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

Author

Listed:
  • Christel Protiére

    (ORS PACA - Observatoire régional de la santé Provence-Alpes-Côte d'Azur [Marseille], AMSE - Aix-Marseille Sciences Economiques - EHESS - École des hautes études en sciences sociales - AMU - Aix Marseille Université - ECM - École Centrale de Marseille - CNRS - Centre National de la Recherche Scientifique, SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale - IRD - Institut de Recherche pour le Développement - AMU - Aix Marseille Université - INSERM - Institut National de la Santé et de la Recherche Médicale, GCU - Glasgow Caledonian University)

  • 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)

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.

Suggested Citation

  • Christel Protiére & Rachel Baker & Dominique Genre & Anthony Goncalves & Patrice Viens, 2017. "Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France," Post-Print hal-03590872, HAL.
    • Handle: RePEc:hal:journl:hal-03590872
    DOI: 10.1177/0272989X17691953
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    1. Stenner, Paul H. D. & Cooper, Deborah & Skevington, Suzanne M., 2003. "Putting the Q into quality of life; the identification of subjective constructions of health-related quality of life using Q methodology," Social Science & Medicine, Elsevier, vol. 57(11), pages 2161-2172, December.
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