©Blue Health Intelligence, an Independent Licensee of the Blue Cross and Blue Shield Association. All rights reserved. Proprietary and Confidential. Blue Health Intelligence (BHI) is a trade name of Health Intelligence Company, LLC

Bridging Data, Analytics and Industry Insights to Develop High Impact Medical Device Value PropositionsNovember 12, 2019 1pm CT/ 2pm ET

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• During the presentation, all participants will remain in listen-only mode

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• After today’s presentation, you will be able to access the on-demand recording of the webinar using the link from today’s live event

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Learning Objectives

• Understand how medical and pharmacy claims information can be used to build and support RWE

• Discover the importance of how large conformed and longitudinally sophisticated datasets create strategic advantages

• Learn how Evidence Street® creates clarity, efficiency, and transparency for healthcare decision makers regarding the current state of evidence

• Understand how real-world evidence is being used in medical device development through an examination of several different case studies

Today’s presenters will share their insights on what is needed to develop win-win partnerships among manufacturers, payers, providers, and patients.

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Today’s Speakers

Russell Robbins, MDAssociate Vice President, Clinical Informatics, BHI

Julia A. Gaebler, PhDPartner, Health Advances

Jessica N. Martin, MBA Director of Evidence Street®

Operations, BCBSA

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Blue Health Intelligence

The nation’s largest health information analytic data warehouse, bringing together the claims experience of over 190+ million unique members nationwide

• Formed in 2005 by the Blue Cross Blue Shield Association (BCBSA) to support analytic needsof Blue Cross Blue Shield (BCBS) health plans

• Spun off as independent company in 2010 to serve the BCBS Plans and external healthcare markets

• Owned by BCBSA and multiple BCBS Plans

• Named a certified Qualified Entity (QE) by CMS

Headquartered in Chicago, IL

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BHI’s Customer Base

Academic Institutions

Government Agencies

Professional Services Firms• Management Consultants• Private Equity

Medical Device Manufacturers

Medical Management

Health Systems

Health Plans

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BHI’s Data Analytics In Action

Blue Distinction Specialty Care• Centers of Excellence Program• Facility designations for cardiac, spine, knee,

hip, and maternity

• A study of cost variations for knee and hip replacement surgeries in the U.S.

• Trends in pharmacy cost• Individual market cost trends• Concussion rate in children

Episodes of Care• A claims engine to evaluate providers• A tool to establish bundled payments

• BHI provides plan results for 1,600+ treatment categories for transparency purposes

Blue Distinction Total Care• ACO/PCMH measurement and evaluation• Incorporate nationally consistent patient-

centered, value-based measures

Provider PerformanceHealth of America Reports

Blue Axis Costs (aka NCCT)

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Power of Real World Evidence (RWE)

Demonstrating the effectiveness of an intervention

Provider performance

Training a predictive model

Populating a product

Market profiling

Where the Market Meets EvidenceJessica N. Martin, MBA, BCBSA

Evidence Street®

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• Evidence Street® is a subscription based website

• Launched in October of 2015 in response to the market knowing that payers do an annual review of literature

Evidence Street® Background

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Subscribers

• Subscriptions available to manufacturers of devices, diagnostics, and pharmaceuticals – Currently have 57 subscribers

• Subscribers submit literature for consideration during the next annual review cycle – Note: Literature submission is not limited to subscribers – a non-subscriber can also submit

• Subscribers have access to the published opinion. The opinion can be used with meetings with the 36 independent Blue Plans– Evidence Street® subscribers do not have any additional access to Blue Plans than non-subscribers

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Objective of Evidence Street®

• Transparency– Review Timing

• When the BCBSA will review a condition (not product) • Submission period for new literature to be considered

– What has been reviewed• Subscribers can see what the BCBSA considered/reviewed during the review process

– Conclusions • Subscribers can view the published review that provides insight into the current state of the

evidence • Reviews provide insight into where there appear to be gaps in the evidence

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Real World Evidence (RWE)

FDA Definition:

Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

Source: https://www.fda.gov/media/120060/download

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Real World Data/Real World Evidence

• BCBSA and Evidence Street® cannot accept the raw data

• BCBSA Evidence Street® conclusions based on published literature

Real-World Case Study: Health and Economic Benefits of Advanced Pneumatic Compression Devices in Patients with Phlebolymphedema [PMID:29914829]Lerman M, Gaebler JA, Hoy S, Izhakoff J, Gullett L, Niecko T, Karaca-Mandic P, O’Donnell T.

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Health AdvancesLeaders In Developing Winning Strategies for Healthcare Innovations

. . . by the Numbers

Completed Projects:

3,000Consulting assignments

since 1992

Professionals:

165+Industry, science, clinical, and business backgrounds

Senior Management:

22Partners and Vice Presidents actively involved in projects

Clients:

900+Companies and

organizations served

Countries:

80Markets where projects have been conducted

Goal:

1Help our clients unlock growth opportunities

worldwide

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Health Advances Dedicated Practice Areas Dedicated practices that serve six key healthcare verticals

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Lymphedema OverviewLymphedema refers to excessive swelling, usually of the arms or legs, caused by ineffective fluid transport in the lymphatic system

• Lymphedema is a progressive and incurable disease, defined by excessive swelling as a result of lymphatic failure (often in the arms and legs), and it requires long-term treatment

• Lymphatic failure may be caused by congenital defects (primary lymphedema), or by extrinsic processes such as surgery, cellulitis, or radiation therapy (secondary lymphedema)

• Poor management of lymphedema is associated with increased risk for cellulitis and ulcers, both costly events

• Phlebolymphedema is a vascular condition that results in lower extremity edema from the combined effects of chronic venous insufficiency (CVI) and lymphedema

• Advanced pneumatic compression devices (APCD), such as Flexitouch (Tactile Medical), help to resolve current swelling and prevent future swelling, regardless of the cause of the lymphedema

Source: Health Advances analysis, Tactile sponsored clinical studies, Lymphinstitute.

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Current Treatment of Lymphedema and Associated SequelaeHome-based APCDs, like Flexitouch, can provide lower cost alternatives to manual lymphatic drainage provided by healthcare professionals

Greater Cost to Payers

Lower Cost

to PayersSource: Health Advances analysis, Finnane 2015, Al-Niami 2009, Tactile sponsored clinical studies, UpToDate.

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Study Objectives and Methods OverviewWe quantified direct Medical Resource Utilization (MRU) and costs associated with use of Flexitouch relative to other lymphedema treatment alternatives and controls

Source: Health Advances interviews and analysis.

Lymphedema Patients

Cohort Demographics

Measured Outcomes

Lymphedema and Sequelae Subgroups

Study Comparison Groups

• Analysis of administrative claims database of lymphedema patients– Claims data secured from Blue Health Intelligence– Data contains five years of claims for ~155,000 lymphedema patients

• Case-matched control design using cohort demographics• Study comparison groups to capture Flexitouch value versus

different lymphedema treatments– Comparison of Flexitouch against conservative therapy, SPCDs, and

other APCDs• Outcomes in terms of both medical resource utilization and cost

– Analysis across patient subgroups (e.g., cancer vs. non-cancer)– Outcomes segmented by claims type, whether tagged with

lymphedema and/or common lymphedema sequelae

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Methods: Analytic Objectives by Comparison GroupThe study examined differential resource utilization and cost outcomes for three distinct comparison groups

Objectives Comparison Groups* Definitions

Demonstrate value of Flexitouch compared to standard-of-care conservative therapy

• Conservative therapy: Includes ≥1 claim for active lymphedema treatment (codes include MLD, lymphedema education, PT/OT)

• Conservative therapy + Flexitouch: Conservative definition + excludes any patients with SPCD or other APCD use

• Conservative therapy + SPCD: Conservative definition + excludes any patients with APCD use

• Conservative therapy + other APCDs: Conservative definition + APCDS other than Flexitouch

Demonstrate adding value of treatment paradigm, prior to use of SPCDs, regardless of disease severity

Establish superiority over other APCDs

*Flexitouch is always adjunctive to conservative therapy.Source:Health Advances interviews and analysis.

• Conservative + Flexitouch• Conservative

• Conservative + Flexitouch• Conservative + SPCD

• Conservative + Flexitouch• Conservative + other APCDs

1

2

3

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Methods: Inclusion CriteriaIdentified lymphedema patients were required to be continuously enrolled in a health plan with medical benefits >12 months before and >6 months after the MRU index date

Medical Resource Utilization Capture (Most Recent 5-Year Window Available in BHI Database)

Year 1 Year 5

• Conservative + FT• Conservative + other APCDs

• Conservative + FT• Conservative

• Resource utilization exceeding the time of enrollment for the matched case was truncated/censored (denoted by the dashed-gray lines)

Utilization captured from 2012 to 2016 (OR)During maximum time continuously enrolled in health-plan during this

time-frame

Matched-control censored to case

timeframe

Individual enters / exits health plans with > 12 months / > 6 continuous enrollment

• Conservative + FT• Conservative + SPCD

Utilization Captured

Note: The graphic is representative of an example of a single patient case and control scenario. Enrollment times vary. MRU = Medical Resource Utilization; FT = Flexitouch.Source: Health Advances analysis.

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Methods: Cohort MatchingThe study employed propensity scores to control for the observed demographic variables and ensure balanced cohorts in the absence of randomization

Source: Health Advances analysis.

• Age• Gender• Geographic region• Payer type

• Elixhauser Comorbidity Index (Includes 31 Common Comorbidities)• All cancers• Heart failure• Chronic venous insufficiency (CVI)• Venous ulcers• Diabetes• Obesity• Iliac Vein Disorders (May Thurner’s Syndrome)• Pulmonary Hypertension• Postphlebitic Syndrome

General Demographics

Clinical Demographics

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Methods: Patient Outcomes and Sub-GroupsWe pre-specified outcomes within high risk sub-populations, enabling targeted conclusions about Flexitouch’s value by patient segment. CVI results are shown today

• Outcomes of lymphedema patients with 2+ infections per year

• Outcomes of lymphedema patients comorbid with chronic venous insufficiency (CVI)

• Outcomes of lymphedema patients with diabetes

• Outcomes of lymphedema patients with cancer

• Outcomes of lymphedema patients without cancer

Lymphedema-Tagged Claims

Sequelae-Tagged Claims

All claims

# Outcome Group

Subgroup Analyses*Outcome Groups Captured For All Subgroups

Total Cost of Care1

2Lymphedema-

Related Outcomes

Lymphedema or Sequelae-Related Outcomes, e.g.,

Cellulitis

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*:Illustrative. Feasibility of subgroup analysis will be determined based on sample size.Source: Health Advances interviews and analysis.

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Results: Study SamplePrior to case-matching there were 17,070 qualified patients, of whom 1,134 were using Flexitouch

Note:Ns represent values prior to case-matching. Patients with a diagnosis of nonfilarial lymphedema were identified on the basis of one inpatient or two outpatient primary or secondary lymphedema diagnosis codes(ICD-9 codes 457.0, 457.1, and 757.0 or ICD-10 codes I97.2, I89.0, and Q82.0). Source:Health Advances analysis.

Diagnosed with a relevant lymphedema diagnosis (e.g., excludes filarial lymphedema)

(n = 81,366)

Continuously enrolled with medical and pharmacy benefits for 12 months pre- and post-index date

(n = 26,902)

Patients on conservative therapy with ≥1 claim for active lymphedema treatment:

(n = 17,070)

Insufficient continuous enrollment

(n = 54,464)

No claims for conservative

treatment(n = 9,832)

Flexitouch(n = 1,134)

SPCD(n = 292)

Conservative Therapy

(n = 14,786)

Other APCD(n = 858)

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Results: Unmatched Lymphedema Population by Treatment GroupOf the continuously-enrolled patients, 36.5% received no professional care for lymphedema, and 55% received conservative therapy alone within the study period

36.5%

55.0%

4.2%1.1%

3.2%

0%

20%

40%

60%

80%

100%

n=26,902

Pat

ien

ts b

y Tr

eatm

ent

Gro

up

Total Population

Conservative + other APCDs

Conservative + SPCD

Conservative + FT

Conservative Alone

No Professional Claims

Lymphedema Population by Treatment GroupUnmatched Continuously Enrolled Lymphedema Patients

• 26,902 lymphedema patients were continuously enrolled with medical and pharmacy benefits for 12 months pre- and post-index date

• Of those continuously enrolled, 17,070 patients qualified for the study

– Qualification required lymphedema diagnosis, 12 months of continuous enrollment pre and post index date, and at least one claim for active lymphedema treatment

Note:Ns represent values prior to case-matching. Source: Health Advances analysis.

Low overall utilization of PCDs suggests potential opportunity to educate providers and grow the market

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Results: Total Lymphedema and Sequelae Healthcare CostsAmong lymphedema patients with comorbid CVI, Flexitouch also demonstrates significant cost offsets relative to conservative therapy, SPCDs, and other APCDs

$3.8 $1.2

$4.0

$12.3

$7.4 $8.4

$0

$3

$6

$9

$12

$15

n=86 n=87 n=34 n=23 n=69 n=67

Comparison 1 Comparison 2 Comparison 3Tota

l Cos

t of

Car

e fo

r LE

an

d

Seq

uel

ae-R

elat

ed E

ven

ts (

US

D

00

0s)

Note:Cost values exclude PCD-related costs. P-values based on gamma log-link GLM.Source: Health Advances analysis, BHI data.

Conservative Alone Conservative + SPCDConservative + FT Conservative + Other APCDsUnfavorably Significant Favorably Significant

-$8,414

-$6,296

-$4,463

Total Cost of Care for Lymphedema and Sequelae-Related EventsPer Patient Per Year

P = 0.001 P = 0.008 P = 0.032

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Results: Medical Resource UtilizationCVI patients with Flexitouch also utilize specific healthcare resources less frequently than other lymphedema patients

Note:Dx = diagnosis.Source: Health Advances analysis, BHI data.

-38%

-59%

0.32

0.13

0.0

0.1

0.2

0.3

0.4

n=86 n=87

Comparison 1

Mea

n H

osp

ital

izat

ion

s

Inpatient HospitalizationsPer Patient Per Year

P < 0.001

62%38%

0%

20%

40%

60%

80%

100%

n=86 n=87

Comparison 1Pat

ien

ts U

sin

g P

hys

ical

Th

erap

y

Patients Using Physical TherapyPost-Treatment Intervention

P = 0.01

Patients with Cellulitis DxPost-Treatment Intervention

P = 0.02

45%22%

0%

20%

40%

60%

80%

100%

n=69 n=67

Comparison 3

Patie

nts

with

Cel

lulit

is D

x

-50%

Slide only highlights positive results for which FT users utilize fewer healthcare resources than comparators.

Conservative Alone Conservative + SPCDConservative + FT Conservative + Other APCDsUnfavorably Significant Favorably Significant

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Key Study Limitation: Flexitouch Age DistributionMost Flexitouch patients in the BHI dataset were 45-64 years of age. The dataset includes some patients >65 years, but small numbers precluded subset analyses

BHI DatasetUnmatched Flexitouch Patients By Age

205

849

72

0

200

400

600

800

1,000

1,200

Flexitouch Patients

Un

iqu

e P

atie

nts 65+

45-64

19-44

0-18

Age Ranges:

Source: Health Advances analysis, BHI data.

1,134

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Conclusions of the Study

• This study examined cost and MRU reductions for Flexitouch over ~2 years of follow-up relative to alternative lymphedema treatment modalities in three high-risk patient sub-segments

• Specifically, phlebolymphedema constitutes a substantial proportion of lymphedema patients in the United States and a significant cost burden that is still likely understated

• Optimizing treatment for CVI patients to reduce costly complications is therefore an important goal

• This analysis demonstrates significant benefits attributable to Flexitouch, a specific APCD, in reducing MRU and total lymphedema costs for these patients relative to conservative therapy, SPCDs, and other APCDs

Webinar Key TakeawaysJanet Hughes, AVP, BHI

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Webinar Key Takeaways

• Longitudinal datasets create strategic advantages for medical device firms, payers, and employers to drive positive results in their overall business strategy

• Large datasets allow for evaluation of patients with rare or uncommon conditions

• Real World Evidence (RWE) using large data sets enable medical device organizations with gaps in their evidence the ability to report in a timely manner rather than executing another clinical trail

• Evidence Street® platform provides impartial medical evidence reviews for medical device, diagnostics, and pharmaceuticals that are transparent, efficient and comprehensive to ascertain if the evidence is sufficient or insufficient to determine the effects on health outcomes

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Ask the Experts | Questions and Answers

Russell Robbins, MDAssociate Vice President, Clinical Informatics, BHI

Julia A. Gaebler, PhDPartner, Health Advances

Jessica N. Martin, MBA Director of Evidence Street®

Operations, BCBSA

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Contact Us

Julia A. Gaebler, PhDjgaebler@healthadvances.com

Jessica N. Martin, MBAJessica.Martin@bcbsa.comSubscription inquires: evidencestreet@bcbsa.com

Russell Robbins, MDRussell.Robbins@bluehealthintelligence.com

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©Blue Health Intelligence, an Independent Licensee of the Blue Cross and Blue Shield Association. All rights reserved. Proprietary and Confidential. Blue Health Intelligence (BHI) is a trade name of Health Intelligence Company, LLC

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