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For innovative drugs, prices according to effectiveness to overcome the price barrier

Today the 80% of Italian medical oncology has accounts in the red: the DRGs (reimbursements for the treatments provided) cover half of the expenses, which continue to grow. The causes? Patients are increasing and living longer, therapies are becoming more demanding and innovative medicines have high prices. To end up "under accusation" for their cost are above all the new "biological" molecules, which, moreover, represent only a quarter of the expenditure in oncology. «Oncologists and the Italian Medicines Agency have been collaborating for years to rationalize the use of high-cost drugs – explains Filippo de Braud, head of the medical oncology division at the National Cancer Institute of Milan -. Since 2005 we have created systems that have been taken as a model by other European countries: cost sharing, risk sharing and payment by result. These are three different ways of sharing the cost of oncological drugs between the Health Service and pharmaceutical companies: they provide for a sort of "discount" or the payment of the innovative therapy only in patients who actually benefit from it. These mechanisms make it possible, as far as possible, to contain expenditure without the sick being affected".

The three systems respond to the watchwords «appropriateness of care» and aim to guarantee the most innovative treatments while avoiding waste, thanks to the careful evaluation of the effectiveness of each single treatment cycle on each patient. The first was the cost sharing, an agreement between Aifa and the pharmaceutical company which provides for a discount on the price of the first cycles of treatment performed by a patient, regardless of the clinical results obtained. Then it went to the risk sharing, which is always a discount, but applied to the first cycles of an innovative drug that is not effective on that single patient (hence the name "risk sharing" between the NHS and the manufacturer). Finally, we arrived at the payment by result which, as Paolo Siviero, director of the Aifa Study Center explained during a conference at the Istituto Superiore di Sanità promoted by the Italian Society of Pharmaceutical Sciences with the contribution of the Sanofi Aventis Foundation: «is the ideal solution, because the State pays to the success of the therapy, evaluated for each patient with certain scientific criteria and times established on the basis of the results of clinical studies. For this reason, Aifa is moving towards the adoption of this principle for all innovative drugs". In 2011 - informs Aifa - with these reimbursement methods 21 oncological drugs were negotiated, indicated for 29 types of tumors. "These systems speed up the arrival of new molecules after approval and allow for the collection of a large number of information on their use - adds de Braud - because sharing the risk or paying based on the result presupposes that precise monitoring is carried out the effect of treatment on each patient. To date we have thus accumulated valuable data on about 180,000 patients who have been treated co

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco