(P-472) Utilization of Anti-cgrp Monoclonal Antibodies for Migraine Prophylaxis Between 2019 and 2020 in Tuscany Region, Italy

Background: Migraine is a neurovascular pain disorder with a severe impact on patients’ social and working life. In 2019, three anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP mAbs), erenumab (ERE), fremanezumab (FRE), galcanezumab (GAL), were licensed in Italy as a new emerging option for migraine prophylaxis.

Objectives: To quantify and describe users of anti-CGRP mAbs in the real-world clinical practice of one Italian region, Tuscany, between 2019 and 2020.

Methods: The population-based regional administrative database of Tuscany, Italy, was used. Subjects with ≥1 dispensing of any mAbs anti-CGRP (ATC N02CD*) reimbursed by the National Health Service between January 1, 2019 to December 31, 2020 were identified among subjects active into the data base at 1 January 2019 with at least 2 years of look-back. The date of the first dispensing was the index date (ID). New users (NU) were subjects with ≥1 anti-CGRP mAbs dispensing during the month of interest and none in the past. The absolute number of NU per month was observed. Baseline demographic and clinical characteristics were also observed: age, sex, hospital diagnoses of comorbidities recorded during 5 years before ID, pharmacotherapies dispensed at least once during 2 years before ID and use of triptans during 12 months before ID.

Results: A total of 267 NU (ERE=154; FRE=22; GAL=91) were identified , of which 203 (76%) were female. Around 70% of both male and female NU were aged 40-64 years. The absolute number of NU increased from 22 in 2019 to 245 in 2020. The first reimbursed dispensing was observed in April 2019 for ERE, in December 2019 for GAL and in September 2020 for FRE. Patients with a hospital diagnoses for psychiatric disorders were 27% of NU. Previous antidepressants and antiepileptics drug use was observed in 56% and 42% of patients, respectively. Beta-blockers were used by 33% of NU. Among available formulations, oral triptans were the most frequently used (65% of NU).

Conclusions: Our findings showed that, according to the release date in the market, ERE and GAL were the most frequently anti-CGRP mAbs prescribed in Tuscany between 2019 and 2020. The observed distribution of both genders of anti-CGRP mAbs NU reflects migraine epidemiology. Other possible prophylactic treatments like antiepileptics, antidepressants and beta-blockers were frequent, although indication of use was not recorded. About two thirds of mAb users received at least a previous oral triptan dispensing. Further analysis of this cohort will compare triptan utilization before and after anti-CGRP mAbs initiation.