Providing insights into the effectiveness of care for breast cancer patients with real-world data
About the project
The Dutch Medication Audit (DMA), a quality registry by the Dutch Institute of Clinical Auditing (DICA), is supported by the Dutch Association of Hospital Pharmacists (NVZA) and the Dutch Joint Healthcare Insurors (ZN). The aim of DMA is to gain better insights into the use and effect of (expensive) medicines in practice, in order to make optimisation recommendations. The quality registration roughly consists of two elements:
1. Comprehensive data analyses, the results of which are offered in a dashboard for participating hospitals.
2. Reflection sessions in which participating hospitals are presented with the results of the analyses and in which there is ample opportunity for in-depth conversations and discussions.
MRDM and LOGEX support DICA in the registration’s practical implementation. MRDM collects, validates, and standardises the data, and LOGEX performs the data analyses.
The project started in 2018 as a program for four disease areas. By the end of 2023, four more disease areas were added. One of the disease areas is breast cancer. 56 hospitals provide data for this disease area around expensive drugs. Recently, the sixth reflection session took place.
The challenge
To achieve DMA’s objectives, a complete and accurate overview of the medication used per patient is needed. This is possible by using the data in the electronic prescription system (EVS) used by Dutch hospital pharmacists. In it, all medications received by patients are documented.
Although the term EVS suggests that we are dealing with a single system, this is not the case. In Dutch hospitals, there is no uniform system for writing or keeping medication prescriptions.
Different systems may be used for this, even within the same institution. For example, the surgical team may use a different system than other departments. This makes it difficult to get a complete overview of all medications prescribed to a patient. Without this overview, it is difficult to accurately understand patient care pathways, prescribed medication dosages and clinical outcomes.
The solution
To make the data available for analysis, different data sources must be linked together. Only then is proper filtering possible to correctly map patient care pathways and associated clinical outcomes. DMA uses data that has already been collected for other purposes, so participation in DMA requires little effort. However, due to the lack of a uniform prescription system, the delivery of this data still represents a significant time investment for hospitals.
Fortunately, DMA can relieve participating hospitals of most of this burden: hospitals can choose to share their raw data from various systems with MRDM. MRDM takes care of linking, validating, and selecting the appropriate datasets. LOGEX’s data specialists and analysts handle proper filtering analyses of these data sets.
With the validated data collected, a multitude of analyses are possible. Several research questions were identified for this reflection session. This was done by the Clinical Audit Board (CAB) of the DMA registry, in close consultation with oncologists in the country, experts from the Integral Cancer Center of the Netherlands (IKNL), the CAB of the NABON Breast Cancer Audit (NBCA), the president of the Dutch Society for Medical Oncology (NVMO) and LOGEX’s data experts.
One of the selected research questions was whether the use of proton pump inhibitors (PPIs), which are commonly prescribed for patients struggling with severe heartburn symptoms, affects the prescribing behavior (especially dosing) and effectiveness of CKD4/6 inhibitors, which is a commonly used therapy in hormone-sensitive, metastatic breast cancer.
The results
The results of these and other analyses were presented during the round table session. After the results were presented, a panel discussion took place, and the participants in the room were invited to join the discussion on the study’s conclusions.
All participating hospitals were notified of the planned round table session several months in advance so that they could register for it. In this session, 24 of the participating hospitals were represented, which meant that a lively yet structured discussion could take place.
Regarding the research question on the influence of PPI inhibitors on the effectiveness of CKD4/6 inhibitors, an interesting conclusion was made. PPIs are known to increase the PH level in the stomach. This inhibits the absorption of CKD4/6 inhibitors and thus possibly reduces efficacy2. However, after analysing the real-world data (RWD) provided by participating hospitals, this could not be confirmed. No difference was observed in the overall survival of patients where CKD4/6 inhibitors were combined with PPI inhibitors, compared to the group not receiving PPIs.
The impact
There was no effect found on the efficacy of CDK4/6 inhibitors when using PPIs in the Netherlands based on RWD. This implies that the fear that by prescribing these drugs the cancer treatment will not be as effective seems unfounded.
This project shows how sharing data and jointly discussing the outcomes of data analyses can contribute to increasing knowledge about treatments. With that knowledge, evidence-based decisions can be made that improve patient care.