Catania, Italy – To guarantee rapid patient access to high cost, innovative therapies, policy makers have introduced cost-containment strategies based on the partial or total reimbursements of a drug price. Under these agreements, market access for a drug is granted more rapidly than expected, provided that the risks of uncertain therapeutic effectiveness/safety are shared with the manufacturer. For example: in the case of failure of an approved novel therapy, after a specific time set for the evaluation of the response, a partial/total reimbursement is offered by the manufacturer to the health care centre. In other words, if the drug doesn’t work, the manufacturer pays back the costs of therapy to the health care centre.

A research team from the University of Catania analysed the outcomes of the application of such strategies in Italy since their introduction in 2006 and found that, considering the high amount of money paid by the National Health System (NHS) to Pharmaceutical Companies (3,696 million Euros), the actual amount paid back from the companies to the NHS has been trifling (121 million). This is due to several reasons, including the lack of incentives for the prescribing centres to detect and report the eventual ineffectiveness [of the drug], and their inefficiencies in the management of the reimbursement procedures.

To overcome such issues, a novel measure named “Success Fee” has been proposed for the payment of approved, but high cost, innovative drugs.  The researchers looked at the drug, pirfenidone, which has been approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The drug is provided by the manufacturer to the health care centre at no cost initially, and the drug is paid only for those patients who benefited from the treatment based on the evaluation of a specific outcome parameter, at a predefined time. Using “Success Fee,” health care centres only have to pay directly for the effective treatments, and so they will be more incentivized to comply with the management of the procedure, as the money saved for the cost of ineffective treatments stays within the prescribing centre itself.

This strategy is expected to work as a powerful tool for sustainability of drug costs, and could be proposed for the payment of other expensive therapies, including oncologic treatments. The full study, “Do the Current Performance-Based Schemes in Italy Really Work? “Success Fee”: A Novel Measure for Cost-Containment of Drug Expenditure,” is published in Value in Health.

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