At the 20th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD) in Copenhagen, Eli Lilly and Company presented new data evaluating the cost‑effectiveness of using confirmatory blood testing to identify amyloid pathology in U.S. patients with cognitive impairment.
In the interview, Dr. Anthony “Nino” Sireci, senior vice president of clinical biomarkers, laboratories and diagnostics at Eli Lilly and Company, highlights key considerations for clinicians and underscores why timely and accurate diagnosis is so important in symptomatic Alzheimer’s disease. He explains that the findings support the use of AD blood tests in patients with symptoms of Alzheimer’s disease as a practical, scalable biomarker that can integrate naturally into existing workflows—helping clinicians triage patients more efficiently across primary and specialty care and strengthening the overall diagnostic pathway.
Kelly Hogan:
Hello, my name is Kelly Hogan. And as a conference producer with Fierce Life Sciences, I have the pleasure of interviewing Dr. Anthony Nino Sireci. He is the Senior Vice President of Clinical Biomarkers, Laboratories, and Diagnostics at Eli Lilly and Company and a board certified clinical and molecular pathologist.
Welcome, Nino. How are you today?
Dr. Anthony Nino Sireci:
Hey, Kelly. Great. Thanks for having me.
Kelly Hogan:
Of course. First question. Lilly presented new data at the Alzheimer's Disease and Parkinson's Disease Conference on the cost-effectiveness of AD blood testing in the US for patients with symptoms of Alzheimer's disease.
What do you think are the most important takeaways for clinicians?
Dr. Anthony Nino Sireci:
Thanks for the opportunity to talk about this study. I think it's a pretty cool addition to the literature around blood tests for the diagnosis of Alzheimer's disease. Let me just tell you a little bit the story first. The study compared two approaches to the diagnosis of Alzheimer's disease. The first was the standard clinical evaluation alone, and the second paired that standard evaluation with a blood test to identify amyloid pathology.
Using a US payer's perspective, from the point of view of a US payer, the study asked about diagnostic accuracy costs and quality adjusted life years gained by these different approaches, and then essentially calculated what we call an incremental cost-effectiveness ratio, say that five times fast, to essentially assess the cost of gaining one quality life year compared between the two approaches.
Important takeaways, I think, from my perspective, but also for clinicians, alongside cognitive testing, that blood test for amyloid pathology proved to be a cost-effective way to identify patients with amyloid pathology without the need for a secondary confirmatory test. That blood test alone in a patient population who were already defined as cognitively impaired was a cost-effective way to identify pathology in those patients.
And more importantly, in sort of more detail, the rates of PET testing and CSF testing, which can be fairly invasive procedures to confirm amyloid pathology, decreased from 51% in the standard arm to 9% in the arm that were tested both with standard approach plus a blood test. That's a pretty significant and drastic reduction in those additional diagnostic tests. What this does is it strengthens the confidence of use of these blood tests in the clinical setting of working up of a cognitively impaired patient as a confirmatory test for the presence of amyloid pathology.
Kelly Hogan:
Interesting. And how do these findings fit into the broader conversation about AD blood tests and their role in streamlining Alzheimer's disease diagnosis?
Dr. Anthony Nino Sireci:
Probably the most important factoid from this presentation and the one that sticks with me is that 40% reduction in the use of PET and CSF as confirmatory tests for amyloid pathology. Today, we know that patients, in order to receive the diagnosis of amyloid pathology and eventually Alzheimer's pathology, go through these additional tests, CSF and PET, which can be invasive and oftentimes difficult to schedule for patients. Difficult for physicians to schedule as well. The reduction in that rate in and of itself is a really eye-opening, kind of interesting key insight from this study when you use blood-based biomarkers.
The second take-home for me is that while the incremental cost does go up in the scenario where you use blood-based biomarkers, it's because you've identified more patients with amyloid pathology who can then go on to treatment, to referral treatment, and therapy. When you look at the overall cost per quality life year gained, it was about $5,000 additional per quality life year gained. And that is well below the standard willingness to pay what we think about from a willingness to pay threshold for payers, which is generally between $50,000 and $150,000. It's a small price to pay for that increase in quality life years gained.
Bottom line. Blood biomarkers. Cost-effective way to identify patients with amyloid pathology, and it avoids these more difficult diagnostics like CSF and PET.
Kelly Hogan:
And what does this research suggest about how clinicians, both PCPs and specialists, can better integrate AD blood tests into their workflow?
Dr. Anthony Nino Sireci:
First and foremost, we should call out the low-hanging fruit, which is every patient deserves to have a mental status exam during their Medicare well visit starting when those Medicare well visits start as a screen for cognitive impairment and for potentially a flag for further workup. I think there's a role at that point for these blood biomarkers to help triage and diagnose patients and get them referred and diagnosed and treated as quickly as possible when appropriate. I think the study shows that you can do that in a cost-effective way through the use of blood biomarkers.
I think an important message is PET, CSF, these confirmatory tests, still have a role to play in the diagnosis. I think blood biomarkers just help triage to whom those tests are offered and decrease the larger role that they currently play in the diagnosis. I think in an ideal world, where we land is a PCP neurologist or a memory specialist visits with a patient, identifies them as having potential cognitive impairment through the variety of clinical tools that they have at their disposal, and then they order an AD blood test to help assess whether or not the cause of that cognitive impairment is, in fact, amyloid or AD pathology. If positive, avoiding the need for confirmatory tests and can then go on to having more frank discussions with patients about diagnosis, planning, and treatment.
Kelly Hogan:
Of course, the challenge still exists that access to Alzheimer's disease diagnostic tools remains uneven. How can AD blood tests help improve access and readiness across the system?
Dr. Anthony Nino Sireci:
I think this is one of the general features of the AD blood test that I think is most promising. We know that not everyone has access to a PET center close to their house or a center that can do their CSF testing close to where they live, and so it becomes difficult for patients who live in more rural areas and resource-restricted regions of the world and underserved regions of even our very own country. AD blood biomarkers have a role to play across the spectrum but particularly in those areas where those more invasive and complicated diagnostics don't necessarily exist easily.
I think, in and of itself, just having access to those diagnostics, the blood diagnostics, will help with access to AD diagnostics. Of course, there is that number, that 40% reduction, in that PET and CSF confirmatory testing. Another big key to why this is going to help patients not only get access to a diagnosis, but get access then to discussions with specialists about disease planning and potential treatment options. I think that's another big access bucket that blood biomarkers opens up for patients.
Again, I think that these biomarkers are non-invasive tools. They're easy to add onto your clinical workup along with your cognitive assessment and really ought to be or will soon play a very large role in how patients are diagnosed and triaged and then eventually treated for Alzheimer's disease pathologies.
Kelly Hogan:
Excellent. Well, thank you very much, Nino. I appreciate the opportunity to take a closer look at this topic with you today.
Dr. Anthony Nino Sireci:
Thanks, Kelly.