Transcript Disclosures

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
Lung Cancer Stage at Diagnosis
7%
15%
I (Localized)
II and III (Regional)
22%
56%
IV (Distant)
Unknown
http://seer.cancer.gov/statfacts/html/lungb.html
NLST
Lung Cancer Cases
Lung Cancer Diagnoses:
CT (n = 1060)
61.8%
649 from positive screens
44 after negative screens
367 in those who missed
screens or after trial
completed
Lung Cancer Diagnoses:
CXR (n = 941)
29.6%
279 from positive screens
137 after negative screens
535 in those who missed
screens or after trial
completed
NLST: Stage Groupings
50%
49%
N Engl J Med 2011;365:395-409
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
April 2015
Insurance Coverage Circa 2014
Covered
Not Covered
Current Recommendations for
Lung Cancer Screening
Summary of Current Guidelines
CMS
Grade B
Recommendation
Primary
Criteria
• 55 – 79 years
• > 30 pack-yrs
• 55 – 74 years
• > 30 pack-yrs
• Current
smoker or
quit < 15 yrs
• Asymptomatic
Secondary
Criteria
• Lung cancer
survivor
• > 50 years
• > 20 pack-yrs
• At least one
other risk
factor (not
second-hand
smoke)
• > 50 years
• > 20 pack-yrs
AND
Added >5% risk of
lung CA within 5
years
• 55 – 80 years
• > 30 pack-yrs
• Current
smoker or
quit < 15 yrs
• Asymptomatic
None
• 55 – 77 years
• > 30 pack-yrs
• Current
smoker or
quit < 15 yrs
• Asymptomatic
None
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
CMS: Additional Requirements
• 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
Lung Cancer Screening in Practice
Lung Cancer Screening Program
• Multidisciplinary program
– Communication is key
– Include PMDs
• “Real time” scan and consultation
– Shared decision making
– NCCN Guidelines
– Smoking cessation counseling
• Referral for incidental findings
Workflow
Patient/PMD call for
or order lung cancer
screening
Eligibility confirmed
Screening clinic
appointment made
Chest Radiology
NP/CTTS
Thoracic Surgeon
Day of Screening
Pre-screen
discussion (clinic)
Check in at Radiology
LDCT Done
CT read by Chest
Radiologist (< 1 hr)
Screening clinic
for results
Duke Thoracic Oncology Program
Screening Algorithm
Screening Clinic
Pre-screen Discussion
(Screening Clinic)
Radiology
Low-dose CT
Screening Clinic
Smoking Cessation Counseling
as appropriate
Negative screen
•
•
•
Discussion of findings
Schedule appt for next annual screen
Letter to referring/PMD with report
Duke Thoracic Oncology Program
Screening Algorithm
Screening Clinic
Pre-screen Discussion
(Screening Clinic)
Radiology
Low-dose CT
Screening Clinic
Smoking Cessation Counseling
as appropriate
Negative screen
•
•
•
Discussion of findings
Schedule appt for next annual screen
Letter to referring/PMD with report
Solid nodule > 6 mm
GGO or part-solid nodule > 5 mm
Multi GGO/GGNs >5 mm or dominant
Positive screen
Duke Thoracic Oncology Program
Screening Algorithm
Positive screen
> 6 mm solid
> 5 mm GGO
Referral to TSU/IP
provider*
Follow-up
imaging
* Can be same day
PET/CT
(> 8 mm solid)
Duke Thoracic Oncology Program
Screening Algorithm
Positive screen
> 6 mm solid
> 5 mm GGO
Referral to TSU/IP
provider*
Follow-up
imaging
* Can be seen same day
PET/CT
(> 8 mm solid)
Advanced
Disease
Biopsy
(IP/Radiology)
Medical Oncology
+
Radiation Oncology
• Developed by leadership of ACCP/ATS
• Endorsed by AATS, American Cancer Society, ASCO
• Describes 9 essential components / 21 policy statements
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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
Lung Cancer Screening and Management:
A Multidisciplinary Effort
Medical
Oncology
Radiation
Oncology
Thoracic
Surgery
Lung Cancer
Screening
Program
Local/Referri
ng Physicians
Chest
Radiology
Smoking
Cessation
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
NLST- False Positives
•
24.2% of CT screens were
positive
NLST- Positive Studies
•
92% of positive CT screens had a
diagnostic evaluation
8.4%
 16 deaths within 60 days
 6 of 16 had benign pathology
• 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 screendetected nodules.”
Ann Thorac Surg 2013; 96:357-60
(Under)
Utilization of VATS for Lobectomy
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