After the patents of branded erythropoietins have expired, biosimilars
have been launched in the EU. Such as generic drugs, biosimilars have lower pricing than originator medicines and the clinicians should be consider also economic concerns in their prescriptions. Despite of the presence of clinical EBM regarding efficacy, safety, quality and the cost saving, the use of biosimilars in Italy is still low(16%), especially in Sicily(2%). The Department of Pharmacy of LHU Palermo enhanced the use of biosimilars in all the County organizing two education courses and publicizing many cost-efficacy evaluations to promote independent assessment on this pharmaceuticals. The Department focalized the area for intervention only in the ESA naïve oncology patients. learn more In fact, while substitution with generic drugs can be done at the hospital pharmacy or retail pharmacy level, the National Regulations stated that interchangeability from one biopharmaceutical branded medicine to a biosimilar must be made only by the physicians, because these formulations may differ from the original and may cause immunogenicity. Since January 2013, the Department stated that in each naïve patient receiving an erythropoietin
for the chemotherapy-induced anemia the hospital pharmacists dispense the cheapest product containing the prescribed substance. All the physicians were informed about this initiative. The physician can prohibit drug substitution by stating ‘do not substitute’ in the form and adding a valid justification. The Department of Pharmacy centralized the distribution of all the prescriptions containing ESAs in their 14 hospital pharmacies ABT-888 spread on Carnitine dehydrogenase County. These pharmacies collected all the data related to the outpatients receiving
ESAs both in an electronic database and in a paper folder. Copy of all the prescription forms related to the naïve oncology patients in Palermo were retrospectively analyzed. The observed period was the first quarter of 2013 compared with every quarter of 2012.Ethic approval was not required. In the first quarter of 2013, after our actions, 38 naïve patients, on the total numbers of 90 naïve oncology patients, were treated with biosimilars (42 %). Data from 2012 showed respectively for each quarter 5%, 12,5%, 10% and 15% of the patients receiving biosimilars. The use of epoetins for CIA was appropriate in all the cases. The treatment was in fact prescribed when the Hb values was in the range (80 g/L–100 g/L), according to the Italian Law. We can also state that no spontaneous reports of suspected adverse drug reactions (ADRs) regarding ESAs (biosimilars or branded) were been received in the period. The same Department is in fact responsible for collecting and processing the reports concerning post-marketing sourveillance in the County. The total expenditure for these drugs amounted to EUR 655,000/trimester (average of 2012).