Barriers and facilitators of exploiting the potential of value-added medicines

ABSTRACT

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.

KEYWORDS:

• Generic price erosion
• health technology assessment
• pharmaceutical research and development
• value added medicines
• value assessment framework

Article Highlights

• Recent directions of pharmaceutical R&D focus on highly expensive medicines for small patient populations.

• Value-added medicines (VAMs) can offer important health and societal benefits for relatively large patient populations in more prevalent diseases at significantly lower R&D costs.

• Several barriers prevent societies from maximizing the benefits of incremental innovation related to VAMs.

• The suboptimal business model related to the development of VAMs has to be improved by public regulatory and policy interventions in order to make the current pharmaceutical policy environment more receptive to incremental innovation with modest premium price.

• A specific value framework is needed to evaluate incremental innovation generated by VAMs.

Declaration of interest

Authors are employees of Syreon Research Institute (SRI). SRI has an ongoing research grant related to value-added medicines from Medicines for Europe. This article, however, was independent from the financial relationship disclosed above. Authors summarized their independent professional opinions and take full responsibility for potential errors in the manuscript. The authors have no further relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Reviewers Disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.