Real-world Prescription Pattern, Discontinuation and Costs of Ibrutinib-Naïve Patients with Chronic Lymphocytic Leukemia: An Italian Healthcare Administrative Database Analysis

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  IMBRUVICA
• Study drug International non-proprietary name (INN) or common name:
  IBRUTINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EL01) ibrutinib

  ibrutinib

  (L01XE27) ibrutinib

  ibrutinib
• Medical condition to be studied:
  Chronic lymphocytic leukaemia

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)

Study design details

• Study design:
  Adults with at least 1 supply of ibrutinib (index date) from 01/01/2016 to 12/31/2017 (accrual period) were selected. Only new users with at least 1 hospital discharge form including primary or secondary diagnosis of CLL (ICD-9-CM code 204.1*) from 01/01/2013 to 12/31/2018 were selected and analysed
• Main study objective:
  This analysis aimed to describe patients with CLL and new users of ibrutinib, in terms of its prescription pattern, focusing on discontinuation, severe AEs, and treatment change reimbursed by the SSN.
• Setting:
  Inpatient and outpatient
• Summary results:
  Out of more than 5 million inhabitants of the ReS database, 69 new ibrutinib users and diagnosed with CLL in 2016 (incidence: 1.6 × 100,000) and 41 in 2017 (incidence: 0.9 × 100,000) were selected. Of these, 21 (19.1%) were FL ibrutinib users and 89 (80.9%) were SLL ones, mostly males and with mean ages (±SD) of 65 ± 14 and 70 ± 10, respectively. The mean annual consumption among FL users decreased from 222.2 DDD per patient treated to 216.0 DDD, while increased among SLL patients from 238.6 DDD to 260.1 DDD, in the first and second follow-up year, respectively. The discontinuation rate was about 40% in the first year, similarly among FL and SLL users. SLL patients discontinued more frequently (52.8% vs 20.0%) in the second year. Very few AEs were recorded. The 62.5% of FL and 55.6% of SLL users discontinuing ibrutinib in 1-year follow-up, while one SLL patient (5.3%) in the second year changed therapy. The 20.0% and 15.9% of all new users in first and second year interrupted ibrutinib. The total integrated cost of FL patients was €55,732 reducing by about €15,000, while it was €58,716 for SLL ones decreasing by €6,000, respectively, in the first and in the second year. Pharmaceuticals were the key cost driver (ibrutinib accounted for more than 77%).

Documents

Study publications

Real-world Prescription Pattern, Discontinuation and Costs of Ibrutinib-Naïve P…