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Four Practical Approaches To Managing A More Effective Device Trial

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Information about Four Practical Approaches To Managing A More Effective Device Trial

Published on May 8, 2009

Author: david.levin

Source: slideshare.net

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Four practical approaches to managing a more effective device trial Blair Keagy, MD, CEO, Medical Products Analytics David Levin, Vice President, Clinipace June 10, 2009

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?

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?

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

Scientific basis not sound

Overestimation of clinically relevant market

Poor reimbursement strategy

Poorly designed or executed clinical studies that fail to convince payers

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

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

FDA approval doesn’t guarantee reimbursement Pre-IDE meeting is very important

{Great} reimbursement ideas from the government Prospective Payment System Inpatient Outpatient

HCPCS (Healthcare Common Procedure Coding System) 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

CPT codes (managed by AMA)

T-code for new technology

Determine physician payment

Alphanumeric system

Determine where product will fit

Under contract to CMS

Guidance to manufacturers

Durable medical equipment

Large part of level II codes

2,800 Level II HCPCS Codes 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

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? Reimbursement considerations when designing a trial

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?

Product use impacts trial design and operations 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

Purchase products at MD request

Facing budget constraints

Increase office efficiency

Allow global fee reimbursement

Covered under DRG (CMS)

Private carriers use global payment

Covered under APCS

Some pass through products

Fee schedules

Cross walking

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 Clinical efficacy must be proven

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

AHRQ Analysis of Aortic Endografts

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?

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?

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

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

Technology is more efficient, but requires more planning Technology-Driven Trials [1997 - ] Design Conduct Analysis Low High Cost 30% Reduction

Successful technology deployment requires focus on process Management Operations Strategy & Planning Design Enrollment Data Capture/Mgt Analysis Regulatory Modeling/Simulation Site/Patient Recruitment Submission Protocol Design Electronic Data Capture [EDC] IVRS PRO Study/Project Management Reporting / Analytics CDM Clinical Trial Portfolio Management IIR / Grants Management

Visibility is king Management Operations Strategy & Planning Start - Up Conduct Close - Out Project Milestones Queries Patient Accrual CRF Status Monitoring Activities

Questions & Answers Commercial Feasibility Analysis | Clinical Development Blair Keagy, MD [email_address] www.mpanalytics.com Digital Clinical Research Organization (dCRO) David Levin [email_address] www.clinipace.com

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