Insights into real-world treatment of cluster headache through a large Italian database: prevalence, prescription patterns, and costs

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000262
• EU PAS number:
  EUPAS1000000262
• Study ID:
  1000000262
• Official title and acronym:
  Insights into real-world treatment of cluster headache through a large Italian database: prevalence, prescription patterns, and costs
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Objective: This study aimed at estimating the treated cluster headache (CH) prevalence and describing prescription patterns and direct costs paid by the Italian National-Health-System. ; ; Methods: Through the ReS database (healthcare administrative data collection of a large sample of the; Italian population), adults in treatment for CH (acute therapy with sumatriptan/subcutaneous or oxygen, associated with preventive therapy with verapamil or lithium) were selected. A crosssectional analysis described the prevalence of CH-treated subjects repeated annually in 2013–2017. A longitudinal analysis of patients selected in 2013–2015 and followed for 2 years provided the prescription patterns.; ; Results: The annual prevalence of CH-treated patients increased from 6.4×100,000 adults in 2013 to 6.7 in 2017. In 2013–2015, 570 patients (80.7% M; mean age 46) treated for CH were found. In 50.4%, the identifying CH treatment was sumatriptan/subcutaneous+verapamil. During follow-up, >1/3 changed the preventive drug and interruption was the most frequent modification, although acute treatments were still prescribed. The mean annual cost/patient ranged from €2,956 to €2,267; pharmaceuticals expenditure represented the 56.4% and 57.3%, respectively.; ; Conclusions: This study showed an important unmet need among CH patients, carrying a high economic burden that should be considered in the evaluation of the impact of incoming therapies (e.g. Calcitonin-Gene-Related-Peptide antibodies).
• Study status:
  Finalised

Research institution and networks

Institutions

Fondazione ReS (Ricerca e Salute), CINECA partner

Italy

Study timelines

Date when funding contract was signed

Actual: 12/06/2019

Study start date

Actual: 12/07/2019

Date of final study report

Actual: 11/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly

Regulatory

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