Making the Case for Lung Cancer Screening [Insert Organization Name] Making the Case for Lung Cancer Screening Introductions Introduce program and goals of the discussion

2014 Estimated New Cancer Cases Leading Cause of Cancer Deaths Second Most Prevalent Cancer Type Among Men and Women Top Three Tumor Types 2014 Estimated New Cancer Cases 3rd lung cancer third most prevalent tumor type 232,670 233,000 1st lung cancer is the leading cause of cancer-related deaths 224,210 27% lung cancer deaths as a percentage of total cancer- related deaths Source: American Cancer Society, Fancer Facts and Figures 2014, accessed: http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/index. Lung cancer is the third most prevalent cancer type and 2nd most prevalent cancer type in men (after prostate) and second most prevalent cancer type in women (after breast) Lung cancer is also the leading cause of cancer-related deaths worldwide

Lung Cancer Stage at Diagnosis Lung Cancer Typically Diagnosed At a Late Stage Lung Cancer Stage at Diagnosis Non-Small Cell Lung Cancer Five-Year Survival Rates, by Stage at Diagnosis Source: J Natl Cancer Inst, 100, no.9 (2008): 630-641; Oncology Roundtable interviews and analysis. This is largely due to the fact that lung cancer is typically diagnosed at a late stage when treatment is less effective More than half of lung cancers are diagnosed at a late stage Five-year survival rate decreases significantly as patients are diagnosed at later stages In comparison, to other cancers, breast, prostate, colon, lung cancer has one of the lowest five year survival rates – overall five year survival for lung cancer is just 16% Additionally while early detection and screening is available for these other tumor types – think mammography, PSA testing, colonoscopy, none has existed for lung cancer until now….

A Key Turning Point NLST Finds Lung CT Screening Leads to Reductions in Mortality NLST Results, LDCT Total Cases 26,000 Negative 72.7% Positive 27.3% Incidental Findings 7.5% 20% percentage reduction in lung cancer mortality in participants that received low-dose CT scans as compared to participants who received standard chest X-rays Study in Brief: National Lung Cancer Screening Trial 2011 study to assess effectiveness of low-dose lung CT screening 53,454 current and former smokers were randomly assigned to be screened once a year for three years with low-dose CT or chest X-ray Participants who received low-dose CT scans had a 20% lower risk of dying from lung cancer than participants who received standard chest X-rays Source: The National Lung Screening Trial Research Team, “Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening,” New England Journal of Medicine, 365, 2011, accessed: http://www.nejm.org/doi/full/10.1056/NEJMoa1102873 The National Lung Cancer Screening Trial in 2011 screened over 50,000 current and former smokers – each individual was randomly assigned to low-dose CT or chest X-ray for once a year screening for three years The NLST participants were ages 55-74 years and had a 30-pack year smoking history The study found that participants that received low-dose lung cancer screening benefited from a 20% reduction in lung cancer mortality and 7% reduction in overall mortality as compared to individuals that received standard chest X-rays

Timeline for CT Lung Cancer Screening Approval NLST Study Prompts USPSTF Approval Commercial Reimbursement for Screening Expected 2015 Timeline for CT Lung Cancer Screening Approval June, 2011 NLST¹ releases initial findings for CT lung cancer screening for high-risk individuals December, 2013 USPSTF gives low-dose CT lung cancer screening “B” recommendation January, 2015 lung cancer screening commercial reimbursement expected to begin 2011 2013 2014 2015 2015 June, 2013 USPSTF² releases draft recommendation April, 2014 MEDCAC³ recommends against Medicare coverage for lung screening What USPSTF “B” Recommendation Means for Lung Screening Programs A grade “B” by the USPSTF means that the USPSTF recommends the service and that there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial The Affordable Care Act requires that all new private health insurance plans cover all preventative services that are rated at a grade “B” or higher by the USPSTF Source: "Screening for Lung Cancer, U.S. Preventative Services Task Force Recommendation Statement,” USPSTF Final Recommendation Statement, Dec. 2013; Oncology Roundtable interviews and analysis The NLST study sparked a lot of interest from the cancer care and preventive care community and as such the study led to the United States Preventive Task Force approving lung CT screening and awarding it a grade B The grade B by the USPSTF essentially means that under the Affordable Care Act all private health plans are required to cover lung screening (or any services graded B or higher by the USPSTF)

Societies Recommending CT Lung Cancer Screening Several Organizations In Support National Comprehensive Cancer Network American Lung Association American Thoracic Society American Society of Clinical Oncology American Association for Thoracic Surgery American Cancer Society American Association of Bronchology and Interventional Pulmonology Society of Thoracic Radiology Society of Thoracic Surgeons International Association for the Study of Lung Cancer Oncology Nursing Society European Society of Thoracic Surgeons American College of Radiology Cancer Care Ontario Societies Recommending CT Lung Cancer Screening Source: Mckee, A et a;., “Rescue Lung, Rescue Life: Translating the NLST results into clinical practice, Oncology Issues, accessed: http://www.nxtbook.com/nxtbooks/accc/oncologyissues_20140304/#/22. And it’s not just the USPSTF, many other clinical societies are also recommending lung CT screening for high-risk individuals as well

Comparing Screening Criteria Organization Criteria National Lung Screening Trial (NLST) 55-74 years old, 30 + pack years, stopped smoking less than 15 years ago United States Preventive Services Task Force (USPSTF) 55-80 years old, 30+ pack years, stopped smoking less than 15 years ago Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative surgery National Comprehensive Cancer Network (NCCN) Category 1a: 55-74 years old, 30 + pack years, stopped smoking less than 15 years ago Category 2b: 50-74, 20+ pack years, have one additional risk factor excluding second hand smoke Risk factors include: tobacco smoking, contact with radon, contact with asbestos or other cancer-causing agents (chromium, arsenic, beryllium, cadmium, nickel, coal smoke, soot, silica and diesel fumes, having had certain other cancers, family who’ve had lung cancer, having had other lung diseases (COPD, pulmonary fibrosis) Source: National Lung Screening Trial Research Team “Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening”  N Engl J Med. 2011 Aug 4;365(5):395-409. Epub 2011 Jun 29. “Screening for Lung Cancer”, USPSTF, http://www.uspreventiveservicestaskforce.org/uspstf/uspslung.htm ; Shaffer A, “CT Screening Evolves Amid Questions and Controversy”, OncLLive, http://www.onclive.com/publications/obtn/2012/september-2012/ct-screening-evolves-amid-questions-and-controversy/2; Many of these organizations only recommend screening in high-risk individuals and typically involve very specific screening criteria: Patient Age Smoking History Any other risk factors (family history, asbestos exposure, significant second hand smoke exposure etc.) The screening criteria most commonly used is outlined for you here

[Insert Program Screening Criteria Here] Our screening program plans to use the following screening criteria Explain if criteria does or does not match NCCN/NLST screening criteria

Putting It Into Context Comparing Mammography and Low-Dose Lung CT Screening Mammography Low-dose CT Lung Cancer Screening False positive rate 10-12% 20-25% False discovery rate 96% False positive biopsy rate 7-15% 0.4-2.4% Number of individuals need to be screened in order to save one life ~800-900 320 Source: National Lung Screening Trial Research Team “Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening”  N Engl J Med. 2011 Aug 4;365(5):395-409. Epub 2011 Jun 29. “Screening for Lung Cancer”, USPSTF, http://www.uspreventiveservicestaskforce.org/uspstf/uspslung.htm Before we go any further, lung CT screening is relatively new, so I thought I’d share some data on how lung CT screening compares to a very well known screening type – mammography As you can see, it fairs quite well Though lung CT screening has a higher false positive rate, it has a lower false positive biopsy rate, meaning fewer patients have to undergo invasive follow-up procedures after the screening Additionally, due to more stringent screening criteria for lung CT screening, lung screening actually has a better rate of return, or you only have to screen 320 patients to save one life as opposed to mammography

Early Detection Boosts Cost-Effectiveness Compares Favorably Compared to Other Screening Types Shift in Stage of Diagnosis Due To CT Screening Screening Cost Effectiveness Change in Number of Lung Cancer Patients Diagnosed by Stage1 Cost Per Life-Year Saved 434% (25%) (93%) Stage A Stage B Stage C Lung CT Screening Cervical Screening Breast Screening Colorectal Screening $11- 26 K $50- 75 K $18- 28 K $31- 51 K Analysis of lung cancer patient volumes at an academic medical center that sees 5,508 new patients per year; calculations based on 463 new diagnoses of lung cancer. Source: Pyenson B et al., “An Actuarial Analysis Shows That Offering Lung Cancer Screening as An Insurnace Benefit Would Save Lives at Relatively Low Cost,” Health Affairs 31(4); Oncology Roundtable interviews and analysis. Not only does lung CT screening compare favorably from a quality standpoint, but also from a cost-effectiveness perspective Given the shift in stage due to screening, screening actually has the lowest cost-per life saved, comparing favorably against cervical, breast, and colorectal screening

Early Detection Boosts Cost Effectiveness (cont.) Study in Brief: Milliman Actuarial Analysis 2012 actuarial analysis of the effects of LDCT lung cancer screening on outcomes and cost Lung CT screening would shift detection from late stages to early stages, resulting in 130,000 more lung cancer survivors in 2012 Authors concluded that offering LDCT screening as an insurance benefit would save lives at low cost compared to routine screenings for other cancers Source: Pyenson B et al., “An Actuarial Analysis Shows That Offering Lung Cancer Screening as An Insurnace Benefit Would Save Lives at Relatively Low Cost,” Health Affairs 31(4); Oncology Roundtable interviews and analysis. Hidden slide, no need to discuss

Apply 3-5% volume estimate to market, or physician panel size Not A Significant Volume Burden individuals at “high-risk” for developing lung cancer, according to NLST estimates 10M Apply 3-5% volume estimate to market, or physician panel size 1,000 x 5% = 50 patients Primary physician patient panel of 1,000 patients can potentially have about 50 patients that would be eligible for lung CT screening Source: The National Lung Screening Trial Research Team, “Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening,” New England Journal of Medicine, 365, 2011, accessed: http://www.nejm.org/doi/full/10.1056/NEJMoa1102873 Now, given the cost and quality benefits of screening, we of course would like to offer the service to individuals who are eligible, or meet the screening criteria The good news is that this will not be a significant burden on you physicians NLST estimates put the number of high-risk patients eligible for lung cancer screening at 3-5-% of the US population, so about 10 million nationwide Bringing this back to the local level – for a primary care physician with a patient panel of about 1,000 patients, this translate to just 50 patients

Screening Follow-Up Managed by Program Lung Cancer Screening Program Flow Map Add Text Here To support you, we have developed an extremely comprehensive lung cancer screening program Let me walk you through the process steps… Let me highlight your role and responsibilities within each step and how our program can support you…..

[Insert Sample Screening Results Report Here] In terms of follow-up, you can expect…. Here is what the follow-up recommendations mean What you will have to do What our program will manage….

Insert Program Contact Information 202.XXX.XXXX [Email address] [Website URL] For more information, contact us at: John Smith XXXXXXXX Does any one have any questions? About the referral process? Screening criteria? Follow-up processes? To contact us to make a referral please….