Real-world insights on the management of migraine patients: an Italian nationwide study

Objectives: Understanding migraine management using data from a sample of patients representative of the Italian general adult population. Methods: Retrospective analysis on IQVIA Italian Longitudinal Patient Database. Two cohorts were created. (a) The triptan user cohort included patients with triptan prescriptions between November 2015 and October 2016. Migraine days were estimated counting triptan and indometacin/caffeine/prochlorperazine (ICP) pills prescribed during the 6 months following first triptan prescription. Patients were categorized as having episodic (EM) or chronic (CM) migraine based on the number of migraine days following International Classification of Headache Disorders criteria. (b) The migraine preventive treatment (MPT) user cohort included patients with MPT prescriptions during the period June 2016-May 2017. MPTs considered included beta-blockers, calcium-channel blockers, antiepileptics, antidepressants and antiserotoninergics. Migraine days experienced by MPTs users were estimated counting triptan and ICP pills prescribed during the 6 months following the most recent MPT prescription, while the number of MPT switches was estimated based on MPT prescriptions during the previous two years. Results: There were 9461 patients with triptan prescriptions to treat migraine acute attacks, which accounted yearly for 0.8% of general adult population. CM patients accounted for 3% of triptan users. There were 2004 patients prescribed with MPTs, which accounted for 0.16% of general adult population. Overall, among MPT users, 291 (15%) were still experiencing at least four migraine days/month, with this proportion increasing with the increase in the number of MPT switches. Conclusions: Results from this study suggest an unmet need in the management of migraine: too many patients did not receive MPTs, with this potentially due to several reasons requiring further investigations. Furthermore, even among patients receiving MPTs, disease control level with now available drugs seems to be sub-optimal

Drugs price and reimbursement regulation: comparators, endpoints and role of the cost-effectiveness

This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021. The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs