Davis C

Wagner AK

Salcher-Konrad M

Scowcroft H

Mintzes B

Pokorny AMJ

Lew J

Naci H

2023-03-29

OBJECTIVE: To evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe. DESIGN: Document content analysis. SETTING: European Medicines Agency. PARTICIPANTS: Anticancer drugs granted a first marketing authorisation by the European Medicines Agency, 2017-19. MAIN OUTCOME MEASURES: Whether written information on a product addressed patients' commonly asked questions about: who and what the drug is used for; how the drug was studied; types of drug benefit expected; and the extent of weak, uncertain, or missing evidence for drug benefits. Information on drug benefits in written sources for clinicians (summaries of product characteristics), patients (patient information leaflets), and the public (public summaries) was compared with information reported in regulatory assessment documents (European public assessment reports). RESULTS: 29 anticancer drugs that received a first marketing authorisation for 32 separate cancer indications in 2017-19 were included. General information about the drug (including information on approved indications and how the drug works) was frequently reported across regulated information sources aimed at both clinicians and patients. Nearly all summaries of product characteristics communicated full information to clinicians about the number and design of the main studies, the control arm (if any), study sample size, and primary measures of drug benefit. None of the patient information leaflets communicated information to patients about how drugs were studied. 31 (97%) summaries of product characteristics and 25 (78%) public summaries contained information about drug benefits that was accurate and consistent with information in regulatory assessment documents. The presence or absence of evidence that a drug extended survival was reported in 23 (72%) summaries of product characteristics and four (13%) public summaries. None of the patient information leaflets communicated information about the drug benefits that patients might expect based on study findings. Scientific concerns about the reliability of evidence on drug benefits, which were raised by European regulatory assessors for almost all drugs in the study sample, were rarely communicated to clinicians, patients, or the public. CONCLUSIONS: The findings of this study highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians.

Department of Global Health and Social Medicine, King's College London, London, UK courtney.davis@kcl.ac.uk.

Department of Population Medicine, Harvard Medical School, and Harvard Pilgrim Health Care Institute, Boston, MA, USA.

Pharmacoeconomics Department, Austrian National Public Health Institute, Vienna, Austria.

Alzheimer's Research UK, Cambridge, UK.

National Cancer Research Institute Bladder and Renal Research Group, London, UK.

School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia.

Alice Springs Hospital, Northern Territory, Australia.

Department of Health Policy, London School of Economics and Political Science, London, UK.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

BMJ. 2023 Mar 29;380:e073711. doi: 10.1136/bmj-2022-073711.

0000-0002-9425-9886

0000-0002-1069-6668

0000-0002-5628-5266

0000-0003-4944-2179

0000-0002-8671-915X

0000-0002-6987-0499

0000-0001-9084-5872

0000-0002-7192-5751

https://pubmed.ncbi.nlm.nih.gov/36990506/?otool=iaurydwlib

https://hdl.handle.net/10137/12435

380

Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe.

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