Need for medicine-related data increases, the system responds to the change slowly

It would be useful to have RWE support the decision-making related to managed introduction and use of medicine. All existing information cannot be used currently due to the deficits in the national data sets and the interpretation of the Secondary Use Act related to the secondary use of social and healthcare data.

Fimea’s Leading Specialist Piia Rannanheimo and Medaffcon’s RWE Lead Mariann Lassenius discussed at Medaffcon’s customer evening the secondary use of social and healthcare data as part of the managed introduction and use of medicine.

From the perspective of authorities and pharmaceutical companies, key challenges include for example the fact that there is no integrated database of hospital medicine consumption at the national level. Collecting data of treatment results is often not systematic in the everyday life of healthcare. In addition, while treatments become more personalised, a need arises to collect more detailed data, for example, related to a patient’s gene mutations or previous treatments.

Another challenge at the moment is the delayed access to data. The data permit applications often go through Findata and the decisions may take long.

Companies only receive register data for studies

Authorities have the legal right to receive necessary information for their work, for example, from Kela and the Finnish Institute for Health and Welfare. It brings possibilities for continuous use of data. Producers of social and healthcare services can often fluently use the data of their own organisation.

Pharmaceutical companies, however, need to gather the data through scientific studies even when the data is used to complete a reimbursement application upon the request of an authority.

– It is no problem for us to conduct studies, but the question-setting of the studies would be more practical if this sort of individual data could be received otherwise than through a scientific research process, tells Mariann Lassenius.

A study is needed, because companies only have access to register data for scientific research, even though an authority request was behind them. This is also related to the use of data as a continuous or single-time process.

Continuous use of data enables, for example, knowledge-based management in a healthcare organisation with the organisation’s own data. From the perspective of national authorities, the continuous use of data is based on the authority’s legal right to process data. Single-time data, in turn, is granted for research.

– These different data utilisation processes, roles and access to data are also important in the HTA (health technology assessment) field. They are issues that we consider, for example, in the RWE4Decisions network, Rannanheimo tells.

It takes time to change the system

Piia Rannanheimo has been involved in several reviews related to the Act on Secondary Use and the use of RWE in pharmacotherapies and pharmaceutical service. They have exhibited the reasons why RWE processes are difficult, and it takes time to change them.

– RWE is connected to several parties, such as healthcare, authorities, individuals and companies. It is easy to conduct pilots, but the systematic change of courses of action is difficult when there are many actors, issues to consider and competing needs. That is, in my opinion, one reason for why things progress slowly.

According to Rannanheimo, Fimea produces, upon the commission of the Ministry for Social Affairs and Health, a proposal for courses of action and a roadmap of how to make data-based activities more effective, enabled and clear in the case of pharmacotherapies and the use of medicine, including the managed introduction of medicine.

– The purpose is to publish a background document related to the commission in early October. This paper can also be commented by companies. 

Rannanheimo states that it would be important to involve pharmaceutical issues also in the development of knowledge-based management in the health and social services counties and in reforming the national information base. These issues are developed as part of the Toivo programme of the Ministry for Social Affairs and Health. The programme is related to the reform of the health and social services counties and the aim is to develop the knowledge-based management of the counties.

– Pharmacotherapies are part of social and healthcare services and data related to them should be interweaved into this programme, says Rannanheimo.

Fimea’s Leading Specialist Piia Rannanheimo and Medaffcon’s RWE Lead Mariann Lassenius discussed the secondary use of social and healthcare data as part of the managed introduction and use of medicine at Medaffcon’s customer evening organised at Espoo Museum of Modern Art Emma on 14 Sep 2022.