NCCN and NCCN Clinical Practice Guidelines in Oncology™

1. NCCN and NCCN Clinical Practice Guidelines in Oncology™ Joan S. McClure, MS Senior Vice President of Clinical Information and Publications National Comprehensive Cancer Network (NCCN)

3. What is the NCCN? An Alliance of 21 Academic Cancer Centers in the United States A National Developer and Communicator of: • Programs to support member institution missions in education, research, and patient care • Scientific/evaluative information to inform and improve the decision-making between patients and physicians to improve quality and effectiveness of care • Developer of benchmarking data regarding quality of cancer care

4. Oncology • Complex group of about 200 different diseases • Managed by multidisciplinary teams • Rapidly evolving standard of care based on large volume of research • Share-care models across disparate settings of care • Coordination of care a significant challenge

5. Two Types of Evidence-Based Guidelines • Process map of integrated interventions over time • Exhaustive review of single decision point

6. NCCN Guidelines • Comprehensive across all stages, modalities and continuum of care • 44 multidisciplinary expert panels • Cancer screening, diagnosis, treatment and supportive care • Updated at least annually and up to 4 times per year since 1995 • Category of evidence and consensus designated for each recommendation • Transparent processes • Centerpiece of suite of tools to support quality oncology care

7. NCCN Clinical Practice Guidelines in Oncology™

8. Components of NCCN Guidelines • Title • Panel List • Names, affiliations, specialties • Algorithm • Step by step clinical decision making map • Staging • Identification of patient subsets • Discussion • Data supporting recommendations and • Issues identified by panel • References • Disclosures • Individual • Organizational

9. Evidence-based Consensus Allows Comprehensive Guideline Evidence-based guideline Continuum of disease and patient care Evidence-based consensus guideline High-level evidence exists Gaps in evidence filled with expert consensus

10. NCCN Levels of Evidence Category 1: Based upon high-level evidence and uniform NCCN consensus that intervention is appropriate Category 2A: Based on lower-level evidence and uniform NCCN consensus that it constitutes appropriate care Category 2B: Based upon lower-level evidence and NCCN consensus that it constitutes appropriate care Category 3: Any level of evidence but major NCCN disagreement that the recommendation is appropriate.

11. Selecting Recommendations • The amount of data available differs across disease sites and across clinical decisions within a disease site • Major change in standard of care supported by consistent, convincing studies which have major impact on outcomes – e.g., Adjuvant trastuzumab in breast cancer • Less dramatic, but significant change in standard of care supported by lower level evidence – e.g., bevacizumab in Glioblastoma • New studies WILL change the standard of care over time Data from multiple studies Expert evaluation Distill appropriate recommendations

12. Examples from Breast Cancer Guideline

13. Disclosure • No industry or any other interest group funds are used to support panel meetings • No industry representatives allowed at meetings • Individual panel members disclose conflicts of interest at each panel meeting and in writing • Potential conflicts of interest published individually • Members are excused from deliberations when degree of conflict warrants • Most panel members have some conflict(s)

14. Implementation of Guidelines • Measure concordance with guidelines • evaluate the quality of care • examine patterns and outcomes of care • evaluate treatments and other interventions • provide feedback to providers • provide feedback to guidelines developers

15. NCCN Oncology Outcomes Database Project Update* * Number of patients abstracted as of October 29, 2009.

16. Standards for Guidelines Development • Provide latitude for both types of guideline development • Permit both evidence and consensus as criteria for inclusion • Accommodate rapid update cycles • Foster transparency and consistency of process • Disclosure of developers potential conflicts • Encourage assessment of implementation