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ICLIO Webinar: ICLIO eCourse Real World Introduction to the Institute for Clinical and Economic Review (ICER): Panel Discussion 12.19.16 1:00pm to 2:00pm EST accc-iclio.org Introductions Moderator: Bill McGivney, PhD McGivney Global


  1. ICLIO Webinar: ICLIO eCourse – Real World Introduction to the Institute for Clinical and Economic Review (ICER): Panel Discussion 12.19.16 1:00pm to 2:00pm EST accc-iclio.org

  2. Introductions Moderator: Bill McGivney, PhD McGivney Global Advisors Panelists: Ivo Abraham, PhD The University of Arizona Cancer Center Ali McBride, PharmD, MS, BCPS The University of Arizona Cancer Center Jennifer Hinkel, MSc McGivney Global Advisors 2

  3. “ Cost and Value of Cancer Care” Ivo Abraham, PhD The University of Arizona Cancer Center

  4. Is the US spending too much? Health Care Expenditures Pharmaceutical (%GDP) Expenditures (%Total) 18.9 17.2 16.6 15.0 15.0 12.3 12.2 11.4 11.1 11.2 10.0 9.9 9.6 9.0 US France Canada UK Sweden Australia Japan US France Canada UK Sweden Australia Japan Health Care Expenditures Pharmaceutical (US$) Expenditures (US$) 9024 1112 783 772 5065 656 626 4496 4367 4207 4152 3971 485 489 US France Canada UK Sweden Australia Japan US France Canada UK Sweden Australia Japan OECD Health Statistics 2016 4 (data shown are for 2014)

  5. Policy options • Cost = payer • Quality partnering Price controls by payer Cost x Quality • • Enforced by payer Accountability • • Performance Driven by payer • • Financial • $ taken in • Quality incentives $ paid out • • $ difference Coordination • • Navigation • Adherence to guidelines Example: UK National • • Access to care Health Service • Example: CMS Oncology • Care Model Abraham I, McBride A, MacDonald K. Arguing (about) the value 5 of cancer care. JNCCN 2016;14:1487-1489

  6. Oncology value frameworks Issues: • Living longer • Living better • Efficacy • Safety • QALY • Thresholds • Cost/price • Value • Societal • Payer Table adapted from: Schnipper LE, Bastian A. New framework to assess value of cancer care: strengths and limitations. Oncologist 2016;21:654-658. 6

  7. Value in (cancer) care Health status Process of Sustainability of achieved or recovery health retained • Time to … • • Survival No recurrence or • complications • Disutility of care Degree of health or treatment • or recovery Long-term process consequences of therapy Dynamic risk-adjustment over time for: type of cancer ⎯ stage of disease – treatment options ⎯ prognosis ⎯ trial efficacy ⎯ real-world effectiveness ⎯ treatment-related consequences and complications ⎯ patient acceptance Accommodate changes in: patient preferences ⎯ guidelines ⎯ clinician decision-making Porter ME. What is value in health care? NEJM 2010;363:2477-2481. Abraham I, McBride A, MacDonald K. Arguing (about) the value of cancer care. JNCCN 2016;14:1487-1489

  8.  Not-for-profit est. 2006 - funded by  non-profit foundations (70%)  life sciences companies (17%)  insurers/providers (9%)  government contracts (4%)  Threshold-driven value  long-term value – value for money – QALY …  short-term value – affordability – budget impact https://icer-review.org 8

  9. Ali McBride, PharmD, MS, BCPS The University of Arizona Cancer Center

  10. Value Based Models Cancer • Costs and treatment innovations continuing to drive the value discussion – Innovation – Newer Therapies – Access to options • Costs continue to increase – Population – Medical Resource – Drug Pricing – End of Life Care The Oncologist 2016;21:651-653 10

  11. Framework for Value Metrics Source Primary purpose Treatment modalities Data Scoring/grading Cost Updating assessed source ASCO Shared decision Pharmaceuticals for solid Clinical trial Net Health Cost/month (advanced Dynamic-value making, patients/ tumors, hematologic Benefit Score disease), cost/ course changes as MDs malignancies (NHB) (adjuvant disease) impact of agents change ESMO Inform public Pharmaceuticals for solid Clinical trial (A,B,C) adjuvant; N/A Not stated policy, clinical tumors (5, 4, 3, 2, 1) for guidelines, advanced Affordability scale (1 – NCCN Providers and Systemic therapies in all Clinical Evidence Block Annually patients, as well major cancer types, trials and Score (5, 4, 3, 2, 5) updated, as other radiation oncology, expert 1) changes as stakeholders imaging, surgical consensus impact of interventions therapies change ICER Inform society; Drugs, devices, Clinical Evidence rating Care value (expressed Reports for inform procedures, and delivery trials, matrix as a QALY) and health individual areas policymakers/pay system innovations econometri system value (judging commissioned, ers cs long-term value) Abacus derived “price” Drug Inform FDA-approved drugs Public data Abacus price Enhancements Abacus policymakers and since 2001 FDA to varies with based on above planned but not physicians obtain clinical benefit, variables vs. industry explicitly stated approval toxicity, specified price innovativeness, etc. The Oncologist 2016;21:651-653 11

  12. Value in Cancer Care • The Institute of Medicine has delineated six elements of value in cancer care: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity.4 • ASCO selected only three of these for its framework — clinical benefit (effectiveness), toxicity (safety), and cost (efficiency) • Analysts used a clinical-benefit score derived from comparisons of overall survival, progression-free survival, or response rates, as well as comparative toxicities of the two regimens to define a “net health benefit” (NHB). N Engl J Med 2015; 373:2593-2595 12

  13. Implications of Value Metrics • Provider Based • Payor Based • Institution Based • Genetic Based What metrics may be superfluous or hard to identify? 13

  14. Implications of Value Metrics Clinical Practice Implementation • Patients Decision • Value Based Workflow – Evaluation for Treatment Options • Outcomes • Outcomes+ Symptom Control+ QOL+ Cost of Treatment – Clinical Trial Outcomes 14

  15. Implications for Metrics 15

  16. Cancer Center Development • Outcome Measures • Structure Measures • Process Measures • Efficiency Measures • Cost-Of-Care Measures • Patients’ Perception -Of-Care Measures Health Aff 2011;30:664-72 16

  17. Jennifer Hinkel, MSc McGivney Global Advisors

  18. Oncology Value Frameworks: Analysis and Strategic Navigation Greatest Potential Impact to Market Access and NCCN ICER: Decision-making Evidence Institute for Blocks Clinical and Autonomy Economic Review ASCO Value MSKCC Drug Framework Abacus 18

  19. ICER: Organizational Timeline and Background 19

  20. Is ICER equipped to make accurate assessments? • ICER’s report on NSCLC has numerous flaws and gaps, mainly pertaining to ICER’s lack of inclusion of all relevant data, apparent biases in its communication of such data and results, and questionable interpretation of available clinical evidence. • Flaws in ICER’s NSCLC report, gaps in methodology, and lack of transparency point to questions regarding ICER’s objectives and alignment

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  22. Principles Proposed for Value Frameworks by Lung Cancer KOLs 22

  23. Questions?

  24. Thank you for participating in the ICLIO e-Course. Presentation slides and archived recording will be available at accc-iclio.org

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