Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France

Christel Protière, Rachel Baker, Dominique Genre, Anthony Goncalves () and Patrice Viens
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Rachel Baker: GCU - Glasgow Caledonian University
Dominique Genre: IPC - Institut Paoli-Calmettes - Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)
Anthony Goncalves: IPC - Institut Paoli-Calmettes - Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), INSERM - Institut National de la Santé et de la Recherche Médicale, AMU - Aix Marseille Université, CRCM - Centre de Recherche en Cancérologie de Marseille - AMU - Aix Marseille Université - IPC - Institut Paoli-Calmettes - Fédération nationale des Centres de lutte contre le Cancer (FNCLCC) - INSERM - Institut National de la Santé et de la Recherche Médicale - CNRS - Centre National de la Recherche Scientifique
Patrice Viens: IPC - Institut Paoli-Calmettes - Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), AMU - Aix Marseille Université, CRCM - Centre de Recherche en Cancérologie de Marseille - AMU - Aix Marseille Université - IPC - Institut Paoli-Calmettes - Fédération nationale des Centres de lutte contre le Cancer (FNCLCC) - INSERM - Institut National de la Santé et de la Recherche Médicale - CNRS - Centre National de la Recherche Scientifique

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Abstract: Background. The past decades have seen advances in cancer treatments in terms of toxicity and side effects but progress in the treatment of advanced cancer has been modest. New drugs have emerged improving progression free survival but with little impact on overall survival, raising questions about the criteria on which to base decisions to grant marketing authorizations and about the authorization procedure itself. For decisions to be fair, transparent and accountable, it is necessary to consider the views of those with relevant expertise and experience. Methods. We conducted a Q-study to explore the views of a range of stakeholders in France, involving: 54 patients (18 months after diagnosis); 50 members of the general population; 27 oncologists; 19 healthcare decision makers; and 2 individuals from the pharmaceutical industry. Results. Three viewpoints emerged, focussing on different dimensions entitled: 1) ‘Quality of life (QoL), opportunity cost and participative democracy'; 2)‘QoL and patient-centeredness'; and 3) ‘Length of life'. Respondents from all groups were associated with each viewpoint, except for healthcare decision makers, who were only associated with the first one. Conclusion. Our results highlight plurality in the views of stakeholders, emphasize the need for transparency in decision making processes, and illustrate the importance of a re-evaluation of treatments for all 3 viewpoints. In the context of advanced cancer, our results suggest that QoL should be more prominent amongst authorization criteria, as it is a concern for 2 of the 3 viewpoints.

Keywords: marketing authorization; Q-methodology; advanced cancer; efficacy criteria; societal perspectives; health policy (search for similar items in EconPapers)
Date: 2017-07
Note: View the original document on HAL open archive server: https://amu.hal.science/hal-03590872v1
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Published in Medical Decision Making, 2017, 37 (5), pp.555-566. ⟨10.1177/0272989X17691953⟩

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Journal Article: Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France (2017)
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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-03590872

DOI: 10.1177/0272989X17691953

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