C omparative effectiveness a manufacturer s perspective
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C omparative Effectiveness: A Manufacturer’s Perspective. AHRQ 2007 Annual Conference September 27, 2007. Peter Juhn, MD, MPH Vice President Evidence and Regulatory Policy Johnson & Johnson Corporate Office New Brunswick, NJ 732-524-6484. Evolving Environment . Challenges.

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C omparative Effectiveness: A Manufacturer’s Perspective

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C omparative effectiveness a manufacturer s perspective

Comparative Effectiveness: A Manufacturer’s Perspective

AHRQ 2007 Annual Conference

September 27, 2007

Peter Juhn, MD, MPH

Vice President

Evidence and Regulatory Policy

Johnson & Johnson Corporate Office

New Brunswick, NJ

732-524-6484


Evolving environment

Evolving Environment

Challenges

Drivers

Activities

Policies

Comparative Effectiveness

Practice Variation

Cost

  • Coverage and Reimbursement

  • Evidence Review

  • Quality Measurement

  • Insurance Benefit Design

  • HIT – EMR, PHR, Data Mining

Coverage with Evidence Development

Aging Population

Access to and Payment for

Innovative and effective products

Quality/Safety

Rising Demand

Pay-for-

Performance

Cost of Technology

Value

Benefit-Risk Determination

Budget Pressures


Healthcare stakeholders

Healthcare Stakeholders

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

Other

Payer

Outpatient

LTCFacilities

Hospitals

Physicians

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Healthcare stakeholders1

Healthcare Stakeholders

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

  • Patient – “am I getting the best care?”

  • Convenient

  • Respectful/compassionate

  • Trusted information about choices

  • Lower out-of-pocket cost

Other

Payer

Outpatient

LTCFacilities

Hospitals

Physicians

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Healthcare stakeholders2

Healthcare Stakeholders

  • Provider – “am I being rewarded for good work?”

  • Better outcomes

  • Higher reimbursement

  • Increased volume

  • More efficiency

  • Chance to innovate

  • Enhanced reputation

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

Other

Payer

Outpatient

LTCFacilities

Hospitals

Physicians

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Healthcare stakeholders3

Healthcare Stakeholders

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

Other

Payer

Outpatient

LTCFacilities

Hospitals

  • Employer – “am I getting value for money?”

  • Lower cost

  • “Best care”

  • Not unhappy beneficiaries/workforce

  • Healthy productive employees

Physicians

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Healthcare stakeholders4

Healthcare Stakeholders

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

Other

Payer

Outpatient

LTCFacilities

Hospitals

Physicians

  • Payer – “am I only paying for effective care?”

  • Lower cost

  • Predictability

  • Better outcomes (influence on later costs)

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Healthcare stakeholders5

Healthcare Stakeholders

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

Other

Payer

Outpatient

  • Regulator – “am I protecting the public health?”

  • Safe and effective products

  • Two types of challenges:

    • Approving a drug later found to be dangerous

    • Not approving a useful drug in a timely fashion

LTCFacilities

Hospitals

Physicians

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Healthcare stakeholders6

Healthcare Stakeholders

Manufacturers

Payers/ Regulators

Pharmaceutical

Medical Devices

Distributor/Wholesaler

Biotech

Employer

Other

Payer

Outpatient

LTCFacilities

  • Manufacturer – “am I being rewarded for safe and effective products?”

  • Improved patient outcomes

  • Recoup R&D investments

  • Fair and transparent coverage process

  • Clear evidence requirements

Hospitals

Physicians

RegulatoryAgency

IntegratedNetworks

Patients

Providers


Key questions about products

Key Questions about Products

  • Does it work? Is it safe?

    • Regulatory Approval

    • Relevant for covered population (i.e. Medicare over 65y)

  • When should it be used? Who will most benefit?

    • Appropriateness guidelines

    • Patient selection criteria

  • How does it compare? Is it definitively better?

    • Earlier generation of technology

    • Within same class of technology

    • Rigor of comparative reviews

  • What is the value? Can the value be captured?

    • Is it cost-effective? Is it cost-saving?

    • Is there an ROI? When? To Whom?


Evidence challenges

Evidence Challenges

  • Availability of evidence

    • Needs for evidence are increasing

    • Large gaps in the existing literature

    • Limited generalizability of trials data to real-world practice

    • Unique challenges of devices

      • Distinguishing operator vs. product effects

      • Short product life-cycles

      • Feasibility of RCTs

  • Conclusions from the evidence

    • Reconciling “average” population effects with individual effects

    • “Shelf-life” of evidence

  • Practical use of evidence

    • Application of evidence to real-world medical decisions

    • Provider “accountability” for using evidence


The promise of ebm

The Promise of EBM

  • Properly developed and applied, evidence-based medicine can:

    • Stimulate the development of high quality information about treatments and devices

    • Enhance consistent and informed healthcare decision-making by physicians, patients, caregivers and payers

    • Support patient access to appropriate technologies

    • Help establish the value of medicines, medical devices, diagnostics and other health services

    • Provide the basis for optimal use of health care resources

    • Promote a more quality-focused and cost-effective healthcare system that delivers superior patient outcomes


The perils of ebm

The Perils of EBM

  • Potential for unintended consequences

    • Justifies coverage decisions based purely on cost without regard for overall effectiveness or value

    • Freezes the pace of innovation to the current generation of products

    • Discriminates against new technologies

    • Leads to prescriptive clinical protocols that do not allow for physician judgment and consideration of patient preferences

    • Focuses too narrowly on clinical morbidity or mortality, ignoring a range of other important patient-reported outcomes (ease of use, compliance, functional status)

    • Changes to coverage policies occur haphazardly without clear rationale, transparency or accountability


Comparative effectiveness

Comparative Effectiveness

  • What is J&J’s position on comparative effectiveness?

    • Help establish the value of treatments

    • Promote a more quality-focused cost-effective health system

    • Help physicians and patients make better decisions

    • Be a way for manufacturers to differentiate products

    • However, it is not the “silver bullet” as it will not automatically solve our cost and quality challenges

  • How should information from CE research be used?

    • Should inform medical decisions, not replace medical judgment with treatment formulas

    • Will need to reconcile “average” population effects and with impacts on individuals that reflect differences in side effects, intolerance, noncompliance, and quality of life


Comparative effectiveness1

Comparative Effectiveness

  • How should it be linked to coverage decisions by payers?

    • Should not serve the cost containment concerns of payers

    • Might be most useful in informing treatment options and assigning appropriate reimbursement premiums

  • How should this information be communicated?

    • Share widely with all stakeholders, particularly providers and patients

    • Consider the dangers of incomplete understanding of results, particularly when communicated in an overly simplistic manner

    • Acknowledge that CE information can be incomplete, misleading, or misinterpreted

  • How should stakeholders be involved?

    • Participate in framing the methods that will be used and prioritizing the key therapeutic areas

    • Promote transparency about the processes, findings, limitations, and appropriate uses of the information


A few suggestions

A Few Suggestions

  • Definitions

    • Comparison of “what to what”

      • Drug to drug; drug to procedure; disease management to not

    • What will success look like – information output vs. impact on care delivery

  • Scope

    • Clinical decision dilemmas vs. population economics

    • Synthesis of current evidence vs. initiating new comparative research

  • Funding

    • Commitment to conduct adequately powered studies

    • Distance from payment authorities

  • Stakeholders

    • Genuine involvement with priority setting, methods review and communication approaches


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