The Overall Cost-Effectiveness of Adjuvant Ribociclib in ER+ Early Breast Cancer

In this interview, Adam Brufsky, MD, PhD, University of Pittsburgh, delves into the economic and clinical implications of adjuvant ribociclib for high-risk estrogen-receptor-positive (ER+) early breast cancer. He unpacks data he presented at the 2025 AMCP Annual Conference suggesting that despite upfront costs, ribociclib may offer long-term value by preventing costly distant recurrences. Dr Brufsky also highlights the urgent need for biomarkers to better identify patients who will benefit most from this targeted therapy.

Please state your name, title, and any relevant clinical experience you’d like to share.

Adam Brufsky, MD, PhD: My name is Dr Adam Brufsky. I am a professor of medicine at the University of Pittsburgh in Pittsburgh, Pennsylvania, and co-director of the Cancer Therapeutics Program at the University of Pittsburgh Medical Center Hillman Cancer Center.

Can you briefly summarize your study and its key takeaways?

Dr Brufsky: I was involved in a collaborative effort with a number of physicians as well as members of the Health Economics and Resource division at Novartis. The idea behind this analysis was to determine the economic cost vs the benefit of adjuvant ribociclib.

Ribociclib has been approved for adjuvant therapy for women and the occasional man with high-risk ER+ early breast cancer. We looked at the number of distant recurrences prevented and the cost of those recurrences and compared them to the total cost of care. Our analysis found that ribociclib costs about $300 000 a year, and the cost per quality life year gained is about $43 000. Typically, anything less than $150 000 for quality of adjusted quality of life gained is reasonable and is usually accepted by most medical authorities around the world. To summarize, there is a cost up front, but the out-back cost of distant recurrence is just as much, if not more.

This study projects a modest increase in life-years and QALYs with RIB+NSAI. From a clinical pathways perspective, how should decision-makers weigh this benefit against the incremental cost of approximately $30,000?

Dr Brufsky: I've been very involved in ClinicalPath (formally Via Oncology). We started Via at the University of Pittsburgh almost 20 years ago. The way we evaluate new therapies—at least from the standpoint of ClincalPath—is that we initially look at efficacy. Then we look at toxicity if 2 regimens are equally efficacious, and then we look at the cost to the payer and to the patient, which falls within what a pathway would have. In terms of a pathway, for this study the quality gained was about $43 000. We did a number of sensitivity analyses that were consistent with this quality gain.  However, there are some assumptions we made that need to be tested a little bit more.

How does this cost-effectiveness profile compare with other adjuvant CDK4/6 inhibitor strategies that have been evaluated or are currently under review?

Dr Brufsky: The assumption that is made in this study is the total cost of care is about $800 000 per patient for their entire lifetime, whether they get adjuvant ribociclib or they get adjuvant endocrine therapy and then have to be treated for progression. My understanding is the cost is fairly similar to what's been done with abemaciclib.

Despite higher up-front drug costs, the analysis found lower downstream costs for recurrence and terminal care. Do you foresee these findings influencing formulary access or payer coverage policies in the near term for patients with early breast cancer?

Dr Brufsky: It may or may not influence them mainly because there was only about 3 and a half years of follow up in the NATALEE trial, which is a big adjuvant ribociclib trial. We need more data on what happens after ribociclib, after progression. We have data from some of the clinical trials, but I think what's going to be important in the future is to back that up with real-world analysis.

We have huge databases, like Flatiron and IQVIA, containing data on people who have been getting  CDK4/6 inhibitors and other therapies for metastatic ER+ breast cancer. Hopefully, we’ll be able to derive more therapy data, not cost data necessarily. We can already do that by pulling the cost out of the various Medicare cost tables, but it's important to know if I'm an insurer looking at a payer, I'm going to say, “Wow! This looks pretty good, and it's reasonable.” But there are limitations that I'm going to want to know more about. That may be the only thing that will have payers not want to accept this upfront. But if you do accept the limitations—maybe the 3- to 4-year follow-up that was used in this study and/or the cost of care in the metastatic setting when someone relapses—this is something that payers would support.

Looking ahead, how might the findings from this study help shape guideline recommendations or integration into value-based care models for early breast cancer management?

Dr Brufsky: There has been a lot of research around cost per local recurrence prevented, but cost per distant recurrence prevented is important because distant recurrence costs a lot more. That's what the study’s analysis showed. Distant recurrence costs a lot of money because someone has to go through all of these expensive therapies indefinitely. In today's environment, people will live a long time. Once they relapse, the median survival in most randomized clinical trials from a couple years ago is about 59 months, 60 months, 65 months—a little over 5 years. But I suspect it's even longer than that with better patient selection.

Patients will be on these therapies for 2 to 4 years if they relapse. What we need to see is not the overall analysis, but the analysis of various subgroups. For stage patients with stage III, they relapse at a higher rate. Most of us accept CDK4/6 inhibitors in that setting. What is more of an edge case is the patients who have T2N0 disease (high risk) or T2N1 (low risk), both of which were included in NATALEE. Those women, and the occasional man, tend to relapse at a lower rate. That has to be taken into account. A separate analysis of those patients should be done.

What this kind of area needs are biomarkers, and I think the payers and us as clinical investigators would like that. We all would love a biomarker that would tell us whether or not patients will really benefit from this treatment. Currently, you will have about 5 patients to treat. If we had some sort of biomarker to prevent recurrence, it would make a lot of this more acceptable to everybody. Those biomarkers are coming. They're not going to be here tomorrow, but a couple years from now they'll probably be here.

Is there anything else you'd like to add?

Dr Brufsky: Adjuvant ribociclib therapy for specific patients has potential and is probably changing the natural history of the disease for certain women. Our problem is that we don't know who these patients are. Right now, we're treating everybody, and that's costly. Where the field is likely heading is to being more selective about who is going to benefit. There will be patients with T2N0 or T2N1 that will benefit from adjuvant ribociclib. We need to spend the next couple years figuring out who they are, and until we do, we may have to absorb the additional costs.