A multi-stakeholder approach in optimising patients’ needs in the benefit assessment process of new metastatic breast cancer treatments
Fatima Cardoso,
Nils Wilking,
Renato Bernardini,
Laura Biganzoli,
Jaime Espin,
Kaisa Miikkulainen,
Susanne Schuurman,
Danielle Spence,
Sabine Spitz,
Sonia Ujupan,
Nicole Zernik,
Jenn Gordon
Affiliations
Fatima Cardoso
Champalimaud Clinical Centre, Champalimaud Foundation and ABC Global Alliance, Lisbon, Portugal; Corresponding author. Breast Unit, Champalimaud Clinical Centre, Champalimaud Foundation and ABC Global Alliance, Av, De Brasília s/n 1400-038, Lisbon, Portugal.
Nils Wilking
Karolinska Institutet, Stockholm, Sweden
Renato Bernardini
University of Catania Medical School, Catania, Italy
Laura Biganzoli
Hospital of Prato and European Society of Breast Cancer Specialists, Florence, Italy
Jaime Espin
Andalusian School of Public Health, Escuela Andaluza de Salud Pública (EASP), Granada, Spain; CIBER en Epidemiología y Salud Pública / CIBER of Epidemiology and Public Health (CIBERESP), Spain; Instituto de Investigación Biosanitaria ibs, Granada, Spain
Kaisa Miikkulainen
ICON Plc, Stockholm, Sweden
Susanne Schuurman
ICON Plc, Stockholm, Sweden at the time of article submission
Danielle Spence
Breast Cancer Network Australia, Australia
Sabine Spitz
Europa Donna, Vienna, Austria and European Patients’ Academy on Therapeutic Innovation (EUPATI)
Sonia Ujupan
Eli Lilly and Company, Brussels, Belgium
Nicole Zernik
Europa Donna, Paris, France
Jenn Gordon
Canadian Breast Cancer Network, Ottawa, ON, Canada
There is a growing understanding as science evolves that different cancer types require different approaches to treatment evaluation, especially in the metastatic stages. The introduction of new metastatic breast cancer (MBC) treatments may be hindered by several elements, including the availability of relevant evidence related to disease-specific outcomes, the benefit assessment process around the evaluation of the clinical benefit and the patients’ need of new treatments.The Steering Committee (SC) found that not all issues relevant to MBC patients are consistently considered in the current benefit assessment process of new treatments. Among these are overall survival, time-to-event endpoints (e.g. progression-free survival), patients’ priorities, burden of disease, MBC-specific quality of life, value in delaying chemotherapy, route of administration, side effects and toxicities, treatment adherence and the benefit of real-world evidence. This paper calls on decision makers to (1) Include MBC-specific patient priorities and outcomes in the overall benefit assessments of new MBC treatments; (2) Enhance multi-stakeholder collaboration in order to improve MBC patient outcomes.
