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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

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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