Zorginstituut Nederland starts new project: Managing patient registries for expensive drugs

Expensive drugs for specialist medical care are increasingly gaining market entry, while uncertainty still exists about their (cost-)effectiveness, their proper positioning in treatment and/or their right indication setting. Moreover, these drugs are often automatically accepted into the standard health care benefit package, under a full price, while these products may still not be fully developed. For those reasons, the Zorginstituut is starting a new project entitled ‘Managing registries for expensive drugs’. The objective is to better measure outcomes of treatment with new drugs in practice. It also involves managing how information from clinical practice is structurally recorded in these registers.

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Effective care

In order to guarantee the best care at the best price, the Zorginstituut wants to promote on the one hand that new innovative drugs can be offered to the right patients rapidly, while it on the other hand wants to restrict use of expensive drugs to only patients for whom the treatments are effective. Due to the developments around these drugs, there is a growing need to continue monitoring their effectiveness, cost-effectiveness and (adverse) effects in practice. This is crucial for continually improving the quality of care for patients and safeguarding our system's sustainability. Information from clinical practice must be structurally recorded in order to be able to measure the outcomes of treatment with a new and expensive drug. This information from daily practice can be collected via patient registries and disorder-based registries.

Managing registers

The Minister for Medical Care asked the Zorginstituut to prepare a plan of action that should benefit the needs and ambitions of the health care stakeholders as well those of the Zorginstituut. On the one hand health care stakeholders, e.g., doctors, researchers and patients, should be able to better monitor the effects of these drugs in order to improve treatments in daily practice. On the other hand the Zorginstituut needs this information from daily practice for assessing appropriate use and managing the health care benefit package. The question whether these drugs have or have not already been assessed before being accepted into the health care benefit package is less relevant; the priority now is having adequate, more uniform patient registries.

Many national and international parties are actively involved with such registries. In practice, however the development of patient registries for monitoring the use and (cost-)effectiveness of expensive drugs is fragmented. A structural, uniform approach to this development and use of patient registries will not start by itself. In this project, the Zorginstituut will explicitly follow other already existing initiatives, and adjust its activities according to their outcomes. To create sufficient room for an iterative approach, the project will be implemented in phases and in close coordination with relevant parties.

For more information, please e-mail rordgm@zinl.nl