Background Since 2015, the Piedmont region has decided to invest in biosimilar medicines with the aim of obtaining price reductions and to promote the switch not only in naïve patients but also in those already treated with an ‘originator’. In 2017 an etanercept biosimilar was awarded in a regional tender and an exchange procedure was implemented by all the health services.
Purpose The aim of the work was to check the switch rate in 2017 from the etanercept originator to biosimilar and verify the adequacy of non-substitutability reports. Data collected were compared with the regional and national ones to understand the impact of the regional measure and, lastly, the economic implications of the operation were analysed.
Material and methods 2017 was the examined year. A drug dataset was extracted from data flow and processed to obtain the switch rate towards the biosimilar etanercept. Patients’ paper files were analysed to catalogue the non-substitutability reports. Data were compared with those published by the Italian Biosimilar Group at regional and national level. Any switch or swap from the etanercept originator to other active substances was verified and a data analysis was carried out to check dispensed units and the expenditure for their purchase from 2014 to 2017.
Results One-hundred and thirteen of 165 patients (68.5%) shifted towards the biosimilar compared to 12% at the national level. Twenty-four patients continued therapy with the originator, 20 switched to other active substancies or to another dose of etanercept (25 mg) and eight stopped the treatment. Prescribing hospitals have non-substitutability rates ranging from 10% up to 40%–60%. The patient pool was unchanged from 2014 to 2017, while costs fell by about 19% in 2017 compared to the previous year.
Conclusion Biosimilars’ introduction is a valid chance to ensure quality, safety and effectiveness, even in a public spending rationalisation context. Etanercept, with its large pool of patients, is a significant cost-saving possibility. Results obtained confirm decisions implemented with high exchange rates compared to the other Italian regions, reduction in costs and the preservation of high assistance levels.
References and/or acknowledgements Italian Biosimilar Group. Italian Biosimilar Drugs Market January–September 2017 (2018).
AIFA. Second Position Paper on Biosimilars Medicines (2018).
No conflict of interest.
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