The Impact of Evidence Based Medicine on Health Disparities

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The Impact of Evidence Based Medicine on Health
Disparities

• Karen A. Vicari, JD
• Executive Director, Alliance for Better Medicine

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Good Evidence Based Medicine

• The integration of best research evidence with
  clinical expertise and patient values.
• David Sackett, et al. Evidence-Based Medicine
  How to Practice and Teach EBM (New York
  Churchill Livingstone, 2000)

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• The Best Research Evidence
• Clinical Expertise
• Patient Values
• Good Evidence Based Medicine

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Why do we need appropriate evidence based
medicine?
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Evidence can be a good thing
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The promise of EBM

• Done well, EBM
• Reduces inappropriate variation in care
• Can lower overall treatment costs
• Can improve patient outcomes
• Can reduce health disparities

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Cost-Cutting EBM

• The Best Research Evidence
• Clinical Expertise
• Patient Values
• Good Evidence Based Medicine

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Examples of cost-cutting EBM

• Rigidly applied treatment guidelines
• Step therapy protocols
• Tiered co-payments
• Formulary restrictions

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• Cost-cutting EBM doesnt allow for
• The clinicians expertise
• Patient values
• Individual patient differences
• Race
• Ethnicity
• Gender
• Co-occurring disorders
• Tolerance and preference issues

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ExamplePatient

• Atypical Rheumatoid Arthritis Patient
• In 2001 (before insurers guidelines?) was told
  to take a new, expensive drug for a very serious
  disease
• Patient, not feeling too bad, decided to try an
  older, cheaper medication
• In 2003, arthritis worsens and patient goes back
  to the same doctor for the newer medication
• Doctor says condition not serious enough
• Condition worsens until patient is disabled in
  2005

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Patient (contd)

• Doctor says patient cant use the new medication
  because patient doesnt meet the insurers
  guidelines.
• Advice to patient Keep your chin up and get
  used to the pain.
• Patient switches doctors. New doctor agrees that
  patient does not meet the insurers guidelines,
  but agrees that since patient is disabled, its
  worth a try.

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• Cost-cutting EBM, or rigidly applied EBM
  threatens individualized patient care
• Cost-cutting EBM disproportionately impacts
  people from different racial and ethnic groups
  and patients with multiple co-occurring disorders

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Healthcare Disparities

• According to the National Healthcare Disparities
  Report
• Disparities related to race, ethnicity, and
  socioeconomic status still pervade the American
  healthcare system.
• Healthcare Disparities exist within many
  subpopulations including women, children,
  elderly, residents of rural areas, and
  individuals with disabilities and other special
  health care needs.

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Cost-cutting EBM

• The Best Research Evidence
• Clinical Expertise
• Patient Values
• Good Evidence Based Medicine

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Oregon Drug Effectiveness Review Project

• Created to control Oregons Medicaid costs
• Has become a standard of cost-cutting EBM
• Similar processes are being followed by other
  payers, including insurance companies and
  Medicaid agencies

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Methodology of DERP (Oregon EBM)

• Choose 3-4 key questions
• Normally limited to the comparative safety and
  effectiveness of drugs in a class
• Rate the quality of available studies
• leads to the elimination of many studies
• Most included studies are RCTs
• Perform a systematic review of the best
  evidence
• Write a long report summarizing the available
  evidence (300-800pp each report)

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• Standard Oregon Key Questions
• Do the drugs in the class differ in comparative
  effectiveness, safety or adverse events?
• Are there subgroups of patients (racial groups,
  gender, or co-occurring disorders) for whom one
  drug is more effective or associated with fewer
  adverse events?
• These questions are too limited to result in a
  meaningful drug comparison
• Dont look at tolerance and adherence
• Very little evidence exists about subpopulations

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Randomized Controlled Trials

• Considered to be the most reliable form of
  evidence to determine efficacy
• RCTs are expensive and most often done by drug
  companies to pass FDA approval
• Reliable because the populations included in
  the trials are highly controlled
• Trial participants are mostly white, young and
  healthy
• People typically subject to health disparities
  are not adequately represented in RCTs

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Efficacy vs. Effectiveness

• Efficacy
• Whether a drug has the potential to treat a
  specific problem.
• Effectiveness
• Whether a drug actually works for a particular
  patient to treat a specific problem.
• Oregons reports determine simple efficacy, and
  based upon this they conclude that all drugs in a
  class are equal in their effectiveness.

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Example Efficacy

• Drug A Works on 60 of the population
• Drug B Works on 60 of the population
• Oregon will conclude or imply that the drugs are
  equal and therefore interchangeable.
• And, indeed, the 2 drugs are equally efficacious,
  but not interchangeable.
• This data tells us nothing about which
  individuals will respond best to each medication.

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What the Oregon reviews dont tell us

• Drug A 3/day for 2wks refrigerated antibiotic
• Drug B 1/day for 1 week antibiotic
• Or
• Drug A Antihistamine which takes 2 days to work
• Drug B Antihistamine which starts working
  immediately
• The drugs are equally efficacious, but in the
  real world, Drug B will probably produce the best
  outcomes

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Examples of known variations in response to
medication by racial and ethnic subpopulations

• Puerto Ricans with asthma have significantly
  lower responsiveness to bronchodilators than
  Mexicans
• 12-23 of Asians are genetically poor
  metabolizers of diazepam, imipramine, and several
  other drugs
• Mexican Americans tend to metabolize certain
  drugs quickly, where Caribbean Hispanic
  populations (Dominicans and Puerto Ricans)
  metabolize the same drugs slowly (including
  cardiovascular drugs and psychotropic agents).

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Summary

• Cost-cutting EBM uses systematic reviews of RCTs
  to determine broad efficacy
• This type of process does not give information
  about which treatment will be most effective for
  a particular individual
• Because of reliance on RCTs, this type of
  process does not include adequate information
  about subpopulations, including racial and ethnic
  groups, children, elderly and those with
  co-occurring disorders

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Populations subject to health disparities are
impacted by EBM

• Racial/ethnic differences in response to
  medication not evident by RCTs
• Language barriers
• Health Literacy barriers
• Cultural barriers
• Lower cost insurances will be more restrictive

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Current users of cost-cutting EBM

• Insurance Companies
• Oregon Drug Effectiveness Review Project
• Consumers Union Best Buy Drugs Program
• Pay for Performance programs
• Agency for Healthcare Research and Quality (AHRQ
  drug reviews)

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What can advocates do?

• Understand the concerns
• Educate others
• Make the patient voice heard (loud and clear)
• Join coalitions

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Key Messages

• EBM cannot be applied too rigidlyit must allow
  for the patient and physician to make the final
  treatment decisions
• Comparative effectiveness reviews dont tell us
  much of value
• Outcomes data and other real world data are
  necessary to determine which patient will benefit
  from which drug

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• Alliance for Better Medicine
• 1127 11th Street, Suite 925
• Sacramento, CA 95814
• Karen Vicari, Executive Director
• [phone]
• kvicari_at_sbcglobal.net