Pricing and reimbursement of pharmaceuticals in Italy

In Italy the price setting of medicines reimbursed by the National Health Service is regulated at the central level by AIFA, the national regulatory authority. Prices of non reimbursed medicines are indeed freely established, with some limitations, by pharmaceutical companies. To contain pharmaceutical expenditure and rationalise the whole sector the following measures have been introduced in the past years: a threshold to public pharmaceutical expenditure (PPE); a reference price system (RPS) for off-patent medicines; a pay-back mechanism as an alternative to price cut. In 2008 Italy launched a reform of the pharmaceutical expenditure governance system with the aim to introduce stability and promote development and competitiveness in the pharmaceutical sector.