Acing the Test: Implementing Best Practices for the Use of Molecular Testing in the Community Setting

Acing the Test: Implementing Best Practices for the Use of Molecular Testing in the Community Setting

Disclosures I do not intend to discuss an off-label use of a product during this activity I have not had any relevant financial relations during the past 12 months to disclose Food for thought The biggest challenge is grappling with the pace of change. It s the speed of change, and everybody is saying, how on earth are we going to choose from this massive menu and how on earth are we going to pay for any of it? It s all so fancy and does it really work and does it help us do anything at all for the patient. But at the same time, we know this is going to grow. If you think about personalized medicine, then there is no end to the number of tests that you could perform. - Focus group member comment Project Goals To understand from a multidisciplinary perspective the current molecular-testing landscape, including barriers to use of molecular testing in the community setting. To identify a variety of community-based cancer programs that are succeeding in implementing molecular testing, thereby improving patient care. To identify key success factors and "best practices," demonstrated through case studies, to successfully implement molecular testing in the community setting. 1

Why this project now? Focal point of personalized medicine Increase in number of molecular tests for oncology (diagnostic and therapeutic) Rise in oncology drugs approved with companion diagnostics No one size fits all approach to the use of, or integration of tests, into the community setting Project Team Advisory Board Members Samuel Caughron, MD, FCAP William J. Laffey, MBA Zaven R. Norigian, Jr., PharmD, BCOP Randall A. Oyer, MD Cary Presant, MD Gail W. Probst, RN, MS, ANP, OCN, AOCN, NE-BC Lonnie K. Wen, PhD (sponsor delegate) John M. Yelcick, MD Consultants Health Equity Associates Susan M. Myers, MA, MPH; Carol Bush, RN; Vijai Jaitley, MPH, MCHES Key Program Components Online Surveys Multidisciplinary Pathologists Focus Groups and Key Informant Interviews Multidisciplinary team members Pathologists 2

Domains of Interest Policies/processes Plans for adoption of new tests Integration of cancer program and pathology Use of guidelines Cost Reimbursement Domains of Interest (continued) Additional tissue collection Education QI/PI Barriers Overcoming barriers Key Survey Findings 3

77.1% report having a process or policy on adoption of new molecular tests No 28.90% Yes 77.10% Does your cancer program/practice have a process or policy regarding adoption of new molecular tests? (i.e., are tests scrutinized for clinical usefulness, clinical reliability and accuracy?) Who leads the process/policy adoption efforts? Other, 14.0% Medical Director, 10.5% Pathologist, 36.8% Medical Oncologist, 21.1% Genetic Counselor, 2.6% When do respondents plan to bring new molecular tests in-house? 11.8% 5.9% 29.4% Within six months Within one year Within two years Not sure when 4

Integration of Cancer Program and Pathology Multidisciplinary 18.8% 9.4% 71.9% Cancer program works with hospital-based pathology department Cancer program contracts with pathology group Cancer program employs a dedicated full-time pathologist Integration of Cancer Program and Pathology Pathologists 47.1% 52.9% Exclusive provider of pathology services Non-exclusive provider of pathology services Pathologist Integration Reported pathologist participation in Tumor Board, Cancer Committee, and Staff Development 11.8% Reported pathologist participation in Tumor Board and Cancer Committee 5.9% Reported pathologist participation in Tumor Board only 5

76.3% of Respondents Use Guidelines for Molecular Testing No 7.9% 84.2% Yes 76.3% Not Sure 15.8% 34.2% 36.8% NCCN ASCO CAP Pathologist Perspective on Policies and Procedures 58.8% 41.2% YES NO Impact of Cost of Testing Multidisciplinary Perspective 6.3% 25.0% 21.9% 25.0% 21.9% 6

Impact of Cost of Testing Pathologist Perspective 31.3% 25.0% 31.3% 12.5% Pathologist Perspective on Reimbursement 43.8% 12.5% 37.5% 6.3% 81.3% of Multidisciplinary Respondents Say MT Saves Money 81.3% 28.7% 7

Pathologist views on saving money 12.5% 18.8% 18.8% 50.0% Additional Tissue Policy? Multidisciplinary Respondents: 34.2% 21.1% No Not Sure Yes Insufficient Diagnostic Tissue Pathology Respondents: Report < 10% EGFR 43.8% Report < 10% for ALK and KRAS 8

Education Regarding Molecular Tests 84.4% 53.1% 31.3% 9.4% 12.5% Cancer Committee Tumor Board In-Service Does Not For Offer Nursing Staff Education Other Staff Education Resources 71.9% 53.1% 31.3% 25.0% ASCO ONS CAP Other Patient Education Resources 50.0% 43.8% 31.3% 18.8% 31.1% ASCO ONS NCI Patient Patient Advocacy Other Information Organization Information 9

Staff Development Needs More than 40 percent of respondents ranked need for professional development on molecular testing, bio-markers and reimbursement as High. Nurses expressed very strong need for education in service as well as in nursing schools. Only 31.1% percent report having a QI/PI process in place for molecular testing No 43.8% Don t Know 25.0% Yes 31.1% Challenges Lack of interest by members of the physician team (pathologists and/or specialty physicians) to transition to individualized care Lack of collaborative relationship between specialty physicians Tremendous upfront investment, competing capital priorities Lack of willingness of administration to take risks and invest time, money and staff upfront* * Indicates a pathologist viewpoint 10

Overcoming Challenges Peer pressure to elevate non-utilizers (MD to MD) Sever contracts of pathologists unwilling to elevate the standard of practice Lead pathologist and oncologists present evidence of necessity to keep current with clinical offerings of competing health systems to prevent loss of downstream revenue* Implement multidisciplinary strategic planning processes, which focus on developing team collaboration and communication strategies * Indicates a pathologist viewpoint Effective Practices Physician champions Pathologist and Medical Oncologist MUST be a collaborative relationship Willingness to evaluate and discuss clinical utility and predictive demand* * Indicates a pathologist viewpoint Effective Practices Administrative support Resources to perform comparative analysis are key Willingness to support significant resources upfront Willingness to accept risk that some tests may be a loss leader for several months 11

Effective Practices Continuous staff education Multidisciplinary clinically oriented cancer conferences Cancer Committee Tumor Board Journal Clubs One Cancer Program s Model Lancaster General Health Lancaster, Pennsylvania Lancaster General Health Beds: 631 in service at both campuses Operating Rooms: 39 Emergency visits: 107,914 Inpatient discharges: 37,166 (includes births) Births: 4,315 Outpatient registrations: 903,145 LG Health physician office visits: 572,783 Surgeries: 41,503 Employees: More than 7,000 Physicians: More than 900 (Includes 245 health system-employed and medical group) Annual health system revenues: Approximately $1 billion 12

Lancaster General Health Cancer Services Lancaster General Health - fifth system in Pennsylvania to offer Gamma Knife tumor treatment technology Region s only affiliate in the Penn Cancer Network, with access to leading research and technological resources Ann B. Barshinger Cancer Center opening in 2013, providing state-of-the-art care using an integrated care approach Lancaster County s only TomoTherapy unit Accredited by American College of Surgeons as an ACOS Comprehensive Community Hospital Cancer Program Other accreditations include ACOS Breast Center, Breast Imaging Center of Excellence and Radiation Oncology Molecular Tests Available at LGH Lung cancer EGFR ALK Colorectal cancer MSI KRAS Melanoma BRAF Uterine cancer MSI Process Automatic MSI testing in colorectal and uterine cancers KRAS testing in metastatic colon cancer BRAF testing in metastatic melanoma Algorithm EGFR, ALK testing in lung cancer Physician request MSI testing in other Lynch-suspected cancers Any testing missed on the automatic pathway 13

Testing Choices Oncology Input Disease-Specific Steering Committees or Tumor Boards Annual technology update Physician request Literature review Guidelines Hayes Institutional Diagnostics Committee Physicians Operations Communications Lessons Learned Tracking compliance Learning experience for physicians Model for new diagnostic modalities To learn more about this project, visit www.accc-cancer.org/moleculartesting. 14

Thank You Support for this educational project is being provided by Pfizer Oncology. 15