The ISPOR Europe conference in 2023, held in Copenhagen, gathered a record number of participants. The Bella Center hosted HEOR professionals eager to learn about the latest trends in their field. The use of real world evidence (RWE) in health technology assessment (HTA) and regulatory evidence generation played a crucial role in the conference program, alongside valuable interpersonal interactions which were also in an important part of the event.
The ISPOR event was rich in content and attendance. The audience gathered in large numbers for the Monday morning welcome session, opened by ISPOR President Brian O’Rouke. O’Rourke noted that the ISPOR conference in Atlanta in May was the largest up to that point, but the European ISPOR surpassed it with over 5,600 participants, setting a record.
Finland took the spotlight in the conference’s first plenary session, where experts from different countries discussed the European Health Data Space(EHDS). The strengths of Finnish real-world data(RWD) were highlighted in the speech by Markus Kalliola, a project director at Sitra.
The idea of one platform containing information from multiple countries and sources was deemed valuable for RWE studies.However, the establishment of EHDS faces challenges. Those are related to data privacy, cultural challenges, and countries readiness to join the platform.
The merging of multiple data sources was also discussed concerning external control arms in a panel moderated by Chris Cameron from Eversana Life Science Services. External control arms are becoming increasingly important when randomized and controlled clinical trials are not feasible.
While external control arms are absolutely at the cutting edge in HTA and regulatory decision-making, specific rules or guidelines do not exist for their use. Thus, a variety of data sources, endpoints, and methods are employed.
The audience of the panel discussion leaned toward combining multiple data sources, although panelists emphasized the importance of having one high-quality data source for external control arms. The key is ensuring that the data is of sufficient quality and collected from the country where it is being utilized.
Throughout the conference, presentations showcased examples where RWD had been utilized in HTA and regulatory decision-making. Most of the examples presented had a positive outcome at the end of the negotiation. However, there was a desire for more examples.
The conference days were so filled with information that attendees had little time to explore Copenhagen’s attractions. Nevertheless, children received souvenirs, the latest from the airport’s LEGO store.
Important topics at ISPOR Europe 2023
Real-world data and real-world evidence:
1. Utilizing RWD in Health Technology Assessment (HTA) and regulatory decision making
2. External control arms are a hot topic in HTA and regulatory
3. More examples of leveraging RWD are needed
Harmonization of European practices:
1. European Health Data Space; a platform containing information from multiple countries and sources
2. EU joint clinical assessment (EU HTA)
3. Standardizing the collection and analysis of RWD by creating guidelines
Liisa joined Medaffcon in January 2020. She has over ten years of experience of working as a scientific advisor and research scientist for private and public sector organizations. Liisa holds a PhD in medical genetics, and she mentions that especially the therapeutic areas related neurology and psychiatry appeal to her.
Liisa’s strengths include strong expertise on medical sciences and research, as well as on creating evidence-based content, because she also has experience of being a science book author. Establishing cross-scientific collaboration, scientific exchange, and creating networks are one of her key work philosophies.
One of her main professional interests is the secondary use of health-related data to create real-world-evidence in order to improve and develop treatment practices. ”Due to the unique registries and data lakes available in Finland, in principle all the required data is already available or accumulating all the time, which makes it important to utilize this real-world-data to improve patient care and general well-being.”
Mariann joined Medaffcon’s team in 2016 after finishing her PhD. The transition to real world evidence (RWE) research was a natural continuum to her previous research career. Through RWE studies, she has had the privilege to gain a broad insight into working with different stakeholders within the healthcare field. The vast proportion of her days goes towards interacting with clients, planning and performing RWE studies, and supporting Medaffcon’s RWE team. Subjects that keep her work interesting are the vast variability of customers and projects, problem-solving, and interacting with people.
“The number of RWE studies has increased since stakeholders within the healthcare industry have an increasing demand for knowledge-based decision making tools that need to be fulfilled. The future, therefore, has an ever-increasing emphasis on RWE”.
Iiro joined Medaffcon in March 2017 as a Biostatistician. For the preceding four years, he has worked as a research assistant in an academic study group, analyzing clinical and genetic patient data. Iiro holds a Master of Science degree in Technology in Bioinformation Technology.
Iiro’s strengths include his strong expertise in statistics and data-analysis, hands-on experience in working with sensitive patient data, and strong interdisciplinary communication skills with experts from various fields. In the field, he is particularly interested in the large data amounts made available with the revolution of technology and how the information received such data can potentially be utilized to draw concrete conclusions, both in order to understand the nature of diseases and to advance the goals of the pharmaceutical industry and patient treatment.
“Machine learning and AI-based solutions will have a major impact on the healthcare sector now and in the future. However, effectively utilizing the already collected and available health-data will have a higher importance in order to improve health-care”.
Heini joined Medaffcon’s Market Access team in the spring of 2018. Heini holds master’s degree in health and social sciences, majoring in Health Economics. Prior to moving into the field of pharmacoeconomics, Heini has worked as an entrepreneur in the health and sport industry. At Medaffcon, Heini works as Market Access Lead with various market access processes and health technology assessments.
Heini has a wide range of expertise in the price and reimbursement processes and health technology assessments in multiple therapy areas. Heini is interested in the possibilities to turn data into understandable information to support healthcare decision-making and thus increase the patient’s well-being. Together with her team and clients she strives to facilitate the provision of bespoke solutions for customers’ pricing and market access needs.
Petri joined Medaffcon in 2022 as a consultant. Petri holds extensive experience in the pharmaceutical industry especially in Market Access, sales and marketing. Before joining Medaffcon Petri worked in various managerial roles in the pharmaceutical industry which has provided him with a comprehensive understanding of the challenges and opportunities in the field. Petri conducted his BBA studies in the Netherlands and Finland providing him with a great basis to work in international organizations.
Petri’s extensive experience in the pharmaceutical industry and his background in business equip him with a unique perspective in the field of Life Science and commercialization of medicines in Finland. His main focus is on helping companies bring Life Science innovations and services to the Finnish market. Petri’s expertise in Market Access, sales and marketing as well as his deep understanding of the pharmaceutical industry provide Medaffcon’s team with valuable information as they provide customer solutions.
“Resource challenges alongside technological development and digitalization provide considerable opportunities to enhance healthcare in Finland. As data collection and digitalization develop, the effectiveness of health technologies can be demonstrated more precisely. While advanced health technologies and medicine offer more effective treatments, bringing them to the market require special know-how and understanding. Thus, companies, the research sector and governmental agencies should continue to further co-operation in effectively bringing health technologies and medicines to the market while simultaneously managing resource allocation in a rational manner.”