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. 2023 Nov;12(11):e230141.
doi: 10.57264/cer-2023-0141. Epub 2023 Sep 15.

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

Benjamin D Bray  1   2 , Sreeram V Ramagopalan  1   3
Affiliations

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

Benjamin D Bray et al. J Comp Eff Res. 2023 Nov.

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.

Keywords: Canadian Agency for Drugs and Technologies in Health; DARWIN EU; European Medicines Agency; Pharmacovigilance Risk Assessment Committee; electronic health records; health technology assessment; real-world evidence; regulatory; reimbursement; spinal muscular atrophy.

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Conflict of interest statement

Competing interests disclosure

The authors have no financial and/or nonfinancial competing interests or relevant affiliations with any organization/entity to declare that are relevant to the subject matter or materials discussed in this manuscript. This includes employment, grants or research funding, consultancies, membership on scientific or other advisory boards, honoraria, stock ownership or options, paid expert testimony, patents received or pending, or royalties.

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-dec... (2023).
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    1. McDonald L, Ramagopalan SV, Lees M. Real-world data really matter. CMAJ. 189, E1293 (2017). - PMC - PubMed
    1. McDonald L, Schultze A, Simpson A, Graham S, Wasiak R, Ramagopalan SV. Lack of data sharing in observational studies. BMJ. 359, j4866 (2017). - PubMed
    1. NICE real-world evidence framework. https://www.nice.org.uk/corporate/ecd9/chapter/overview (2022).

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