Welcome to CAP s Hot Topics in Pathology Webinar Series sponsored by the Personalized Health Care Committee

Transcription

1 Welcome to CAP s Hot Topics in Pathology Webinar Series sponsored by the Personalized Health Care Committee This webinar on The Business Argument for Cancer Genomic Testing Using a Sequencing Platform is presented by James Crawford, MD, PhD, FCAP, John Pfeifer, MD, PhD, FCAP, and Lynn Bry, MD, PhD, FCAP. Your host is Jill Kaufman, PhD. For comments about this webinar or suggestions for upcoming webinars, please contact Jill Kaufman at jkaufma@cap.org THE WEBINAR WILL BEGIN MOMENTARILY. ENJOY!

2 The Business Argument for Cancer Genomic Testing Using a Sequencing Platform James Crawford, MD, PhD, FCAP, John Pfeifer, MD, PhD, FCAP, and Lynn Bry, MD, PhD, FCAP cap.org v. #

3 James M Crawford, MD, PhD, FCAP Chair, Dept of Pathology & Laboratory Medicine, Hofstra North Shore-LIJ School of Medicine, Uniondale, NY Senior Vice-President for Laboratory Services, North Shore-LIJ Health System, Manhasset, New York Member of CAP Personalized Health Care Committee; Chair of Business- Genomic Analysis Work Group Member of CAP Policy Roundtable Committee; Chair of ACO Work Group Served on CAP Case for Change Module 1 Supply and Demand and Module 2 Roles and Value Propositions 2012 College of American Pathologists. All rights reserved. 3

4 Lynn Bry, MD, PhD, FCAP Director, Center for Clinical and Translational Metagenomics Associate Director, Partners Center for Personalized Genetic Medicine Associate Pathologist at Brigham & Women's Hospital Member of CAP Personalized Health Care Committee Member of CAP Policy Roundtable Committee Served on the Case for Change Module 4 Emerging Technologies 2012 College of American Pathologists. All rights reserved. 4

5 John D Pfeifer, MD, PhD, FCAP Vice Chair for Clinical Affairs, Department of Pathology, Washington University School of Medicine Leadership Group, Genomics and Pathology Services at Washington University (GPS@WU) Professor of Pathology, Professor of Obstetrics and Gynecology, and Director of the Molecular Genetic Pathology Fellowship Member of CAP Personalized Health Care Committee 2012 College of American Pathologists. All rights reserved. 5

6 Disclaimer The College does not permit reproduction of any substantial portion of the material in this Webinar without its written authorization. The College hereby authorizes attendees of the CAP Webinar to use the pdf presentation solely for educational purposes within their own institutions. The College prohibits use of the material in the Webinar and any unauthorized use of the College s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Opinions expressed by the speaker are the speaker s own and do not necessarily reflect an endorsement by CAP of any organizations, equipment, reagents, materials or services used by participating laboratories College of American Pathologists. All rights reserved. 6

7 Disclosure Dr. Crawford-No disclosures Dr. Bry-sits on the Scientific Advisory Board for ispecimen Dr. Pfeifer- Consulting: Novartis, Strand Analytical Labs Consulting: Various firms for medicolegal cases Royalties: LWW and Elsevier 7

8 The Questions What is the decision-making process for adopting Genomic Testing technologies for your institution? o Patient Care needs o Business considerations o Other Who are the decision-makers? o Section/Division Directors o Department Chairs o Senior Institutional Officials 8

9 Methodology Survey of early adopters o One hour telephone interview o Standard set of open-ended questions o Answers compiled Target audience(s) for this survey o The next rank of adopters o Department chairs and institutional decision-makers o Observers on-the-sidelines 9

10 Which focus area? Germline Cancer Infectious Disease 2012 College of American Pathologists. All rights reserved. 10

11 Which focus area? Germline Cancer Infectious Disease 2012 College of American Pathologists. All rights reserved. 11

12 Topics addressed in the survey Choice of Genomic Analysis Tests for Clinical Use Drivers and Barriers Reimbursement considerations Lessons Learned from Early Adopters CAP resources for Adoption 2012 College of American Pathologists. All rights reserved. 12

13 Survey metrics 14 Institutions interviewed, in 10 different states In their persons, during the 14 Interviewees had 93 publications relevant to Genes/Diagnosis Research and Clinical applications including: o Next Generation Sequencing/Targeted Sequencing Including Cancer Gene Panels o Bioinformatics Pipeline o Molecular Surgical Pathology o Digital Molecular Imaging 2 of them CLIA-certified laboratories for NGS 2012 College of American Pathologists. All rights reserved. 13

14 The Evolution of Molecular Testing Single gene test Large molecular panel Exome Genome 2012 College of American Pathologists. All rights reserved. 14

15 Reasons why Pathology Departments considering NGS technologies in-house for diagnostic testing Develop clinical and research programs. Innovation, keep institution at the forefront. Believe the platforms will eventually prove cost-effective for complex testing at high volumes College of American Pathologists. All rights reserved. 15

16 Considerations for bringing in NGS platforms If used clinically, identify tests where the data and analysis can provide clinically useful data beyond existing technologies. o Target to institutional strengths. Have clear research and clinical uses. Business plan for the entire infrastructure (technical, bioinformatics and reporting). Understand the economics of cost-per-test. Integrate with other institutional initiatives College of American Pathologists. All rights reserved. 16

17 Testing Derive from commerically available multiple panels Pharmacogenomics Gene panels for specific germline conditions or particular tumor types 2012 College of American Pathologists. All rights reserved. 17

18 Drivers to implement Genomic Analysis Define how to leverage this technology for improvements to patient care. Innovation. Keep Pathology current and active in this evolving area. Improve environment for trainees 2012 College of American Pathologists. All rights reserved. 18

19 Cons Very expensive. Time and effort needed to implement and maintain vs. using other types of testing that would currently provide the same information. We don t know how to interpret most of the variants in an exome or genome. Complex both technically and for the IT/bioinformatics and computational infrastructure needed. How to manage/store the data, from the IT, medical, ethical and legal standpoints College of American Pathologists. All rights reserved. 19

20 In house vs out-source aspects of Genomic Analysis Per institutional funding and infrastructure, many sites prefer to keep in house if possible. o Control of pipelines, discovery activities. At a minimum, keep some sequencing in house for targeted assays or confirmation. Many see that sequencing is commodity and there are benefits to out-sourcing while the technology is currently expensive and complicated to manage. Focus local resources on content development and interpretation 2012 College of American Pathologists. All rights reserved. 20

21 Approval process Key issues that need to be addressed when seeking the resources to set up an NGS lab: Define the clinical need (leverage institutional expertise) Define the business plan Determine the cost-benefit ratio of bringing NGS testing inhouse (does it support existing programs, what is being spent on send outs, what s the return on investment) 2012 College of American Pathologists. All rights reserved. 21

22 Reimbursement Need to demonstrate value to payors beyond currently methods (panels versus single gene tests) Until reimbursement hurdle sorts itself out within your payor mix, it s probably wise to limit the NGS test menu initially Reimbursement for NGS will doubtless follow the rules of the marketplace: payors will reimburse, but will make deals with labs to do this testing at the lowest price Conversations with payors can be more productive if you enlist clinical colleagues to be part of the discussion 2012 College of American Pathologists. All rights reserved. 22

23 Competitive Advantage of NGS: Institution X s View Demonstration of clinical utility will provide a competitive advantage. In-house bioinformatics, analytics,and reporting provide an added value to our clinicians Position pathology in the center of individualized treatment plans, instead of just a reporting-of-values type of service. Provides strategic advantage with the hospital, since alignment with the clinician base tends to get the hospital s attention There is the question of how do you bring NGS into the everyday world when there is so much pressure on price, when the technology is so complicated, and when many clinicians don t understand this except in a very big picture way 2012 College of American Pathologists. All rights reserved. 23

24 Competitive Advantage of NGS: Institution Y s View Will enable pathology as a discipline to demonstrate to our clinical colleagues: o we own this, this is what we do o we re preparing our trainees to do this o we ll take care of it, we ll explain it to you o leave it to us, we ve got it covered It will only be a competitive advantage for a couple of years before most institutions are doing it 2012 College of American Pathologists. All rights reserved. 24

25 Lessons Learned From Early Adopters: Institution A Small institutions might want to wait for: o the platforms and informatics and reporting to be worked out o the clinical utility is firmly established in the literature It s a trade-off: Is it better to get NGS in two years when things are pre-packaged, or be a leader in the field? NGS is a much bigger and more complicated endeavor than you expect 2012 College of American Pathologists. All rights reserved. 25

26 Lessons Learned From Early Adopters: Institution A (continued) Success depends on adequate resources (money and people); the technology and bioinformatics are not plug-andplay Do you have the required informatics? It s a lot easier to generate the data than to interpret it; you really have to adequately resource the informatics function for interpretation Will the clinical load support an NGS lab? 2012 College of American Pathologists. All rights reserved. 26

27 Lessons Learned From Early Adopters: Institution B It s important to be adequately capitalized when you start off It s important to be adequately staffed when you start off It s possible to go from zero to a customized panel in under a year; many labs will soon be doing NGS since it will become a requisite for oncology practice Embrace change; it s a brave new world, and NGS will enhance our medical practice as pathologists 2012 College of American Pathologists. All rights reserved. 27

28 Lessons Learned From Early Adopters: Institution B (continued) Must work very closely with your oncologists and hematologists because you don t want to offer something that they re not going to feel is useful in their practice Start simple to build the expertise; start with a small sequencer Bioinformatics will be key 2012 College of American Pathologists. All rights reserved. 28

29 Lessons Learned From Early Adopters: Institution C Put together an interdisciplinary group that can help you select the gene panel Get your feet wet means start small; build your volume gradually so you keep your quality up The amount of data is huge, so if you can t manage that, you are very quickly going to find yourself incapable of keeping up with the information and the clinical demands for your services Match your platform with the testing you want to do 2012 College of American Pathologists. All rights reserved. 29

30 Lessons Learned From Early Adopters: Institution C (continued) A whole exome can actually be a quicker and cheaper way to develop panels than customized capture probes Regulatory issues arise (for example, you can t force people to order a panel) 2012 College of American Pathologists. All rights reserved. 30

31 Lessons Learned From Early Adopters: Institution D Know the politics of your institution Carefully consider the additional work to do a customized panel as opposed to use of a commercially available kit 2012 College of American Pathologists. All rights reserved. 31

32 How to Measure Success Improved patient care Elimination of redundancy Enhanced education of our trainees (and our clinical colleagues) Support of translational research Competitive advantage Growth in test volumes Economically viable Level of reimbursement 2012 College of American Pathologists. All rights reserved. 32

33 PROJECTIONS from Early Adopters: Expectations, Future GA applications, Next steps The expectation is that every lab will be able to build on experience: each panel will become easer to develop; each platform will be easier to validate; the bioinformatics will become more straightforward; more pathologists and clinicians will embrace NGS with time As more targeted therapies are developed, the role of NGS for directing therapy will grow, which emphasizes that constant updating of testing will be needed For inherited diseases, the expectation is that the whole exome will become a sort of a universal technical assay from which the relevant genes are subjected to bioinformatic analysis For cancer, given depth of coverage issues and mutational spectrum, customized gene panels may persist longer 33

34 Examples of CAP Genomic Resources available today Genomic Analysis Resource Guide o New 2012 Resource that contains selected journal articles, insights from early adopters, and CAP Resources for adoption of -large molecular panels, exome, and genome o Go to to register Accreditation Checklist of NGS o Molecular Pathology Checklist has been updated to include clinical application of genomic analysis, more specifically next-generation sequencing (NGS), to prepare its laboratory customers for advancements in genomic testing o Checklist is available -> Accreditation and Lab Improvement -> About Accreditation Checklists -> Purchase CAP Checklists 2012 College of American Pathologists. All rights reserved. 34

35 Summary Genomic Analysis is just the next molecular test Represents a great opportunity for pathologists Provides new tools for patient diagnosis 2012 College of American Pathologists. All rights reserved. 35

36 Next in the Hot Topics in Pathology Webinar Series Molecular Microbiology in the Community-Based Practice Thursday, January 31, 11:00-12:00 PM Central o Cindy McCloskey, MD, FCAP This webinar will provide laboratory professionals with the tools to evaluate molecular infectious disease tests for incorporation into the community-based clinical laboratory. Current FDA-approved platforms and assays will be reviewed with the discussion focusing on comprehension of basic molecular technologies and evaluation of clinical utility. Upon completion of this session, participants should have a better understanding of molecular infectious disease tests that are currently on the market and how these tests are being used in clinical practice. Register by going to College of American Pathologists. All rights reserved. 36

37 Access Archived Webinars-View Recording & Download Presentation PDF go to Archived Webinars on Getting Started and Taking Next Steps in Molecular Pathology The Why, What, and How of Identifying Patients at Risk for Hereditary Cancer Syndromes in Surgical Pathology Practice (Alexis Carter, MD, FCAP) + other alexis Molecular Tests and Pathology Practice: What Every Community Pathologist Should Know/Clinical Requests for Molecular Tests (Alexis B Carter, MD, FCAP) How to Build and Fund a Viable Molecular Lab (Frederick Kiechle, MD, PhD, FCAP) Cancer: The Critical Role of Pathology in Personalized Health Care (Eric Walk, MD, FCAP) Archived Webinars on Genomic Analysis, Large Molecular Panels, Exome, Genome Whole Genome Analysis as a Universal Diagnostic: A Pathologist s Perspective (Mark Boguski MD, PhD, FCAP) Clinical Use of Whole Genomic and Whole Exome Today(Paula North, MD, FCAP and David Bick MD) Next-Generation Sequencing for the Clinical Laboratory (Karl V. Voelkerding, MD, FCAP) Next-Generation Sequencing (John Pfeifer, MD, FCAP) 2011 College of American Pathologists. All rights reserved. 37

38 Access Archived Webinars-View Recording & Download Presentation PDF go to Archived Webinars on Organ Based Pathology Molecular Diagnosis for Lung Cancer Patients (Philip T. Cagle, MD, FCAP) Molecular Diagnosis for Colorectal Cancer Patients (Antonia R. Sepulveda MD, PhD, FCAP) Molecular Markers in Breast Cancer (David G. Hicks, MD, FCAP) Molecular Testing Guidelines for Selection of EGFR and ALK Tynsine Karnase Inhibitors in Non-Small Cell Lung Cancer (Neal I Lindeman, MD, FCAP and Marc Ladanyi, MD, FCAP) Molecular Diagnostics of Lung Cancer (John Iafrate, MD, PhD) Breast Cancer and Molecular Tests (Kenneth J. Bloom, MD, FCAP) Molecular Testing and Hematopathologic Conditions (David Czuchlewski, MD, and Mohammad Vasef, MD, FCAP) Molecular Genetics of Pancreatic Neoplasms (Ralph Hruban, MD)- also on Genomic Analysis 2012 College of American Pathologists. All rights reserved. 38

39 A New CAP Tool- Short Presentations On Emerging Concepts (SPECs) Pathology SPECs are: o o o Prewritten PowerPoint presentation on emerging topics where molecular testing plays a key role in patient management. Designed for pathologists to customize and use for educating other physicians and health care leaders in their communities. Focused on molecular tests that are actionable to patient care today. Now Available: Emerging Concepts in the Workup of Colorectal Cancer Emerging Concepts in Therapeutic Guidance for Metastatic Melanoma Emerging Concepts in the Diagnosis and Workup of Thyroid Cancer Emerging Concepts in Colorectal Cancer Hereditary Non-Polyposis Cancer (Lynch Syndrome) Emerging Concepts in the Workup of Polycythemia and Thrombocythemia: JAK2 To register, go to the CAP Member tab on cap.org. You do not need to be a member to utilize this free tool College of American Pathologists. All rights reserved. 39

40 A New CAP Tool-Pathology Resource Guides The CAP has created the Pathology Resource Guides, a new tool to assist pathologists in understanding key emering technologies. These Resource Guides are a new CAP member benefit available at no charge. Genomic Analysis (large molecular panels, exome, genome) Digital Pathology In Vivo Microscopy Molecular Diagnostic LAUNCHED AT CAP 12 Register through the CAP member tab. You will receive periodic updates for two years. Questions? Contact capguides@cap.org College of American Pathologists. All rights reserved. 40

41 CAPconnect is a professional community for CAP members. It offers: o Networking o Getting insights and feedback from peers o Accessing CAP resources o Keeping informed on professional issues Join the community now by going to capconnect.cap.org and signing up! 2012 College of American Pathologists. All rights reserved. 41

42 CAP 2013 Policy Meeting

43 2012 College of American Pathologists. All rights reserved.

44 THANK YOU! Thank you for attending our webinar The Business Argument for Cancer Genomic Testing Using a Sequencing Platform by James Crawford, MD, PhD, FCAP, John Pfeifer, MD, PhD, FCAP, and Lynn Bry, MD, PhD, FCAP. For comments about this webinar or suggestions for upcoming webinars, please contact Jill Kaufman, PhD, Director of Personalized Health Care at jkaufma@cap.org NOTE: There is no CME/CE credit available for today s free webinar. 44