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. 2023 Jan;12(1):e220194.
doi: 10.2217/cer-2022-0194. Epub 2022 Dec 1.

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 10

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R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 10

Alex Simpson et al. J Comp Eff Res. 2023 Jan.

Abstract

In this latest update we discuss the transportability of comparative effectiveness evidence across countries. We highlight results of a survey indicating that European HTA agencies are reluctant to accept real-world data from other countries, review recent benefit assessments indicating a potential softening of a requirement for the use of local real-world data in Germany, and outline a recent review presenting approaches that can correct for a lack of transportability.

Keywords: Europe; HTA; RWE; comparative effectiveness research; health technology assessment; real-world evidence; transportability.

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Conflict of interest statement

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

References

    1. Hernán MA, Hernández-Díaz S. Beyond the intention-to-treat in comparative effectiveness research. Clin. Trials 9(1), 48–55 (2012). - PMC - PubMed
    1. Westreich D, Edwards JK, Lesko CR, Cole SR, Stuart EA. Target validity and the hierarchy of study designs. Am. J. Epidemiol. 188(2), 438–443 (2019). - PMC - PubMed
    1. Bullement A, Podkonjak T, Robinson MJ et al. Real-world evidence use in assessments of cancer drugs by NICE. Int. J. Technol. Assess. Health Care (2020). https://pubmed.ncbi.nlm.nih.gov/32646531/ - PubMed
    1. Hatswell AJ, Baio G, Berlin JA, Irs A, Freemantle N. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014. BMJ Open 6(6), e011666 (2016). - PMC - PubMed
    1. Patel D, Grimson F, Mihaylova E et al. Use of external comparators for health technology assessment submissions based on single-arm trials. Value Health 24(8), 1118–1125 (2021). - PubMed

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