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Analysis of Drug Utilization and Health Care Resource Consumption In Journal name: Biologics: Targets and Therapy Article Designation: Original Research Year: 2018 Volume: 12 Biologics: Targets and Therapy Dovepress Running head verso: Degli Esposti et al Running head recto: Biologic therapies utilization and healthcare resource in PsO and PsA open access to scientific and medical research DOI: http://dx.doi.org/10.2147/BTT.S168691 Open Access Full Text Article ORIGINAL RESEARCH Analysis of drug utilization and health care resource consumption in patients with psoriasis and psoriatic arthritis before and after treatment with biological therapies Luca Degli Esposti1 Objectives: To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic Valentina Perrone1 arthritis (PsA) before and after treatment with biological therapies in a real-world setting and Diego Sangiorgi1 to determine the relative consumption of health care resources. Stefano Buda1 Design: Retrospective observational study. Margherita Andretta2 Setting: Real-life clinical setting in 5 Italian local health units. A total of 351 male and female patients with at least 1 prescription for a biologi- Maurizio Rossini3 Participants: cal drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid Giampiero Girolomoni4 For personal use only. arthritis, ankylosing spondylitis, or Crohn’s disease were excluded. 1 CliCon Srl, Health Economics and Results: The major health care cost (excluding drug costs) was represented by hospitaliza- Outcomes Research, Ravenna, Italy; 2Pharmaceutical Department Local tions, mainly related to PSO /PsA-associated disorders and cardiometabolic disorders. Use of Health Unit, ULSS 9 Scaligera, Verona, conventional drugs among biologics-naïve patients reached 50% in PSO and 80% in PsA; their 3 Italy; Department of Medicine, use decreased following initiation of biological therapy. After the start of biological treatment, Section of Rheumatology, University of Verona, Verona, Italy; 4Department the incidence of hospitalization decreased both for PSO (from 12.3% to 3.2% in day hospital of Medicine, Section of Dermatology regimen and from 2.4% to 0.4% for conventional admission) and for PsA (from 11.1% to 8.1% and Venereology, University of Verona, and from 10.1% to 3.0%, respectively). Mean annual costs for hospitalization before biologi- Verona, Italy cal treatment were €217 and €537 for PSO and PsA, respectively, while mean annual cost for concomitant drugs slightly increased after biologics initiation: from €249.8 to €269.4 for PSO and from €331.8 to €346.9 for PsA. The major consumption of health care resources occurred Biologics: Targets and Therapy downloaded from https://www.dovepress.com/ by 54.70.40.11 on 09-Mar-2020 in the quarter preceding the beginning of biological treatment. Conclusion: The consumption of health resources is mostly related to hospitalization, seems to peak during the quarter before the beginning of biologics therapies, and subsequently decreases after biologics initiation. Further studies should focus on prescription scheme and economic burden of PSO and PsA in Italy to help optimize health care resources and potentiate services for patients. Keywords: psoriasis, psoriatic arthritis, biological treatment, health care costs, hospitalization Introduction Psoriasis (PSO) is a chronic inflammatory, immune-mediated, genetically based dis- Correspondence: Luca Degli Esposti ease affecting the skin and joints with a significant impact on quality of life. PSO is CliCon Srl, Health Economics and Outcomes Research, via Salara 36, 48100 observed in 0.9%–8.5% of world population.1 In addition, European epidemiological Ravenna, Italy data confirm that about 2%–3% of Caucasian population is affected by this disorder.2,3 Tel +39 0544 38393 Email [email protected] In Italy, the prevalence of PSO is estimated around 2.8%, with higher rates in men submit your manuscript | www.dovepress.com Biologics: Targets and Therapy 2018:12 151–158 151 Dovepress © 2018 Degli Esposti et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms. php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work http://dx.doi.org/10.2147/BTT.S168691 you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Degli Esposti et al Dovepress than women.4 Approximately 30% of patients with PSO (with tomical–therapeutic–chemical (ATC) code of the drug, a range from 6% to 42%) will develop psoriatic arthritis the number of packs, the number of units per pack, the (PsA).5 PsA is a chronic inflammatory disease of the joints dosage, the unit cost per pack, and the prescription date; associated with cutaneous PSO or with a familial history of • the Hospital Discharge Database, containing information PSO.3 In the Italian population, the estimated prevalence of on discharge for each hospitalization, in particular, dates PsA is 0.42%.6 A prompt diagnosis (ideally within 12 months of admission and discharge, and main and accessory from initial symptoms) and adequate treatment of PsA may diagnoses, coded according to the ICD, IX Revision, prevent/delay disease progression, avoiding permanent and Clinical Modification (ICD-9-CM); irreversible bone damage.7 • the Specialized Outpatient Healthcare, recording the The selection of therapy in patients with PSO depends on specialist services (visits, laboratory tests, diagnostic disease severity, presence of PsA and/or other comorbidities tests) given to the patients under reimbursement from or not, as well as patients characteristics and preferences.8 the NHS; Several therapeutic options are available for patients with • the Disease Exemption Database, which contains all PSO, including topical treatments, ultraviolet radiation, ICD-9-CM codes relative to the disease exemptions for conventional systemic therapy (methotrexate, cyclosporine, the subjects under investigation; from this database, all acitretin), biological drugs targeting single proinflammatory the information useful for diagnosis and/or comorbidities cytokines (TNF-α, IL-12/23 and 17 inhibitors) and, only (to be integrated with those coming from hospitalization recently, the PDE4 inhibitor, apremilast.9 PsA treatment and drug consumption) were derived. includes symptomatic drugs (nonsteroidal anti-inflamma- According to Italian privacy policy (D. lgs. 196/03 and tory drugs [NSAIDs], glucocorticoids, classical disease- subsequent modifications), each patient was assigned an modifying antirheumatic drugs [DMARDs] [methotrexate, anonymous code, which was not disclosed to the researchers. leflunomide, cyclosporine, sulfasalazine]), biological drugs The anonymous code for each subject was present in all the (anti-TNF-α, anti-IL 12/23/17) and apremilast.8,10 According For personal use only. databases and allowed the linkage between them. Accord- to the Italian Medicines Agency (AIFA) guidelines, biologi- ing to the policy governing the conduction of retrospective cal drugs can be prescribed and reimbursed by the National observational studies,12 the local ethical committee of each Health System (NHS) only after failure, contraindications, participating local health unit was notified of this study and or intolerance to conventional systemic treatments.11 accepted it. A preliminary version of this paper has been The main objective of the present work was to describe published as a journal supplement in Italian.13 the therapeutic courses of patients with PSO and PsA before and after treatment with biological therapies in a real-world Cohort definition setting. The secondary aim of the study was to determine the All the patients aged ≥18 years with at least 1 prescription consumption of health care resources in patients with PSO for a biological drug for PSO or PsA from January 1, 2010 and PsA including drugs, diagnostic interventions, special to December 31, 2013, were included in the study. During Biologics: Targets and Therapy downloaded from https://www.dovepress.com/ by 54.70.40.11 on 09-Mar-2020 medical examinations, and hospitalizations, in relation to the the inclusion period, the date of the first biological prescrip- therapeutic strategy utilized. tion was considered as the index date. All patients were Methods observed for 12 months from the index date (observational Data sources follow-up period) and clinically characterized in the 12 months preceding the index date (clinical characterization Patient data were retrieved from the administrative data- period). Only patients with biologic drug prescription were bases of 5 Italian local health units distributed throughout considered for this analysis. The diagnosis of PSO or PsA the national territory with a population of health-assisted was identified through hospitalizations, exemption codes for individuals of approximately 3.3 millions. PSO [code ICD-9 =69601 or exemption code 045.696.0] or The following archives were used: PsA [code ICD-9 =696.0 or exemption code 045.696.1], and • the Health-assisted Subject Database, containing patients’ the medical prescriptions of anti-PSO drugs for topical use demographic data (year of birth and sex);
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