Menu Back to Poster-Presentations-Details

P212: Effectiveness of the Additional Risk Minimization Measures for Luspatercept Among Healthcare Professionals in Europe

Poster Presenter

Samuel Ewusie

Associate Director, Safety Evidence and Science
Bristol-Myers Squibb Company
United States

Objectives

The objective of this non-interventional post-authorization safety study (PASS) was to evaluate the effectiveness of the additional risk minimization measures (aRMMs) for luspatercept among healthcare professionals (HCPs) in the European Union (EU)/European Economic Area.

Method

This cross-sectional survey study was designed to assess HCP knowledge of the key messages on the HCP Checklist (criterion: 80% correct answers) and provision of the Patient Card to Women of Childbearing Potential (WCBP; criterion: 80% “always”).

Results

A total of 24,231 HCPs were invited to participate in the study, of which 188 (target of 200 HCPs) completed the survey, resulting in a response rate of 0.8%. Approximately 45.7% of the HCPs (86 out of 188) had not prescribed luspatercept prior to survey completion. Among luspatercept prescribers, 28.7% (27 out of 94) had prescribed to WCBP. Most HCPs were hematologists (46.3%), followed by oncologists (17.6%), internists (17.0%), or other specialties (19.1%). The criterion of =80% correct was achieved for 2 out of 11 survey questions. However, at least half of HCPs answered 6 out of 11 survey questions of the key messages on the HCP Checklist correctly. About 80% of the HCPs surveyed were from Italy, among whom 36.5% were hematologists. In Austria, Belgium, and Germany combined, 82.5% of the HCPs were hematologists. Among HCPs who reported to have prescribed luspatercept and those who prescribed specifically to WCBP before survey participation, at least half provided correct answers to 9 out of 11 survey questions. A total of 27.1% of HCPs were aware of the luspatercept Patient Card, which must be provided to WCBP. This proportion was higher among luspatercept prescribers (42.6%) and highest among prescribers to WCBP (55.6%). Among HCPs who were aware of the luspatercept Patient Card, 82.4% reported “always” providing it to WCBP. HCPs reported their preferred primary source of safety information as the EU summary of product characteristics (SmPC, 36.2%), the European Medicines Agency website (25%), and the National Competent Authority websites (12.8%). Only 6.9% of HCPs reported using the luspatercept HCP Checklist as the main source of safety information regarding the use of luspatercept in WCBP.

Conclusion

The results from the present study indicate that all HCPs in our sample had at least a baseline knowledge level of the key safety messages outlined on the HCP Checklist. However, the measured knowledge level was below the protocol pre-defined criterion of 80%. Among the relevant population (prescribers to WCBP), the knowledge level of the key risk messages was higher. The results were mainly driven by Italy, which represented approximately 80% of all HCPs who participated in the survey but where only 36.5% of HCPs were hematologists. Awareness was higher among surveyed HCPs from Belgium, Austria, and Germany combined, where 82.5% were hematologists. The utility of the HCP Checklist as an additional risk minimization measure and source of safety information was limited. Actual and potential prescribers tend to prefer the approved, readily available EU SmPC as a source for necessary safety information. The EU SmPC remains an appropriate source of safety information as a routine risk minimization measure as it contains all the key messages on the HCP Checklist and is readily accessible and available to all HCPs. Alternatively, among HCPs who were aware of the Patient Card, the Patient Card was successfully provided as an additional reminder about the pregnancy prevention requirements and contraceptive methods needed to ensure effective minimization of the risk of luspatercept in WCBP (i.e., the targeted risk category), as outlined in the EU SmPC. The results of the present study suggest that HCPs prefer to reference the EU SmPC as their main source for needed safety information rather than the HCP-focused aRMMs. However, patient-targeted tools are deemed useful by HCPs and are handed out to their patients for their information and utilized as a reminder tool as intended. Co-authors: Z. Zakaite, I. Kim, G. Zhang, R. Zaman, A. Makwana, M. Sharma, T. Hernandez, and S.T. Kaehler