for younger patients, up to 35% (95% CI 30·9–39·1) for men in their early 50s, with large differences seen between male and female patients (15% lower for women in same age group). The median time to revision for patients who had surgery younger than age 60 was 4·4 years. Our study used novel methodology to investigate and offer new insight into the importance of young age and risk of revision after total hip or knee replacement. Our evidence challenges the increasing trend for more total hip replacements and total knee replacements to be done in the younger patient group, and these data should be offered to patients as part of the shared decision making process. Oxford Musculoskeletal Biomedical Research Unit, National Institute for Health Research.