A SeRP powered Trusted Research Environment (TRE) has been used in the recent study (pre-print): ‘Value-Based Healthcare in practice: IDEATE, a collaboration to design and test an outcomes-based agreement for a medicine in Wales’.
Project IDEATE (Innovation in Data to Evolve Agreements That Enhance patient health outcomes) is a collaboration to design and test an outcomes-based agreement for a medicine in Wales.
‘SeRP provides a mechanism to analyse data whilst ensuring patient data are safeguarded…’
The study was led by Pfizer Ltd in collaboration with Lane Clark & Peacock LLP, Digital Health and Care Wales, Swansea Bay University Health Board, Betsi Cadwaladr University Health Board and Swansea University. The study was funded by Pfizer Ltd.
Abstract
Objective: To develop a sustainable, scalable methodology for the design of outcome-based agreements (OBAs) that works on the ground and dynamically overcomes historical challenges.
Methods: Project IDEATE co-created solutions to known (and emergent) challenges via iterative workshops and real-world data analysis to develop and refine a hypothetical model for an OBA in a trusted research environment. A cross-disciplinary collaboration between NHS Wales, industry, and academia was developed. Data were collected from Welsh national datasets and used to inform a novel linked-dataset. OBA scenarios, with different contract parameters, were analysed to assess impact on the proportion of contract payment due and the volatility of payments.
Results: An approved, in market, locally advanced and metastatic breast cancer treatment was selected as the test case. The total number of patients in the treatment cohort (2017-2020) was n=99, and 286 in the control cohort (2014-2016). The final outcome variables selected were: 1) 1-year survival, 2) intolerance to treatment (deferral), and 3) the total days disrupted by care. The primary scenario included all three outcomes measured at the population level and used a linear payment model. Volatility analyses demonstrated contract parameters can dramatically alter the contract output with greatest risk from a single, binary outcome contract design. 1
Conclusions: The design of an OBA is a complex process that requires a multidisciplinary approach. By better pinpointing which medicines are a good fit for an OBA, assessing solutions to data, outcomes, and contracting challenges, IDEATE provides a strong foundation for future success of OBAs in the UK.
The paper discusses how SeRP was used in the study and outlines the collaborative interplay between study partners:
‘The data were collated within a Trusted Research Environment: The Secure e-Research Platform (SeRP). SeRP provides a mechanism to analyse data whilst ensuring patient data are safeguarded. Access to the data is strictly controlled by the data custodians. Prior to entering the secure environment, data were de-identified and pseudonymised and then linked across datasets by DHCW [Digital Health and Care Wales]. Project data scientists worked with Welsh oncologists and data owners to develop a protocol for analysis of the data, including algorithms for each outcome of interest.’
‘Data are the vehicle for changing how we assess performance, value, and the patient benefit of a medicine. IDEATE would not have been successful without the creation of a novel linked dataset. We demonstrated how a trusted research environment, i.e., UK SeRP, within an information governance framework was a good-fit solution to allow secure, controlled access to patient data.’
Burton J, Halsby K, Sáinz de la Fuente G et al. Value-Based Healthcare in practice: IDEATE, a collaboration to design and test an outcomes-based agreement for a medicine in Wales, 25 June 2024, PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-4613924/v1]
Read the full paper at: https://www.researchsquare.com/article/rs-4613924/v1