1. Applying Genomics to Daily Clinical Practice Current Status and Major Challenges
Michael Seiden M.D. Ph.D.

2. Current Status and Major Challenges
The utilization of precision medicine and genomics has not been optimized in the clinical practice
Likely >90% of patients with cancer are treated outside of NCI designated cancer center (i.e. community practice)
Principle obstacles to address by panelists
Fragmentation
Knowledge gap
Efficient decision support
Costs and risks

3. The US Oncology Network and Vantage Oncology
National Reach
>350 sites of care in 19 states
>1,000 physicians
>800K patients treated annually
Innovative Clinical Care
~63K patients enrolled in clinical trials
Participated in development of nearly 60 FDA-approved cancer therapies
Leading Value-Based Care
13 practices accepted to the Oncology Care Model
85% of providers using ClearValue PlusSM
20 disease states in Value Pathways
Vantage Oncology
The US Oncology Network

4. The US Oncology Network
>45
400
Practices on single EHR
Sites of care in 29 states
Independent practices
>1,300
>250K
Option to use McKesson’s co-owned molecular lab
Affiliated physicians
New cancer patients treated annually 60
Research Sites with 2500 patients enrolled in trials

5. Network Precision Medicine with NSCLC Pilot
Gene
Mutations Detected
KRAS
All mutations in codons 12, 13, and 16
EGFR
All common mutations in exons 18-21: p.G719C/S/A, p.T790M, p.L858R, p.L861Q, exon 19 deletions, exon 20 insertions
BRAF
p.G466V, p.G469A, p.L597V, p.V600E
NRAS
All mutations in codon 61
PIK3CA (PI3K)
p.E542K, p.E545K/Q, p.H1047R
MAP2K1 (MEK1)
P.Q56P, p.K57N, p.D67N
AKT1
p.E17K
PTEN
p.R233X
HER2
Exon 20 insertions
Purpose: To test the ability of The US Oncology Network to develop and implement standards for genomic testing
Recommendation: Physicians in The Network order the med fusion NSCLC panel for every new Stage 3 and 4 non- squamous NSCLC patient
*ALK and ROS1 are tested reflexively

6. Communicating the Advantages to Practices
Improved patient care
Greater clinical trial accrual
Local marketing opportunities
Decreased data entry
Payer relationships

7. Current NSCLC Pilot Status
Average of 400 new metastatic NSCLC patients a month across The Network
88 samples tested in April – July, 5.5% of cases

8. Lessons Learned
Test ordering process varies – must customize for each practice
Patient financial responsibility is the key concern of the practice
Only 50% of time tests ordered by medical oncologist
Communication with local pathology departments can be critical
Don’t underestimate IT related challenges

9. Fragmentation

10. Eligible Population Statistics
From April – July, 494 physicians in The US Oncology Network saw at least one new, Stage III / IV NSCLC patient
Total of 1,335 patients were seen across The Network from April - July
Mean average was 2.7 patients per physician; median was 2 patients
# of Physicians

11. Physician Fragmentation

12. Lab Fragmentation
Lab companies go directly to consumer (community physicians)
Avoid electronic connectivity as it slows the sales process
Deliver results by PDF which make it difficult to search ordering patterns

13. Efficient Decision Support and Knowledge Gap

14. Challenges of Knowledge Gap & Decision Support
Average community oncologist sees all blood based and solid tumors. Typically round at two hospitals and have 7-8 hours of office time with patients (range 10-40).
Recent estimate is 10 minutes to complete EHR documentation. Average 8-10 minutes per patient for review of outside data, history, physical exam, review of recommendations.
No simple way to connect to clinical trials in efficient manner.
Average age of oncologist in The US Oncology Network is 54. Completed medical oncology training in 1993.

16. Cost and Risk

17. Cost
Risk
High deductible cost plans potentially add burden to patients
Risk transfers to clinicians who now need to consider total cost of care

18. Oncology Care Model A CMMI Pilot Experiment
800 physicians and 35,000 patients to participate in The Network this year
Responsible for total costs including labs, medications, imaging, hospitalization, and emergency departments
One-sided risk for two years, then two-sided risk
If practice profits decrease this will directly impact physician income –a strong motivation to follow well vetted value pathways to maximize predictability
Essentially all major commercial payers watching closely and in most cases designing similar alternative payer models

19. In Conclusion: Challenges for the Panelists
What strategies should be developed to achieve a logical, feasible, affordable path forward?
Ideally a strategy should:
Provide patients with a precision medicine strategy with maximal chance of providing useful information
Provide providers with an efficient way to utilize this type of testing and act on these results
Provide the greater oncology community with the maximal insight of translating the genomic results with clinical recommendations that have maximal validity
Provide payers with confidence that this is money well spent