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Industry Update
15 September 2023

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 13

Abstract

In this latest update we highlight a report from the European Medicines Agency on their use of real-world evidence (RWE) in decision making, RWE reporting guidance from the Canadian Agency for Drugs and Technologies in Health and highlight some new data demonstrating the value medicines for spinal muscular atrophy have brought patients.

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References

1.
European Medicines Agency. Use of real-world evidence in regulatory decision making – EMA publishes review its studies. https://www.ema.europa.eu/en/news/use-real-world-evidence-regulatory-decision-making-ema-publishes-review-its-studies (2023).
2.
McDonald L, Schultze A, Carroll R, Ramagopalan SV. Performing studies using the UK Clinical Practice Research Datalink: to link or not to link? Eur. J. Epidemiol. 33, 601–605 (2018).
3.
McDonald L, Ramagopalan SV, Lees M. Real-world data really matter. CMAJ. 189, E1293 (2017).
4.
McDonald L, Schultze A, Simpson A, Graham S, Wasiak R, Ramagopalan SV. Lack of data sharing in observational studies. BMJ. 359, j4866 (2017).
5.
6.
Cox O, Sammon C, Simpson A, Wasiak R, Ramagopalan S, Thorlund K. The (harsh) reality of real-world data external comparators for health technology assessment. Value Health. 25, 1253–1256 (2022).
7.
CADTH. Guidance for Reporting Real-World Evidence. https://www.cadth.ca/guidance-reporting-real-world-evidence
8.
Wang SV, Pottegård A, Crown W et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol. Drug Saf. 32, 44–55 (2023).
9.
Bray B, Ramagopalan SV. R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11. J. Comp. Eff. Res. 12(5), e230008 (2023).
10.
Leahy TP, Kent S, Sammon C et al. Unmeasured confounding in nonrandomized studies: quantitative bias analysis in health technology assessment. J. Comp. Eff. Res. 11(12), 851–859 (2022).
11.
Bray B, Ramagopalan SV. R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 12. J. Comp. Eff. Res. 12(7), e230092 (2023).
12.
Ramagopalan SV, Treharne C, Pearson-Stuttard J, Subbiah V. For what it's worth: the complex area of medicine value assessment. J. Comp. Eff. Res. 12(9), e230120 (2023).