A pilot project between Fimea, university hospitals and Sitra is emerging as a model for providing additional evidence on new pharmacotherapies

The three centres of the FinOMOP consortium; HUS Helsinki University Hospital and the wellbeing services counties of Pirkanmaa and Southwest Finland, together with Fimea, carried out a pilot project to develop an operating model for providing additional information on new pharmacotherapies. 

Sitra funded the pilot by the FinOMOP consortium and the Finnish Medicines Agency Fimea as part of a wider Health Data 2030 project. The pilot project ran during 2023.

“We funded the pilot project to learn from the OMOP data model. The decentralised analysis enabled by the model will streamline the use of health data and facilitate international research activities in Finland. The benefits are visible for citizens, society and companies: we get better care and pharmaceutical RDI activity is boosted," says Saara Malkamäki of Sitra.

A description of the approach was the main outcome of the pilot

For the first time, the pilot used the OMOP databases of three university hospitals and a decentralised analysis approach. OMOP is an international vocabulary- and data model developed for the secondary use of patient data, enabling the comparability of patient data from different providers and even from different countries. In Finland, the OMOP harmonisation of patient data has been carried out by the FinOMOP consortium, which includes university hospitals, the Finnish Institute for Health and Welfare (THL), the University of Helsinki and a number of companies in the field. 

Harmonised databases following the same data model allow identical analyses to be carried out locally in each OMOP centre, without the need to combine personal data between centres (= federated i.e. decentralised analysis). Only anonymous summary data between centres are aggregated and reported centrally. A decentralised analysis model with harmonised patient data  strengthens the security and speed of data collection and improves the quality of data extractions.

In the pilot, Fimea identified the information needs related to the introduction and the use of new medicines for three case studies (new treatments for multiple myeloma and SMA and CAR-T treatments). The OMOP centres were tasked with assessing how best to meet the information needs by using the hospitals' OMOP databases, extracting the necessary data and producing statistical data for Fimea.

The centres submitted the statistical data to Fimea, which aggregated the results and assessed their usefulness in evaluating the therapeutic and economic value of medicines. Findata ensured the anonymity of the data before aggregating and submitting the datasets to Fimea.

OMOP databases have potential for monitoring the controlled use of medicines

The patient registers managed by the wellbeing services counties contain a wealth of valuable information needed for the managed entry of new medicines and treatment optimisation . Often the need is for disease- or patient group-specific follow-up information. As it stands, the wider use of patient data is limited by issues such as lack of accessibility, reusability, quality, and timeliness, as well as cost. 

“For the first time, we were able to test a systematic way of collecting and producing follow-up data on new treatments for hospital use. In the past, our monitoring has been largely based on wholesale data.  The pilot showed us the potential of OMOP databases and the importance of interaction between the operators, and also what the key development needs are from the point of view of our data needs," says Vesa Kiviniemi, Head of Assessment, HTA division.

Lessons from the pilot guide the development of service concept

The pilot identified issues that needed further clarification and development. The longest lead times and the greatest need for improvement were found in the areas of contracts and permits, the completion of OMOP databases and the assessment of the quality of the extracted data. 

"This pilot has shown how important it is to continue developing models and databases in cooperation with data users in order to meet future customer needs," says Tarja Laitinen, a representative of the FinOMOP consortium. "By developing policies and services, we can promote more effective use of health data for different purposes."

The developed approach, the development needs and the proposed measures are presented in a final report prepared by the stakeholders of the pilot.

Pilot project final report (Sitra)

Further information:

Piia Rannanheimo, Chief Specialist, Fimea tel. +358 29 522 3517, piia.rannanheimo(at)fimea.fi

Tarja Laitinen, Senior Medical Specialist, Finnish Institute of Molecular Medicine FiMM, University of Helsinki, tarja.laitinen(at)helsinki.fi

Kimmo Porkka, Professor of Personalised Cancer Medicine, University of Helsinki Senior Medical Officer, HUS Cancer Centre, Hematology Research Unit, kimmo.porkka[at]hus.fi

Arho Virkki, Chief Analytics Officer, Wellbeing Services County of Southwest Finland, arho.virkki(at)varha.fi

Saara Malkamäki, Specialist, Well-being solutions, Sitra, saara.malkamäki(at)sitra.fi