Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Survey study
Study drug and medical condition

Name of medicine

TECARTUS

Study drug International non-proprietary name (INN) or common name

BREXUCABTAGENE AUTOLEUCEL

Anatomical Therapeutic Chemical (ATC) code

(L01XL06) brexucabtagene autoleucel
brexucabtagene autoleucel
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

100
Study design details

Main study objective

The main objective of this study was to measure the HCPs awareness and knowledge of RMMs for Tecartus, as described in the Risk Management Plan (RMP), specifically, to conduct a survey to measure knowledge and understanding of the key messages in the HCP-directed additional RMMs and the Summary of Product Characteristics (SmPC) for Tecartus.

Outcomes

Measured HCPs knowledge of known important identified risks associated with Tecartus and assessed HCPs understanding of how to identify and treat cytokine release syndrome and serious neurologic AEs and understanding of handling and administration of Tecartus to maintain product viability, and awareness of the patient alert card (PAC), distribute the PAC, and inform patients about the PAC’s content.

Data analysis plan

Responses to questions for all completed surveys were analysed using descriptive statistics (count, ranges, proportions, and scores). HCPs knowledge was evaluated and expressed as proportions or scores. The results were presented overall, as well as by country and HCP specialty where sample size allows. Categorical variables were described by the number and proportion in each category. Frequency point-estimates with 2-sided 95% confidence intervals using the binomial distribution (eg, Wald or Clopper-Pearson method, as appropriate) were constructed to describe the proportion of HCPs aware of the specified risks. Key questions within the survey were identified as being essential to measure HCPs knowledge of the additional RMMs. Given the complexity of some of the key messages included in the Tecartus RMMs, an acceptable level of knowledge on these essential questions is set at 80%.