Preview of the Panel Discussion on IMPLEMENTATION OF MOLECULAR TESTING: Demonstrating Clinical Utility and Measuring Health Outcomes

Julie Lynch:
Hi, my name is Julie Lynch. I’m a post-doctoral scholar at the [inaudible 00:00:04] VA Medical Center in Massachusetts. I lead an initiative for the administration called VADGF. This project gathers molecular test data from all the labs that service VA medical centers nationally. The purpose of the project is to provide data to help clinical leaders ensure equity in access to the implementation of genomic medicine and to evaluate the clinical utility of these tests.

Today, we have with us two VA clinical leaders Dr. Michael Kelly who is National Director of Oncology and Miss Vickie Venne the lead genetic counselor of our national genomic medicine program. We also have representatives of laboratories with whom we are developing research collaborations. Miss Donna Polizi is the Associate Director for Government Accounts for Genomic Health. Mr. John Hammond is Senior Director of Policy and Reimbursement for Veracyte.

We will start this preview of our panel discussion by asking Dr Kelly and Miss Venne to spend five minutes discussing some of the challenges we have faced in the VA evaluating the implementation of clinical utility of molecular testing. Dr. Kelly, do you want to begin?

Michael Kelly:
Thanks Julie, I think there are two main issues to discuss. First is the appropriateness of applying guidelines which were developed on populations outside the VA to a unique population of patients in the VA. An example of this is in lung cancer where veterans smoke at a higher rate or they’ve been exposed to various toxic agents including Agent Orange in Vietnam. Then what is the modification, if any, that needs to be made to guidelines in molecular testing for cancer patients. EFGR testing for lung cancer is a typical example recommended to be tested in all patients with [a known 00:01:45] carcinoma. What is the incidence in the VA? Is it appropriate to test [of that 00:01:50] incidence?

Then, the second that I’d like to touch on is once you’ve determined what testing you’re going to be doing for a population such as the VA population where is that information stored in the medical record? How can you tell as a health system administrator or a policymaker that the test is being used appropriately and then delivering good value for the individual patient and for the health system as a whole? I think there are other examples that we can touch on as we go forward with the next-generation of sequencing and the increase in use of molecular genetics in directing therapies. There’s a question if it’s going to be applicable to the majority of patients with any type of cancer.

Vicki Venne:
As we move from genetic testing to [germinate 00:02:31] testing I think there’s another very interesting example that we can use in terms of moving stuff from bench to bedside. That really is something like genetic testing for [polyps or cessation 00:02:43] Again, we have a relatively large VA population that is getting colonoscopies. In fact, I spoke with a GI physician just yesterday in a site that’s doing about 2,000 colonoscopies a year.

As a result one of the fabulous parts is that really don’t identify very many colon cancers because they’ve taken the polyps out before they become cancerous. On the other hand, approximately 40% of those veterans have polyps. Over time, they will have 10 or more polyps. This past March the NCCN published its guidelines around the [polyp 00:03:14] story indicating that individuals who have had a lifetime burden of 10 or more polyps would be candidates for genetic testing. You look at the other side of this and the global etiology of colon cancer, probably only 5 to 10% of our veterans really are going to have their colon cancer as a result of something inherited. As Dr. Kelly said, the vast majority may well have environmental causes for those colon cancers.

One of the things that we’re going to looking to be at now is are those NCCN guidelines, it’s clear they were developed from national comprehensive cancer centers, very, very reputable cancer programs often dealing with very high risk families. Are those going to be appropriate for our VA population? I think that’s going to be another place where we really have to look at guidelines and the way things are developed. Do they apply to our VA population? That’s going to be another spot of opportunity to discuss the clinical utility of these tests that are coming down the pike, others that are actually relatively well established.

Julie Lynch:
Thanks Vickie and Mike, moving on to the laboratory perspective, Miss Polizio, perhaps maybe you can discuss the role of labs in sharing data and cooperating hospitals, federal agencies such as DNCI, NDA and cooperating with researchers to evaluate clinical utility of these new tests.

Donna Polizio:
Yes, Julie, that is true. Genomic Health as a provider of laboratory services and also a test developer of [on the site 00:04:32] DS, breast and colon and prostate cancer assays, we feel that it’s very important to enhance patients’ treatment decisions that lead to better outcomes for these patients and having the appropriate patients tested.

The work we’ve done with sharing data with the VA specifically has enabled the VA to see that the appropriate patient is getting the assay and following that whether it’s through the NCCN guidelines or just through better patient access to these tests.

We do have the ability to share data with the VA through the VAGDS program on any patient that’s tested. We’re also sharing our data with things like the genetic test registry on NCI, again, just so that people have a better understanding of when the appropriate patients should be tested. That’s the most important thing.

Julie Lynch:
Mr. Hanna, perhaps you would like to discuss the types of studies can participate in to help healthcare systems evaluate clinical utility within their specific patient population.

John Hanna:
Thanks, Julie, as genomic testing has become more and more prevalent across the United States, the care community has coalesced around the need for labs and researchers to demonstrate improvements in health outcomes as evidence of clinical utility of these new tests. These studies can look at a wide range of variables. What we see most frequently today is an assessment of change in physician behavior and treatment patterns of patients as a proxy for future health outcomes as the test matures in the marketplace.

Over time, we see genomic testing being evaluated in the longer-term health outcomes to see, in fact, is there an improvement in the longer-term health of the patient. That could take a number over of different representations for these patient populations. It could be in the case of Oncotype avoiding unnecessary chemotherapy. In the case the Afirma test offered by Veracyte avoiding unnecessary surgical procedures on patients who are suspected of potentially having thyroid cancer.

These studies demonstrate that patients are, in fact, better off over their lifetime by having this genomic procedure or test performed and that informing the physician treatment pattern. That’s what we have seen in the clinical utilities space. We’ve seen payers adopting health technology assessment models that lead towards these types of evaluations and decision making for coverage.

Julie Lynch:
Thank you very much. Thank you everybody for participating in this podcast. I’m looking forward to our audience panel presentation and discussing these issues in more detail.

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