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Specific topics included in this episode:

  • Background on Approval Pathways

  • 505(b)(2) Pathway

  • Interchangeability

  • Potential Barriers to Uptake

  • Payer Implications

  • Provider Implications

  • Manufacturer Motivations for 505(b)(2) Pathway

  • Coding and Reimbursement

  • Manufacturer Pricing and Formulary Access Considerations

  • Development Considerations

  • Prescriber Pushback​

"The positive aspects of a 505(b)(2) for a health plan is that they can offer medication that may be less expensive than the brand reference product. In addition, the 505(b)(2) product may be on the U.S. market sooner than a generic ANDA product. The 505(b)(2) may also offer new contracting opportunities against the brand product for the same clinical area. And if the reference product has a patent, the 505(b)(2) may be able to bypass that issue. On the negative side, the brand product manufacturer may classify the 505(b)(2) as another brand, which again, as we talked to before, could impinge on current contract terms. In addition, it may be hard to switch patients to a 505(b)(2) product and even once the switch has been done, further switching to a generic ANDA product (once available) will be harder since interchangeability is lacking."

Our Executive Clinical Pharmacy Team discusses 505(b)(2) products and how they compete in the marketplace alongside brand and generic drugs, tackling pricing, market access, and stakeholder implications. 



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