ISPOR EU
November 12 - 15, 2023
Copenhagen, Denmark
Trinity’s ISPOR Annual 2023 Poster Presentation Schedule
Email: info@trinitylifesciences.com to discuss one of our presentations listed below.
Implications of the Implementation of the Joint Committee Assessment on Launch Planning for Medical Technologies in Europe
Poster Session 2
Date: 13 November 2023 (Monday)
Poster Session Time: 15:30 – 18:30
Presenting Author: Sonia Acosta
Abstract:
The EU-wide Joint Clinical Assessment (JCA) is set to be operational from January 2025. The Trinity team reviewed the available literature and summarized the JCA implications for medical device launch planning and evidence-generation requirements, including the central role that HEOR expertise across different geographies will play in product success.
Improving Access to Behavioral and Mental Health Therapies in the EU: An Analogue Assessment Deep Dive
Poster Session 4
Date: 14 November 2023 (Tuesday)
Poster Session Time: 15:30 – 18:30
Presenting Author: Anna Alonso
Abstract:
Historically, access to branded mental health therapies has been sparse in Europe. Despite the substantial unmet need for novel mental health therapies, there is a notable disconnect between evidence requirements for favorable health technology assessments (HTA) and feasibility to deliver from a clinical perspective. The Trinity team explored HTA outcomes for behavioral therapies to identify key evidence generation strategies for optimizing access in Europe.
Environmental Sustainability Success Stories From the Pharmaceutical and MedTech Industries in Europe: A Targeted Literature Review
Poster Session 3
Date: 14 November 2023 (Tuesday)
Poster Session Time: 10:30 – 13:30
Discussion Period: 12:30 – 13:30
Presenting Author: Liz Hamilton
Abstract:
The pharmaceutical and MedTech industries have a significant negative environmental impact, but a shift toward emphasizing sustainability is underway. Trinity examined industry leaders’ high-impact case studies from across the product life cycle that showcase the benefits of thoughtful R&D, manufacturing, packaging, and disposal decisions on carbon emissions, water use, raw materials sourcing, and waste generation. Sustainability is a valuable commercial lever in pharma, and represents an opportunity to drive uptake and regulatory approval as well as cost savings, especially in regions with carbon neutrality goals and in markets with limited methods of differentiation.
The JCA is Coming: Will the EU Band Together?
Poster Session 3
Date: 14 November 2023 (Tuesday)
Poster Session Time: 10:30 – 13:30
Discussion Period: 12:30 – 13:30
Presenting Author: Jessica Couninhan
Abstract:
A new pan-European HTA regulation established January 2022 will require member states to give “due consideration” to joint clinical assessment (JCA) reports in their national HTA assessments starting in 2025. This regulation review considers the potential impact of widespread European adoption of the JCA as a new requirement for HTAs. N=8 ex-payer stakeholder interviews across Germany, France, Italy, and Spain add a primary research perspective on the impact of JCA. Payers interviewed believe the economic assessment of new products (post-JCA implementation) will evolve. Although it is still an open question as to what those changes will look like and when they will go into effect across each country individually, there is the potential for a more standardized European clinical assessment procedure. This may also enable shifts in economic considerations/assessments across Italy and Spain towards a cost-effectiveness (CE) model, as manufacturers will likely design their future clinical trials in compliance with JCA priorities (which will more closely reflect CE model priorities vs. budget impact). Overall, payers had positive perspectives regarding JCA implementation, though it will require the trust of both payers and manufacturers to become the sole HTA process across the EU.
Potential Impacts of the EMA-HMA Joint Statement Supporting Biosimilar Interchangeability in Biosimilar Access in the EU
Poster Session 3
Date: 14 November 2023 (Tuesday)
Poster Session Time: 10:30 – 13:30
Discussion Period: 12:30 – 13:30
Presenting Author: Andreia Ribeiro
Abstract:
On April 21, 2023, the EMA-HMA published a statement on the scientific rationale supporting the interchangeability of biosimilars, by recognizing their clinical equivalence to originators based on almost two decades of Real-World Evidence. Since the implementation of switching and substitution policies without prescriber’s consent falls outside the EMA’s jurisdiction, this research aims to explore payer reactions to this endorsement and potential impacts in biosimilar utilization policies in the EU5.
Clinical Manifestations and Disease Burden of Primary Mitochondrial Myopathies (PMM): Results from a Patient Journey Analysis Show Substantial Healthcare Resource Utilization
Poster Session 1
Date: 13 November 2023 (Monday)
Poster Session Time: 10:30 – 13:30
Discussion Period: 12:30 – 13:30
Presenting Author: Sri Saikumar
Abstract:
Diagnosis and management of PMM can be challenging due to this heterogeneity of clinical manifestations. With no approved treatments for PMM, current practices focus on symptom management and do not address the underlying cause. A patient journey analysis was performed to quantify barriers faced by US patients in their odyssey from clinical manifestation to management.
Real World Healthcare Databases- What are the Existing Database Options We Have in the US and EU5?
Poster Session 3
Date: 14 November 2023 (Tuesday)
Poster Session Time: 10:30 – 13:30
Discussion Period: 12:30 – 13:30
Presenting Author: Abby Silber
Abstract:
Demonstrate various databases publicly and commercially available in the US, UK, Italy, France, Germany, and Spain (EU5) to evaluate patient journeys, clinical manifestations, and healthcare resource utilization in these countries. The aim of the research was to explore claims-based databases in the US and EU5 and provide examples of each database type. The research aims to potentially increase visibility in available sources for real-world data sources that can be assessed by health economics and outcomes research practitioners/pharmaceutical manufacturers to address their product specific evidence gaps across key markets.
Public Engagement Influences Health Technology Assessment Outcomes in Latin America
Poster Session 3
Date: 14 November 2023 (Tuesday)
Poster Session Time: 10:30 – 13:30
Discussion Period: 12:30 – 13:30
Presenting Author: Andreia Ribeiro
Abstract:
Showcasing LatAm countries at the forefront of incorporating broader public participation into their HTA processes, our statistical analysis of HTA reports in Brazil uncovers a significant correlation between increased public involvement through public contributions and a shift from negative to positive HTA recommendations. This emphasizes the pivotal role of public engagement in shaping HTA outcomes in the region.
