Clinical benefit of cancer drugs approved in Switzerland 2010-2019

• Published in: PloS one Vol. 17; no. 6; p. e0268545
• Main Authors: Adam, Roman, Tibau, Ariadna, Molto Valiente, Consolación, Šeruga, Boštjan, Ocaña, Alberto, Amir, Eitan, Templeton, Arnoud J
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 10.06.2022; Public Library of Science (PLoS)
• Subjects: Antimitotic agents; Antineoplastic agents; Antineoplastic Agents - therapeutic use; Biology and Life Sciences; Cancer; Cancer therapies; Clinical trials; Complications and side effects; Criteria; Drug therapy; Drugs; Evaluation; FDA approval; Humans; Marketing; Medical Oncology; Medicine and Health Sciences; Neoplasms - drug therapy; Oncology; Patient outcomes; Patient safety; People and Places; Quality of Life; Switzerland; Switzerland
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0268545

It is unknown to what extent cancer drugs approved in Switzerland by the Swissmedic fulfil criteria of clinical benefit according to the European Society of Medical Oncology Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS), the American Society of Clinical Oncology Value Framework version 2 (ASCO-VF) and the Swiss OLUtool v2 (OLUtool). An electronic search identified studies that led to marketing authorisations in Switzerland 2010-2019. Studies were evaluated according to ESMO-MCBS, ASCO-VF and OLUtool. Substantial benefit for ESMO-MCBS, was defined as a grade A or B for (neo)adjuvant intent and 4 or 5 for palliative intent. For ASCO-VF and OLUtool clinical benefit was defined as score ≥45 and A or B, respectively. Concordance between the frameworks was calculated with Cohen's Kappa (κ). Factors associated with clinical benefit were evaluated by logistic regression. In the study period, 48 drugs were approved for 92 evaluable indications, based on 100 studies. Ratings for ESMO-MCBS, ASCO-VF and OLUtool could be performed for 100, 86, and 97 studies, respectively. Overall, 39 (39%), 44 (51%), 45 (46%) of the studies showed substantial clinical benefit according to ESMO-MCBS v1.1, ASCO-VF, OLUtool criteria, respectively. There was fair concordance between ESMO-MCBS and ASCO-VF in the palliative setting (κ = 0.31, P = 0.004) and moderate concordance between ESMO-MCBS and OLUtool (κ = 0.41, P<0.001). There was no significant concordance between ASCO-VF and OLUtool (κ = 0.18, P = 0.12). Factors associated with substantial clinical benefit in multivariable analysis were HRQoL benefit reported as secondary outcome for ESMO-MCBS and the ASCO-VF and blinded studies for OLUtool. At the time of approval, only around half of the trials supporting marketing authorisation of recently approved cancer drugs in Switzerland meet the criteria for substantial clinical benefit when evaluated with ESMO-MCBS, ASCO-VF or OLUtool. There was at best only moderate concordance between the grading systems.