Protocols and Laws for Transitioning to Biosimilars

Ryan Haumschild, PharmD, MS, MBA, and Kathy Oubre, MS, recall what protocols and laws their organizations needed to abide by when transitioning to their biosimilars programs.

Ryan Haumschild, PharmD, MS, MBA: When you go to implement biosimilars, it’s important to make sure that you’re bringing through your strategy, and you have all of the decisions made through a shared decision-making framework. That means that you want to make sure nursing is involved, the providers are involved, quality is involved, everyone has insight into and transparency regarding why we’re trying to implement biosimilars, and the benefits of them. As we create transitions, we want input from everyone, patient family advocates, etc, to make sure we’re always doing the right thing. As we went to drive forward with biosimilar implementation, we continued to bring the biosimilars initially through our P&T [pharmacy and therapeutics] committee and created a monograph. Over time, our physicians and the greater P&T committee said, “We get the concept of biosimilars. Once they’re approved by the FDA to highly similar products, you don’t need to bring them forward, because we recognize more biosimilars are going to come to market. Let’s approve the concept of biosimilars and have some standard work in the way we look at biosimilars, but after that’s complete, let’s defer to pharmacy to choose the best product that provides the best pricing to our organization and our patients. That way we can reduce carrying costs and create more real time implementation.” That’s also important because we had payers that were already requiring biosimilars. If we don’t become efficient in the way that we onboarded these biosimilars to formulary, we may end up getting a lot of denials, which creates frustration for the patient, our providers, and the organization. Getting that P&T approval and that P&T policy approval on biosimilars allows us to be a lot more operationally efficient. When it comes to switches, you want to consult your local board of pharmacy rules and regulations. We want to make sure that we’re complying with any of those regulatory considerations. We made sure we did our homework within our P&T-approved policy, and within our provider approval for making those substitutions that actually complied with local board of pharmacy regulations and allowed us to be successful with our strategy and utilizing biosimilars. In addition to that, we also had payer mandates that were requiring it, and we were having to tag our physicians anyway to have them switch it out. By creating this policy and procedure, it met our regulatory requirements, it met our shared decision-making requirement, and it met the needs for that just-in-time treatment plan that benefitted the patient.

Kathy Oubre, MS: The protocols that we used to drive this transition were to build new treatment plans for all of those biosimilars, update any existing treatment plans, and then use detailed workflows around the steps for authorization, administration, and adherence. The next step is to develop reports internally, and within our EMR [electronic medical records], to monitor all of those moving parts. Last, for switches, the way biosimilars are designated requires both physician-approval and patient-reconsent for therapy for interchange to occur. From a state and regulatory perspective, we have not seen that be a large barrier within our transition.

This transcript has been edited for clarity.

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