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Renewable drug therapy challenges the current complex drug evaluation system  

“Renewable drug therapy challenges the current complex drug evaluation system,” states Lauri Pelkonen, a leading expert at the Ministry of Social Affairs and Health (STM). For this reason, the evaluation activity is being reformed to better respond to changes in the operating environment.   

“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).  

The Medicines and Pharmacy Economics project ensures the implementation of rational drug therapy   

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.  

Introduction of new drugs in the Programme of Prime Minister Orpo’s Government, e.g. drugs as part of healthcare  

  • Continue reforming drug matters: Ensure the implementation of rational drug therapy. The goal is to improve, among other things, the effectiveness of drug treatments. Drug matters are part of the RDI growth programme.  
  • Drug treatment and supply guidance will be consistently developed as part of social and health care.   
  • Effectiveness is promoted within the service system via a package of effective methods and best practices.   
  • Nationally, effective methods are emphasised, and less beneficial treatments and studies are reduced. Decisions are based on national social and health care methods and drug evaluation work.   
  • Evaluation activities for outpatient and institutional drugs are being reformed via safe and effective drug therapy.   
  • Improve the cost-effectiveness of drug treatments and evidence-based prescribing and use of medicines.   
  • Continue conditional reimbursement.  

Drug evaluation activities are reformed in three main areas  

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.  

Drug evaluation activities are being reformed in phases, e.g. HTA regulation 

  • National implementation of the HTA regulation for healthcare methods; government proposal: Fall 2024   
  • Unified evaluation processes for outpatient and hospital drugs, government programme   
    o Task force to prepare proposals; deadline: Fall 2025  
    o Gradual progress: unification of hospital drug processes   
    o Close connection to the broader reform of social and healthcare methods   
  • Continued conditional coverage of the drug reimbursement system   
  • Temporary legislation 12/2025 – permanent establishment and development needs   
  • Other possible issues  
  • Functionality of the drug reimbursement system, personalised treatments
    (proposals by Professor Heikki Ruskoaho)  

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

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.  

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