Autoimmune Testing in Primary Care: A Comprehensive Approach

TRANSCRIPT for Webinar with the title: Autoimmune Testing in Primary Care: A Comprehensive Approach

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Immune testing and primary care, a comprehensive approach by Quest

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Diagnostics.

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I'm today's moderator, Anne Freeman, Senior Product Manager for Autoimmune and

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Immunology Testing at Quest Diagnostics.

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Today we're going to take a closer look at the evolving role of primary care

0:19
physicians in diagnosing autoimmune diseases.

0:23
And if we can jump to the next slide, that would be great.

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Thank you.

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Yeah.

0:28
So as I said today, we will take a deeper role into the look

0:33
into primary care physicians and diagnosing autoimmune diseases.

0:37
We'll also look at some associated comorbidities for patients with

0:41
autoimmune disease as well as some more advanced testing options for primary care

0:47
physicians.

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My guest today is Dr Anne Salm, Director and Lead Medical Science Liaison

0:54
for Infectious Disease and Immunology in the Quest Diagnostics Medical Affairs

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Division.

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Dr Salm, as always, it's a pleasure to be working with you

1:04
today.

1:04
Thank you so much for joining me for this presentation.

1:08
Oh, thanks, Anne.

1:09
Thanks for inviting me to present on this important and timely topic.

1:14
Fantastic.

1:14
So let's start off with the role of primary care in autoimmune testing and

1:20
diagnosis.

1:21
What makes lab testing and possible referral to specialty care unique in the

1:27
case of autoimmune diseases?

1:32
Well, for primary care clinicians, there are three key challenges.

1:36
When a patient presents with suspected autoimmune disease #1 there are any

1:42
efficiencies in ANA testing as it is a fairly sensitive test for autoimmune

1:47
disease, but not very specific, requiring additional lab testing and

1:52
follow up to a positive ANA.

1:55
Also, weakly positive ANA may occur in normal

1:58
healthy individuals, sometimes leading to unnecessary

2:02
rheumatology referrals.

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The second is the amount of time it takes in some regions of the US to get into a

2:10
rheumatologist.

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While there are about 5600 board certified rheumatologists in the US,

2:16
according to the American College of Rheumatology,

2:20
in 2023 it could take an average of six months to be seen by a rheumatologist via

2:25
primary care referral.

2:28
Finally, the third challenge, there's an increased awareness and

2:32
education around autoimmune disease.

2:34
What used to be thought of as a singly occurring condition,

2:38
we now know that the presence of 1 autoimmune disease increases the

2:42
likelihood of an individual developing A secondary autoimmune disease.

2:47
The Autoimmune Association estimates roughly 25% of autoimmune patients have

2:52
more than one autoimmune condition.

2:55
Additionally, there seems to be an increase in

2:58
autoimmune disease downstream to COVID infection.

3:03
So there are several population health level studies that have looked at the

3:09
relationship between autoimmune disease and other comorbid conditions including

3:16
heart disease, cancer, depression, interstitial lung or kidney disease,

3:22
osteoporosis or pregnancy complications.

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Let's zoom in on comorbid cardiovascular risk in autoimmune patients. Next slide.

3:34
So for autoimmune patients the risk of developing cardiovascular disease

3:38
increases.

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Interestingly, cardiovascular disease is the leading

3:43
cause of death in patients with rheumatoid arthritis and lupus.

3:48
According to the American Heart Association in 2024,

3:51
their guideline for primary stroke prevention.

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Rheumatoid arthritis patients have about a three fold increase risk of developing

4:00
a hospital myocardial infarction and about a six fold increased risk of

4:05
developing a silent MI in the pursuit of treating the whole person.

4:10
Knowing the relationship between autoimmune disease and other

4:14
comorbidities like cardiovascular disease can help inform patient management

4:19
decisions and ultimately improve outcomes.

4:23
Wow.

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So I can see with the increased risk for heart disease that it really would be

4:29
important for a patient to get to that autoimmune diagnosis quickly.

4:34
Traditionally, ANA by immunofluorescence or ANA by IFA

4:38
was the go to test when primary care providers suspected an autoimmune disease.

4:44
But what are some of the downsides to that approach?

4:48
Yeah, that is so true about ANA being the go to

4:51
test and that was the standard for quite some time.

4:55
But there are drawbacks to this approach and we've come to better under as we've

4:59
come to better understand autoimmune diseases.

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For instance, not all autoimmune diseases produce a

5:06
positive ANA.

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Scientific evidence.

5:08
Evidence is well established that ANA is positive in 90 to 95% of lupus patients.

5:15
However, it's only positive in roughly 20 to 40%

5:18
of rheumatoid arthritis patients.

5:20
Looking deeper into our own internal data at Quest in 2024 at result trends for ANA

5:26
in comparison to some other autoantibodies for autoimmune disease.

5:32
ANA was negative on patients with positive tests for rheumatoid arthritis

5:39
like rheumatoid factor, CCP and/or MCV.

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Similarly, ANA was negative in patients who tested

5:47
positive for autoantibodies associated with lupus mixed connective tissue

5:52
disease such and and mixed connective tissue disease such as dsDNA, RNP,

5:58
and or Smith/RNP.

6:02
So, in an effort to simplify in an effort to

6:05
support education and build awareness around auto antibody prevalence in

6:10
patients with autoimmune disease, we Quest have consolidated several dozen

6:15
peer reviewed publications and counting to develop this auto antibody prevalence

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chart.

6:21
The columns represent the most commonly encountered autoimmune diseases such as

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moving from left to right, systemic lupus erythematosus,

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mixed connective tissue disease, systemic sclerosis, zilbrin,

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Poly and dermatomyositis, autoimmune thyroid,

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and rheumatoid arthritis.

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The rows represent various autoimmune related biomarkers and their percent

6:50
prevalence.

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So moving down you can see those auto antibodies are listed.

6:57
The green highlights represent biomarkers mentioned in guidelines associated with

7:02
each autoimmune disease.

7:05
For instance, you can see in the CCP in the RA column.

7:09
CCP and RF are mentioned in rheumatoid arthritis diagnostic guidelines.

7:15
They show a prevalence of 71 and 77% in patients with established RA,

7:21
while positive ANA prevalence is only 38% in the same group.

7:27
ACR lupus guidelines mentioned ANA beta 2 glycoprotein antibodies,

7:34
complement C3 and C4 cardiolipin antibodies, double stranded DNA,

7:41
Smith and Smith/RNP auto antibodies, myositis guidelines mention Jo-1 antibody.

7:51
And then in the Sjorgen's column we're highlighting Green, the SS-A.

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This is mentioned in the Sjorgen's diagnostic guideline.

7:59
So we're looking at testing beyond ANA.

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So as we look at testing beyond ANA, there are other autoimmune biomarkers

8:06
that may be worth considering in primary care.

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As primary care providers, how might we, Quest,

8:13
partner with you to improve one's patients' timeline to rheumatology

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referral?

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How might testing beyond ANA in patients with suspected autoimmune disease

8:23
facilitate or shorten the timeline to diagnose?

8:29
So while it may seem daunting at first as a primary care physician to look through

8:34
the myriad of auto and autoimmune biomarkers to know which to select in

8:39
pursuit of testing beyond ANA, we Quest have heard this.

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And we understand as we've looked at the autoimmune diagnostic landscape,

8:48
the increase in autoimmune disease incidents and prevalence.

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While access to board-certified rheumatologists in some regions of the US

8:56
continues to be strained.

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The role of primary care clinicians becomes increasingly important in closing

9:04
diagnostic gaps by improving qualified referrals testing beyond ANA.

9:13
So as a national reference lab, Quest Diagnostics offers a variety of

9:17
autoimmune testing panels, one of which is the ANAlyzeR panel.

9:21
We know that assessing patients for autoimmune disease can be challenging in

9:25
the primary care setting.

9:27
We also know that symptom overlap exists among many autoimmune conditions,

9:32
making it difficult for primary care clinicians to know what tests to run

9:36
beyond ANA.

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This ANAlyzeR panel includes 25 autoimmune biomarkers,

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many of which our guideline recommended for the 8 most commonly occurring

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autoimmune conditions: lupus, mixed connective tissue disease or (MCTD),

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RA, systemic sclerosis, myositis, Sjogren and antiphospholipid syndrome and

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autoimmune thyroid disease.

10:08
Thank you for that.

10:09
And lastly, what can you share about coverage and

10:13
cost for the ANAlyzeR panel?

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I know that's a question that always comes up.

10:18
Yep, absolutely.

10:19
That is an excellent question.

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So we're looking at our internal data at Quest,

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roughly 70% of patients who undergo ANAlyzeR testing see a zero out of pocket

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cost.

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We also know that Quest is in network for about 90% of insured lives in the US.

10:38
Fantastic.

10:39
Thank you for that.

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So this brings us to the end of our prepared material for today.

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Thank you so much, Dr Salm, for sharing how the ANAlyzeR panel can

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provide a comprehensive first step evaluation for a patient with a suspected

10:56
autoimmune disease and that by evaluating multiple biomarkers at the same time in

11:02
one panel, it can get the patient on the path to a

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faster diagnosis.

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And with autoimmune diseases, a faster diagnosis that facilitates

11:11
earlier treatment can lead to better patient outcomes and not just for the

11:15
progression of their autoimmune disease, but it also allows their healthcare

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provider to better manage those associated comorbidities like

11:24
cardiovascular disease risk.

11:27
We do have time for some questions and it looks like we have a couple submitted.

11:33
Let me just pop over to the Q&A.

11:37
Great.

11:38
This one looks like it's for Dr Salm.

11:40
What feedback have you heard from rheumatologists who get who get patients

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referred to them with all of this testing already done?

11:51
Yeah.

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So I mean, there can be some variability in the

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rheumatologist that I've spoken to across the country.

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But by and large, when it comes to a patient being referred

12:02
to a rheumatologist, there have been rheumatologists who have

12:06
felt strongly that if primary care can do more testing beyond ANA,

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they've got more information at their fingertips to be able to work with.

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So while it isn't a perfect one-size-fits-all in all geographies

12:22
across the country, there have been certainly plenty of

12:26
recommendations for putting together a panel like ANAlyzeR.

12:31
Great, thank you.

12:34
OK, another one, how would you suggest we manage a patient

12:40
with a low ANA antibody titer?

12:44
Sure.

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So in the general population, a 1:40 sort of titer can exist.

12:54
It may be about roughly 98% sensitive, but only about 67% specific.

13:01
We do at Quest have a 1:80 titer.

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That is a new change.

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We were screening and and flagging 1:40s until recently.

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So now the cut off in broadly across the industry,

13:15
generally the 1:80 is the cut off for a positive.

13:19
So I'm just knowing that that 1:40 can be occurring in normal healthy individuals.

13:27
A fair amount, roughly 20 to 30% of healthy individuals

13:31
can have a very low titer that does happen.

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So interpret with caution when it's low titer like that.

13:38
OK, great.

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Thank you.

13:41
Let's see.

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Next question, what is the expected turn around time for

13:45
ANAlyzeR and what sample do we need to submit?

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I can take that one to give Doctor Salm a break.

13:52
So our published turn around time is 7 to 10 days, but in many regions,

13:58
we're seeing results report back into offices in as little as four to five days.

14:04
And then for clients that collect in their office,

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the sample type we need is 3 refrigerated SST tubes,

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so serum separator tubes that will get us plenty of sample to complete all the

14:17
components in the ANAlyzeR panel.

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So 3 refrigerated SST tubes.

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OK, now let's see back to a Dr Salm question.

14:30
In what cases might a patient be negative for ANA but positive for some other

14:36
biomarkers associated with rheumatic disease?

14:39
I think you had some of that data on Slide 6.

14:44
I don't know Jasmine, if you want to pop back to Slide 6,

14:48
that was our some of our Quest internal data.

14:55
OK.

14:56
Yeah.

14:57
So the Quest internal data shows that for patients that have, you know,

15:04
a negative Ana but are positive for things like RFCCP or MCVA little over.

15:12
Let me see, I'm having a hard time.

15:14
Let me just take a look here.

15:17
Just wanted to make sure I'm quoting it right.

15:21
Yes, some of the data is smaller on this one.

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Yeah, it is kind of little.

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OK.

15:26
So in our patients that were negative for ANA but positive for biomarkers

15:31
suggestive of rheumatoid arthritis, we saw about a little over 30% of of

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those patients fell into that.

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So this is a year's worth of data.

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Same goes for a negative ANA with biomarkers associated with lupus or mixed

15:45
connective tissues.

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So this would be your dsDNA, Smith or Smith/RNP,

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about 17% showed a negative ANA, but we're still positive for some of

15:54
these other lupus or mixed connective tissue disease.

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So this is information that we've put out in materials at Quest.

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So you certainly you can if you want to take a closer look,

16:06
that is something that our reps can provide to you, but that that does occur.

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And so that's another reason why this ANAlyzeR panel has really turned out to

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be helpful in testing beyond ANA in the primary care setting.

16:20
Fantastic.

16:22
Had someone asked if you could revisit or reiterate what you said about coverage

16:29
and patient, what kind of bills patients might expect.

16:35
Sure.

16:36
So if we want to advance to the slide, that includes that information.

16:41
Jasmine, it was the second to last one.

16:46
Yeah.

16:47
Are you going to jump all around the deck, Jasmine?

16:50
Yeah, it's the water.

16:54
There you go.

16:56
So when we're looking at the coverage of ANAlyzeR,

17:00
there's about 70% that are not going to pay any out of pocket at all.

17:06
But what isn't mentioned in the slide or in the presentation,

17:10
but might be also helpful is that of those that do pay out of pocket,

17:14
the median cost out of pocket for those remaining individuals that do have to pay

17:20
is less than $200 out of pocket.

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And that's again based on our internal data.

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And then the last question I have so far and again if you have any questions,

17:31
feel free to drop them in the Q& A section.

17:34
The last one I have so far is with the increase in value based healthcare models,

17:39
what kind of a burden is this test putting on the healthcare payer?

17:44
So not so much what does it cost the patient,

17:47
which is we can see is often very little, but what does it,

17:50
what is the cost to the healthcare system?

17:53
Yeah, Yeah.

17:54
That's a great question.

17:56
So there have been some population based economic studies and models that have

18:01
shown the importance of diagnosing patients with autoimmune disease sooner

18:07
rather than later.

18:08
The longer it takes to diagnose an autoimmune condition,

18:13
the more the poorer the outcomes.

18:16
So certainly earlier intervention is is always better.

18:21
Particularly we see that in RA it's been difficult to talk broadly across all

18:27
autoimmune diseases.

18:28
So if so, we have some studies that you know,

18:31
certainly our payer access group has has poured over in alongside the payers,

18:36
the major payers that we meet with on a regular basis to talk about ways in which

18:42
you know, diagnosis, early diagnosis early interventions can

18:46
help improve that overall healthcare burden.

18:49
If you as a client or or any of our reps want some of those studies certainly

18:55
reach back out to me.

18:56
But it is well understood certainly published in Lupus and RA because of the

19:02
higher prevalence of those autoimmune conditions that earlier interventions are

19:08
are better and save a great deal in terms of the overall healthcare burden and cost

19:14
to patients and to caregivers.

19:17
Fantastic.

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And I can also share that while our individual rates with payers are varied

19:25
based on our contracts, we can share that for 95% of our claims

19:30
the healthcare payer is paying less than $500.00.

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So we're not we're not talking about billing thousands of dollars to the

19:39
healthcare payers.

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So, you know, probably less than an X-ray or an

19:43
emergency room visit, although I don't exactly know what those

19:46
cost.

19:46
So, and that appears to be the end of the

19:50
questions unless there's any further ones, which I don't see.

19:58
So I want to thank you, Doctor Salm for joining us for this

20:02
webinar.

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It will be recorded and available shortly.

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If anyone has any colleagues that weren't able to make it today and if anyone has

20:11
any additional questions, please feel free to reach out to Doctor

20:15
Salmurai or feel free to reach out to your Quest Diagnostics commercial

20:20
representative.

20:22
Great.

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And thank you so much for your time today.

20:24
Thank you.