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Preventable Toxicity: The Pharmacogenomics Case for DPYD Testing in Oncology | Precision Medicine Pharmacist Podcast · Pharmacy Podcast Network

• 0:05
  Speaker 1: You are listening to the global network of podcasters dedicated
• 0:09
  Speaker 1: to the pharmacy profession.
• 0:10
  Speaker 2: Welcome to the Pharmacy Podcast Network.
• 0:31
  Speaker 3: Welcome to the Precision Medicine Pharmacist podcast, part of the
• 0:35
  Speaker 3: Pharmacy Podcast Network. Our host, doctor Melissa Smith, an expert
• 0:39
  Speaker 3: in pharmacogenomics and advocacy, brings in other professionals in the
• 0:43
  Speaker 3: field to dive into how pharmacogenomics is improving patient lives
• 0:47
  Speaker 3: with accuracy and awareness. This is the Precision Medicine Pharmacist podcast.
• 1:04
  Speaker 1: Welcome to the Precision Medicine Pharmacist part of the Pharmacist
• 1:07
  Speaker 1: Podcast Network. I'm doctor Melissa Smith. In today's episode, we're
• 1:12
  Speaker 1: exploring the power and the responsibility of pharmacogenetic testing and
• 1:16
  Speaker 1: the cancer care space, and we're focusing on DP wide testing.
• 1:20
  Speaker 1: And joining us today is Karen Merritt, and she is
• 1:24
  Speaker 1: a patient advocate who co founded Advocates for Universal DPD
• 1:29
  Speaker 1: SLASH DP wide Testing, and this was after losing her
• 1:33
  Speaker 1: mother to chemotherapy toxicity that may have been preventable. Karen,
• 1:38
  Speaker 1: first of all, welcome. I'm so happy to have you
• 1:40
  Speaker 1: on today's episode. Not a more perfect person to speak
• 1:44
  Speaker 1: about such an important testing that needs to be brought
• 1:48
  Speaker 1: more awareness to I want to really begin with you
• 1:53
  Speaker 1: touching on your personal story, because when you and I
• 1:56
  Speaker 1: spoke prior, we really dove deeply into this and I
• 1:59
  Speaker 1: think this is so to why this is such an
• 2:01
  Speaker 1: important mission for you.
• 2:03
  Speaker 2: Yes, well, thank you for having me, Melissa. So, I
• 2:06
  Speaker 2: didn't know anything about pharmacogenomics or DPYD before my mom
• 2:11
  Speaker 2: started her first infusion for five FU chemotherapy for her
• 2:15
  Speaker 2: calling cancer or actually more specifically anal cancer, and they
• 2:22
  Speaker 2: said it was fairly well tolerated. You know, the risks
• 2:26
  Speaker 2: are low of any any problems. My mom started her
• 2:30
  Speaker 2: infusion on a Monday, and by Friday she knew she
• 2:34
  Speaker 2: was dehydrated, had to go to the emergency room get fluids.
• 2:38
  Speaker 2: At this point would have been a perfect opportunity for
• 2:41
  Speaker 2: the er staff work for oncology to come down and
• 2:44
  Speaker 2: see her and realize, oh my gosh, she's you know,
• 2:47
  Speaker 2: showing signs of toxicity to this five FU. They did not,
• 2:53
  Speaker 2: She was not seen, They did not call her oncologists.
• 2:55
  Speaker 2: They gave her fluids, which you know, after the diarrhea
• 2:59
  Speaker 2: and she was severely dehydrated, so she got a little
• 3:03
  Speaker 2: boost of energy, felt better. Went home a couple of
• 3:06
  Speaker 2: days later, collapsed, taken to the hospital and when she
• 3:13
  Speaker 2: was admitted, they said, oh, this looks like toxicity to
• 3:17
  Speaker 2: five if you because of DPD deficiency. And in the
• 3:20
  Speaker 2: notes it says there was no way to know this
• 3:23
  Speaker 2: before starting chemo. From what I know now, this is wrong.
• 3:26
  Speaker 2: You can have a genetic test for DPYD. And so
• 3:32
  Speaker 2: she spent an amazed and incredible, excuciating pain in the
• 3:38
  Speaker 2: ICU with around the care and she died on July second,
• 3:42
  Speaker 2: twenty fourteen, less than three weeks after starting For about
• 3:46
  Speaker 2: three weeks after starting her chemotherapy. An important thing that
• 3:51
  Speaker 2: we found out after my mom passed away is that
• 3:54
  Speaker 2: we should have had her death certificate change to make
• 3:57
  Speaker 2: the first cause of death the toxicity to five FU chemotherapy.
• 4:02
  Speaker 2: Because of DPD deficiency, this drug causes multi system organ
• 4:08
  Speaker 2: failure and so what's listed as the cause of death
• 4:12
  Speaker 2: is cardiac arrest because that was the last body organ
• 4:15
  Speaker 2: that gave out. So what this did is that the
• 4:18
  Speaker 2: hospital did not report her death as an adverse drug
• 4:22
  Speaker 2: event to the FDA. So the FDA is not getting
• 4:27
  Speaker 2: a full picture of the number of patients that are
• 4:30
  Speaker 2: dying or having the adverse drug events. Because of Flora yourself.
• 4:35
  Speaker 2: We co founded a nonprofit organization to be able to
• 4:40
  Speaker 2: raise awareness and the nonprofit is advocates for universal DPD
• 4:45
  Speaker 2: SLASHDPID testing. So with discovering that this was DPD deficient,
• 4:50
  Speaker 2: that this could have been a test, gotten found some
• 4:56
  Speaker 2: other individuals who experienced the same thing. Didn't do much
• 5:01
  Speaker 2: for a few years, and then we kind of got
• 5:04
  Speaker 2: a big cohort of us. Then we decided that we
• 5:07
  Speaker 2: would we needed to have a nonprofit so that we
• 5:10
  Speaker 2: would have an organization to talk about when we were advocating.
• 5:15
  Speaker 2: And our mission is to make the standard of care
• 5:18
  Speaker 2: be DPID testing for any patient who's going to be
• 5:21
  Speaker 2: given five FU chemotherapy or the oral version CAPE side
• 5:26
  Speaker 2: of being.
• 5:26
  Speaker 1: And yes, your nonprofit that you developed is I wanted
• 5:29
  Speaker 1: to make sure to highlight that here on the screen
• 5:31
  Speaker 1: for everybody and if you want to visit that and
• 5:34
  Speaker 1: get more information for it, it's a test for DPD
• 5:37
  Speaker 1: dot org. That's a great resource for information and one Karen,
• 5:41
  Speaker 1: I just want to say thank you for sharing that.
• 5:44
  Speaker 1: That's not an easy story to share, the passing of
• 5:46
  Speaker 1: your mother from something that could have been preventable for her,
• 5:49
  Speaker 1: But I love that it was an opportunity for you
• 5:52
  Speaker 1: to turn that around and really allow this to be
• 5:55
  Speaker 1: a platform for you to bring awareness around it and
• 5:59
  Speaker 1: allow people to to prevent that for one of their
• 6:02
  Speaker 1: loved ones that may need to go on these types
• 6:04
  Speaker 1: of therapies. And the other thing I wanted to bring
• 6:07
  Speaker 1: up is just kind of a information really about what
• 6:12
  Speaker 1: DPYD is and why this gene is important for us
• 6:16
  Speaker 1: to be testing. Even outside of this, just kind of
• 6:18
  Speaker 1: the science behind it. So DPYD is a gene that
• 6:22
  Speaker 1: encodes for DPD and a key enzyme that metabolizes medications
• 6:26
  Speaker 1: like the fluoro perimidines like five floor you're still and
• 6:30
  Speaker 1: cape syllabines. So recently we're going to talk about the
• 6:34
  Speaker 1: FDA update to zolota or cape syllabines indication for testing.
• 6:39
  Speaker 1: So there are certain dp wedy variants that reduce or
• 6:43
  Speaker 1: eliminate DPD activity. And the reason this is important because
• 6:47
  Speaker 1: without enough enzyme, the drug isn't cleared and it accumulates,
• 6:51
  Speaker 1: so it builds up in the body, causing really serious toxicities.
• 6:55
  Speaker 1: And there's a lot of you know, there's pre treatment
• 7:00
  Speaker 1: and testing more commonly utilized in Europe, but now with
• 7:05
  Speaker 1: the help with Karen Merritt and her advocacy for this,
• 7:08
  Speaker 1: we're getting we're seeing more of this becoming more of
• 7:11
  Speaker 1: a common testing now in the United States, especially with
• 7:15
  Speaker 1: this big update with the FDA label. I mean, I
• 7:17
  Speaker 1: think it's a little late for it personally.
• 7:19
  Speaker 2: But.
• 7:22
  Speaker 1: And I want you to really highlight that for me, Karen,
• 7:25
  Speaker 1: and just kind of talk with me about this. I mean,
• 7:28
  Speaker 1: this is huge because FDA labeled updates for Cape sitabine.
• 7:31
  Speaker 1: This is significant and for folks that before taking this
• 7:36
  Speaker 1: and not being recommended, this is a life saving gene
• 7:41
  Speaker 1: to be testing for.
• 7:42
  Speaker 2: Yeah, the FDA labeling update is huge. And a little
• 7:48
  Speaker 2: backstory there is that the FDA was petitioned by the
• 7:53
  Speaker 2: president of our nonprofit and there have been several label
• 7:57
  Speaker 2: changes to Cape sided mean because of the advocacy of
• 7:59
  Speaker 2: men members of our group. In twenty twenty they took
• 8:03
  Speaker 2: away the word rare that patients are DEPD deficient, so
• 8:07
  Speaker 2: that was the huge in twenty twenty two, in December
• 8:12
  Speaker 2: of that year, they added that clinicians should consider testing
• 8:20
  Speaker 2: and they should discuss DPD deficiency with patients, so that
• 8:25
  Speaker 2: was getting stronger but not what we wanted. So this
• 8:27
  Speaker 2: new labeling update that just happened in early October is
• 8:33
  Speaker 2: a milestone. And it went from consider testing to test
• 8:37
  Speaker 2: for rec test for genetic variants of DPD before starting
• 8:44
  Speaker 2: cape sidabing. This is huge and pharmacists really hold the key,
• 8:50
  Speaker 2: especially with cape sidabing that is an oral pill because
• 8:56
  Speaker 2: like we all know, when we go to the pharmacist
• 8:58
  Speaker 2: or we receive our medication, there's multiple pages with all
• 9:02
  Speaker 2: this information about the drug. So the change that the
• 9:06
  Speaker 2: FDA made this time is a black boxed warning, which
• 9:10
  Speaker 2: is the highest level of warning that the FDA gives
• 9:14
  Speaker 2: for for medications. This is a milestone for patient safety.
• 9:19
  Speaker 2: And now we are anxiously awaiting the FDA to make
• 9:22
  Speaker 2: the same labeling update for flur your cell the infusion
• 9:26
  Speaker 2: of five.
• 9:27
  Speaker 1: F You yes, and I'm surprised that it didn't do
• 9:31
  Speaker 1: it simultaneously, to be honest with you, and I know
• 9:34
  Speaker 1: that your advocacy group is probably in the works of
• 9:38
  Speaker 1: you know, submitting and that's something I wanted to highlight
• 9:41
  Speaker 1: here too, is we can we talked about what you
• 9:45
  Speaker 1: are able to do as let's say a pharmacist or
• 9:48
  Speaker 1: a practitioner that's wanting to raise awareness and bring this
• 9:51
  Speaker 1: to the forefront where it can update the labeling again
• 9:54
  Speaker 1: for five floor yourself. So what is your organization doing
• 9:57
  Speaker 1: currently for this?
• 9:59
  Speaker 2: Well, we had petitioned along with Cape Side of Being,
• 10:04
  Speaker 2: to the FDA to have these labeling changes. So they
• 10:08
  Speaker 2: made the same labeling change in twenty twenty to take
• 10:12
  Speaker 2: out the word rare for flora urosel rare that DEPD
• 10:16
  Speaker 2: deficiency is rare. And then in twenty twenty four is
• 10:22
  Speaker 2: when March of twenty twenty four is when the FDA
• 10:26
  Speaker 2: added the same wording into Flora urosel that they had
• 10:30
  Speaker 2: for Cape Side of Being, which was the consider testing
• 10:33
  Speaker 2: for DPD and talk to your patients about testing and
• 10:40
  Speaker 2: the risks if you're DPD deficient. Now we are actually
• 10:47
  Speaker 2: calling and emailing the FDA and actually getting a response.
• 10:51
  Speaker 2: They cannot talk about it at this moment, but in
• 10:56
  Speaker 2: May of twenty twenty five, the FDA put out a
• 11:00
  Speaker 2: public docket requesting information or comments from stakeholders, which would
• 11:06
  Speaker 2: be on cologists, patients, caregivers, pharmacists, the lab communities, lots
• 11:12
  Speaker 2: of patient advocacy groups. They got over one hundred and
• 11:16
  Speaker 2: twenty five comments, which is pretty dramatic for a public docket,
• 11:21
  Speaker 2: and so we think that the FDA took some of
• 11:25
  Speaker 2: that information into this labeling change for cape cidobene and
• 11:30
  Speaker 2: flurry yourself is on the way, is our hope. I
• 11:34
  Speaker 2: think it's just more complex because it's an infusion drug
• 11:39
  Speaker 2: and not an oral drug.
• 11:42
  Speaker 1: Makes sense, Yes, I mean that's sad that they can't
• 11:46
  Speaker 1: speak to it, especially when one and that's in a
• 11:50
  Speaker 1: similar family of drug that can cause these toxicities. Without
• 11:53
  Speaker 1: knowing this gene information prior, it can be you know,
• 11:56
  Speaker 1: like I said, I keep reiterating this, it's life saving
• 11:59
  Speaker 1: to know this ahead of time of taking these therapies.
• 12:02
  Speaker 1: And you would think that in the ecology space that
• 12:04
  Speaker 1: this would have been utilized prior to ever administering these therapies.
• 12:10
  Speaker 1: But you're right the FDA and they will, and a
• 12:11
  Speaker 1: lot of times with providers they are gunshy to just
• 12:16
  Speaker 1: you know, unless it's being referred to by the FDA,
• 12:20
  Speaker 1: unless it's going with very high levels of evidence. With
• 12:23
  Speaker 1: regards to the genetic testing, they are not usually utilizing
• 12:27
  Speaker 1: it or really making themselves aware of it and researching
• 12:31
  Speaker 1: upon it. But you would think that in the the
• 12:33
  Speaker 1: oncology space that this wouldn't be the case for the
• 12:35
  Speaker 1: These medications have been around them for a long time,
• 12:38
  Speaker 1: so for them to be utilizing them, using them, prescribing them,
• 12:42
  Speaker 1: and them not being fully versed on the complexities of
• 12:49
  Speaker 1: the genetics, I mean not necessarily the complexities, but just
• 12:56
  Speaker 1: the awareness around them. It would be common sense, yes,
• 13:02
  Speaker 1: common sense prescribing, right, You would think that they would
• 13:05
  Speaker 1: want all information in front of them before prescribing toxic
• 13:08
  Speaker 1: type chemotherapies to their patients that are wiping out their
• 13:11
  Speaker 1: immune systems, causing systemic organ failures and potential death with
• 13:16
  Speaker 1: knowing something as simple as this, And this is why
• 13:19
  Speaker 1: pharmacogenomics is really so important prior to it should be
• 13:23
  Speaker 1: a common test that's done for everybody, even if they're
• 13:26
  Speaker 1: not in the oncology space. It really should be something
• 13:29
  Speaker 1: that's done just like a metabolic panel right at the
• 13:31
  Speaker 1: time of being seen by your primary care having all
• 13:34
  Speaker 1: these genes into a database for you when we're aligning
• 13:40
  Speaker 1: it with your medication selection. This would and you're right
• 13:43
  Speaker 1: that pharmacists are we're the advocates for the pharmacogenomic testing,
• 13:47
  Speaker 1: that's for sure, but the providers really just are hesitant
• 13:53
  Speaker 1: to use a lot of times because their extent of
• 13:56
  Speaker 1: knowledge in the and pharmacology is limited in school for them.
• 14:00
  Speaker 1: Yes they know how to diagnose, Yes they know how
• 14:02
  Speaker 1: to prescribe based off protocol, but when we get into
• 14:06
  Speaker 1: the genetic information, the path of physiology, pharmacokinetics, pharmacodynamics, that's
• 14:11
  Speaker 1: not their will. Well, this is ours. So that's where
• 14:14
  Speaker 1: I also see a slight gap in its utility and
• 14:18
  Speaker 1: being able to prevent more things like the DPYD testing
• 14:24
  Speaker 1: and toxicities with certain medications for patients. So you're spot
• 14:29
  Speaker 1: on as far as what we're discussing today. I'm really
• 14:31
  Speaker 1: glad that we're able to bring more awareness to it.
• 14:35
  Speaker 1: And that's a great kind of leading point to a
• 14:37
  Speaker 1: next question for me is you know, we saw kind
• 14:40
  Speaker 1: of the experience with your mom and with other colleagues
• 14:44
  Speaker 1: that you've encountered or even practitioners you've spoken to. What
• 14:48
  Speaker 1: kind of barriers have you encountered with them? Just as
• 14:52
  Speaker 1: far as your work has gone, I.
• 14:54
  Speaker 2: Think some of it is it's a change, right, It's
• 14:58
  Speaker 2: a shift in the way you're normally doing something and
• 15:02
  Speaker 2: how do you do that? And pharmacists or hospital administrators
• 15:08
  Speaker 2: putting it into the workflow. That would be super helpful.
• 15:13
  Speaker 2: Other barriers that we've seen is the testing takes too long.
• 15:17
  Speaker 2: Well that's changed, right. You used to take three weeks.
• 15:21
  Speaker 2: Now you can get it as early as three days.
• 15:24
  Speaker 2: And a lot of institutions that are implementing, and the
• 15:29
  Speaker 2: Veterans Administration as well. It's you you get. You request
• 15:34
  Speaker 2: the DPYD test at your initial intake appointment, and oftentimes
• 15:40
  Speaker 2: that result is going to be back sooner than some
• 15:43
  Speaker 2: of the other scans and things that you're requesting at
• 15:47
  Speaker 2: the beginning. So that kind of takes away that that
• 15:50
  Speaker 2: time window that waiting. If that way, when you're going
• 15:54
  Speaker 2: to be making a treatment decision, you already have those
• 15:57
  Speaker 2: test results rather than getting to that treatment decision appointment
• 16:01
  Speaker 2: and saying, oh, well, we don't want to wait two
• 16:03
  Speaker 2: more weeks to see if you're DPD deficient. So this
• 16:06
  Speaker 2: is kind of like changing the workflow. Used to be
• 16:10
  Speaker 2: insurance coverage and that was a real barrier, and so
• 16:16
  Speaker 2: that is definitely changing. It's covered by Medicare now, and
• 16:20
  Speaker 2: once it's covered by Medicare, independent or private insurance companies
• 16:24
  Speaker 2: are also covering it. We see ETNA covering it, we
• 16:30
  Speaker 2: see United Healthcare. In some situations we see a lot
• 16:34
  Speaker 2: of the blue crosses, and some of this is stemming
• 16:37
  Speaker 2: from the member Like Carolon is a member benefit management
• 16:43
  Speaker 2: company of like how PBMs help pharmacy benefits, Well, this
• 16:48
  Speaker 2: is the testing benefit comes from the member benefit groups.
• 16:54
  Speaker 2: And I learned from carol On that they're implementing they've
• 16:57
  Speaker 2: moved DPYD from investigatortional to a metal acnomstic. Yes, so
• 17:04
  Speaker 2: it's now medically necessary in carol On member benefit groups.
• 17:10
  Speaker 2: So that is going out to all of the insurance.
• 17:14
  Speaker 1: Yeah. It's one thing to change something on a packaged
• 17:18
  Speaker 1: insert label, right, it's another for it to be covered
• 17:21
  Speaker 1: through insurance companies. You're absolutely right and follow suit with that,
• 17:25
  Speaker 1: and by making it medically necessary, that eliminates the necessity
• 17:29
  Speaker 1: of prior authorizations, the delay and care, the accountability with
• 17:33
  Speaker 1: how insurance companies really follow suit with medicare is kind
• 17:38
  Speaker 1: of my line of thought there is that when they
• 17:42
  Speaker 1: have it on their docket for coverage. You said it
• 17:45
  Speaker 1: spot on that that's when the commercial insurances will follow
• 17:48
  Speaker 1: suit as well. So that has definitely been and where
• 17:52
  Speaker 1: I've seen it more prevalently being covered to is in
• 17:56
  Speaker 1: long term care experienced there with the long term care population,
• 18:01
  Speaker 1: and I know we have pediatric pharmacists around the country
• 18:04
  Speaker 1: working with pharmacogenomics. Jenna Quinn heads that division of that.
• 18:08
  Speaker 1: I mean, on a national level, she's doing great work.
• 18:10
  Speaker 1: I'm curious as far as how she works that in
• 18:15
  Speaker 1: as well with the payment structure for young children, you know,
• 18:18
  Speaker 1: getting coverage for it too. I think she works specifically
• 18:22
  Speaker 1: with ACO groups for that, but I don't quote me
• 18:24
  Speaker 1: on that. Let's even strike that because I'm not sure
• 18:26
  Speaker 1: about that. Okay.
• 18:29
  Speaker 2: Another interesting thing about coverage to and insurance companies and
• 18:35
  Speaker 2: you know, financial toxicity for patients is if you look
• 18:40
  Speaker 2: about you know, in twenty fourteen dollars at the time,
• 18:45
  Speaker 2: a DPYD test was probably you know, maybe five hundred dollars,
• 18:49
  Speaker 2: maybe six hundred dollars. But the cost of my mom's
• 18:54
  Speaker 2: er visit and then ambulance ride to the hospital and
• 19:00
  Speaker 2: two plus weeks of round the clock ICU care, ICEE
• 19:04
  Speaker 2: you care with all of the specialists that came in
• 19:07
  Speaker 2: every day, all of the medications. Just the twenty four
• 19:11
  Speaker 2: to seven care in a hospital was over half a
• 19:14
  Speaker 2: million dollars. And that was in twenty fourteen. I mean,
• 19:18
  Speaker 2: that right there is just it's an economic decision, it's
• 19:22
  Speaker 2: a patient safety decision, and quite frankly, it's a risk
• 19:26
  Speaker 2: management decision.
• 19:29
  Speaker 1: Yes, that right there just really awakened me in this
• 19:34
  Speaker 1: conversation to comparing the cost of what your family had
• 19:38
  Speaker 1: to endure, your mom had to endure, and the accumulating
• 19:41
  Speaker 1: cost of things that she could have avoided with a
• 19:44
  Speaker 1: five hundred dollars test instead of five hundred thousand dollars.
• 19:47
  Speaker 1: In the end of it, that right there justifies anybody
• 19:51
  Speaker 1: receiving it, because the nice thing about genetic testing is
• 19:54
  Speaker 1: that it's a one in most instances, it's a one
• 19:57
  Speaker 1: time test when we have a comprehensive gene evaluation ran
• 20:01
  Speaker 1: not just a single isolated gene, and that was only
• 20:04
  Speaker 1: for DPYD. Now we have the pharmacogenomics which encompasses this
• 20:08
  Speaker 1: additional gene as well. More of the pharmacogenomic laboratory since
• 20:12
  Speaker 1: this update and even prior to that, have been incorporating
• 20:15
  Speaker 1: DPYD testing. Their cost is anywhere between the three hundred
• 20:21
  Speaker 1: dollars window to about five hundred dollars and you're getting comprehensive,
• 20:25
  Speaker 1: like forty one genes within the spread of the genes
• 20:30
  Speaker 1: available in pharmacogenomic testing. So you're really getting more bang
• 20:34
  Speaker 1: for your book, if you will, more comprehensive knowledge and insight,
• 20:38
  Speaker 1: and really more patient safety when the genetic testing's done
• 20:42
  Speaker 1: up front, and it's a cost savings ultimately on the
• 20:45
  Speaker 1: back end, And I hate to think of it in
• 20:47
  Speaker 1: that way, but it truly is. I mean, it could
• 20:48
  Speaker 1: save so much money in the healthcare system that is
• 20:52
  Speaker 1: already a broken system, right we are are healthcare costs
• 20:56
  Speaker 1: are astronomical compared to other countries. It's just insane. So
• 21:01
  Speaker 1: I like that point about it as well.
• 21:04
  Speaker 2: One of the things that we did discover is that
• 21:07
  Speaker 2: when the FDA made the labeling change to cape cidebeing
• 21:11
  Speaker 2: in twenty twenty two, Flora Urso in twenty twenty four
• 21:17
  Speaker 2: to consider testing and then to clinicians needed to discuss
• 21:21
  Speaker 2: test DP WHIT testing with patients, that a lot of
• 21:25
  Speaker 2: our colleges were not aware of those labeling changes.
• 21:28
  Speaker 1: Yes, and there was actually something that an associate of
• 21:32
  Speaker 1: yours posted on LinkedIn today. It was his name's Jack Paveli.
• 21:38
  Speaker 1: Is that how you pronounce his last name?
• 21:40
  Speaker 2: PhD?
• 21:41
  Speaker 1: And it was the actual dphite variants that are of
• 21:46
  Speaker 1: high significance to test for when we're testing for dp white,
• 21:51
  Speaker 1: because there's going to be different variants that are more
• 21:53
  Speaker 1: specific for the different Yes perfect And if you down
• 22:00
  Speaker 1: to the image, it'll uplook, you'll see the FDA update
• 22:03
  Speaker 1: DPID testing recommended before starting zealota, and then it actually
• 22:07
  Speaker 1: has the list of the top variants to look for
• 22:10
  Speaker 1: within that image when we're testing for potential toxicities when
• 22:15
  Speaker 1: administering five for lower yoursel and zolota. So these are
• 22:19
  Speaker 1: a really good ones for us to be aware of, and.
• 22:23
  Speaker 2: This is really key. Originally the FDA's stance was we're
• 22:29
  Speaker 2: not going to recommend DPID testing because there is no
• 22:34
  Speaker 2: FDA approved test. And so now we have an FDA
• 22:39
  Speaker 2: approved test, and I didn't realize that advice was a test.
• 22:43
  Speaker 2: But a very key point that is in that you
• 22:47
  Speaker 2: just shared with those variants is that the Association for
• 22:51
  Speaker 2: Molecular Pathology came out with a recommendation in August of
• 22:56
  Speaker 2: twenty twenty four of the variance that should be included
• 23:01
  Speaker 2: in lab DPID assays and they broke it down into
• 23:05
  Speaker 2: two tiers. Tier one is must have variants, which are
• 23:10
  Speaker 2: seven which you see on that lab device. Test that
• 23:14
  Speaker 2: got approved seven variants from AMPS Tier one, and then
• 23:19
  Speaker 2: AMP Association for Molecular Pathology also added a Tier two,
• 23:24
  Speaker 2: which would be would be nice to have, So it
• 23:28
  Speaker 2: would be nice to have in addition to the tier
• 23:31
  Speaker 2: one for my advocacy the gold standard. We would love
• 23:36
  Speaker 2: to see full DPID gene as the gold standard because
• 23:42
  Speaker 2: there are rare variants that are not included on the
• 23:46
  Speaker 2: AMP Tier one in tier two, and the reason for
• 23:49
  Speaker 2: that is because they are not they haven't been documented
• 23:53
  Speaker 2: enough in the scientific literature and they haven't seen those
• 23:58
  Speaker 2: variants enough. And most of the research has been done
• 24:04
  Speaker 2: on Caucasians Northern European descent, right, but we're finding out
• 24:13
  Speaker 2: that there are rare variants from other backgrounds, so we're
• 24:20
  Speaker 2: getting there, right. This is when my mom was tested,
• 24:24
  Speaker 2: there was only one variant on most lab DPID panels,
• 24:30
  Speaker 2: and that same lab that tested my mom now has
• 24:33
  Speaker 2: five variants. And I think everybody's quickly trying to catch
• 24:37
  Speaker 2: up with the Association for Molecular Pathologies Tier one to
• 24:42
  Speaker 2: two variants, but it takes it takes time.
• 24:45
  Speaker 1: Yeah, it definitely does. Yeah, I'm really glad that you
• 24:49
  Speaker 1: clarified on that because it makes a difference when as
• 24:52
  Speaker 1: a pharmacist we're reviewing the information and the laboratories that
• 24:55
  Speaker 1: we're working with. It helps with with making sure that
• 25:01
  Speaker 1: we're being that comprehensive with all the genes that are
• 25:03
  Speaker 1: available to us, right, So thank you for sharing that.
• 25:07
  Speaker 1: That's very very helpful.
• 25:09
  Speaker 2: Yeah, we plan on tests fordpd dot org. We plan
• 25:15
  Speaker 2: on putting up a list of labs that have tier
• 25:19
  Speaker 2: one and Tier two variants being tested. That's very important
• 25:26
  Speaker 2: to us. As well as on our website, we have
• 25:28
  Speaker 2: a list of leaders in Testing, which are the cancer
• 25:32
  Speaker 2: centers in the United States that test all patients prior
• 25:37
  Speaker 2: to cape site being and florae or so.
• 25:40
  Speaker 1: I love that because we need somewhere that's consolidated and
• 25:43
  Speaker 1: you guys have created that. So this is a great
• 25:45
  Speaker 1: resource for reference for that. And that one is on
• 25:49
  Speaker 1: the test for DPD dot org. Correct.
• 25:52
  Speaker 2: Yeah, And you can do after the test for DPD
• 25:55
  Speaker 2: dot org backslash leaders in Testing and then they're there's
• 26:00
  Speaker 2: a map there and a button to push and you'll
• 26:03
  Speaker 2: see a list of we ever broken down by ones
• 26:06
  Speaker 2: that test system wide and then we have a list
• 26:11
  Speaker 2: of some that it's only one oncology group. So it
• 26:16
  Speaker 2: might be only the GI cancers, or it might be
• 26:19
  Speaker 2: only the breast cancer doctors that are testing. Again, our
• 26:25
  Speaker 2: hope is that all cancer centers will have a system
• 26:29
  Speaker 2: wide policy in place. I think some of them call
• 26:32
  Speaker 2: it an s bar. And I just learned this morning
• 26:37
  Speaker 2: that Yale Cancer Center and Smilo Cancer Center that are
• 26:41
  Speaker 2: one and there are an NCCN member institution, and as
• 26:46
  Speaker 2: of October thirtieth, they will be testing all their patients
• 26:49
  Speaker 2: before five f You and CAPE side being good.
• 26:54
  Speaker 1: They should be.
• 26:56
  Speaker 2: I mean, we're considering this is like a train in
• 26:59
  Speaker 2: there is leaving the station. Are you going to get on? Yes?
• 27:03
  Speaker 2: You don't want to be in the caboose.
• 27:05
  Speaker 1: You want to be think that they would be found
• 27:07
  Speaker 1: negligent if they weren't right. It's so important for them
• 27:11
  Speaker 1: to protect themselves as the prescribers of these therapies and
• 27:16
  Speaker 1: to be aware of it. It's they have to do
• 27:18
  Speaker 1: their due diligence to do no harm to their patients,
• 27:20
  Speaker 1: and this is part of that.
• 27:21
  Speaker 2: So one of the other implementation challenges has been guidelines. Right,
• 27:27
  Speaker 2: A lot of oncologists are going to be looking to
• 27:30
  Speaker 2: the guidelines to make sure that they're following standard of care,
• 27:34
  Speaker 2: and so we as well as petitioning the FDA for
• 27:38
  Speaker 2: labeling change is. We have been with our medical advisors
• 27:43
  Speaker 2: and other oncologists and pathologists and pharmacists and PGX advocates
• 27:50
  Speaker 2: petitioning the NCCN Colon Cancer Panel over the last eight
• 27:56
  Speaker 2: to ten years and they in March of twenty twenty
• 28:01
  Speaker 2: five the colon anal, rectal and small bowel Cancer's guideline
• 28:06
  Speaker 2: did put in test for DPD deficiency. But we think
• 28:14
  Speaker 2: that they need to make it just a blanket across
• 28:17
  Speaker 2: all guidelines. And if we wait till the guideline annual
• 28:25
  Speaker 2: circuit comes through, it's going to take too long for patients.
• 28:29
  Speaker 2: So we need that to move a little closer. As
• 28:32
  Speaker 2: CO now has in their template when they're going over
• 28:37
  Speaker 2: all new guidelines, they are now having a discussion about
• 28:41
  Speaker 2: DPYD testing when a new guideline or a guidelines being updated,
• 28:45
  Speaker 2: and one was just updated for breast cancer. I don't
• 28:50
  Speaker 2: know specifically which one. It should come out very soon.
• 28:57
  Speaker 2: They just had a a public comment on it for
• 29:01
  Speaker 2: as CO members and it says the panel recommends DPHD testing.
• 29:06
  Speaker 2: So all these pieces are coming together, the labeling, the guidelines,
• 29:11
  Speaker 2: the insurance, and we still need to get all clinicians
• 29:17
  Speaker 2: pharmacists aware of you know how important that this is
• 29:22
  Speaker 2: and that it is in the labels and that the
• 29:24
  Speaker 2: guidelines are changing.
• 29:26
  Speaker 1: Excellent, Yes, I mean providers, they are big on guidelines.
• 29:29
  Speaker 1: So if we can show them there, show them the
• 29:31
  Speaker 1: significance of it there, they are more inclined to follow.
• 29:36
  Speaker 1: That's absolutely correct. I was just looking at the dp
• 29:39
  Speaker 1: WHD tasks and laboratory data that your your website has
• 29:44
  Speaker 1: and it's I'm pleased to see that lab core quest
• 29:48
  Speaker 1: one home is part of this uh Indiana University Genetic
• 29:52
  Speaker 1: Testing Laboratories, the Mail Clinic.
• 29:56
  Speaker 2: RPRD and that list is out a little bit outdated.
• 30:01
  Speaker 2: We will be updating it that that was pre Tier one.
• 30:05
  Speaker 1: Yes, and if there's any pharmacists or any hospitalists oncologists
• 30:11
  Speaker 1: and you're using a particular laboratory or you have on
• 30:15
  Speaker 1: site testing at your clinics for this, please make Karen
• 30:19
  Speaker 1: aware so that way she can update this list and
• 30:23
  Speaker 1: it can be made more accurate to the times, especially
• 30:26
  Speaker 1: if it's been newly added. Access DX is on here
• 30:29
  Speaker 1: as well, which that doesn't surprise me.
• 30:32
  Speaker 2: Yeah, yes, thank you, Melissa. We would love to add
• 30:36
  Speaker 2: labs that are testing, and we'd love to add cancer
• 30:39
  Speaker 2: centers that are testing. I just had somebody reach out
• 30:43
  Speaker 2: to me from Miami Cancer Institute as we know about
• 30:47
  Speaker 2: their PGX implementation. The list is growing and we're so
• 30:52
  Speaker 2: thankful because the whole reason that we have our nonprofit
• 30:57
  Speaker 2: is to make sure other families don't suffer. Have a
• 31:00
  Speaker 2: loved one suffered? Yes, and it's you're just you're blindsided
• 31:05
  Speaker 2: and you feel like nobody told you about this.
• 31:08
  Speaker 1: Now, I want to go into some quick fire facts
• 31:10
  Speaker 1: and I want to pose this first question with you, Karen,
• 31:14
  Speaker 1: and and does a negative DPYD test result in a
• 31:18
  Speaker 1: guaranteed safety profile for a patient?
• 31:21
  Speaker 3: That is no.
• 31:22
  Speaker 2: And I'm not medically trained or scientifically trained, but what
• 31:27
  Speaker 2: I have read is that there are other reasons you
• 31:30
  Speaker 2: can have toxicity to chemotherapy or medications, but specifically for
• 31:36
  Speaker 2: five if you it is a tool in the toolbox
• 31:41
  Speaker 2: to test for DPD deficiency, but it's not a going
• 31:47
  Speaker 2: to protect one hundred percent protection.
• 31:49
  Speaker 1: Right, It's something that makes awareness around dosing and and
• 31:53
  Speaker 1: and even appropriateness for prescribing in these patients to begin with,
• 31:59
  Speaker 1: of course, But yes, I do agree with you that
• 32:01
  Speaker 1: it's not necessarily a guaranteed safety net, even because any
• 32:06
  Speaker 1: kind of chemotherapy has its involved types of risk versus
• 32:10
  Speaker 1: benefits right for treatments, and a lot of these quick
• 32:14
  Speaker 1: fire questions we may have already answered, but we can
• 32:16
  Speaker 1: go from here as far as being quick and deliberate
• 32:19
  Speaker 1: with them. In DPID testing, is it required before five
• 32:24
  Speaker 1: floor your serial or capes cape citabine. I think we've
• 32:26
  Speaker 1: already addressed this, thanks, and that's a yes. So that's
• 32:32
  Speaker 1: definitely a yes that it's it's not required yet for
• 32:34
  Speaker 1: five floor a year or so, but it is required
• 32:36
  Speaker 1: for cape citabing currently under Zaloda. How long does it
• 32:39
  Speaker 1: take to typically get a test? I would say right now,
• 32:43
  Speaker 1: on average for any type of genetic testing, a blanket
• 32:46
  Speaker 1: statement is seven to fourteen days. It's much faster when
• 32:48
  Speaker 1: the clinics have a laboratory to assess and task genetically
• 32:54
  Speaker 1: on site. So that's usually maybe our two or three
• 32:57
  Speaker 1: day turnaround, maybe even quicker, just depends on the environment
• 33:00
  Speaker 1: and who you're sending your test to. Does it negate? Okay,
• 33:04
  Speaker 1: we already talked about that. One one of the top
• 33:06
  Speaker 1: variants pharmacists should know. We talked about this with the
• 33:09
  Speaker 1: tiered level ones from the Association for Molecular Pathology, So
• 33:12
  Speaker 1: there's two different tiers. We'll highlight that at the end
• 33:16
  Speaker 1: tier with a link to that, and we talked about
• 33:19
  Speaker 1: guidelines and ones that we should be following. We have
• 33:23
  Speaker 1: the sea Pick guideline for the floor of PERIMEDINGES and
• 33:27
  Speaker 1: DPYD testing and this is under the sea Pick guidelines
• 33:30
  Speaker 1: that's also updated there. But you also can go to
• 33:33
  Speaker 1: Package Inserts for Zealota currently for its updated information on
• 33:38
  Speaker 1: timing of testing, etc. And then pharmacists can pharmacists order
• 33:46
  Speaker 1: or recommend this testing. Of course, we can always recommend
• 33:49
  Speaker 1: it depending upon your state. In how you are in
• 33:52
  Speaker 1: association with a collaborative practice agreement with a provider working
• 33:56
  Speaker 1: with the oncology teams. Here is where you would actively
• 33:59
  Speaker 1: have authority to assist in the ordering of this testing.
• 34:05
  Speaker 1: Typically with pharmacists, we are a barrier to the ordering
• 34:10
  Speaker 1: of PGX testing in the cash paying market, so this
• 34:13
  Speaker 1: is an area of insurance billing. So it's important when
• 34:16
  Speaker 1: you're in affiliation with any oncology team that that's in
• 34:20
  Speaker 1: you're the clinical pharmacist overseeing any of the prescriptions being
• 34:24
  Speaker 1: prescribed in that space. That's where you would be able
• 34:26
  Speaker 1: to have collabtive practice agreement and be able to order
• 34:30
  Speaker 1: under the supervision of a pro of the practicing oncologists
• 34:33
  Speaker 1: there too. So that's where I could see pharmacists being
• 34:36
  Speaker 1: able to do that. Okay, and we're going to close
• 34:41
  Speaker 1: up today because we've definitely covered so much on this
• 34:45
  Speaker 1: topic and I'm so grateful for you being here. Is
• 34:48
  Speaker 1: there any last message you'd like to share with our
• 34:50
  Speaker 1: pharmacy audience today about where we can We've mentioned this
• 34:55
  Speaker 1: before quite a few times, but any last notes you'd
• 34:57
  Speaker 1: like to leave.
• 34:58
  Speaker 2: Yeah, I think farm y are essential to making testing
• 35:02
  Speaker 2: possible and collaborating with clinicians very important with the education
• 35:10
  Speaker 2: that pharmacists can do along with genetic counselors possibly at
• 35:14
  Speaker 2: their institutions. If you are at an institution that does
• 35:18
  Speaker 2: not yet have DPYD testing implemented, I believe we talked
• 35:23
  Speaker 2: about and Melissa is going to put a link in
• 35:27
  Speaker 2: for you with a guide to implementing DPYD testing by
• 35:32
  Speaker 2: Teresa Hoe and her colleagues. Find and find a champion
• 35:39
  Speaker 2: at your center and be bold explaining to your champion
• 35:43
  Speaker 2: into the oncologists that this is life saving, sharing real
• 35:48
  Speaker 2: world examples of what happens when it's not tested, and
• 35:52
  Speaker 2: that this is a risk management for clinicians and institutions
• 35:59
  Speaker 2: from a life saving standpoint. If there's a champion pharmacist
• 36:05
  Speaker 2: that can collaborate with the champion oncologist at your center,
• 36:10
  Speaker 2: that is one way to go around. And I know
• 36:13
  Speaker 2: my local cancer center, they their lab and their so
• 36:18
  Speaker 2: the pharmacists and the genetic counselors, they went around and
• 36:20
  Speaker 2: did a road show they called it, and talked to
• 36:23
  Speaker 2: all of their cancer center locations and shared with this
• 36:28
  Speaker 2: is how you ordered the test, this is how we're
• 36:30
  Speaker 2: going to put it into your workflow, and when the
• 36:33
  Speaker 2: rules come back, we're here to walk you through it.
• 36:37
  Speaker 2: And one of the reasons that's so important is sometimes
• 36:40
  Speaker 2: when you do a multi gene panel and not just DPYD,
• 36:44
  Speaker 2: you're going to find out about other genetic variants for
• 36:48
  Speaker 2: things that don't infect affect your chemo. And sometimes on
• 36:54
  Speaker 2: cologists we've heard, don't want to hear about the other
• 36:57
  Speaker 2: drugs that they might have to be. You know, it's
• 36:59
  Speaker 2: it's some news. So here comes the pharmacist in to
• 37:03
  Speaker 2: educate and help with that whole process. So it's definitely
• 37:08
  Speaker 2: a collaboration and that's where I see pharmacists really really being.
• 37:15
  Speaker 1: Definitely and for the providers listening to this, pharmacists are
• 37:18
  Speaker 1: your advocate in the precision medicine space. We are here
• 37:21
  Speaker 1: to help support you and to make sure that you're
• 37:25
  Speaker 1: utilizing the information, all information to your patient's benefit. We
• 37:28
  Speaker 1: want to make sure that all medications taken in combination
• 37:31
  Speaker 1: are going to be safe at the drug to drug
• 37:34
  Speaker 1: interaction level, and then also incorporating the drug gene information
• 37:37
  Speaker 1: as well because it's so important and can be life saving.
• 37:40
  Speaker 1: Cannot emphasize that enough.
• 37:42
  Speaker 2: I have to say that the also the the oncologists
• 37:46
  Speaker 2: and the pharmacists that have implemented pre treatment DPID testing
• 37:51
  Speaker 2: into their workflow are so happy to talk with other
• 37:57
  Speaker 2: pharmacists and oncologists about how to how we did it
• 38:01
  Speaker 2: and you don't do it.
• 38:03
  Speaker 1: Letting a burden, right and pharmacist is the person to
• 38:07
  Speaker 1: help lessen the load of you worrying about the intricacies
• 38:10
  Speaker 1: of these interactions and support you and your patients to
• 38:14
  Speaker 1: make them be able to come out on the other
• 38:17
  Speaker 1: end of this. Cancer is a difficult and you know
• 38:20
  Speaker 1: treatment and it's a difficult, difficult road for them to experience.
• 38:24
  Speaker 1: So by doing this and working with the pharmacists, you
• 38:27
  Speaker 1: just are really elevating the patient care by so much.
• 38:31
  Speaker 2: It's life saving.
• 38:32
  Speaker 1: Absolutely to our listeners, you are on the front lines
• 38:36
  Speaker 1: of precision medicine, advocate for your patients, support DPYD testing,
• 38:40
  Speaker 1: and help prevent preventable toxicities. This has been the precision
• 38:44
  Speaker 1: medicine pharmacists. Subscribe, share and like this episode, and visit
• 38:49
  Speaker 1: the tesk for DPD dot org to learn more.
• 39:07
  Speaker 2: A people believe to di