A Non-interventional Post-authorisation Safety Study (PASS) as an Effectiveness Check of the Prescriber Checklist for Mycamine® (micafungin)

Study type

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

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Multi-national, non-interventional study

Population studied

• Short description of the study population:
  A survey of healthcare professionals who have prescribed Mycamine at least once within 12 months prior to the survey, who practice in any of the participating countries including France, Germany, Greece, Netherlands, Poland, Spain and Sweden. ; Inclusion Criteria: ; 1. HCPs must have prescribed Mycamine within 12 months prior to taking the survey.; 2. HCPs must provide permission to share their anonymized responses with the EMA or NCAs; ; Exclusion Criteria ; 1. HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.; 2. HCPs who have been direct employees of Astellas, ICON, Syneos, Parexel, GfK, EMA, or an NCA in the participating countries within the past 5 years.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  0

Study design details

• Main study objective:
  The primary objectives were to assess prescribers’ knowledge levels of: Potential risk of liver tumours associated with Mycamine, and the restricted indication for Mycamine (because of the potential risk of liver tumours, Mycamine should have only been used if other antifungals were not appropriate).
• Outcomes:
  -Percentages of HCPs with correct responses to questions regarding: Potential risk of liver tumours associated with Mycamine -Percentages of HCPs with correct responses to questions regarding: the restricted indication for Mycamine (because of the potential risk of liver tumours, Mycamine should have only been used if other antifungals were not appropriate). Percentages of HCPs: -that recall receiving the updated PC -with correct responses to questions regarding: o Hepatic precautions for use o Precaution for use related to haemolytic anaemia/haemolysis in patients with a history of specific conditions o Precaution for use in patients with a history of renal impairment
• Data analysis plan:
  Primary analysis population included HCPs who have completed at least 1 of the primary endpoint survey questions. Descriptive data analyses was conducted for all primary/secondary objectives. Levels of receipt and knowledge was calculated with 95% 2-sided confidence intervals (CI) and was reported overall, by country type (local guideline/standard of care more aligned vs. less aligned with the aRMM regarding restricted indication), and by HCP group. Knowledge related endpoints were analysed by HCP speciality, primary source of information for antifungal treatment selection (ATS), and primary setting/circumstance under which Mycamine is typically prescribed.

Documents

Study results

9463-PV-0002-abstract-disclosure-redacted (1) (1)