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.

中文翻译：

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开发增值药物潜力的障碍和促进因素。

简介：药物研发 (R&D) 成本高昂，由于负担能力的限制，只有少数患者可以获得创新药物。增值药物 (VAM) 可以显着降低研发成本提供潜在收益。涵盖的领域：VAM 可以解决不同的医疗保健需求和问题，包括超说明书用药、患者依从性差、与多种药物相关的问题、居家需求和/或个性化的医疗保健服务。然而，一些障碍阻止社会最大限度地利用与 VAM 相关的渐进式创新的好处。通用制造商的预算和经验有限，无法证明新 VAM 的价值。当前的市场独占性选项并不能有效地排除搭便车，也不能保证 VAM 创新者的投资回报。VAM 的价值主张与当前 HTA 框架的一致性有限，因此，增量创新没有得到承认，也没有得到付款人不同定价的奖励。此外，VAM 通常仅被处方者视为仿制药。专家意见：可能需要重新考虑当前的做法，以充分利用 VAM 的社会效益，包括更有效的政策来保证增量创新的市场独占性，承认公平的价格溢价基于特定的价值框架和对低成本证据生成方法的接受。