Background Italy is one of the European countries where a Risk Sharing Scheme between healthcare institutions and pharmaceutical companies has been widely implemented. It is a new model proposed to accelerate the authorisation and the availability on the market of new drugs. Since September 2007, the Italian drug agency has developed a web register to record data to monitor patients who receive medicines under a Risk Sharing Scheme: the physician prescribes medicines from a list of high-cost oncology drugs and the Italian drug agency validates each prescription and e-mails the hospital pharmacy to release the drug. The non-responding patients are documented in the web register by the health authorities and the pharmacist applies for reimbursement to the pharmaceutical company. Since 2011, Sicily Region has had a hospital pharmacist officially appointed in each pharmacy department to be in charge of obtaining refunds from manufacturers for undocumented non-responding patients and to supervise the pay-back procedures.
Purpose To quantify the amount clawed back from manufacturers after the appointment of the Risk-Sharing pharmacist.
Materials and Methods We detected and examined unresponsive patients recorded in the Registro AIFA-onco. The pay-back procedures were subsequently completed.
Results The number of registered patients increased by 83% and 451 non-documented patients were recorded: 190 Erlotinib, 103 Sorafenib, 57 Sunitinib, 38 Lapatinib, 14 Everolimus, 1 Pemetrexed, 20 Bevacizumab, 20 Cetuximab, 12 Gefitinib, 2 Vinflunine, 16 Lenalidomide, 3 thalidomide, 1 Panitumumab, 7 Bortezomib, 4 Azacitidine, 3 Trabectedin.
The ex-factory expense was €6,340,011.66: €431,063.89 recovered, €145,678.92 is waiting for reimbursement and €136,220.50 has been denied reimbursement.
Conclusions The appointment of a pharmacist enabled us to monitor pay-back procedures and assess responding and non-responding patients reliably.
No conflict of interest.
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