Final report – Case study phase ROR DGM
The Dutch National Health Care Institute presents its vision on data availability in healthcare, based on 4 completed case studies from the program "Regie op Registers voor Dure Geneesmiddelen" (ROR DGM), which translates to "Managing Registries for Expensive Medicinal Products." Our vision is that data regarding the effects of expensive medicines in clinical practice should be available to healthcare stakeholders with a legitimate need. Additionally, the National Health Care Institute has established conditions contributing to a well-functioning healthcare data landscape. We also recommend continuing the activities of ROR DGM until the desired goals are achieved.
Background for this ROR DGM report
ROR DGM, in collaboration with stakeholders, conducted 4 case studies. The aim of these case studies was to develop a protocol to make disease-specific patient registrations suitable for monitoring the (cost) effectiveness of expensive medicines. The case studies provided valuable information on the technical, administrative, and legal aspects of data collection, as well as the desired governance and financing.
Vision: data availability for broad disease registration
Our vision is to make practical healthcare data available to healthcare parties with a legitimate need. This includes data related to use and effects of expensive medicines. The approach should be as follows:
- Healthcare data are recorded in the regular healthcare process with supporting software systems, enabling reuse for primary and secondary purposes. This helps prevent additional administrative burdens. Primary goals include the provision of healthcare from healthcare professionals to patients, while secondary goals encompass scientific research, innovation, and policymaking.
- There is an information desk with knowledge about a condition that regulates data access, ensuring people's privacy.
Existing programs and initiatives should collaborate to pool resources and knowledge for improved data availability in healthcare. Achieving the goals of the Integral Care Agreement (IZA) requires joint efforts to accelerate data availability in healthcare.
Conditions for a healthcare data landscape
In our vision, a well-functioning healthcare data landscape meets the following conditions:
- Information about medications is part of treatment information and is collected within the patient's care pathway.
- Data on patients' health and treatment is available for both primary and secondary purposes.
- The dataset's content is jointly determined, with involvement from physicians and patient representation, at a minimum.
- Data collections are disease-focused.
- Data must be recorded in the electronic patient record (EPR) in a standardized and structured manner, enabling multiple uses.
- Specific attention must be given to orphan drugs because registrations for rare diseases always require an international approach.
Recommendation: Extend ROR DGM program
The case study phase of ROR DGM has provided valuable insights and results for the future of data availability in healthcare. It is crucial that these findings continue to be explored. The National Health Care Institute recommends extending the program to the Minister of Health, Welfare, and Sport (VWS). This recommendation is made because the goals and vision of data availability from ROR DGM have not yet been achieved. We anticipate that extending the program will support the attainment of IZA objectives for data availability of expensive medicines.
About the ROR DGM project
With the increasing availability of innovative medicines, there is often uncertainty about their effectiveness and for whom they work best. These medicines are usually expensive. The program "Regie op Registers voor Dure Geneesmiddelen" (ROR DGM) by National Health Care Institute focuses on an information landscape where the practical effects of expensive medicines can be monitored. This ensures that patient care is tailored appropriately, and healthcare remains accessible to everyone.