Tecartus Survey: Quantitative Testing of Health Care Professional Knowledge About Tecartus® Risk Minimisation Measures

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:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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%.