EVALUATION OF THE EFFECTIVENESS OF THE ADDITIONAL RISK MINIMISATION MEASURES FOR GLOFITAMAB: A PASS SURVEY AMONG HEALTHCARE PROFESSIONALS IN EUROPEAN COUNTRIES

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  COLUMVI
• Study drug International non-proprietary name (INN) or common name:
  GLOFITAMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX28) glofitamab

  glofitamab

Population studied

• Short description of the study population:
  HCPs from geographically dispersed countries within the European Economic Area (EEA) (Austria, Belgium, Bulgaria, Croatia, France, Germany, Greece, Italy, Portugal, Norway, and Sweden) where Glofitamab is approved and reimbursed will be targeted for participating to this survey.; The study population will be restricted to physicians(oncologists/haematologists/haematologist-oncologists/others) who meet the following inclusion criteria for study entry:; - Having prescribed Glofitamab to patients with relapsed or refractory (R/R) Diffuse large B-cell lymphoma (DLBCL) in routine clinical practice. ; - Willing to participate in the survey.
• 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:
  120

Study design details

• Study design:
  Primary data collection via a web-based questionnaire of HCPs (in countries where applicable only) who have prescribed Glofitamab. The self-reported survey will be an anonymous, cross-sectional, multinational, conducted in 11 countries within the European Economic Area (EEA).
• Main study objective:
  The study aims to evaluate, through a self-reported survey, the effectiveness of the aRMMs included in the RMP for Glofitamab in terms of key process indicators. In this study key process indicators encompass prescribers’ awareness of the Educational Materials (EMs), knowledge/comprehension of the important identified risk of TF and adherence with respect to the safety messages in the HCP brochure.; The primary objectives are:; 1. To assess prescribers’ awareness of the Glofitamab EMs by estimating the proportion of prescribers who acknowledge having received the EMs and read the HCP brochure.; 2. To assess prescribers’ knowledge of the risk of TF that may occur with Glofitamab use and on the specific guidance for risk minimisation measures for TF, as described in the HCP brochure, by estimating the proportion of prescribers with correct responses to the risk knowledge questions.; 3. To assess prescribers’ adherence with respect to the aRMMs by estimating the proportion of prescribers whose responses to the practice-related questions are consistent with the guidance provided in the HCP brochure.; The secondary objective is:; 1. To assess whether the prescribers self-reported the HCP brochure as useful for their clinical practice.;
• Setting:
  The survey will be conducted among HCPs who prescribed Glofitamab in inpatient; and/or outpatient settings in 11 countries within the EEA. The survey will start within at; least 12 months following the implementation of the local aRMMs as per European; guideline on Good Pharmacovigilance Practices (GVP), Module XVI (Rev 3) (EMA 2017c).
• Data analysis plan:
  All the analyses will be descriptive, and no comparative analysis will be reported. The statistical results will be presented by prescribers’ specialty and per country (if possible, given the number of respondents), and overall. Continuous variables will be described by their mean, standard deviation, and median, first quartile (Q1), third quartile (Q3), minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. Confidence Interval (CI) of 95% will be evaluated, when applicable. The analysis of participation rate will be conducted reporting response rate, partial response rate and refusal rate. The analysis of questionnaires will be conducted using completed questionnaires submitted by the participants.; ; Specifically, the proportions of answers among participants will be evaluated by reporting the; frequency of each option provided by the participants. Success of the aRMMs for HCPs is defined as an 80% threshold based on the percentage of prescribers classified as aware of, knowledgeable about and/or adherent to the aRMMs. Overall results will be presented both unweighted (results obtained from raw data) and weighted. A weight variable will be applied to each statistical unit (i.e., the HCPs) during the results calculation to correct any over- or under-sampling that may have occurred for a country.; This weight variable will indicate how many unit(s) of the population of interest an observation will count in a statistical procedure. Its value will change per country.