Wall Street Perspective Diagnostics - McDermott+Consulting...Growth in Sequencing Expected to Be...
Transcript of Wall Street Perspective Diagnostics - McDermott+Consulting...Growth in Sequencing Expected to Be...
William Blair or an affiliate does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. This report is not intended to provide personal investment advice. The opinions and recommendations herein do not take into account individual client circumstances, objectives, or needs and are not intended as recommendations of particular securities, financial instruments, or strategies to particular clients. The recipient of this report must make its own independent decisions regarding any securities or financial instruments mentioned herein.
Wall Street Perspective Diagnostics
April 18, 2018
Amanda Murphy, CFA [email protected]
Max Smock [email protected]
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Analyst Bio
Amanda Murphy, CFA, partner, joined William Blair in 2006. Ms. Murphy is a healthcare analyst with a focus on diagnostic services and life sciences. Previously, Ms. Murphy worked at Caremark as a business analyst and as a senior consultant within PricewaterhouseCoopers’s strategy consulting division. She received a B.S. in biology from Boston College’s honors program and holds an M.B.A. in finance, accounting, and economics from the Kellogg Graduate School of Management at Northwestern University.
Amanda Murphy, Partner Analyst – Healthcare Diagnostic Services, Life Sciences +1 312 364 8951 [email protected]
Companies Under Coverage Diagnostic Services Foundation Medicine, Inc. (FMI) Genomic Health, Inc. (GHDX) Invitae Corporation (NVTA) Laboratory Corp. (LH) Myriad Genetics, Inc. (MYGN) NeoGenomics, Inc. (NEO) Quest Diagnostics Inc. (DGX) Veracyte, Inc. (VCYT) Life Sciences Bio-Techne Corporation (TECH) Bruker Corporation (BRKR) Illumina, Inc. (ILMN) Pacific Biosciences, Inc. (PACB) Repligen Corporation (RGEN) Waters Corporation (WAT)
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Stock Valuation – How Do Investors Think About Stocks?
( )1
FCFEEquity value
1
∞
=
=+
∑t
ttr
Sum of future free cash
flows
Discounted back to
present value
Stock value equals the net present value of future cash flows
• Cash flow = volume of tests x what you actually get paid
• Discount rate = how much risk am I willing to take to hold this asset
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Diagnostics Investment Thesis Demographic trends support increased usage (volume growth)
• Aging population
• Cancer incidence increases by age
Innovation in sequencing platforms
• Cost per base reductions faster than Moore’s law
• Increase in sequencing tests on the market
Increased use of personalized medicine/targeted therapeutics
• Targeted therapeutics in pipeline
• Favorable regulatory environment
Transition to value-based care
• Need to lower cost of cancer care
• Diagnostics mechanism to more appropriately guide treatment
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Demographics Are a Major Factor in Driving Healthcare Usage
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Demographics Are a Major Factor Affecting HC Spending Growth
• Numbers of Medicare enrollment expected to surge with aging baby boomer population
• At the same time, the number of workers per beneficiary is expected to decline—creating a material funding challenge for the program
• Healthcare spending has slowed from recent levels but is still well in excess of GDP
• This situation is expected to become worse as the intensity of services and overall prices of Medicare are expected to accelerate
• This is expected to push healthcare to 20% of U.S. GDP ($5.5 trillion) by 2025
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2020 E
Source: U.S. Census Bureau
Baby Boomers are driving material growth
in the size of the Medicare population…
Num
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Cancer Prevalence/Cost to Treat Driven by Aging Population
• There are 1.74 million patients expected to be diagnosed with cancer a year—or 4,700 cases a day
• Mortality rates have declined and overall cancer incidence is down/stable, but the number of patients living with cancer is expected to grow from 15.5 million in 2016 to 26.1 million in 2040
• Average total treatment costs for patients in commercial insurance plans that were in active treatment for cancer reached $60K in 2014 (year-over-year growth of 19%)
• Over half of total costs are for outpatient services and the average combined cost of all drugs used by each patient represents 28% of the total cost of care
• Out-of-pocket costs are a major concern; average healthcare spending per patient increased from $2,000 in the month preceding diagnosis to as high as $25,000 in the month of diagnosis
Estimated cancer prevalance by age in the U.S. population from 1975 (216 million) to 2040 (380 million)
Source: Bluethmann et. al, “Anticipating the ‘Silver Tsunami’: Prevalence Trajectories and Co-Morbidity Burden Among Older Cancer Survivors in the United States.” Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 25.7 (2016)
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Cost of Cancer Care – Key Focus of All Stakeholders
• Genentech’s survey of five key stakeholder groups
• Control of cancer costs and cancer specialty drug costs one of top five issues
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Diagnostics as a Cost-Savings Mechanism • Diagnostics are a small portion of the spending but drive meaningful treatment decisions
• Separation of pharma coverage and diagnostic coverage within payer decision making
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group
2016 Medicare Spend by Type of Expenditure (total of $672.1 billion)
40%
22%
2% 1%
1%
6%
6%
16%
2% 5%Hospital Care
Physician and Clinical Services
Other Professional Services(including Dental)
Lab spend
Other Health, Residential, andPersonal Care
Home Health Care
Nursing Care Facilities andContinuing Care
Retail Outlet Sales of MedicalProducts
Government Administration
Net Cost of Health Insurance
Lab spend accounted for $6.8 billion
Source: The 2017 Genentech Oncology Trend Report
Percentage of Total Cancer Care Expenditures across Service Categories (2015)
29%
24%
22%
6%
5%
4%3%
3% 2% 2%Drug and drug administration
Hospital care
Physicians and clinical services(non-drug)
Palliative care and hospice
Cancer screenings
Molecular/biomarker testing
Genetic testing and counseling
Cancer care managementprograms (diseasemanagement)Cancer survivorship programcare
All other services
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Innovation in Sequencing Has Been Astounding
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Source: National Human Genome Research Institute and Illumina company reports
Cost of Sequencing has Decreased Faster than Moore's Law
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Cost per Genome Illumina Sequencing Revenue (TTM)
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1. Jan 2010 - Illumina launches HiSeq 20002. Jan 2012 - Illumina launches HiSeq 25003. Jan 2014 - Illumina launchesNextSeq 5004. March 2014 - Illumina launches HiSeq X5. Jan 2017 - Illumina launches NovaSeq
Cost per Base Has Declined Faster Than Moore’s Law
Source: Illumina filings and William Blair estimates
Illumina: Annual Shipments
230
914 1,020
1,627 1,700 1,970 1,985
436
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457 402 245 307
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High-throughput instruments Benchtop instruments
• Illumina has driven major reductions in cost per base since the HiSeq was first launched in 2010; the HiSeq X was a game changer lowering whole genome sequencing to $1,000 a genome
• At the same time, the company has focused on “democratizing” sequencing; the vast majority of the installed base is “benchtop platforms”
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Growth in Sequencing Expected to Be Driven by Targeted Panels • While WGS is now accessible at a cost of less than $1,000 per genome and declining, targeted
sequencing is expected to drive the majority of market growth
Note:* Including non-human WGS (e.g., plant whole genome sequencing, bacterial sequencing, de novo genome sequencing from non-human organisms), gene fusion, and counting applications (e.g., NIPT)
Source: DecBio Consulting
$-
$1.0
$2.0
$3.0
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$5.0
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Other RNA-SeqTargeted Resequencing* WESHuman WGS
WW NGS Market by Application (2014-20) Billions of dollars
CAGR (2014-17) (2017-20)
22% 19%
15% 13%
17% 12%
12% 6%
26% 14%
18% 12%
Shift of some current panels to WES / WGS and price decline offset by adoption for applications by (new) customers (e.g.,
liquid biopsy trials)
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Innovation in Sequencing
• As an example, the Broad has generated over 16 petabases of sequencing data since the HiSeq was first launched in 2010
• A petabase is one thousand trillion base pairs, which is over 33,000 times as much sequence as was completed in the human genome project.
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Proliferation of Genetic Testing
Source: Concert Genetics; 2017 Update: The Current Landscape of Genetic Testing
Total Testing Products on the Market
Source: Concert Genetics; 2017 Update: The Current Landscape of Genetic Testing
Note: Concert Genetics defines a genetic testing unit (GTU) as an orderable testing unit that is newly added to an existing catalog in its database.
• Roche invests $1.2 billion in Foundation Medicine
• Tempus raised > $200 million
• Grail raised over $1 billion to bring a pre-screening liquid biopsy assay to market
• Genetic information company Invitae raised >$400 million
• Liquid-biopsy company Guardant raised >$550 million
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Treatment Paradigms Becoming Only More Complex
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Targeted Therapeutic Pipeline
Source: IQVIA Institute for Human Data Science; Global Oncology Trends 2017
Late Phase Oncology Pipeline Molecules, 2006 to 2016 • Eighty-seven percent of the overall late stage pipeline are targeted therapeutics
• Almost all tumor types have seen increased segmentation based on biomarkers, age, and/or histology
• Biopharma pipeline is robust with over 1,100 number of therapies in phase III
• Ten percent of trials are currently using biomarker-based segmentation
• As an example, PD-1 and PD-L1 inhibitors have seen rapid uptake across cancers
• 728 trials using a PD-(L)1 inhibitor were posted to clinicaltrials.gov in 2017 with an additional 138 in 2018 to date; 140 of these are Phase III
Source: IQVIA Institute for Human Data Science; Global Oncology Trends 2017
Immuno-Oncology PD-1 and PD-L1 Inhibitor Update in the U.S.
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Increased Complexity of Care
Source: IQVIA Institute for Human Data Science; Global Oncology Trends 2017
Percent of Biomarker-Based Segmentation in Selected Tumors
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Increased Use of Biomarkers by Pharma
• William Blair’s 20th bi-annual CRO survey (in collaboration with Life Science Strategy Group); n of 136 biopharma companies
• General responses indicate a healthy fundamental demand environment; most optimism since the recession
• Biopharma companies across the board expect a 1% to 2% greater percentage change in R&D in 2018 and 2019; overall expect midsingle-digit R&D budget growth, if not better, in the coming three years
• In another bullish indicator for 2018 demand, biotechnology funding in the first quarter was up 45% compared with a year ago; this comes on the heels of an increase of 37% during all of 2017
• Thirty percent use biomarkers currently in the majority of trials; over 60% expect to increase use of biomarkers post-commercialization
Source: Life Science Strategy Group, LLC and William Blair & Company, LLC
William Blair Spring CRO SurveyPercentage of clinical trials currently using at least one biomarker (all respondents; n=136)
30%32%
18% 18%18%
10%
7%
4%
19%
9%7%
26%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Pre-commercialization Post-commercialization
% o
f res
pond
ents
0 to 20% 21 to 40% 41 to 60% 61 to 80% 81 to 100% Don't know/ Unsure
Percentage of pre-commercialization clinical trials / post-commercialization marketing using at least one biomarker
~30% of respondents currently use biomarkers in the majority of clincial trials but less than 15% of
respondents currently use biomarkers post commercialization
Source: Life Science Strategy Group, LLC and William Blair & Company, LLC
William Blair Spring CRO SurveyExpectations for use of associated biomarkers over time (all respondents; n=136)
23%
17%
52%
42%
21%24%
1%1% 1%4%
15%
0%
10%
20%
30%
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50%
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70%
Pre-commercialization Post-commercialization
% o
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pond
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Significant increase Modest increase No change Modest decrease Significant decrease Unsure
Percentage of pre-commercialization clinical trials / post-
~60% expect to see increased use of biomarkers post commercialization
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• Median time for drug approval has dropped from 10.25 years (2013) to 9.8 years in 2016 as the FDA has incorporated expedited review pathways (e.g., Breakthrough Therapy Designation)
Favorable Regulatory Environment – Approvals
Source: Global Oncology Trends 2017; IQVIA Institute for Human Data Science
Time for Patent Filing to Approval in the United States
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“By proposing streamlined approaches for our colleagues in the research and development communities, the FDA hopes to enable more efficient access to safe and effective, novel targeted therapies for the patients who need them.”
– Scott Gottlieb, M.D., Commissioner of the FDA
Favorable Regulatory Environment – Biomarkers
Note: Approvals include novel drugs and genericsSource: FDA
Pharmacogenomic Biomarkers in Drug Labeling: FDA Approvals by Year
1 0 0 0 1 2 1 04 1 1 1
6 7 8 9
3124
85 84
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Annual Number of FDA Cleared or Approved (PMA) Companion Diagnostic Devicesversus FDA NME Approvals
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What Are Investors Concerned About?
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Reimbursement!
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Reimbursement Success Stories
Source: Company releases
Oncotype Dx (Breast) Quarterly Test Volume
Q1'06: NHIC covers Oncotype Dx breast
Q3'06: Aetna covers Oncotype Dx breast
Q1'07: -UNH covers Oncotype Dx breast-
Humana covers Oncotype Dx breast
(4m)
Q2'07: -Cigna covers Oncotype Dx breast (9m)
-UK launch of Oncotype Dx breast
Q1'07: -UNH covers Oncotype Dx breast
-Humana covers Oncotype Dx breast
(4m)
Q2'13: Palmetto coverage expansion for
Oncotype Dx breast
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Test
volu
me
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sand
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Oncotype Dx Breast (Genomic Health)
Source: Company releases
Afirma + Percepta Quarterly Test Volume
Q1'12: Palmetto covers Afirma
Q2'13: -UNH covers Afirma (27m)
-Aetna covers Afirma (22m)
Q3'13: Humana covers Afirma
Q4'13: Cigna covers Afirma (13m)
Q1'14: EmblemHealth covers Afirma
Q2'14: Premera Blue Cross covers Afirma
Q4'14: Blue Shield of California covers
Afirma (3m)
Q1'16: Percepta approved in NY
Q1'17: -Noridian LCD for Percepta (17m)-Palmetto LCD for
Percepta
Q2'17: Anthem covers Afirma (40m)
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me
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Afirma and Percepta (Veracyte)
Source: Company releases
Cologuard Quarterly Test Volume
Q4'14: Cologuard NCD effective
Q1'15: Cologuard additional insurer
coverage
Q3'15: BCBS RI covers Cologuard
Q1'16: -Anthem BC of California covers Cologuard (4.5m)-Anthem BCBS of Georgia and BC of
Virginia cover Cologuard
Q2'16: -Harvard Pilgrim and Johns
Hopkins Health Plans cover Cologuard
-Anthem coverage for Cologuard in IN, OH,
KY, MO, WI
Q3'16: Cologuard additional insurer
coverage (cumulative 82m commercial)
Q4'16: TRICARE covers Cologuard
Q1'17: -Humana covers Cologuard-Aetna expands
Cologuard coverage
Q2'17: UNH covers Cologuard
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Reimbursement Success Stories – Case Study Afirma
Indeterminate Patients 94,000Thyroid Surgery $10,000
Total Cost $940,000,000
Indeterminate Patients 94,000Afirma GEC $3,500
Cost $329,000,000Indeterminate Benign 47,000
Ultrasound (3 per year) $900Cost $42,300,000
Indeterminate Suspicious 47,000Thyroid Surgery $10,000
Cost $470,000,000Total Cost $841,300,000
Direct Annual Savings $98,700,000
Sources: Company reports and William Blair & Company, L.L.C. estimates
Lower Cost and Improved Quality-Adjusted Life
Cost Savings and Quality of Life
Without Afirma GEC
With Afirma GEC
Annual Cost Savings
0.0% 0.0%7.5%
92.5%
0%
20%
40%
60%
80%
100%
Worse QALYIncreases Costs
Worse QALYDecreases Costs
Better QALYIncreases Costs
Better QALYDecreases Costs
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Companies/Investors Have Invested a Lot in Bringing Value-Added Tests to Market
Source: Company reports, William Blair estimates
Diagnostic Services: 2017 Revenue and Net Income by Company
$771
$341
$266 $259
$153
$72 $68 $48 $72
($4)
($114)
$11
($161)
($31)
($123)
($55)
($400)
($200)
$0
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MYGN GHDX EXAS NEO FMI VCYT NVTA Care Dx
US$
Milli
ons
Revenue Net income
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Reimbursement – 2016/2017 Was “Depths of Despair”
• In late 2015, CMS opted to use the code-stack methodology for new 2016 CPT codes, which drove a market cap loss of $1.5 billion (almost 10%) for the space
• CMS reversed this decision two months later (opting to gapfill)
• Genomic Sequencing Procedure (GSP) codes priced below expectations (most at ~$600)
• PAMA pricing was published (worse than expected)
-30%
-25%
-20%
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-10%
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Feb-15 May-15 Aug-15 Nov-15 Feb-16 May-16 Aug-16 Nov-16 Feb-17 May-17 Aug-17 Nov-17 Feb-18
Note: Diagnostic Services average includes FMI, DGX, NEO, LH, GHDX, MYGN, NVTA, and VCYT
Nov. 21, 2016: final gap-fill rates published for new CPT codes
Jun. 17, 2016: CMS publishes final PAMA rule
Jun. 10, 2016: CMS publishes preliminary gap-fill codes for 2016 codes
Nov. 17, 2015: CMS revises and gap-fills new codes
Sep. 25, 2015: CMS opts to cross walk-new CPT codes
Sep. 25, 2015: proposed PAMA rule published
Jul. 8, 2015: Preliminary PFS shows FISH increase
Oct. 2, 2015: Draft LCD for CGP in advanced non-small cell lung
Dec. 23, 2016: Final LCD for CGP in advanced non-small cell lung
Dec. 23, 2016: Three draft LCD for CGP in advanced colorectal, melanoma, and ovarian
Dec. 1, 2017: FMI gets PMA/draft NCD
Mar. 16, 2018: FMI gets finalized NCD
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NGS Reimbursement Has Progressed Slowly
PayeraNumber of
policiesNumber of tests within policies
Percentage of policies covering all included tests
Percentage of policies covering none of included
tests
Percentage of policies covering some but not all included tests
Payer no.1 7 48 43 29 29
Payer no. 2 15 116 13 60 27
Payer no. 3 4 40 25 25 50
Payer no. 4 15 54 13 73 13
Payer no. 5 14 55 29 36 36
Total 55 313 22 51 27
Multigene test policy coverage by payer
Source: Phillips, Kathryn A et al. “Payer Coverage Policies for Multigene Tests.” Nature biotechnology 35.7 (2017): 614–617. PMC. Web. 13 Apr. 2018.
• Medicare via Palmetto and the CMS via most recent NCD has been “a more willing payer”
• Coverage polices for sequence-based tests/panels across private payers varies meaningfully, although we are seeing some progress
• Cigna began covering whole exome sequencing in 2015 for certain indications • UNH began covering whole exome sequencing in 2017
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Increased Focus on “Lab Test Management”
• Increased payer focus on lab management programs • July 2017 - Anthem launched its “Genetic Testing Solution” via AIM Specialty Health for
fully and self-insured members; required medical necessity review for all genetic tests • October 2017 – UnitedHealthcare targets national implementation of its prior
authorization program for genetic tests
Source: 2017 Genentech Oncology Trend Report
Most payers do not actively manage lab testing vendors/platforms
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What Are Investor Hot Buttons?
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New Medicare NGS National Coverage Determination
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Price (Normalized)
Sources: Company reports and FactSet
Jan. 12, 2015: Investment from Roche
Oct. 2, 2015: Draft LCD for CGP in advanced non– small-cell lung
Dec. 21, 2015: FMI gets coverage for advanced non–small-cell lung by UNH
Aug. 2, 2016: FDA accepts FMI for parallel review
Dec. 23, 2016: Final LCD for CGP in advanced non–small-cell lung Dec. 23, 2016: Three draft LCD for CGP in advanced colorectal, melanoma, and ovarian
Dec. 1, 2017: FMI gets PMA/draft NCD
Mar. 16, 2018: FMI gets finalized NCD
Foundation Medicine (FMI) Normalized Stock Price Bristol TMB data
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New Medicare NGS National Coverage Determination
Still a number of outstanding questions: • Will there be a pathway for clearance for NGS-based assays for CDX indication? • Does one, pan-cancer CDx indication imply coverage under the NCD? • Will private payers follow suit? • Do we even need biomarkers if pharma is successful with all-comers strategy?
A number of companies have pointed to plans to pursue FDA approval/clearance:
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Source: Kaiser/HRET Survey of Employer-Sponsored Health Benefits, 2006-2017
Distribution of Health Plan Enrollment for Covered Worker by Plan Type
2% 3% 3% 3% 7% 8% 8% 9% 7% 9% 9% 9%2% 3% 4% 6%6%
9%12% 11% 14%
15%19% 19%
0%
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80%
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100%
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
HAS-Qualified HDHP HDHP/HRA
Consumer Now a Key Buyer of Healthcare
Highest 20%
Highest 20%
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Focus on Garnering Consumer “Mindshare”
Source: The Advisory Board Company
Retail Clinics Expected to Grow
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Big Data – Use of AI and Machine Learning
Source: StartUp Health; Insights Digital Health Funding Report Q1 2018
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IMPORTANT DISCLOSURES
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Q&A
https://www.genentech-forum.com/trend-reports.html https://www.iqvia.com/institute/reports/global-oncology-trends-2017-advances-complexity-and-cost Pharmaceutical Outsourcing & Services: CRO Industry Update: Results From Spring 2018 Survey of Biopharmaceutical Sponsors - 04/06/18 10:00AM Life Sciences: Conclusions From NGS Survey Conducted in Collaboration With Genome Web (n=303) - 01/04/18 11:17PM