Study identification

EU PAS number

EUPAS1000000153

Study ID

1000000153

Official title and acronym

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

DARWIN EU® study

No

Study countries

Italy

Study description

An observational retrospective non-interventional cohort study aimed to describe the prescription pattern of new users of ibrutinib affected by chronic lymphocytic leukemia (CLL), focusing on discontinuation, severe adverse events (AEs) and change of treatment, and to assess the healthcare expenditure directly charged to the Italian National Health Service (SSN). Out of new users of ibrutinib from 01/01/2016 to 12/31/2017, only patients with at least a primary or secondary in-hospital diagnosis of CLL (ICD-9-CM code 204.1*) from 01/01/2013 to 12/31/2018 were further broken down according to the ibrutinib’s line treatment (first line—FL; second or later line—SLL) and analysed. They were characterized by sex and age in the selection period. Mean annual consumption (defined daily doses [DDD]), treatment discontinuation, changes of therapy, interruptions and healthcare costs in charge of the SSN were assessed during two follow-up years.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Letizia Dondi 0009-0001-3168-6856

Primary lead investigator
ORCID number:
0009-0001-3168-6856

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
No external funding
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable