NCCN Guidelines on CDK4/6 Inhibitor Treatment Regimens


Dr Kettle outlines NCCN guideline-directed therapy surrounding CDK4/6 inhibitors.

Ryan Haumschild, PharmD, MS, MBA: Dr Kettle, when we’re making decisions so many times, [we] as providers and also payers really utilize the NCCN [National Comprehensive Cancer Network] guidelines as great support in terms of coverage [and] in terms of therapy use,…even many of us [who] develop our own internal pathways. A lot of times we use NCCN as the foundation. So…as a pharmacist and as someone who’s a key decision maker in your organization, in clinic, what is the importance of NCCN guidelines and how is the NCCN positioning of CDK4/6s important, especially in the frontline use sector?

Jacob K. Kettle, PharmD, BCOP: It’s a great question and I think you highlighted a lot of key parts. The NCCN guidelines in many ways dictate most of what we do in terms of payor coverage. And you know, from a financial perspective, [it’s] really critical to have an understanding because again, it is a driving piece of payer coverage. The other part of the puzzle as far as how does it play into clinical decision-making, I think it’s [that] oncology has [become] so incredibly complex. And it changes so quickly. And in particular,…talking about CDK4/6s, we have 3 drugs, lots of overlap, but also a lot of subtle important nuances between them. I think this is where NCCN guidelines are so critical to…help provide that baseline foundational knowledge where you again have that kind of agreed upon consensus of what’s right most of the time. But again, [we] also want to preach and make it clear to our care teams or physicians that it is not that we are permanently and forever beholden to the guidelines. There are times when expertise, clinical experience, and particular clinical situations dictate deviation from the guidelines. So it’s really important to understand…how that fits in and not be overly prescriptive and overly reliant on what we use the guidelines for, but also understand that it’s a really good…consensus starting point to facilitate discussion. As far as the CDK4/6 inhibitors, they all have recognition in the NCCN guidelines, both in first-line use and second-line use. There are some differences between which have Category 1 approval and which don’t, and in which settings. Of course, that Category 1 approval is based off whether or not overall survival has been demonstrated. One of the biggest caveats is which drugs have Category 1 approval and which don’t. And so, in the first-line setting again, ribociclib, abemaciclib, and palbociclib in combination with aromatase inhibitor [are] all mentioned, but because of that delineating overall survival data, ribociclib has that Category 1 designation. And then in the second-line setting fulvestrant is your hormonal therapy backbone. And then again you can use ribociclib abemaciclib, or palbociclib, but in this case both ribociclib and abemaciclib…have that Category 1 designation. So again, it’s important to understand there [are] some subtle differences, some nuances. There [are] great debates that can be had about what are the factors that led to differences in patient population selection, all those things that led to [some trials having] an overall survival advantage and some not. Those are great questions to have. And I think, again, NCCN is…our foundational baseline consensus of where we can start. It’s a great place to generate discussion and…important to know maybe we have a slight preference for a drug that has their Category 1 designation, but also,…maybe because of [an adverse] effect profile or a drug that has a more amenable treatment schedule, maybe that’s better. So maybe in those cases we…deviate from a Category 1 drug instead of sticking to it, maybe go to…another recommended drug that may be more palatable to the patient.

Transcript is AI generated and edited for clarity and readability.

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