A Non-Interventional Post-Authorization Safety Study (NI-PASS) to Check the Effectiveness of the Patient Card for Enfortumab Vedotin: Insights From Qualitative Interviews With German Patients and Caregivers

OBJECTIVES: Enfortumab vedotin (EV) is a urothelial cancer treatment approved by the European Medicines Agency. The EV Patient Card (PC) provides information on risks of potential side effects associated with EV. As part of the EU Risk Management Plan, an effectiveness check of the PC will be conducted via a survey of patients and caregivers, assessing knowledge of key safety risks. Pre-survey interviews were undertaken for evaluation of knowledge and awareness of PC contents, and to assess draft survey questionnaire clarity. The overall objectives were to: (1) assess patients’/caregivers’ knowledge of EV-associated skin reaction risks, awareness and knowledge of PC content, and reported behaviours to minimise skin reaction risks, (2a) conduct qualitative interviews to more thoroughly explore responses, and (2b) undertake cognitive pretesting to identify unclear questionnaire items and confirm translation accuracy.

METHODS: Moderators remotely conducted one-on-one interviews, including qualitative inquiry on knowledge and awareness of PC content, and pretesting of the German questionnaire. Patients and caregivers of patients who had received EV, were 18+ years, resided in Germany, and agreed to participate were eligible. The web-based survey will launch in Germany and 6 other European countries.

RESULTS: Participants (n=4; 1 patient, 3 caregivers) were broadly aware of EV treatment risks and described experience or awareness of at least one key risk of skin reactions and at least one key treatment risk. All participants could summarize PC contents and purpose. Two participants reported using prevention measures to minimise the risk of skin reactions. Three participants described the PC as useful and planned to carry it to future HCP visits. Participants found the questionnaire clear and understandable.

CONCLUSIONS: Minimal questionnaire updates were indicated from the pretesting results. While this small sample pre-assessment suggests general awareness of the PC and its content, the survey will provide a more comprehensive assessment.