The Nordic countries join forces in HTA medicine assessments
The aim of the cooperation is to harmonize processes and produce joint assessments that each country can use in its own decision-making.
Up to 20–30 Percent of All Care May Be of Low Value to Patients
Eliminating low-value care is a key means of safeguarding the sustainability and quality of healthcare. Real-world evidence plays an important role in this, enabling better decision-making both in clinical practice and in the regulation and pricing of medicines. International initiatives support this development, but the final decisions on the value and cost-effectiveness of treatments are still made at the national level. This was emphasised by HUCH Chief Medical Officer for Clinical Auditing, Sami Pakarinen, in his address at Medaffcon’s client event at EMMA.
“Up to 20–30 percent of all care provided may be of low value to patients. Therefore, resources should be directed primarily to interventions with the strongest evidence of effectiveness, supplemented where necessary with real-world evidence (RWE),” notes Sami Pakarinen, Chief Medical Officer for Clinical Auditing in HUCH.
As healthcare expenditures rise, so too does concern about the prevalence of low-value care. Low-value care refers to practices that provide no significant benefit to patients or are not cost-effective. Such care can cause adverse effects or unnecessary costs for hospitals. It also consumes resources that could otherwise be allocated to more effective treatments or other critical needs.
“This threatens the sustainability and quality of healthcare. Eliminating low-value care also requires active measures—so-called de-implementation,” Pakarinen says.
Examples include involving patients in shared decision-making, informing them about the harms of low-value care, and explaining the natural course of diseases. Real-world data (RWD) is crucial for identifying and discontinuing low-value and costly medicines once they have entered the market.
The Importance of National Assessments in Adoption Decisions is Increasing
Registry-based observational data and post-marketing studies have shown that benefits observed in clinical trials—for example, survival—do not always materialize in routine practice. In such cases, a treatment may not be as cost-effective as assumed.
“As medicines are being brought to market more quickly, and often based on limited clinical evidence, the importance of assessments in adoption and pricing decisions is increasing,” Pakarinen says.
The European Medicines Agency’s (EMA) marketing authorisation process does not assess the therapeutic or economic value of a medicine. Obtaining marketing authorization does not require evidence of patient-relevant outcomes, such as improved quality of life, nor does it necessarily involve comparison with other treatments. The system also does not address the price of the medicine.
Starting in 2025, the EU will gradually introduce Joint Clinical Assessment (JCA) of medicines. Initially, these assessments will focus on cancer medicines and advanced therapy medicinal products (ATMPs, such as cell and gene therapies).
A JCA report will systematically compile the available evidence on a medicine’s effects and related uncertainties. National authorities will continue to be responsible for assessing costs, budget impact, and cost-effectiveness.
Finland is Participating in Several International Initiatives
- HUCH is part of DARWIN EU®- network which is EMA’s system for harnessing real-world healthcare data (OMOP CDM) for supporting more effective, timely, and evidence-based regulatory decisions on medicines in Europe
- Fimea (Finnish Medicines Agency) collaborated with Finnish university hospitals and the Finnish Innovation Fund Sitra to pilot RWE (real-world evidence) generation using the OMOP Common Data Model and federated analytics (2023). This model allowed hospitals to share aggregated data for treatments like multiple myeloma — without transmitting individual-level records. Data were pooled and assessed for health technology assessment (HTA) needs
- The VALO (NSCLC)-project (2025) test in practice and demonstrate the effectiveness of cross-border Nordic cooperation in the use of harmonised health data
- Coming VALO2-project, where the main goal is to demonstrate how real-world research can be conducted across national borders using Secure Processing Environments (SPE), Trusted Research Environments (TRE), or similar controlled data access infrastructures. Jointly prepare for and implement the European Health Data Space (EHDS) legislation in the Nordic countries with using pseudonymised personal health data
- Limitations: the Finnish secondary-use legislation doesn’t yet fully support federated analytics; nor does it explicitly prohibit it
Medaffcon’s annual EMMA event was held on September 10th at the Espoo Museum of Modern Art – and for the first time also in Stockholm. Since 2016, EMMA has brought together experts and decision-makers to explore timely themes in healthcare, market access, data-driven decision-making and more.
