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Pharmacy Cost Management: Can you benefit from recent FDA guidance on biosimilar replacements?

| August 09, 2019
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The U.S. Food and Drug Administration issued guidance May 13 that clears the way for pharmacists to replace some expensive biological medical products with certain biosimilars. This change has the potential to help companies save thousands of dollars in pharmacy costs. Here are three things you can do to make sure you’re benefiting:

1. Understand the basics

According to the FDA, Biological Products or biologics are large-molecule drugs produced through biotechnology in a living system. They’ve become the standard of care for some serious diseases such as autoimmune disorders, cancer, and diabetes. Think Enbrel, Epogen, Humira, Neulasta, or Remicade. Biosimilars are highly similar to the original or reference product approved by the FDA. If they are proven to have no clinically meaningful differences from the reference product, they are allowed a faster approval process. And they can be less expensive.


2. Talk with your PBM or consultant

You’ll want to know how they’re working on your behalf to take advantage of this guidance.

  • Will your plan recognize biosimilars?
  • If so, which ones or for which therapeutic categories?
  • How will the plan handle biosimilars within its prior authorization and step therapy programs?
  • Will you grandfather employees who are currently using a biologic?

3. Consider employee communication

If you’re grandfathering employees with exiting biologic prescriptions, you may not need to communicate about this change right away. But if you plan to shake up their current protocols, you’ll want to work with your carrier or PBM to coordinate communication and present the company’s point of view on this change. If you’re like most companies, specialty pharmacy costs are a primary risk to your health care spending. So, it’s smart to act early on this new guidance. Just a few slight changes could make a significant difference in your 2019 plan costs.

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