Real-world use of biological drugs in patients with psoriasis/psoriatic arthritis: a retrospective, population-based study of years 2010-2014 from Southern Italy.

BACKGROUND: Biological drugs, such as infliximab, etanercept, adalimumab, ustekinumab, golimumab and certolizumab are third-line therapy for psoriasis (PsO) and psoriatic arthritis (PsA), but they may be used at earlier stage in severe forms. This study investigated the pattern of use and costs of biological drugs for PsO/PsA in a large population from Southern Italy during the years 2010-2014. METHODS: This was a retrospective, population-based, drug-utilization study, using healthcare administrative databases of the ASL (Local Health Unit) and two hospitals of Messina Province (Sicily) in the years 2010-2014. Incident users of adalimumab, ustekinumab, infliximab, etanercept and golimumab for PsO/PsA were characterized. Yearly prevalence of use and costs, as well as time to treatment discontinuation and switch were assessed. RESULTS: During the study period, 517 patients received at least one study drugs prescription for PsO/PsA and 304 (58.8%) were incident users, mostly treated with adalimumab (33.6%). Incident users were mostly males (59.8%), with a median age of 49 years. The prevalence of biological drugs users in PsO/PsA increased from 4.3 to 6.9 per 10,000 inhabitants from 2011 to 2014. Pharmaceutical expenditure of the study drugs almost doubled (from 2.6 to 4.7 million euros over 5 years of observation). During the first year of treatment, discontinuation occurred in 31.8% of incident users and switch was not infrequent (7.4%). CONCLUSIONS: Prevalence of use and costs of biological drugs for PsO/PsA substantially increased in recent years in a large population of Southern Italy. Larger uptake of lowest cost biological drugs, and biosimilars whenever available, may help access to the most innovative drugs.

Author Correction to: Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy.

Unfortunately, many errors were identified in the published article. The original article was corrected.

Prevalence of Use and Cost of Biological and Non-Biological Targeted Therapies for Cancer Treatment: A 5-Year Picture from Southern Italy.

BACKGROUND AND OBJECTIVES: Considering the clinical and economic burden of biological and non-biological targeted therapies in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological and non-biological targeted therapies for cancer treatment in a general population of Southern Italy in the years 2010­2014. METHODS: This was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010-2014. In this study, users of biological and non-biological targeted therapies for cancer treatment were characterized and the prevalence of use and costs were calculated over time. The potential impact of biosimilars on the expenditure was also estimated. RESULTS: Of a population of 653,810 residents in the Messina area during the study years, 2491 (0.4%) patients received at least one study drug. The most frequently used were monoclonal antibodies (mAbs) (n = 1607; 64.5%) and tyrosine kinase inhibitors (TKIs) (n = 609; 24.4%). mAbs were mainly used by females (60.3%) for metastasis due to an unspecified primary tumor, lymphomas, or breast cancer (24.2, 16.7, and 13.7%, respectively). Most users of small molecules were males (56.3%) being treated for multiple myeloma, metastasis due to unspecified primary tumor, leukemia, and lung cancer (13.1, 12.6, 9.5, and 8.9%, respectively). During the study years, the prevalence of use doubled from 0.9 to 1.8 per 1000 inhabitants; likewise, the related expenditure grew from €6.6 to €13.6 million. Based on our forecasts, this expenditure will grow to €25 million in 2020. Assuming a 50% biosimilar uptake (trastuzumab and rituximab), a potential yearly saving of almost €1 million may be achieved. CONCLUSIONS: In recent years, the use and costs of biological and non-biological targeted therapies in cancer patients dramatically increased in a large population from Southern Italy. This trend may be counterbalanced by adopting biosimilars once they are available. Claims databases represent a valid tool to monitor the uptake of newly marketed biological drugs and biosimilars as well as other non-biological targeted therapies.

How much are biosimilars used in southern Italy?: a retrospective analysis of epoetin utilization in the local health unit of Messina in the years 2010-2011.

BACKGROUND: Epoetins are one of the three biologics for which biosimilars are available in Italy. So far, there is a lack of Italian national/regional longitudinal data about epoetin use. OBJECTIVE: The aim of this study was to evaluate the prescribing pattern of epoetins (reference products and biosimilars) in a Local Health Unit (LHU) of Southern Italy in recent years. METHODS: A retrospective drug utilization study was conducted during the period 1 January 2010 - 31 May 2011. The data source was the dispensing database of the Messina LHU, which contains anonymized data about dispensed drugs (including epoetins) that are prescribed by specialists to the residents in the catchment area. Indication of use and prescribed dosage of epoetins were derived by the therapeutic plans filled in by specialists and linked to drug dispensing records. Prevalence of epoetin use in the province of Messina (653 810 inhabitants) in 2010 was calculated. Furthermore, frequency analyses by sex, age, indication of use of epoetin users, as well as measurement of volume of use (defined daily dose [DDD]/1000/day) and expenditure of epoetins in 2010 were also performed. Analysis of the switching pattern between different reference products and biosimilar epoetins was performed. RESULTS: Overall, 4288 patients were treated with epoetins during the study period (mean age ± SD: 74.2 ± 13.7; females: 52%). Darbepoetin alpha and reference product epoetin alpha accounted overall for 79.8% of epoetin users, while biosimilars of epoetin alpha accounted for 0.9%. Among 1247 epoetin users for whom the therapeutic plan was revised, 1065 (85.4%) were treated because of anemia due to chronic kidney disease and 158 (12.6%) because of chemotherapy-induced anemia. In 2010, prevalence of epoetin use was 5.5 (95% CI 5.3, 5.7) per 1000 inhabitants in the province of Messina. The volume of use and related expenditure for epoetins was 3.58 DDD/1000 inhabitants/day and Euro 5 572 457 (about Euro 8.50 per capita/day) in 2010. Switching between different epoetins was very frequent (21.8% of users) but switching from reference products to biosimilars was very rare. CONCLUSIONS: Epoetins are frequently dispensed to residents in the province of Messina, mainly for the treatment of chronic kidney disease-related anemia, with a relevant impact on the pharmaceutical expenditure covered by the National Health System. Use of biosimilar products is very low in both naïve patients and in those who switch from other reference product epoetins.