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

ABSTRACT

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 cross-sectional 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).

KEYWORDS:

• Real-world evidence
• cluster headache
• prescription pattern
• italy
• administrative databases
• observational study
• pharmacoepidemiology

Supplemental data

Supplemental data for this article can be accessed here.

Article highlights

• A slight increase in the prevalence of patients treated for Cluster Headache (CH) was retrieved from 6.4 per 100,000 in 2013 to 6.7 per 100,000 in 2017; this could be explained by a greater awareness of clinicians about pharmacological treatment and by an easier access to services.

• This real-world analysis provided a detailed picture of the prescription patterns of CH, also in terms of the modification (switches or interruptions) of the preventive therapy occurring in 40.7% of treated subjects

• Each patient treated for CH generated a direct mean cost, paid by the National Health Service, of € 2,956 and of € 2,267, respectively, in the first and in the second follow-up year, and expenditure for drugs accounted for 56.4% and 57.3%, respectively.

• An important unmet need among CH patients exists, carrying a high economic burden that should be considered in the evaluation of the impact of incoming therapies.

Declaration of interest

SaCe has received honoraria as speaker or Advisory Boards from Ely-Lilly, Novartis, Allergan and Teva. VF has received honoraria as speaker or for participating in advisory boards from Ely-Lilly, Novartis and Teva. GP has received honoraria as speaker from Ely-Lilly, Novartis, Allergan and for participating in advisory boards from Teva. APM has received personal fees for participation in study committees sponsored by Bayer, Fresenius, Novartis outside the present work. The other authors declare that they have no competing interests.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributions

CP, SaCe, GR and LD conceived the study. GR and LD conducted the analyses. CP and SaCe wrote the first version of the article. SiCa, AP, APM, IE, AA, VF, GP, PC and NM. contributed to the interpretation of the results and revised the manuscript. All authors read and approved the final manuscript.

Ethical approval

This is an observational, non-interventional database study, re-utilizing administrative data for the purpose of addressing a research question. The study was conducted under specific agreements between Fondazione ReS and Italian Regional/Local Health Facilities, participating in the ReS database. All these institutions have general legal and ethical frameworks that allow them to conduct research by making secondary use of administrative data and provided sufficient guarantee of individual records’ deidentification.

Ricerca e Salute (ReS) is a non-profit Foundation whose main aim is to create useful tools to plan and monitor, at different levels and for different stakeholders, issues related to healthcare policies. These tools are based on the use of Real-World health Data. To achieve this goal, administrative data-flows are transferred from several local Italian health authorities, under specific agreements, to the ReS Foundation to create the ReS database. The data received by the ReS Foundation are the same sent periodically by the local health authorities to the Italian Minister of Health. ReS activities may be supported by public or private Institutions with unrestricted funding for research.

Prior posting

Part of results has been submitted as abstract to ‘The International Headache Congress - IHS and EHF joint congress 2021’ that will be taken in Berlin on 8 – 12 September 2021.

Availability of data and material

The datasets generated and analyzed during the current study are not publicly available, they come from anonymized administrative databases owned by the Italian Regional Health Facilities and they were analyzed by Fondazione ReS under a specific agreement.

Additional information

Funding

The study came from a report partially supported by Eli Lilly. Definition of goals, data collection, statistical analysis plan, interpretation of the data, and manuscript are completely managed by the authors, without any kind of interference by the partial financial supporter.