Identifying treatment discontinuation with biological drugs for immune-related inflammatory diseases using administrative healthcare data: a scoping review

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105337
• EU PAS number:
  EUPAS105336
• Study ID:
  105337
• Official title and acronym:
  Identifying treatment discontinuation with biological drugs for immune-related inflammatory diseases using administrative healthcare data: a scoping review
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Administrative/claims healthcare data have become an essential tool for studying the long-term use of biologic drugs in the real-world clinical practice. However, the major limitation of administrative/claims data is represented by the lack of clinical information, including the date and the reason for drug discontinuation. Nevertheless, this information can be derived using appropriate algorithms. In general, algorithms to identify discontinuation events using administrative/claims data should be designed by the investigator according to both the information on the utilization of the study drug that is recorded into the data source (e.g. days supplied, number of dosage units, strength) and the expected pattern of use of the drug of interest in the study population (e.g. one administration per month). The measurement of the duration of each drug utilization record whenever days supplied are not available, the length of the allowed gap between two consecutive drug utilization records, the possibility of stockpiling medications and the time-wise approach to identify the date of discontinuation requires specific investigator choices that can ultimately affect the levels of persistence observed in the study population. As with any medication used for chronic diseases, the monitoring of the long-term use is paramount to ensure patient safety and treatment effectiveness. With respect to biological drugs used for immune-mediated inflammatory diseases (IMIDs), monitoring of long-term persistence can indirectly provide valuable information about patients' satisfaction with treatment, safety, and effectiveness. Therefore, we aim at performing a scoping review of the published literature to describe and discuss the different approaches adopted to identify in administrative/claims data the discontinuation of biological drugs in patients affected by IMIDs.
• Study status:
  Planned

Research institution and networks

Institutions

Azienda Ospedaliera Universitaria Integrata Verona

Networks

VALORE

Study timelines

Date when funding contract was signed

Planned: 01/01/2018

Study start date

Planned: 01/06/2023

Date of final study report

Planned: 29/09/2023

Sources of funding

Other

More details on funding

Italian Medicine Agency (AIFA)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable