Boccia Ralph, Jacobs Ira, Popovian Robert, de Lima Lopes Gilberto
Center for Cancers and Blood Disorders, Bethesda, MD.
Global Medical Affairs, Pfizer Inc., New York, NY.
Cancer Manag Res. 2017 Jun 1;9:197-205. doi: 10.2147/CMAR.S133442. eCollection 2017.
The US Patient Protection and Affordable Care Act (ACA) aims to expand health care coverage, contain costs, and improve health care quality. Accessibility and affordability of innovative biopharmaceuticals are important to the success of the ACA. As it is substantially more difficult to manufacture them compared with small-molecule drugs, many of which have generic alternatives, biologics may increase drug costs. However, biologics offer demonstrated improvements in patient care that can reduce expensive interventions, thus lowering net health care costs. Biosimilars, which are highly similar to their reference biologics, cost less than the originators, potentially increasing access through reduced prescription drug costs while providing equivalent therapeutic results. This review evaluates 1) the progress made toward enacting health care reform since the passage of the ACA and 2) the role of biosimilars, including the potential impact of expanded biosimilar use on access, health care costs, patient management, and outcomes. Barriers to biosimilar adoption in the USA are noted, including low awareness and financial disincentives relating to reimbursement. The evaluated evidence suggests that the ACA has partly achieved some of its aims; however, the opportunity remains to transform health care to fully achieve reform. Although the future is uncertain, increased use of biosimilars in the US health care system could help achieve expanded access, control costs, and improve the quality of care.
美国《患者保护与平价医疗法案》（ACA）旨在扩大医疗保健覆盖范围、控制成本并提高医疗保健质量。创新生物制药的可及性和可负担性对ACA的成功至关重要。与许多有通用替代药物的小分子药物相比，生物制品的生产难度要大得多，这可能会增加药品成本。然而，生物制品已证明能改善患者护理，从而减少昂贵的干预措施，进而降低医疗保健净成本。生物类似药与参照生物制品高度相似，成本低于原研药，通过降低处方药成本有可能增加可及性，同时提供等效的治疗效果。本综述评估了：1）自ACA通过以来在实施医疗保健改革方面取得的进展；2）生物类似药的作用，包括扩大生物类似药使用对可及性、医疗保健成本、患者管理和治疗结果的潜在影响。文中指出了美国生物类似药采用的障碍，包括认知度低以及与报销相关的经济抑制因素。评估证据表明，ACA部分实现了其一些目标；然而，仍有机会对医疗保健进行变革以全面实现改革。尽管未来不确定，但在美国医疗保健系统中增加生物类似药的使用有助于扩大可及性、控制成本并提高护理质量。
