four practical approaches to managing a more effective device trial

Four practical approaches to managing a more effective device trialBlair Keagy, MD, CEO, Medical Products AnalyticsDavid Levin, Vice President, Clinipace

April 10, 2023

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Sponsors

Commercial Feasibility Analysis | Clinical Development

Digital Clinical Research Organization (dCRO)

Device and drug trials are not all alike• Will the clinical development plan limit the use of the product to a

sub-segment of the TAM?

• Will FDA approval limit the market to a sub-segment of the TAM?

• Will payers require an initial use of an alternative therapy form before approving payment?

• Is there potential for marketing directly to patients?

• Are there strong potential competitors?

• Can competitors rapidly develop a competing or identical product?

• Is this a quantum leap forward in technology?

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• Scientific basis not sound

• Overestimation of clinically relevant market

Poor reimbursement strategy

• Poorly designed or executed clinical studies that fail to convince payers

Reasons devices fail to achieve commercial success

Objects in the mirror are farther than they appear• Good engineering doesn’t guarantee clinical trial and/or commercial

success

• When planning your next clinical trial you must consider…

– Select the appropriate regulatory path

– Incorporate a reimbursement strategy to maximize your trial and product success

– Understand your patient population and customer setting

– Ensure complete trial visibility with technology-driven processes

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Pre-IDE meeting is very important

FDA approval doesn’t guarantee reimbursement

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Prospective Payment System

Inpatient Outpatient

{Great} reimbursement ideas from the government

Level I • CPT codes (managed by AMA)• T-code for new technology• Determine physician payment

Level II • Alphanumeric system• Determine where product will fit

SADMERC • Under contract to CMS• Guidance to manufacturers

DMEPOS • Durable medical equipment• Large part of level II codes

HCPCS (Healthcare Common Procedure Coding System)

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A Codes Miscellaneous services and supplies

B Codes Enteral or parenteral treatment

C Codes Drugs and biologics (pass-through)

D Codes Dental codes

E Codes Durable medical equipment

H Codes Alcohol and drug abuse treatment

J Codes Drugs that cannot be self-administered

Q Codes Biologics such as dermagraft

2,800 Level II HCPCS Codes

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• How difficult will it be to obtain reimbursement codes?

• Will hospitals realize a cost savings?

• Will the device add patient benefit?

• Will physicians be reimbursed for use of the device?

• What is potential for favorable AHRQ and BC/BS TEC determination?

• Will the device have patient appeal?

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Reimbursement considerations when designing a trial

Hospitals • Purchase products at MD request• Facing budget constraints

Physician Offices • Increase office efficiency• Allow global fee reimbursement

Inpatients • Covered under DRG (CMS)• Private carriers use global payment

Outpatients • Covered under APCS• Some pass through products

Laboratories • Fee schedules• Cross walking

Product use impacts trial design and operations

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• Final approval from appropriate government bodies

• Scientific evidence must permit conclusions concerning effect on outcomes

• Improve net health outcomes

• As beneficial as any established alternative

• Attainable results outside investigational setting

• CMS is relying on AHRQ for payment decisions

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Clinical efficacy must be proven

AHRQ Analysis of Aortic Endografts

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Hospitals make purchasing decisions

Yet, device and drug trials are alike

• Are the case report forms user-friendly?

• Are key safety measures included in the protocol?

• Are statistical parameters valid?

• Is the protocol powered properly?

Does the market potential justify the cost of the trial?

• Can the protocol be adequately funded?

• Are the objectives achievable?

• Does the trial include gathering economic data?

• Will patient enrollment be prohibitive?

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Clinical trials are a major investment• Clinical trial protocol development• Statistical analysis• Standard project management• University overhead (28%)• IRB review fee• IRB administrative fee• Site/Patient recruitment• Data management • Clinical monitoring (e.g. 4 visits x 15 sites)• Costs for non standard of care studies• Regulatory document management• Site management (including site payment) • Regulatory submission

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Technology is more efficient, but requires more planning

Technology-Driven Trials [1997 - ]

Design Conduct Analysis

Low

High

Cost

30% Reduction

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Successful technology deployment requires focus on process

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Management

Operations

Strategy & Planning

Design Enrollment Data Capture/Mgt Analysis Regulatory

Modeling/SimulationModeling/Simulation

Site/Patient RecruitmentSite/Patient Recruitment

SubmissionSubmission

Protocol DesignProtocol Design

Electronic Data Capture [EDC]Electronic Data Capture [EDC]

IVRSIVRS

PROPRO

Study/Project ManagementStudy/Project ManagementReporting / AnalyticsReporting / Analytics

CDMCDM

Clinical Trial Portfolio ManagementClinical Trial Portfolio Management

IIR / Grants ManagementIIR / Grants Management

Visibility is king

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Management

Operations

Strategy & Planning

Start - Up Conduct Close - Out

Project Milestones

Queries

Patient Accrual

CRF Status

Monitoring Activities

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Questions & Answers

Commercial Feasibility Analysis | Clinical Development

Blair Keagy, MDbkeagy@mpanalytics.comwww.mpanalytics.com

Digital Clinical Research Organization (dCRO)

David Levindlevin@clinipace.com www.clinipace.com