Expanding access to treatment and ensuring quality

The FDA-approved biosimilar products have demonstrated similar efficacy and safety to their originator biologics in clinical trials.6 Health care decision-making to prescribe or reimburse biosimilars over originator biologics can reduce health care costs while maintaining quality and health outcomes. Where priced lower, biosimilars may expand access to appropriate treatment for conditions managed with biologics, allowing more patients to be treated, to be treated earlier, and to be treated with an expanded range of therapeutic interventions where previously restricted due to budget constraints.12,30 In March 2015, CMS indicated that with biosimilars, Medicaid programs could achieve cost savings and greater access to expensive therapeutic treatments for chronic conditions.21,34

Earlier access to treatment with biologics or approved biosimilars can lead to improved outcomes through symptom control and reduced symptom severity. For example, a study of patients with rheumatoid arthritis found that earlier treatment with biologics resulted in less joint damage and associated morbidity and longer maintenance of independence and productivity, compared with delayed treatment.35 Evidence of wider and earlier use of biologics (including biosimilars) is available in Europe, where biosimilars have been successfully adopted.29,30 Although the impact of increased access to biologics has not been assessed, increased use suggests a clinical need and the potential for improved patient outcomes.12 Given that certain subgroups have been shown to have poor adherence to biologic treatments due to high drug costs,36 observed improvements in outcomes may be enhanced by better adherence generated by the lower cost of biosimilars.

In addition to improvements in outcomes and adherence, health care quality can also be viewed in terms of the supporting services traditionally provided by the manufacturers of originator biologics. Manufacturers of approved biosimilars may offer similar services, such as specialist pharmacy services, patient-access support mechanisms, assistance with reimbursement administration, and assurance of continuous supply of product.37

Importance of value

The aim of the ACA to contain health care costs while improving quality and outcomes is in line with a more general shift in health care priorities from volume to value. Through health care cost reductions, expanded access to care, and ensuring quality, biosimilars add value to health care reform efforts already underway, such as the CMS Bundled Payments for Care Improvement (BPCI) initiative. The BPCI was launched in 2013 to assess whether episode-of-care-based payments could reduce costs to Medicare without adversely impacting quality.38 In a BPCI case study (which did not include biosimilars), bundled Medicare payments for lower-extremity joint replacement per episode decreased – primarily due to the reduced use of institutional post–acute care – without a significant change in quality outcomes.38

ACOs have been leading the way in ACA efforts to increase the value of health care. One component of this shift is the convergence of payer and provider concerns. Traditionally, payers have focused on costs such as direct pharmacy expenditures, whereas providers have been concerned with clinical outcomes. As health care reform transforms the health care landscape, payers and providers are increasingly being forced to grapple with the same concerns. In the vanguard of health care reform, ACOs are the advance scouts of the shift to value-based medicine. They are the first group of providers to grapple with cost-effectiveness, quality metrics, and patient satisfaction, and their innovations pave the way for more mainstream efforts.

Barriers to biosimilar adoption in the USA

While offering the potential to aid health care reform, considerable uncertainty remains about how biosimilars will fare under health care reform, as it is not entirely clear how important factors such as cost, clinical and real-world evidence, and policy will influence health care delivery and ongoing implementation of the ACA.39

Perceptions of biosimilars

Several opinion surveys of US health care professionals have highlighted a cautious reception of biosimilars, mainly driven by safety concerns and the need for more evidence.40–44 These surveys have emphasized that rigorous regulatory standards are needed for clinicians to consider biosimilars as acceptable alternatives to the standard of care.42 For example, most survey respondents wanted biosimilars to be identifiable as such and to have a different nonproprietary name from the innovator biologic medicine.42 Respondents also wanted any notable differences to be distinguished42 and felt that the originator’s indications should not automatically be transferred to biosimilars.43,45 The transferability concern was especially resonant when it came to immunotherapies, in which one drug can have multiple indications for diverse diseases.

As noted in an industry-sponsored Biosimilars Forum Survey of 1,201 providers prescribing biologics across multiple therapeutic areas, prevalent perceptions may lead to a reluctance by some US physicians and payers to switch patients well maintained on biologics to biosimilars, especially for those requiring long-term treatment for chronic conditions such as rheumatologic and immunologic disorders.45 Health care professionals familiar with biologics, particularly rheumatologists and dermatologists, noted that long-term clinical evidence of the safety and immunogenicity of biosimilars was required for decision-making about their use in chronic disorders.45 The authors suggested that counterdetailing by certain manufacturers, which aimed at rheumatology practices to raise questions about the biosimilar pathway and the concept of biosimilarity, may have been a factor in the perceptions identified in the survey.45 Consequently, biosimilar uptake may be faster for acute diseases than for chronic diseases. Overall, surveyed US clinicians acknowledged the potential for biosimilars to increase patient access to a broader range of appropriate treatments and to reduce health care costs,45 with many receptive to prescribing, administering, or dispensing biosimilars; however, there remain substantial knowledge gaps and a need for information.41