Background New indications for established products (EPs) – marketed for 8 years or more – may represent a high societal value; but pharmaceutical manufacturers criticize the disincentives to expand indication of EPs and deliver the potential value for the society, such as lack of intellectual propriety or data protection, price cuts for new indication, generic competition, internal reference pricing. Incentive policies for orphan drugs or pediatric indications have driven EP development in these specific areas. Capturing the societal benefit of EP development is on the European Commission agenda. The objective of this research was to propose new potential incentives for the development of EPs through an international expert panel. Discussion The expert panel suggested the following incentives for EPs that provide an added value in new indications:
• To extend the market protection period following introduction of a new indication
• To develop differential pricing regulation for different indications of the same active ingredient.
• Three processes may help achieving differential pricing:
o Differential market access agreement such as rebate or other financial-based or outcome-based managed market entry agreements for different indications
o Electronic prescription including indication to ensure the right product is used for each specific indication when generic do not match extension of indication
o To avoid or delay systematic therapeutic reference pricing
Conclusion Current regulations can represent a serious disincentive to develop new indications for EPs. EPs may offer treatment options with well-known safety. They have a potential to reduce off-label use and contain prescription escalation toward expensive products. Policy changes, both regulatory, through data protection and market exclusivity, and pricing, by rewarding the effort to bring new indication for EPs, are needed to capture the full societal value of EPs.