Pricing for multi-indication medicines: a discussion with Italian experts

Negotiating the prices of drugs with multiple indications presents important challenges that impact a range of stakeholders and can result in delayed patient access to potential life-saving treatments.
A broad range of stakeholders was recently assembled by the UK Office of Health Economics to work toward consensus on the challenges and solutions which promote better patient access and sustainable health care and innovation. The expert panel considered that differentiating payment based on value at the indication-level represents an important part of the solution for multi-indication therapies, for which implementation must recognise divergent country health systems and experience. Considering this conclusion the present paper represents a multi-step project developed by an Italian Board of experts with the primary aim of driving a deeper understanding of the critical issues and solutions relating to access to multi-indication therapies in Italy. By starting form evidence on the positive impact of value-based differential prices on innovation and access to innovative medicines, the experts discussed and defined the specific features of payment models that could be implemented in the Italian context.

Impact statement
o Negotiating the prices of drugs with multiple indications presents important challenges.
o In the case of extensions of indication throughout a drug lifecycle, it is necessary to perform a specific evaluation applying the principle of value-based pricing.
o Value-based pricing implies that a value framework is agreed, using a multi-inclusive approach, that value is measured, and that a decision-making path that converts a value into a price is defined.
o Value-based pricing managed per indication through specific entry agreements should be integrated and corrected with a price/volume approach every time the new indication extends the patient population from orphan/rare diseases to more prevalent ones.