Introduction: Pharmaceutical research and development (R&D) is costly and only a minority
of patients can access innovative medicines due to affordability constraints. Value-added
medicines (VAMs) can offer potential benefits at significantly lower R&D costs. Areas
covered: VAMs may address different health care needs and problems, including off-label
use of medicines, poor patient adherence, problems related to polypharmacy, need for
home and/or personalized health care services. However, several barriers prevent societies
from maximizing the benefits of incremental innovation related to VAMs. Generic manufacturers
have limited budget and experience to demonstrate the value of new VAMs. Current market
exclusivity options do not efficiently exclude freeridership and do not guarantee
a return on investment for VAM innovators. Value propositions of VAMs are limitedly
consistent with current HTA frameworks, consequently, incremental innovation is not
acknowledged, nor rewarded with differential pricing by payers. Moreover, VAMs are
often perceived solely as generic medicines by prescribers. Expert opinion: Current
practices may need to be reconsidered to exploit the full societal benefit of VAMs,
including more efficient policies to guarantee market exclusivity for incremental
innovation, acknowledgment of a fair price premium based on a specific value framework
and the acceptance of low-cost evidence generation methods.
