Patterns of anti-CGRP mAbs use and triptan consumption before and after anti-CGRP treatment initiation: a descriptive drug utilization study in Tuscany region, Italy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48413
• EU PAS number:
  EUPAS45727
• Study ID:
  48413
• Official title and acronym:
  Patterns of anti-CGRP mAbs use and triptan consumption before and after anti-CGRP treatment initiation: a descriptive drug utilization study in Tuscany region, Italy
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  In 2019, three monoclonal antibodies(mAbs) that target calcitonin gene-related peptide (CGRP),or its receptor,were approved in Italy for both episodic and chronic migraine prophylaxis:erenumab,galcanezumab and fremanezumab. Given the recent introduction of anti-CGRP mAbs on the market, real-world evidence on utilization patterns and the characteristics of patients using anti-CGRP mAbs is still scarce. Therefore, this study aims to re-use routinely collected healthcare data from the administrative database of Tuscany region, Italy, in order to: 1) provide real-world evidence on patients initiating an anti-CGRP mAb, 2) describe the utilization pattern of these medications up to 15 months of follow-up and 3) observe the consumption of triptans, proxy of migraine occurrence, before and after initiation of anti-CGRP therapy. A descriptive, population-based, pharmaco-epidemiological cohort study on the utilization of anti-CGRP mAbs in clinical practice will be performed using the regional administrative datasource of Tuscany, in Italy. Subjects with ≥1 dispensing of any mAb anti-CGRP (ATC N02CD*) reimbursed by the National Health Service between April 1, 2019 to June 30, 2021 and none in the past will be identified and labelled as "new users". The date of the first dispensing will be considered as the cohort entry date. New users will be described in terms of demographic and clinical characteristics. Patients non-persistent to the initial anti-CGRP drug and with a dispensing of an anti-CGRP mAb other the index drug received will be identified and labelled as “discontinuers” and "switchers" respectively. Additionally, patients with ≥ 2 triptan dispensings in the 6 months before cohort entry will be selected . Among them, the mean monthly number of dosage units dispensed during the six months before cohort entry will be compared with that observed in the same population of users within five follow-up windows (i.e. 0-3, 3-6, 6-9, 9-12 and 12-15 months).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Headache Centre, Careggi University Hospital, Department of Health Sciences, University of Florence, Italy

Study timelines

Date when funding contract was signed

Planned: 04/10/2021

Actual: 04/10/2021

Study start date

Planned: 17/01/2022

Actual: 17/01/2022

Date of final study report

Planned: 31/10/2022

Sources of funding

Other

More details on funding

Agenzia Regionale di Sanità Toscana

Regulatory

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