1. How, Who, What Happens Next? Betty C. Tong, MD, MHS Division of Cardiovascular and Thoracic Surgery Co-Director, Lung Cancer Screening Program Duke University Medical Center

2. Disclosures Member, NCCN Lung Cancer Screening Guidelines panel (no compensation) Consultant, W.L. Gore (fees donated to Women in Thoracic Surgery)

3. Outline Background and rationale for lung cancer screening – Current guidelines and recommendations – Insurance coverage and reimbursement Components of a successful lung cancer screening program – Fundamentals and logistics – Challenges The future

4. http://seer.cancer.gov/statfacts/html/lungb.html

5. NLST Lung Cancer Cases Lung Cancer Diagnoses: CT (n = 1060) 649 from positive screens 44 after negative screens 367 in those who missed screens or after trial completed Lung Cancer Diagnoses: CXR (n = 941) 279 from positive screens 137 after negative screens 535 in those who missed screens or after trial completed 61.8%29.6%

6. N Engl J Med 2011;365:395-409 50% 49% NLST: Stage Groupings

7. 20% reduction in lung-cancer specific mortality with LDCT 6.7% reduction in overall mortality with LDCT N Engl J Med 2011;365:395-409

8. Insurance Coverage Circa 2014 CoveredNot Covered April 2015

9. Current Recommendations for Lung Cancer Screening

11. Summary of Current Guidelines CMS Primary Criteria 55 – 79 years > 30 pack-yrs 55 – 74 years > 30 pack-yrs Current smoker or quit < 15 yrs Asymptomatic 55 – 80 years > 30 pack-yrs Current smoker or quit < 15 yrs Asymptomatic 55 – 77 years > 30 pack-yrs Current smoker or quit < 15 yrs Asymptomatic Secondary Criteria Lung cancer survivor > 50 years > 20 pack-yrs AND Added >5% risk of lung CA within 5 years > 50 years > 20 pack-yrs At least one other risk factor (not second-hand smoke) None None Grade B Recommendation

12. CMS: Additional Requirements Must be performed at specialized centers – Radiology imaging center with appropriate expertise, equipment – Must collect and submit data to a CMS-approved national registry Registries ?? APPROVEDApplication In Progress

13. Initial LDCT must be ordered during a lung cancer screening counseling and shared decision making visit Documentation 1.Eligibility Criteria are all met and documented 2.One or more decision aids to discuss benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, total radiation exposure 3.Counseling on importance of adherence to annual LDCT screening, impact of comorbidities, willingness to undergo diagnosis and/or treatment 4.Counseling on smoking cessation (or continued abstinence), including offering additional tobacco cessation counseling services if appropriate CMS: Additional Requirements

14. Lung Cancer Screening in Practice

15. Multidisciplinary program – Communication is key – Include PMDs “Real time” scan and consultation – Shared decision making – NCCN Guidelines – Smoking cessation counseling Referral for incidental findings Lung Cancer Screening Program

16. Patient/PMD call for or order lung cancer screening Chest Radiology Thoracic Surgeon NP/CTTS Workflow Eligibility confirmed Screening clinic appointment made

17. Check in at Radiology Day of Screening LDCT Done Screening clinic for results Screening clinic for results CT read by Chest Radiologist (< 1 hr) Pre-screen discussion (clinic)

18. Pre-screen Discussion (Screening Clinic) Low-dose CT Negative screen Discussion of findings Schedule appt for next annual screen Letter to referring/PMD with report Discussion of findings Schedule appt for next annual screen Letter to referring/PMD with report Smoking Cessation Counseling as appropriate Duke Thoracic Oncology Program Screening Algorithm Screening Clinic Radiology Screening Clinic

19. Low-dose CT Negative screen Positive screen Smoking Cessation Counseling as appropriate Solid nodule > 6 mm GGO or part-solid nodule > 5 mm Multi GGO/GGNs >5 mm or dominant Solid nodule > 6 mm GGO or part-solid nodule > 5 mm Multi GGO/GGNs >5 mm or dominant Duke Thoracic Oncology Program Screening Algorithm Discussion of findings Schedule appt for next annual screen Letter to referring/PMD with report Discussion of findings Schedule appt for next annual screen Letter to referring/PMD with report Screening Clinic Radiology Pre-screen Discussion (Screening Clinic) Screening Clinic

20. Positive screen > 6 mm solid > 5 mm GGO > 6 mm solid > 5 mm GGO Referral to TSU/IP provider* Follow-up imaging PET/CT (> 8 mm solid) PET/CT (> 8 mm solid) Duke Thoracic Oncology Program Screening Algorithm * Can be same day

21. Positive screen > 6 mm solid > 5 mm GGO > 6 mm solid > 5 mm GGO Advanced Disease Biopsy (IP/Radiology) Biopsy (IP/Radiology) Referral to TSU/IP provider* Medical Oncology + Radiation Oncology Medical Oncology + Radiation Oncology PET/CT (> 8 mm solid) PET/CT (> 8 mm solid) Duke Thoracic Oncology Program Screening Algorithm * Can be seen same day Follow-up imaging

22. Developed by leadership of ACCP/ATS Endorsed by AATS, American Cancer Society, ASCO Describes 9 essential components / 21 policy statements – Who is offered screening, and for how long – Technical aspects of LDCT scans – Interpretation of scans / definition of “positive” – Standardized reporting – Management algorithms – Patient and provider education – Data collection – Smoking cessation

23. Smoking Cessation

24. Rationale for Including Tobacco Cessation Counseling with LCS Decreases risk of lung cancer and other smoking-related conditions Increases cost effectiveness of lung cancer screening It is the right thing to do Required by CMS for reimbursement

25. Estimated mean life-years, QALYs, costs per person, ICERs Used 3 alternative strategies – Screening with LDCT – Screening with radiography – No screening Conclusions – LDCT cost $81,000 / QALY gained – Caveat: “modest changes” in assumptions would greatly alter results

26. Modeling used to estimate QALYs saved by lung cancer screening and treatment Included cost of “intensive” cessation programs – Generic NRT vs. buproprion vs. varenicline Hypothetical cohort 50-64 yo with > 30 p-y smoking – 2/3 current smokers – 1/3 former smokers

28. Medical Oncology Radiation Oncology Chest Radiology Thoracic Surgery Local/Referri ng Physicians Smoking Cessation Lung Cancer Screening Program Lung Cancer Screening and Management: A Multidisciplinary Effort

29. Current Challenges Logistics – Protocoling for scans – Insurers slow to get on point – Standardized reporting Access for un- and underinsured Referring providers – Appropriate referrals for screening – Follow-up after initial screening study

30. Getting “Buy In” Multidisciplinary team approach includes Primary Care, General Medicine and Pulmonary Provider Education – Teaching Conferences/Grand Rounds – Community outreach – Electronic alerts and reminders in EMR

31. Role of the EMR in Screening BPAs for primary care providers Direct access to patients – Electronic reminders (e.g. MyChart) – Reminder letter sent via mail – Pop-up message at check-in kiosk “Hard stops” to ensure clinical eligibility during ordering process Smoking cessation materials and resources Decision aid

32. BPA Example

33. So What Happens Next? Improving existing screening and diagnostic modalities to increase precision and reduce risk – Non-invasive prediction models – Safer practices Adjunctive testing – Biomarkers

34. Reducing Risk in Lung Cancer Screening

35. 24.2% of CT screens were positive NLST- False Positives

36. NLST- Positive Studies 92% of positive CT screens had a diagnostic evaluation  16 deaths within 60 days  6 of 16 had benign pathology 8.4%

37. Overdiagnosis: Detection of disease that does not contribute to death Results in unnecessary treatment, morbidity, cost, worry

38. Overdiagnosis: Detection of disease that does not contribute to death Results in unnecessary treatment, morbidity, cost, worry Lung Cancer (LDCT)18% Breast Cancer (Mammo)30-54% Prostate Cancer (PSA)29-44% Etzioni et al. JNCI 2002; 94: 981-990

39. Risk Reduction Increased size threshold for “positive” Predictive models/algorithms Improving surgical outcomes – Underutilization of VATS/Robotics? – Use of new technology

40. Retrospective analysis of I-ELCAP data N = 21,136 Measured frequency of positive results and delays in diagnosis using more restrictive size thresholds 10.2% positives using 6 mm threshold Ann Intern Med 2013; 158:248-252.

41. Frequency of a positive result and cases of lung cancer diagnosed within 12 months of enrollment Ann Intern Med 2013; 158:248-252.

43. NELSON: Dutch trial of LDCT vs. usual care in high risk participants, 7155 in CT group Calculation of lung cancer probabilities based on nodule characteristics (diameter, volume, etc.) Use of nodule volume and/or volume doubling time improves predictive ability for lung cancer in management algorithms

44. “…strongly encourages the use of MITS, inclusive of both video-assisted and robotic approaches, whenever available, for the diagnosis and treatment of screen- detected nodules.” Ann Thorac Surg 2013; 96:357-60

45. Utilization of VATS for Lobectomy (Under)

46. New Technology Improved precision of TBBx, VATS wedge In lieu of diagnostic VATS?

47. Summary Screening with LDCT is here, and Thoracic Surgeons are important members of the LCS Team Lung cancer screening programs – Multidisciplinary collaboration – Must include smoking cessation There is still room for improvement – Better and more tools for accurate prediction – Safer procedures

48. Thank You