ISPOR EU 2023 Research Posters

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Implications of the Implementation of the Joint Committee Assessment on Launch Planning for Medical Technologies in Europe

Acosta Luis S1, O’Hara M2, Yeh M2

1Trinity Partners, LLC, London, UK, 2Trinity Life Sciences, Waltham, MA, USA

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

Snow AC1, Iyer M1Alonso A2, Oshinowo B2

1Trinity Life Sciences, San Francisco, CA, USA, 2Trinity Life Sciences, London, UK

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

Hamilton L1, Goldman E2, Dehipawala S2, O’Hara M2

1Trinity Life Sciences, Washington DC, DC, USA, 2Trinity Life Sciences, Waltham, MA, USA

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?

Bryan A1, Wu K1Counihan J2, Hunt M1

1Trinity Life Sciences, New York, NY, USA, 2Trinity Life Sciences, Colorado Springs, CO, USA

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

Ribeiro A1, Sazakli EA2, O’Hara M3, Martin De Bustamante M3, Vandeyar A3

1Trinity Life Sciences, Matosinhos, 13, Portugal, 2Trinity Life Sciences, New York, NY, USA, 3Trinity Life Sciences, Waltham, MA, USA

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.

Real World Healthcare Databases- What are the Existing Database Options We Have in the US and EU5?

Silber A1, Oak B1, Kulkarni A2, Goswami L3, Kataria D3, O’Hara M1, Hadker N1

1Trinity Life Sciences, Waltham, MA, USA, 2Trinity Life Sciences, Malden, MA, USA, 3Trinity Life Sciences, Gurgaon, Haryana, India

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

Tôrres L1, Nacazume J2, Vega M3, Boers Trilles V4, Bustamante M4Ribeiro A5

1Trinity Life Sciences, Belo Horizonte, MG, Brazil, 2Trinity Life Sciences, São Paulo, SP, Brazil, 3Trinity Life Sciences, London, England, UK, 4Trinity Life Sciences, San Francisco, CA, USA, 5Trinity Life Sciences, Matosinhos, 13, Portugal

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.

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