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

Disclosures

• Member, NCCN Lung Cancer Screening Guidelines panel (no compensation)

• Consultant, W.L. Gore (fees donated to Women in Thoracic Surgery)

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

15%

22%

56%

7%

Lung Cancer Stage at Diagnosis

I (Localized)II and III (Regional)IV (Distant)Unknown

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

NLSTLung Cancer Cases

Lung Cancer Diagnoses: CT (n = 1060)

649 from positive screens44 after negative screens367 in those who missed

screens or after trial completed

Lung Cancer Diagnoses: CXR (n = 941)

279 from positive screens137 after negative screens535 in those who missed

screens or after trial completed

61.8% 29.6%

N Engl J Med 2011;365:395-409

50%

49%

NLST: Stage Groupings

20% reduction in lung-cancer specific mortality with LDCT6.7% reduction in overall mortality with LDCT

N Engl J Med 2011;365:395-409

Insurance Coverage Circa 2014Covered Not Covered

April 2015

Current Recommendations for Lung Cancer Screening

Summary of Current GuidelinesCMS

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

ANDAdded >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 BRecommendation

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

??APPROVED Application In Progress

• 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

Lung Cancer Screening in Practice

• 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

Patient/PMD call for or order lung cancer

screening

Chest Radiology Thoracic SurgeonNP/CTTS

Workflow

Eligibility confirmed

Screening clinic appointment made

Check in at Radiology

Day of Screening

LDCT Done

Screening clinicfor results

CT read by Chest Radiologist (< 1 hr)

Pre-screen discussion (clinic)

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

Smoking Cessation Counseling as appropriate

Duke Thoracic Oncology Program

Screening Algorithm

Screening Clinic

Radiology

Screening Clinic

Low-dose CT

Negative screen

Positive screen

Smoking Cessation Counseling as appropriate

Solid nodule > 6 mmGGO 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

Screening Clinic

Radiology

Pre-screen Discussion (Screening Clinic)Screening Clinic

Positive screen

> 6 mm solid> 5 mm GGO

Referral to TSU/IP provider*

Follow-up imaging

PET/CT(> 8 mm solid)

Duke Thoracic Oncology Program

Screening Algorithm

* Can be same day

Positive screen

> 6 mm solid> 5 mm GGO

Advanced Disease

Biopsy (IP/Radiology)

Referral to TSU/IP provider*

Medical Oncology+

Radiation Oncology

PET/CT(> 8 mm solid)

Duke Thoracic Oncology Program

Screening Algorithm

* Can be seen same day

Follow-up imaging

• 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

Smoking Cessation

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

• 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

• 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

Medical Oncology

Radiation Oncology

Chest Radiology

Thoracic Surgery

Local/Referring

Physicians Smoking Cessation

Lung Cancer Screening Program

Lung Cancer Screening and Management: A Multidisciplinary Effort

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

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

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

BPA Example

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

Reducing Risk in Lung Cancer Screening

• 24.2% of CT screens were positive

NLST- False Positives

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%

• Overdiagnosis: Detection of disease that does not contribute to death

• Results in unnecessary treatment, morbidity, cost, worry

• 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

Risk Reduction

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

• 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.

Frequency of a positive result and cases of lung cancer diagnosed within 12 months of enrollment

Ann Intern Med 2013; 158:248-252.

• 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

“…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

Utilization of VATS for Lobectomy(Under)

New Technology

• Improved precision of TBBx, VATS wedge• In lieu of diagnostic VATS?

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

Thank You