Navigating the 505(b)(2) Pathway: Operational, Clinical, and Economic Strategies for Oncology Practices

In this episode of Treating Together, managing editor Sabrina Serani sits down with 3 experts at the intersection of oncology pharmacy, health informatics, and drug distribution to unpack the 505(b)(2) regulatory pathway and what it means for cancer centers navigating today's complex drug landscape.

Guests:

• Jessica White, PharmD, Vice President, Specialty Programs & Portfolio Management at McKesson
• Derek Burns​, PharmD, Senior Director, MID Solutions at McKesson
• Nick Brady​, Director, Health Informatics at Central Arkansas Radiation Therapy Institute (CARTI)​

What We Cover:

The 505(b)(2) Pathway Explained — Jessica breaks down how the 505(b)(2) new drug application differs from a traditional NDA, allowing drug developers to build on existing FDA-recognized data through bridging studies. The result: faster approvals, lower development costs, and drugs that improve on — rather than simply duplicate — what's already on the market.

Why Oncology, Why Now — Nick explains how 505(b)(2) drugs address a critical pain point in oncology practice: supply disruption. When reference products go on allocation or become unavailable, these drugs provide a meaningful alternative — and in some cases, meaningful clinical improvements like reduced toxicity, modified dosage forms, or improved adherence.

The Real Friction Points — Derek identifies where practices actually get stuck: not at the clinical level, but in operations. Launching without a brand name, missing J-codes, absent ASP data, and gaps in the CMS NDC crosswalk all create hesitation in revenue cycle teams. The underlying problem, he argues, is almost never resistance to innovation — it's undefined coverage, coding, and workflow clarity at launch.

Who Needs to Be at the Table — Nick walks through Carti's internal adoption process, emphasizing that economic evaluation must run in parallel with patient impact assessment. A cross-functional team — pre-certification, pharmacy (both infusion and dispensing), billing and coding, and claims monitoring — needs to move together, with a single source of truth so that no one on the front lines is working from conflicting information.

Practical Strategies for Adoption — The group converges on two key approaches: front-load organizational alignment before the first dose is given, and start narrow with a defined pilot population before any broad rollout. Derek and Jessica also stress the value of a designated practice champion who can coordinate across departments and pressure-test coverage and economics in advance.

The Patient at the Center — When everything is working, patients experience seamless transitions between products, fewer delays, and — in some cases — therapies that are easier to tolerate and stay on. The panel emphasizes that a well-integrated 505(b)(2) strategy should be invisible to the patient while delivering real downstream clinical and economic benefit.

Safety Considerations — Derek underscores that practices managing multiple agents within the same drug category face real risks around dispensing, billing, and administration if labeling and workflows aren't airtight. Jessica notes that the industry is correcting course, with more manufacturers now launching 505(b)(2) products with distinct brand names — reducing the risk of misidentification.

Where the Pipeline Is Headed — Jessica closes with a look at the road ahead: more branded manufacturers entering the 505(b)(2) space, a growing pipeline from traditional generic manufacturers focused on oncology, and a strategic emphasis on supply redundancy and clinical improvements for older, well-established agents that have experienced drug shortages.

Key Takeaways:

• Treat 505(b)(2) drugs as an operational, clinical, and financial tool, not just an economic play.
• Every oncology practice will likely carry multiple agents in the same category; managing that inventory safely is non-negotiable.
• If you've seen one 505(b)(2), you've seen one. Ask what's actually different, what the evidence supports, and how it fits your patients.
• "Not yet" is more accurate than "never": even practices not ready to adopt should be educating staff now.