The global demand from hospitals for real-world evidence is rapidly increasing. Yet, decision-makers outside the United States are frequently challenged by the assumption of transferability of data and evidence from one county to another. Conversations with Gary O’Brien and colleagues at an Irish hospital, university, and government health authority sparked the idea to write-up a case-study with lessons learned so far.
TL;DR : data –> evidence –> policy –> (slow/hard) –> practice
#for data scientists that like to keep things tidy clinical_practice <- data %>% GenerateEvidence(hard_work) %>% inner_join(policy, by = safety, cost_effectiveness) %>% mutate(utilization = ifelse(time, change, no_change))
The case-study paints an interesting portrait of how new cancer evidence informed European regulatory decisions biosimilar drugs and then trickled down to slowly change clinical practice in Ireland. The Irish Department of Health (DoH) is in the process of developing a new national biosimilar medicines policy. They aim to increase biosimilar use by creating a robust framework where biologicals and biosimilars can be used safely, cost-effectively, and confidently in the health service.
- There was a significant time lag between regulatory approval and clinical acceptance of biosimilar infliximab CT-P13 in Ireland.
- In this example from an Irish teaching hospital, the introduction of the biosimilar first to new patients, along with a switching study executed in parallel, helped to raise prescriber confidence.
- Increased biosimilar medicine usage is of benefit to all stakeholders including patients, prescribers, healthcare payers, and manufacturers.
Read the full story in this issue of Value and Outcomes Spotlight.
O’Brien G, Mulcahy M, Byrne S, Carroll D, Courtney G, Walshe V, Adamson B. Biosimilar Adoption and Acceptance in Ireland—Still More to Be Done. Value & Outcomes Spotlight. 2018 Jul; 4(4):29-31.
TL;DR means “too long; didn’t read”