Sustained efficacy results from an RWD study

A recent nationwide real-world data (RWD) study, published in European Journal of Gastroenterology & Hepatology, demonstrated that ustekinumab provides sustained effectiveness in treating moderate to severe ulcerative colitis (UC). Conducted as a chart review study, the study included nearly all patients in Finland who received ustekinumab between September 2019 and December 2021. Data collection was performed using a data collection system inside SPESiOR secure processing environment.

    Key findings of the study include:
  • Partial Mayo Score and faecal calprotectin values significantly decreased from median 5.0/1262 at baseline to 1.0/215 after one year.
  • Ustekinumab persistency was 63% at one year.
  • Faecal calprotectin and extraintestinal manifestations were found to be associated with ustekinumab persistency.
  • Discontinuation was most commonly due to primary nonresponse (65 patients, 75% of reasons).
  • Antibodies to ustekinumab were uncommon (<5 patients, <21%), and discontinuation due to adverse effects were rare (<5 patients, <6%).

The study’s findings align with previous real-world evidence and offer valuable insights into the long-term effectiveness of ustekinumab in real life routine clinical practice.

Read the article here.

Contact Erkki Soini (CEO) for more information.

Alzheimer’s Disease Risk Prediction Tool is Cost-Effective

A recent modelling study by ESiOR Oy and VTT Technical Research Centre of Finland assessed the cost-effectiveness of a machine learning-based risk prediction tool for Alzheimer’s disease (AD) in Finland. This tool, which is still under development, aims to support early diagnosis and improve long-term health outcomes for AD patients.  

Key Findings:

    • Greater health benefits at lower costs – The assessment tool increased quality-adjusted life years (QALYs) in the model while simultaneously reducing costs.

    • Risk assessment is cost-effective when integrated with other services – In the model, using the risk assessment tool alongside other social and healthcare services was cost-effective when disease-modifying AD treatments, which will soon be available, were in use.

    • The tool can improve AD treatment – The tool can significantly enhance the early detection of Alzheimer’s disease, enabling timely interventions and comprehensive care.

Read the Full Study in Value in Health  

Picture: Stock Images

The Societal Value of Clinical Drug Trials in Finland: 10 Million Euros per Trial 

The Societal Value of Clinical Drug Trials in Finland: 10 Million Euros per Trial

A study by ESiOR Oy and Pharma Industry Finland conducted in the Spring 2024 estimated that the societal value an average clinical drug trial conducted Finland at €10 million, considering both direct and indirect impacts.

Key Findings:

  • Direct Value: The average direct value of care provided in a clinical drug trial is estimated at €1.2 million, with 41% coming from drugs paid by sponsors and 34% from treatment and monitoring.
  • Total Societal Value: Estimated at €10 million per trial, including benefits from spill-over health benefits (73%) and cost savings (15%).
  • Impact on Healthcare: Between 2018 and 2023, clinical drug trials contributed an estimated €880 million annually to Finland’s healthcare system.

The present study builds on our earlier regional findings from North Savo, where research investments at Kuopio University Hospital returned the Wellbeing Service County of North Savo €3.9 of value for every €1 invested.  The new findings highlight the broader societal benefits of clinical trials, reinforcing their importance beyond the direct healthcare costs at the national level.

Billions of euros worth of health benefits and health care cost savings are threatened, unless the decades long decline in number of clinical trials is reversed.  

Read More About the Study’s Findings 

Event: ISPOR Europe 2024, Barcelona, Farmasian päivät 2024 

Previous study in Northern Savo:  ISPOR – Should Hospitals Do Contract Research? Costs, Net Monetary Benefit, and Return on Public Sector Investments in Research at Kuopio University Hospital

Picture: Stock Images

Pulmonary Hypertension in Finland: Key Findings from the FINPAH Study (2008–2020)

Pulmonary Hypertension in Finland: Key Findings from the FINPAH Study (2008–2020)

The FINPAH study offers valuable insights into pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) in Finland, analyzing data from 2008 to 2020. This real-world data serves as a critical resource for improving the diagnosis and management of these conditions.

Key Findings:

  • Incidence: 4.0 and 2.9 cases per million per year for PAH and CTEPH, respectively.
  • Diagnosis: The median time from symptoms to diagnosis was 1 year for PAH patients.
  • Patient Demographics: The mean age at diagnosis for PAH patients was 57, with 73% being women.
  • Survival Rates: At 1 year, 91.3%/94.6% survival; at 5 years, 62.6%/79.4% survival for PAH/CTEPH patients.
  • Treatment Impact: Pulmonary endarterectomy (PEA) patients had better survival rates than non-PEA CTEPH patients.

The study underscores the importance of early diagnosis, treatment guidelines, and treatment adherence to improve patient outcomes and aligns with international trends in PAH and CTEPH management.

Read More About the FINPAH Study

Picture: Stock Images

Meta-Analysis: Visual Disturbances with Trifocal Intraocular Lenses

A recent meta-analysis published in Ophthalmology and Therapy sheds light on the visual disturbances reported by patients following bilateral implantation of the PanOptix trifocal intraocular lens (IOL) during cataract surgery. This comprehensive review of 11 studies conducted across 10 countries presents valuable insights for clinicians and patients when considering IOL options. 

Key Findings: 

  • Halos: 43.9% of patients experienced halos, with 5.4% reporting them as  severe. 
  • Glare: 33.6% of patients experienced glare, with 2.9% reporting it as severe. 
  • Starbursts: 30.4% of patients experienced starbursts, with 3.4% reporting them as severe. 

Notably, only around 5% of patients found these disturbances to be severe, and approximately 3% found them very bothersome. 

These findings can help guide decision-making for IOL selection and set realistic expectations for patients undergoing cataract surgery. 

Read the Full Article 

ESiOR´s best wishes

What an Incredible Journey This Year Has Been!

As 2024 draws to a close, the elves at ESiOR are taking a moment to reflect on an amazing year of innovation, and collaboration. From delivering smarter solutions to unlocking impactful insights, we’ve had a truly remarkable year – thanks to our talented team and incredible partners!

Now, it’s time to spread a little holiday cheer and look ahead to the opportunities 2025 will bring. 

In the coming year, we’re gearing up for even more exciting projects in effectiveness, cost-effectiveness, predictive modelling, and data analytics, along with new partnerships and innovations to explore.

Here’s to continuing our journey together in 2025 and making it the most remarkable year yet!

Wishing you a joyful holiday season and an inspiring New Year!

Noora Jämsén has joined our team

It’s a pleasure to share some exciting news just before the holidays: Noora Jämsén has joined our team! 

Noora is a designer specialized in service design, and she is starting with us in the role of Service and Product Designer. She brings valuable expertise, fresh insights, and experience example from the technology industry. Noora has a strong passion for creating meaningful solutions that genuinely enhance user and customer experiences.

Her skills and enthusiasm for innovative development open up fantastic opportunities for us to grow and move forward. We’re thrilled to welcome her as part of our team!

Warmest welcome, Noora! 

5th Nordic RWE and AI conference 28-29 January 2025, Helsinki

5th Nordic RWE and AI conference: How will broad use of RWD and AI change Drug discovery and development and will the use of data improve the competitiveness of EU in R&D and result in value based decision making and healthcare?


Venue: University of Helsinki, Main Building Auditorium, Fabianinkatu 33, 00170 Helsinki, Finland Main Building, Fabianinkatu 33 | Opetustilat

Time: 28.1.2025, 12:00-17:40 and Networking Event 18:00-19:30 and 29.1.2025, 09:00-15:20 (times EET)

Registration: survey.esior.fi/index.php/239491


Day 1

12.00 Registration, networking and exhibition

12.45 Welcome, background and practicalities. Mia Bengtström Lecturer, University of Helsinki and Associate professor, Åbo Akademi University

Chair: Nicolas Vaugelade-Baust, Nordic Evidence Generation Director, Novartis

13.00 Using RWE and AI in the development of medicine to solve patient’s unmet medical needs and improving the competitiveness of EU. Anders Rething Borglykke, Vice President, Real World Evidence, Novo Nordisk A/S

  • The talk will be an introduction to how Novo Nordisk uses RWD throughout the value chain with a focus on clinical development. The talk will include a call to action for using better and appropriate data in order to increase the usefulness of the results necessary to achieve the ambition of using RWE to all aspects of clinical drug development including regulatory submissions.

13.25 Empowering data-driven medicines regulation in the EU: unlocking the power of real-world data and AI. Luis Pinheiro, Senior Epidemiology Expert, Data Analytics and Methods Taskforce


Implementation of EHDS – how to improve the competitiveness of the Nordic Region by using the excellent RWD assets

13.50 TEHDAS2 and VALO Value from Nordic health data – VALO – Sitra. Persephone Doupi, Senior Medical Officer, Finnish Institute for Health and Welfare (THL)

  • As the European Health Data Space Regulation is progressing to its formal status, implementation work is also advancing intensely across Europe. We will take a closer look into the main projects coordinating EHDS implementation for secondary use, TEHDAS2 Joint Action on the EU-level and the Nordic Council of Ministers’ funded project VALO (Value from Nordic health data) in the Nordic region.

14.15 European Health Data Space – a stealth revolution. Richard Bergström, Vice President European Affairs, IQVIA


Use of RWD and AI towards value based decision making and healthcare

14.40 The global value of Nordic data – pharma perspective.Emmi Tikkanen, RWE Scientist, Global RWE Platform, Pfizer

Chair: Tarja Laitinen, Senior Medical Advisor, FIMM – Institute for Molecular Medicine Finland, University of Helsinki

15.00-15.35 Coffee, exhibition and networking.

15.35 The global value of Nordic data – selected use cases. Emilie Toresson Grip, Director, Head of RWE and Analytics, Quantify Research

  • Overview of the key comparative advantages of the Nordic RWD landscape, compared to other US/EU RWD assets. Illustrated by highlighting examples of pan-Nordic research in collaboration with global pharma stakeholders, including the added value of Nordic data in international, multi-country studies

15.55 Secure Processing Environment (SPE) – Your Gateway from Individual Level RWD to RWE. Erkki Soini. CEO, ESiOR Oy. Chairman on the Board, Kuopio Health

  • SPE can provide a secure platform for collecting, transferring, managing, analysing, presenting, and storing social, health, trial, and other sensitive real-world data (RWD) for research, knowledge management, and education purposes used in research, development, decision making, market access, and value-based healthcare. In addition, some examples of SPE use in cardiovascular and other diseases with Nordic perspectives will be presented.

16.15 Nordic data landscape today and tomorrow. Riikka-Leena Leskelä, Research Director and Senior Partner at Nordic Healthcare Group

  • Current possibilities to conduct Nordic RWE studies and how future changes in the data landscape will make data utilization easier

16.35 Use of RWD/RWE in medicines development and regulatory decision making. Sini Eskola, PhD Candidate at University of Utrecht and WHO Centre for Pharmaceutical Policy and Regulation; Director, Regulatory Strategy, EFPIA

16.55 Using Federated Data Networks and Common Data Models for Health Technology Assessment. Ravinder Claire, Scientific Adviser – Science Policy and Research Programme, National Institute for Health and Care Excellence

17.20 Comparative effectiveness of first line pembrolizumab vs. chemotherapy in advanced non-small cell Lung-cancer after approval and reimbursement: A Norwegian Population-Based Cohort Study. Simon Boge Brant, PhD, NordicRWE

17.40 Thank you for the Day and walking to the City Hall


18.00- 19.30 The Networking Reception



Day 2

Chairs: Martta Ranta, Head of Medical Research, Abbvie and Juha Laine, Nordic HEOR Manager and RWD Advisor, Roche

Use of RWD and AI towards value based decision making and healthcare contineous

9.00 Real-world data as an enabler for value-based healthcare. Irene Eriksson, EMEA Partnership Lead, J&J

  • The Nordic real-world data (RWD) presents opportunities to support the ongoing development of value-based healthcare. Furthermore, the integration of artificial intelligence (AI) provides tools to address emerging challenges, thereby freeing up valuable resources to promote patient- and person-centered care. This presentation will explore the key elements of the Nordic RWD landscape that enable the development of sustainable healthcare systems.

9.25 Building a Foundation for Evidence-Based Healthcare: The Impact of Real-Time Data in Clinical Decision-Making, Real-World Evidence Generation, and Building Registries. Joakim Söderberg, Head of Business Development, BCB Medical

  • Traditionally, real-world data (RWD) has been derived from static extracts of registries, electronic medical records (EMRs), and similar systems. However, with the disease-specific registries used in the daily clinical work, RWD is generated from continuously updated, dynamic, “living” datasets. With the dynamic datasets, the ability to capture trends, assess interventions, and make adjustments in real-time becomes feasible, bridging the gap between research and day-to-day clinical care.

9.45 Use of natural language processing and machine learning to extract smoking status from patient texts in Finnish data lakes: lung cancer outcomes related to smoking as case example. Olivia Hölsä, Data Scientist, Medaffcon Oy

  • Finnish data lakes provide endless RWE opportunities especially in oncological indications with access to deep clinical data. However, many clinically relevant variables there such as smoking status are widely recorded in free text format, and natural language processing methods are required to include them in RWE studies.

10:00 Why does the Nordics exceed in RWE – or could we do better?

Real-time hospital-level clinical cost-effectiveness RWD production and reporting at HUS/HUCH. Sami Pakarinen, Chief Medical Officer of Clinical Auditing (deputy) at HUS/HUCH

  • Nordic Case: Valo and EU Case: Oncovalue, implementing value-based oncology care at European cancer hospital

EU Case: IHI Prominent, digital platform for precision medicine. Linus Jönsson, Professor, Karolinska Institute

Fireside discussion moderated by Lisse-Lotte Hermansson, Country Director Medaffcon AB

Discussion with Sami Pakarinen and Linus Jönsson:

  • What are the challenges in RWD for cost effectiveness analysis?
  • Why is collaboration, data harmonization and interoperability important?
  • How can we avoid data access delays and continue to lead in the health data space?


10.40 Networking break


11.00 Harnessing the Finnish national registers to generate RWE. Anna-Maija Tolppanen, Professor, University of Eastern Finland

  • Possibilities and challenges of using Finnish national registers are discussed through examples of previous multi-country and single-site studies and ongoing projects including Real4Reg https://www.real4reg.eu/

11.25 The Power of Next-Gen Anonymization: Secure, Compliant, and Accessible Data. Tuomo Pentikäinen, CEO, VEIL.AI

  • AI-enhanced next-generation anonymization technology is transforming the data landscape. It improves access to real-world data for evidence generation, facilitates secure cross-border sharing of clinical research data, and enables privacy-compliant datasets for AI training.

11.45 HealthHub Finland EDIH – Auria Clinical Informatics – Agile Path for RWD Research. Arho Virkki, Chief Analytics Officer, Wellbeing Services County of South-West Finland (Varha)

12.05 Real World Evidence Reveal Unjustified Antibiotic Use for the treatment of acne. Johanna Vinblad, Senior Manager Market Access, PharmaLex (part of Cencora)

  • Antibiotic resistance is a significant and escalating issue that can be mitigated through responsible use of antibiotics. This study provides a descriptive analysis of adherence to Swedish treatment guidelines for moderate acne and evaluates the potential impact on oral antibiotic usage if adherence to these guidelines were enhanced.


12.30-13.30 Lunch


Use of RWD and AI in Drug discovery and development

13.30 Transforming drug development using Large Scale Data to find novel treatments for understudied medical needs. William Hennah, Senior Scientist Genomics at Orion Pharma Oy

  • How do you gain RWE to support drug development when the medical need is poorly defined in health records, and how do you get that precious RWE into the hands of research scientists? I’ll present Orion’s work on co-developing the DeepPheWAS R package, that allows for dynamic phenotype creation to address lacking information in large scale population datasets, and the POD3 platform, that brings public and proprietary data into one place supporting collaborative multidisciplinary research.

13.55 The power of combining Norwegian Healthdata and AI: A case example from Novartis and Akershus University Hospital.

Intro – 5 min: Nicolas Vaugelade-Baust, Nordic Evidence Generation Director – Novartis

Case example: Tatjana Bosnjak-Olsen – Medical Lead Norway – Novartis, Jesper Ravn – Senior Advisor Technology and ehealth – Akershus University Hospital

International perspective: Benjamin Gmeiner – Head of Medical Data Strategy & Science Germany – Novartis

14.30 Transforming Clinical Trial Practices through Real-World Data. Tero Ylisaukko-oja, CEO, founder, MedEngine Oy

  • Real-world data (RWD) have great potential to revolutionize clinical development, particularly in rare diseases. By leveraging RWD in natural history studies, researchers can gain valuable insights into disease progression and identify key factors—such as demographic, genetic, and environmental influences—that shape patient outcomes under current standards of care. These insights are crucial for designing clinical trials with optimal duration, meaningful endpoints, and the possibility of incorporating external control arms. Data from the Nordic countries provide a uniquely robust foundation for conducting these transformative studies.

14.50 Can you outsource data interpretation to AI?Paavo Raittinen, PhD, Head of Commercial Data Services, Oriola

15.10-15.20 Next steps. Thank you for participating and funding, Mia Bengtström


We thank our supporters!

Inspiring Days Ahead: ISPOR Europe & Pharmacy Days

We’re thrilled to be part of these two events this November, bringing insights and innovation to healthcare and health economics.

Pharmacy Days 2024

This weekend, November 15-16, we’re attending Pharmacy Days 2024 at the Helsinki Exhibition Center. A fantastic platform for advancing well-being services, we’re excited to showcase four innovative posters aimed at driving industry impact.

ISPOR Europe 2024: Driving Health Innovation

From November 17-20, we’ll be in Barcelona for the ISPOR Europe 2024 conference, the premier event in health economics and outcomes research (HEOR).

This year’s theme, “Generating Evidence Toward Health and Well-Being,” underscores the vital role of scientific evidence in enhancing global health. The event will dive into the science, practice, and policies of healthcare value assessment, offering a broader perspective on health economics and outcomes research (HEOR). Key topics include the physical, mental, and social dimensions of healthcare innovations

We’re looking forward to engaging discussions, sharing ideas, and learning. If you’re attending, let’s connect! 

Pharmacy Days 2024 at Helsinki Exhibition Center- We are also there!

At Pharmacy days 2024, we will present no less than four innovative posters, the results of each of which will help to increase the effectiveness and cost-effectiveness of the welfare industry and wellbeing services counties sector:

  • Integrating Architecture Methodology into Health Technology Assessments and Pharmacoeconomic Evaluations 
Väätäinen S, Soini E. Integrating Architecture Methodology into Health Technology Assessments and Pharmacoeconomic Evaluations. Pharmacy days 2024 [poster]. 

  • The Benefits of Conducting Clinical Drug Trials in the Finnish Public Health care: The Society Gains 10 Million Euros of Value per Trial
Väätäinen S, Ehlers P, Tamminen N, Soini E. The Benefits of Conducting Clinical Drug Trials in the Finnish Public Health Care: The Society Gains 10 Million Euros of Value per Trial. Pharmacy days 2024 [poster]. 
  • Pharmaceutical Work Provided by the Finnish Community Pharmacies Results to Significant Cost Savings and Value for Society
Haikonen-Salo L, Jalkanen K, Väätäinen S, Mankinen P, Soini E. Pharmaceutical Work Provided by the Finnish Community Pharmacies Results to Significant Cost Savings and Value for Society. Pharmacy days 2024 [poster]. 
  • Comparison of SPESiOR and Other Secure Processing Environment (SPE) -type Environments from Finnish, Nordic, European, and Global Settings
Soini E, Väätäinen S. Comparison of SPESiOR and Other Secure Processing Environment (SPE) -type Environments from Finnish, Nordic, European, and Global Settings. Pharmacy days 2024 [poster]. 
See you at Pharmacy days 15–16 November at the Helsinki Exhibition Center!
 
Additional information: Erkki Soini

HealthTech Investor Summit Connecting European HealthTech Entrepreneurs and Investors

We are participating in the HealthTech Investor Summit on 9-11 December 2024 at the Bruges Congress and Convention Center (BMCC), Belgium.

The HealthTech Investor Summit is the only event connecting European healthtech entrepreneurs with the investors, clusters and mentors they need to succeed. The future lies at the crossroads of health and technology. This is a unique space, where healthtech, medtech, and digital solutions have the power to revolutionize people’s lives.

More information about the HealthTech Investor Summit

ESiOR´s CEO Erkki Soini, one of the speakers at the Digital Health Society Summit

We are excited to announce that Erkki Soini will be speaking at the Digital Health Society Summit on November 6th, under the theme “Who Are the Champions in Our Ecosystems – Deep Dive into Data & Digital Work of Ecosystems in the Global ECHAlliance Network” together with Andy Bleaden from ECHAlliance – The Global Health Connector and Michael Frandsen from WARD 24/7 (Denmark).

The 6th Digital Health Society Summit is set to take place virtually on November 5-6, 2024. This year’s theme focuses on “Modernization in Healthcare over the Next Five Years: How Will Healthcare Embrace Digitalization and Catch Up with Other Sectors?” The Summit will address the challenges healthcare systems face in adopting digital technologies while highlighting the potential benefits. It aims to foster connections among stakeholders from public and private sectors, including governments, businesses, academia, and civil society, building on ECHAlliance’s collaborative efforts through the Global Health Connector Partnership, which spans regions including Africa, India, the Americas, and the Far East.

More information about the Digital Health Society Summit

Additional information: Erkki Soini