Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimiliars

Abstract

AimThe purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products.MethodsAn observational retrospective study based on administrative and laboratory databases of three local health units was conducted. All adults diagnosed with hematological malignancies and who had received at least one epoetin (either reference product or biosimilars) prescription for the first time between 1 January 2010 and 30 April 2012 (enrollment period) were included. The date of the first prescription of epoetin within the enrollment period was defined as index date (ID). Patients were followed up for 4 weeks after ID (follow-up period) and were investigated for the 1-year period before the ID. The difference between the last hemoglobin (Hb) measurement after ID and the one prior to ID (ΔHb) was evaluated. The drug cost analysis was conducted from the perspective of the Italian National Health System.ResultsOverall, 69 patients were included in the study; 48 of them received reference epoetin product and 21 received biosimilars as first prescription. Among reference product users, the mean ± standard deviation (SD) age was 62.5±14.7 years; this cohort of patients was slightly significantly younger than the biosimilar users (71.8±11.8 years). The mean ± SD overall Hb level prior to treatment was lower among patients who started with biosimilar products (9.6±1.1 g/dL) compared to those who started with a reference product (10.1±2.1 g/dL). No significant differences in ΔHb were observed between biosimilar and originator groups during the followup period. The mean ± SD cost per patient was €667.98±573.93 and €340.85±235.73 for the reference product and biosimilar users, respectively (p=0.065).ConclusionOur study showed that the use of biosimilar products might contribute to controlling health care costs (in terms of drug treatments) for patients with hematological malignancies being maintained by high-quality anemia therapy. Our findings also showed some discordances regarding the most appropriate therapeutic approach in daily clinical practice.

Antithrombotic Treatment Patterns in Patients With Atrial Fibrillation in Italy pre- and post-DOACs: the Repair Study

“…The structure of this DB has been described in detail elsewhere [15]. It includes various DBs: beneficiaries’ DB, containing patients’ demographic data; pharmaceuticals prescription DB, providing information for each drug prescription, such as the anatomical therapeutic chemical (ATC) code; hospital discharge DB, containing information on the diagnosis-related group reimbursement rate, reasons for hospitalization according to the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); outpatient specialist services DB, collecting information on visits or outpatient services provided to patients; and laboratory tests DB, containing blood test results for each patient.…”

Healthcare Resources Use in Patients with Human Immunodeficiency Virus (HIV). Real-World Evidence From Six Italian Local Health Units

“…The study was conducted using administrative and laboratory databases (DB) of 6 Italian Local Health Units (2,249,345 inhabitants, 3.7% of the Italian population) geographically distributed throughout the country (50% North, 50% Middle Italy). The structure of these DBs have been described in detail elsewhere [15]. In particular, the following DBs were used: the Health-Assisted Subjects DB, the Medication Prescription DB, the Hospital Discharge DB, the Ambulatory Care Specialist DB and the Laboratory DB.…”

Pharmacoeconomic Evaluation of Cancer Biosimilars Worldwide: A Systematic Review

“…A total of 17 studies were finally included in this study, and the detailed information is displayed in Figure 1 ( Aapro et al, 2012a ; Aapro et al, 2012b ; Nikolaidi et al, 2013 ; Abraham et al, 2014 ; Ianotto et al, 2014 ; Mehta and Hay, 2014 ; Sun et al, 2015 ; Valentina et al, 2016 ; Bongiovanni et al, 2017 ; Cesarec and Likić, 2017 ; Gulácsi et al, 2017 ; McBride et al, 2017 ; Rognoni et al, 2018 ; Giuliani and Bonetti, 2019 ; Lee et al, 2019 ; Trautman et al, 2019 ; McBride et al, 2020 ). All included studies were published in last decade, of which 8 studies were reported in the recent three years.…”

“…Only one study was nested in randomized controlled trials (RCT) ( Giuliani and Bonetti, 2019 ). Concerning the range of included costs, most studies only took drug cost into consideration ( Aapro et al, 2012a ; Aapro et al, 2012b ; Ianotto et al, 2014 ; Sun et al, 2015 ; Valentina et al, 2016 ; Bongiovanni et al, 2017 ; McBride et al, 2017 ; Giuliani and Bonetti, 2019 ), and official database was the main data source. McBride et al study also included administration, and condition-related cost ( McBride et al, 2020 ).…”

“…Except the time horizon of one study unspecified ( Ianotto et al, 2014 ), one being lifelong ( Mehta & Hay, 2014 ) and one being four weeks ( Valentina et al, 2016 ), time horizon of the other studies varied from one to six chemotherapy cycles. Therefore, most studies would likely not capture longer-term benefits of treatment with biologics.…”