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Abstract
Introduction
Vismodegib (Erivedge; Roche), a Hedgehog pathway inhibitor (HPI), is indicated for the treatment of symptomatic metastatic basal cell carcinoma (BCC) and locally advanced BCC inappropriate for surgery or radiotherapy. Due to the known risk of HPI teratogenicity, the Erivedge Pregnancy Prevention Program (PPP) was introduced at approval (2013) as part of the EU Risk Management Plan.
Methods
Structured, quantitative Web-based surveys were conducted in 2015 (Wave 1), 2016 (Wave 2), and 2017/2018 (Wave 3) among prescribing oncologists and dermato-oncologists in Austria, France, Germany, Hungary, and the United Kingdom to assess the effectiveness of the Erivedge PPP.
Results
Overall, 95%, 87%, and 91% of respondents in Waves 3 (N = 181), 2 (N = 214), and 1 (N = 207), respectively, were vismodegib prescribers. The surveys consistently showed a high awareness about the risk of teratogenicity associated with vismodegib (98%, Wave 3; 95%, Wave 2) and that a high proportion of prescribing physicians took appropriate precautions to minimize this risk (95%, Wave 3; 92%, Wave 2; 88%, Wave 1). Physicians were also highly aware of the Erivedge PPP (70%, Wave 3; 67%, Wave 2; 71%, Wave 1).
Conclusion
Survey data suggest that the risk of teratogenicity with vismodegib has been effectively communicated to the prescribing community.
Acknowledgements
The authors would like to thank Angela Duffy, Ilaria Landino, and Madeleine Knowles of The Research Partnership UK, and Larissa Macedo of Roche for support in conducting the survey. Medical writing assistance for this manuscript was provided by Karen Yee, PhD (ApotheCom, London, UK), and funded by F. Hoffmann-La Roche Ltd.
Disclosure statement
All authors are employees of F. Hoffman-La Roche Ltd. and hold stock/stock options in Roche.