VALUE IN ONCOLOGY PROBLEMS, SOLUTIONS & AN EXPERIMENT Derek Raghavan MD PhD FACP FRACP FASCO

1. VALUE IN ONCOLOGY PROBLEMS, SOLUTIONS & AN EXPERIMENT Derek Raghavan MD PhD FACP FRACP FASCO President, Levine Cancer InstituteASSOCIATION OF CANCER EXECUTIVES, January 2014

2. PHILOSOPHY OF CANCER TREATMENT Cure when possible Maximize length and quality of life Pioneering in science Laboratory to clinic Clinic to laboratory Care of the patient and family Rationalize costs when possible and ethically sound l 1

3. LET’S START WITH HEALTH CARE IN GENERAL IN THE U.S.A. WHAT ARE THE KEY PROBLEMS THAT RELATE TO ONCOLOGY?

4. HEALTH CARE: THE GOVERNMENT SHELL GAME • The U.S. population has “expectations” for health care • Nobody is interested in health care unless illness involves them – patients, families, friends (somewhat) • Governments cannot afford to provide the care that the population expects • NOBODY wants to pay for health care • Lobbyists lobby • Why did the Oregon experiment fail?????

5. A SHARED RESPONSIBILITY • The population and health behavior – smoking, obesity • Death is an un-American activity • The medical profession – profits, fear of litigation, lobbying • The pharmaceutical industry – profits, lobbying • Politicians • The legal profession – profits, lobbying, stirring the pot

8. Health Care Spending by Country Percent of GDP (2008) Source: 2008 Data from the Organization for Economic Cooperation and Development. 7

9. Factors Influencing Oncology Practice • Community expectations • General, the press • Specific, patient satisfaction • Trajectory of change of outcomes • Pace of the science • Multiplicity of clinician constituencies • Learned Societies • Changing Demographics • Government • Legislation • Funding for Research • Payment for services/Medicare/etc. • Government as a provider • Reimbursement changes • Payers/Insurers • Employers • Organized Research Groups • Advocacy Organizations

10. Community Expectations • The Press – cancer a “hot” topic • “War on Cancer” generated false expectations, regularly revised as false expectations • Driven by politicians • Driven by experts with/ without skin in the game • Dartmouth • Ethicists • Leapfrog, Press Ganey & clones – patient surveys • Conflicts of interest in government evaluations • Health Policy “experts” • Influence of advocacy groups • Tension between science and opinion? • Influence of opinion leaders

11. Community Expectations • The Press – cancer a “hot” topic • “War on Cancer” generated false expectations, regularly revised as false expectations • Driven by politicians • Driven by experts with/ without skin in the game • Dartmouth • Ethicists • Leapfrog, Press Gainey & clones • Conflicts of interest in government evaluations • Health Policy experts • Influence of advocacy groups • Tension between science and opinion? • Influence of opinion leaders

12. What’s the deal in NH? What’s up in LA?

13. What’s The Story in NH and LA NH: Small area Educated Fewer indigent High density academics High density proximate hospitals Dartmouth engineers of healthcare Work conditions Liberal state LA: Poverty Large state Poor access Poor education African American cultural issues Targeting of advertisers Work conditions Conservative state

14. 5 WORST STATES FOR HEALTH INSURANCE TEXAS NEVADA ALASKA (“I can see Russia from my kitchen!” Tina Fey 2008) FLORIDA GEORGIA 13

15. 14

16. Don’t Forget the Centers that “Skim” Medicare Medicaid Need Not Apply!!!

17. Strategy for Health Plans (Porter & Teisberg, 2006) • Provide health information and support to patients/physicians • Organize around medical conditions, not geography or administrative functions • Provide comprehensive disease management/prevention services for all members, healthy or unhealthy • Provide information and transparency regarding outcomes • Restructure the health plan – provider relationship • Reward excellence/innovation • Redefine the health plan – subscriber relationship • End cost-shifting practices 16

18. BOTTOM LINE OF A SENSIBLE APPROACH PARTNERSHIP INVOLVE KEY STAKE HOLDERS FUNCTIONALLY DRIVEN COMPREHENSIVE TRANSPARENT REWARD EXCELLENCE 17

19. Government Remember those little politicians!! • Consumer • Federal • State • Local • Payer • Research • Regulator • Examples: • NCI • Regulates research • Regulates centers • Funds research • Funds cooperative groups • Does research • FDA

20. Trajectory of Change of Outcomes vs Expectations • Changing Endpoints • Survival • Quality of life • Cost • Patient satisfaction • Molecular targets • (Not well connected to community expectation) • “Hype” • Institutional advertorials • Meetings & abstracts • Real progress • Peer reviewed publication • National survival statistics

21. Proposed Strategic Approach to Cut Health Care Costs • Stay on top of the science • Integrate clinical trials with rational design and careful costing • Manage across the system • Porter & Teisburg • Avoid skimming • Reduce unnecessary tests • Blue ocean/Red ocean strategy • Rational selection of treatment: • Outcomes should drive • Strong scientific rationale • Structured palliative care • Measure and present robust outcome data • Listen to the lay evaluations, but structure them carefully • Don’t listen to everyone

22. My Strategy Physicians and bio-medical organizations reduce costs Address tort reform in a meaningful way – costs to system are VASTLY under-estimated Provide a safety net – especially for chronic disease and those who run out of health insurance Improve access Re-educate the community about realistic expectations Require training for those who tinker with the system Reward excellence Transparency Refine costs of biomedical development

23. SO…Where does Levine Cancer Institute fit? Addressing costs and inconvenience of care Attracting new expertise to the region Bringing research to this area A new model of patient support Standardization and evidence based approaches Symmetrical care across the Carolinas – for everyone!

25. INITIAL CONCEPT: VISION STATEMENT • The Levine Cancer Institute will be recognized by cancer patients and their families, referring physicians, and the communities we serve as the “first choice” provider in the Carolinas and the Southeast, and further renowned as one of the premier cancer care providers in the country. • Unified cancer network – concept of “ONE-ness” in 2011 • personalized service • high quality outcomes • Clinical trialsand access to research/screening/navigation/palliative services • Collaboration enterprise-wide to • Enhanced quality • Enhanced access • Each CHS patient entry point will be a portal into a network of specialized services • Incorporation of translational research • NATIONAL/INTERNATIONAL presence 24

26. Our Vision – Changing the Course of Cancer Care Unified enterprise-wide network Spread across two states Patient-centered Connected across the enterprise Clinically integrated Best-practice collaboration across the enterprise 25

27. Structure for Enterprise Engagement & Collaboration May 13,2011 Enterprise Summits Education, Networking/Team Building 2x/Year Launch by May 2011 Enterprise Cancer Strategy Council Coordination of Enterprise Cancer Initiatives Quarterly Launching March-April,2011 Charlotte Regional Cancer Strategy Council Western Regional Cancer Strategy Council Lowcountry Regional Cancer Strategy Council Upstate Regional Cancer Strategy Council Tumor Site Team Quality Council Monthly Market Development, Regional Tumor Site Planning & Development Algorithm Developed by “Oncology Solutions”

28. Levine Cancer Institute: Charter Members • An-Med, Anderson SC • Blue Ridge, Valdese NC • Carolinas Medical Center • Cleveland Regional Medical Center, Shelby NC • Lincolnton Hospital • Mercy Hospital, Charlotte NC • Northeast Hospital, Concord NC • Pineville Hospital, Pineville NC • Roper St Francis Hospital, Charleston SC • Stanly Regional Medical Center, Albemarle NC • University Hospital, Charlotte NC • Union Hospital, Monroe NC

29. Levine Cancer Institute Membership Criteria • Central IRB – Chesapeake • Local 0.1 FTE leader • Staff participation in tumor boards/conferences • E-treatment pathways • Patient Navigation • SOP’s and quality • Clinical trials infrastructure • Participation in survivorship programs • Complementary/integrative cancer medicine program • E-genetic counseling • Disparities program

30. Recruitment • 100+ thus far • 50 locally • 50 nationally • Academic programs – clinician investigators • Clinical programs • Moving from general to sub-specialty practice • Integration of staff – no second-class citizens

31. PROGRAMS INNOVATIONS IN PROGRESS 30

33. Edward S. Kim, MD Chair, Solid Tumor Oncology Melanoma Stage IV OR unresectable Stage III Distant metastatic disease OR UNresectable Stage III Treatment “Monthly Section Meetings” Patients should be considered for multidisciplinary discussion to determine potential for surgical resection ECOG 1609 AdjIpivs IFN • Biopsy of distant disease • LDH • CT C/A/P & MRI brain OR PET/CT • Path for BRAF mutation See Follow-up Stage IV NED Resectable Surgical Resection Trial NEEDED Clinical Trial Ipilimumab Chemotherapy BRAF - Not an IL-2 candidate Clinical Trial Ipilimumab BRAF inhibition Chemotherapy Without brain metastases BRAF + PROCLAIM Registry Disseminated (Unresectable) IL-2 Candidate SELECT DFCI Phase II BMS SRS +/- WBRT BRAF - With brain metastases Clinical trial or Observation BRAF + Phase II Roche MO25743

34. 33

35. Survivorship • Survivorship Program • Identification via Tumor Registry and Physicians • Structured algorithms • Engagement of medical staff of system hospitals & practices • Engagement of key physicians for patients • Administrative system-wide structure • Examples: • Long term survivor after radiotherapy for breast cancer • Long term survivor after chemotherapy for metastatic testis cancer • Psychological issues • Kids who are now grown-up’s 34

36. Levine Oncology Program for Seniors • Years 3-4 • Geriatrician in place & support base in development • Specific oncology personnel – Daniel Haggstrom MD, Raghava Induru MD • Established track record of published data • Focus on the WELL-ELDERLY • Based at Mercy Hospital and Stanly Hospital 35

37. Cancer Flying Squad • Led by Dennis Devereux MD (Stanly) & Mike Lutes (Union) • Sub-specialty home services • Building towards home chemo/tumor measurements/transfusion • Helps with early discharge • Reduces Average Length of Stay • Reduces re-admissions • Sensible fiscal model – patients who won’t come to hospital • The right thing to do 36

38. Integrative Cancer Medicine Program • Leadership: Chasse Bailey-Dorton MD, Wendy Brick MD (in future?) • Structured studies • Broad options – music therapy, art therapy, diet, etc. • Provision of accurate information • De-criminalization for up to 50% • Clinical trials • Education for patients on early phase trials • Pastoral Care Academy – David Carl – 25 CHS pastors, October 2012

39. Evolution, 2012-2013 12 Levine Cancer Institute participating groups Phase I clinical trials unit(s) in progress Phase II clinical trials – based throughout CHS Tumor Specific Teams Educational courses Leadership at Roper/St Francis Navigator Academies 1 and 2 Single Tumor Registry Treatment pathways/protocols Administrative team in place Academic leadership identified Cancer pharmacology lab team HOT lab Hem/Onc fellowship planning Cancer Emergency Dept Network Survivorship initiatives Patient satisfaction/value/cost 38

40. Potential Impact of Levine Cancer Institute(work-in-progress) • Care near home – less travel, accomodation, time • Evidence-based standard approaches • Optimal support – navigation, survivorship • E-genetic counseling • Focused cancer research and clinical trials • Resources spread through the system – ALL patients • Electronic support – tumor boards, video conferences, access

41. Cost Containment – Broader Efforts

42. EXPERIMENT: ARE THE FOLLOWING IMPROVED? • QUALITY • via standardized, evidence based pathways • System-wide tumor conferences, education, pathway design • System approach to drug shortages • IMPROVED COST • via pathways, trials, access, less travel • Integrated selection of palliative/supportive care • Trial selection linked to clinical practice section policy

43. Early Evidence Press Ganey – 99% System-Wide for LCI Commission on Cancer – 8 programs, all with max. merit QOPI External Advisory Board – no concerns

44. Proposed Strategic Approach to Address Health Care Costs • Stay on top of the science • Integrate clinical trials with rational design and careful costing • Manage across the system • Porter & Teisburg • Avoid skimming • Reduce unnecessary costs • Blue ocean/Red ocean strategy • Rational selection of treatment: • Outcomes should drive • Strong scientific rationale • Structured palliative care • Measure and present robust outcome data • Listen to the lay evaluations, but structure them carefully • Don’t listen to everyone