Managed care and specialty pharmacy professionals have mostly favorable views regarding the safety and efficacy of biosimilars, according to the findings of a survey study published in Journal of Managed Care & Specialty Pharmacy. These results can be used to develop, implement, and enhance strategies to achieve the goals of the Biologics Price Competition and Innovation Act (BPCIA).
Established in 2009, the BPCIA provides an abbreviated US Food and Drug Administration (FDA) pathway for approving biosimilars that (through testing) have displayed interchangeability with their FDA-approved referenced biologic products. According to the authors, the goals of the BPCIA are to “stimulate price competition and thereby facilitate greater access to biologic therapies for patients with indicated conditions.”
To conduct this study, the Academy of Managed Care Pharmacy (AMCP) disseminated approximately 10,0000 online survey invitations via email to its database of members and customers. The first 300 responders comprised this study. The responders were queried on their biosimilar perceptions and given a list of 16 strategies for overcoming biosimilar adoption barriers and were then prompted to rate the likelihood of each strategy being effective in achieving the goals of BPCIA on a 5-point rating scale. Participants were also given six barriers to biosimilar adoption, and (also on a five-point rating scale) were asked to rate their perceived level of difficulty in overcoming each barrier. After using response frequencies to describe the ratings of both strategies and barriers, the researchers analyzed the responses to discern whether responses differed among participants partitioned by work organization.
Results of the study indicated positive perceptions with respect to adopting biosimilars, with 84% of respondents agreeing or strongly agreeing that FDA-approved biosimilars are both safe and effective. Moreover, the results showed that the two highest rated strategies (91% and 90%, respectively) for propelling the goals of the BPCIA were: to enhance prescriber education about evidence that supports switching to biosimilars, and to increase FDA guidance on pharmacy-level protocols for substituting a referenced biologic with a biosimilar. Conversely, the lowest rated strategies (39% and 40%, respectively) were: for requiring patients who switch a biosimilar to undergo therapeutic drug monitoring and using quotas as an incentive for providers to prescribe biosimilars.
The authors noted several study limitations, including the relatively small sample size of only a few hundred respondents, as said that “potential biases related to their standard professional practices and goals may limit the implementation of the survey findings to achieve BPCIA goals, especially if multi-stakeholder approaches are not enacted.”
However, overall, they wrote that the findings “indicate respondents’ largely positive views on the viability of numerous and diverse strategies,” adding that the “first steps to applying the findings may involve discussions and deliberations about which strategies are best aligned with an organization’s goals and capabilities.”