“The situation is exceptional, as the entire industry unanimously sees a common large goal and big picture. A lot of groundwork has been done. I am optimistic and trust that we will make progress,” Lauri Pelkonen from the Ministry of Social Affairs and Health states.
Pelkonen spoke about the development and future of national drug evaluation activities at Medaffcon’s Emma customer event.
Pelkonen shifted to the position of leading expert at the Ministry of Social Affairs and Health (STM) in January. In his role, he coordinates the preparation of government programme records related to medicines and pharmacy economics. He will work in this expert role until the end of 2026, after which he will return as the director of Hila (Pharmaceuticals Pricing Board).
Led by Pelkonen, the Medicines and Pharmacy Economics project continues the reform of drug matters based on the roadmap of Prime Minister Juha Sipilä’s government and ensures the implementation of rational drug therapy. This project prepares and implements the government programme’s objectives concerning medicines and pharmacy economics.
“The goal of the reform is to improve the effectiveness, safety, quality, economy, equality, and availability of drug treatments. Structural reforms aim to improve the sustainability of public finances,” Pelkonen states, a leading expert at the Ministry of Social Affairs and Healthl (STM).
The project is extensive. Its topics include pharmacy regulation and economics, development of drug evaluation activities, adoption of new drugs, digitalisation and information management in drug therapy, guidance in drug therapy, and drug availability.
“Politically, the most interesting aspect is the pharmacy economy and its regulation. Views on the development of pharmacy operations are very diverse,” Pelkonen says.
The drug affairs reform is a cross-governmental project that began during Prime Minister Juha Sipilä’s term with the preparation of a roadmap. Various studies on the pharmaceutical sector’s development were conducted during Prime Minister Sanna Marin’s term. These studies are the background for the Programme of current Prime Minister Petteri Orpo’s Government records on drug matters.
According to Pelkonen, never before has a government programme included as many drug matters as it does now under Prime Minister Petteri Orpo.
Drug evaluation activities are being reformed to better respond to changes in the operating environment, especially in three main areas: European-wide clinical evaluations of drugs (EU HTA) will be gradually implemented starting in 2025. In 2025, cancer drugs and ATMP preparations will be included; in 2028, rare disease drugs; and in 2030, all drugs. A service reform project aims to increase the effectiveness of healthcare methods. Pelkonen’s led Medicines and Pharmacy Economics project includes drug treatment evaluations.
The service reform aims to reform and strengthen the national evaluation of healthcare methods by consolidating expertise and resources into one entity. Uniformly evaluated, effective, and cost-effective methods are adopted in social and health care.
There is no guideline in the government programme on dismantling multi-channel financing of drug therapy. Of the themes, this programme has been on the agendas of different governments for the longest – almost 20 years. Pelkonen does not believe this programme will be implemented in 2026, as Prime Minister Sanna Marin’s government outlined.
Complexity complicates current drug evaluation
According to Pelkonen, a major problem with the current evaluation activities is their complexity, poor predictability, insufficient resources for evaluating all new drugs and indications, and the fact that recommendations of Council for Choices in Healthcare in Finland (COHERE Finland) are not binding in hospital medicines.
“Complexity arises because the drug dosing method defines the process. Several authorities participate, and the criteria for assessment and decision-making are different,” Pelkonen states.
The controlled introduction of new drugs is hampered by a situation where resources are limited, there is a growing need for treatments, and the industry can endlessly create new opportunities.
In evidence-based decision-making, assessment involves challenges. A central question is whether the achievable health benefits can be considered sufficient relative to the costs incurred.
Medaffcon Oy provides research, expert services and consultancy to meet the needs of the pharmaceutical industry and healthcare sector. Emma, its invite-only event, addressed the development and future prospects of assessment activities as part of the introduction and reimbursement processes for new drugs, as well as the utilisation of healthcare registry data and innovative new opportunities. Lauri Pelkonen, the leading expert at the Ministry of Social Affairs and Health (STM), spoke at the event about the development and future of evaluation activities. The event was held on April 10, 2024 at the Espoo Museum of Modern Art.
Sairaaloiden tietoaltaista saadaan hyvin monipuolista tietoa kliinikoiden työn tueksi. Helsingin yliopistollisen sairaalan (HUS) Porvoon sairaalan keuhkosairauksien ylilääkäri Heikki Ekroos esitteli Medaffconin EMMA-asiakastilaisuudessa tutkimuksia, jotka on tehty HUSin tietoallasdatan pohjalta.
Real-world data (RWD) created in Finnish healthcare is comprehensive and high-quality. Sweden, another Scandinavian country, also offers high-quality healthcare data for real-world evidence generation.
The EU introduces changes to the assessment of medicines: EU HTA application in evaluations will gradually start next year
Sr. Health Economist
Market Access Lead
MSc (Health Economics)
+358 44 326 4477
heini.honkanen@medaffcon.fi
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.
Sr. Consultant
BBA
+358 40 355 6111
petri.maatta@medaffcon.fi
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.”
Lead RWE Epidemiologist
PhD, MSc
Dr Johanna Simin joined Medaffcon in May 2023. She is a trained epidemiologist based in Sweden. She obtained her master’s and doctoral degrees from Karolinska Institutet, Stockholm, where she continued her work as a post-doctoral researcher focusing mainly on the long-term effects of prescription drugs. Her international projects have been based on high-quality Swedish health data registries, many of the cohorts being globally among the largest. She has broad experience in international collaborations between leading universities and pharmaceutical companies and has supervised postgraduate students nationally and internationally.
“What drives me is the purpose of my work – I believe in enhancing health with big data. Here, the Nordics offer incomparable real-world possibilities”.
Sales Lead
eMBA
+358 50 305 5963
tomi.vahevaara@medaffcon.fi
Tomi Vahevaara started working at Medaffcon in January 2017 as a Sales Director. He has been working in the pharmaceutical industry for over 35 years. Therefore, he has gained wide-ranging experience in international expert and managerial positions within the innovative pharmaceutical industry. Before joining Medaffcon, Tomi worked for ten years as the Managing Director of Eli Lilly for Finland, the Baltic States, and Poland.
Tomi has solid and wide-ranging expertise in different positions in the pharmaceutical field and is well connected in the entire health industry network. He serves as the Chairman of the Board of the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities and as a Board Member in the Finnish Co-operative for Pharmaceutical Injury Indemnities. Tomi is particularly interested in the significant economic and investment opportunities for Finland and those companies working in the Finnish health industry.
Marketing Manager
Marketing Lead
+358 50 585 8615
milla.kalliokoski@medaffcon.fi
Milla joined Medaffcon September in 2023 as the Marketing Manager. She is responsible for overseeing Medaffcon’s marketing activities, including brand management, digital marketing, go-to-market activities with international sales, events, and also involded in different customer projects.
Milla has extensive experience in launching various brands, such as a global Hublet ICT Saas Business, a new human resource brand under Otiga Finland, and numerous product launches in the consumer goods and cosmetic industries. She has worked with global and Finnish brands and growth companies in marketing, communications, and digitalization positions across different industries, including ICT, Health Tech/Health and Wellness Business, Human Resources, and Consumer Goods/Cosmetics. In the last five years, she has held positions as Head of Marketing/Communications positions.
She completed her Bachelor of Business Administration degree in 2008, specializing in entrepreneurship, leadership, and marketing. Additionally, she studied economics at the University of Vaasa, focusing on managing a growth company. She is particularly interested in the opportunities that artificial intelligence brings to the development of business and constantly develops herself through these areas.