OBJECTIVES:

Outcome-based agreements (OBAs) have the potential to align the incentives of payers and providers of therapeutics around patient and population health. Many barriers prevent their routine implementation across healthcare systems, including the availability and quality of data to link payments to outcomes. We aimed to create a novel real world data (RWD) environment with linked datasets for breast cancer patients in Wales from 2005 to 2020 to test an experimental, retrospective OBA.

METHODS:

We linked datasets covering patients with in Wales from 2005 to 2020. We used the Welsh Breast Cancer Audit dataset linked across CaNISC, ChemoCare, PEDW, APC, OPA, EDDS, and ONS death datasets. Data were de-identified, pseudonymised, linked, and analysed within the Secure e-Research Platform (SeRP). Inclusion criteria and 10 outcomes of interest were determined through multidisciplinary expert workshops. Missingness analyses were conducted on inclusion and outcome variables. All data integration and cleaning were performed in SQL.

RESULTS:

We created a first of its kind linked, integrated data environment in Wales within SeRP. Key parameters from an experimental OBA created a unique population in the data and demonstrated feasibility. The unique population is comprised of 696 patients with incident non-operable, locally advanced or metastatic breast cancer from 2014 to 2020; 99% female with median age of 72 years at inclusion. We defined and standardised five outcomes: 1-year survival, 30-day mortality, tolerance of treatment, spinal cord compression, and days disrupted by care. Five of the 10 outcomes (e.g. progression free survival) were not included due to lack of dataset access, free-text format, and high missingness.

CONCLUSIONS:

RWD will be vital to enable implementation and monitoring of OBAs. Integration with additional datasets, more consistent data capture to enable inclusion of outcomes most relevant to stakeholders, a cost-effective method to extract data from free-text fields, and reduced missingness are future developments needed.