Abstract: 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.
Keywords: Affordable Care Act, biologics, health policy, patient care, access
INTRODUCTION TO HEALTH CARE REFORM IN THE USA
The Patient Protection and Affordable Care Act (ACA), which became a law in the USA on March 23, 2010,1 aims to solve long-standing challenges the US health care system is facing related to access, affordability, and quality of care.2 Although the ACA is under scrutiny from the current US administration, its aims to expand coverage, contain costs (despite additional coverage-based use), and improve health care quality3 are likely to continue under a revised health care act, even if repealed and replaced. The ACA, as it stands, is intended to make health care more affordable for families, seniors, businesses, and taxpayers alike and to facilitate coverage of previously uninsured Americans, as well as those whose insurance coverage is still inadequate.4 Addressing access to and affordability of innovative biopharmaceuticals is an important part of the ACA. Of particular interest is the role of biosimilars in improving access and patient care.
Biosimilars are medicinal products demonstrated to be highly similar to an already-approved biological product.5,6 Unlike generics of small molecules, which are relatively easy to produce and do not require clinical trials for regulatory approval, biologics cannot be duplicated because of the complexity in the manufacturing process. In addition, unlike generics, clinical trials are required for biosimilars to demonstrate product biosimilarity. The ACA amended the Public Health Service Act to create a tailored licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with a biological product already licensed by the US Food and Drug Administration (FDA). This pathway has been defined in the Biologics Price Competition and Innovation Act (2009)5 and has opened the door to increased therapeutic options in the armorarium of patient care.