[PHP323] Extension of Indication With Mature Products: Toward More Incentives Rewarding Innovation?
2015 Value in Health
Nayroles, G. | Gabriel, S. | Tolley, K. | Espin, J. | Toumi, M. | Kornfeld, A. | Frybourg, S. |
Mature products (MPs – marketed for 10 years or more) are widely used off label (from 15 to 35% according to studies) despite little evidence on benefit risk ratio. This exposes patients to risks or lack of efficacy and healthcare providers to liability. However manufacturers are rarely investing in R&D development for MPs. Indeed MPs face price cuts in Europe, whether due to generic competition, price negotiations or inclusion in reference price groups. Moreover new indications, even if demonstrating a higher value of the drug, often lead to price reductions in Europe due to a combination of price/volume agreements and external reference pricing.