Emerging Issues: Challenging AntiGenerics Legislation Whats old is new again' - PowerPoint PPT Presentation

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Emerging Issues: Challenging AntiGenerics Legislation Whats old is new again'

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One Exception If a prescriber writes 'DAW' or 'Dispense As Written' ... 30 years of 'DAW' shows generics reduce costs to patient and system ... – PowerPoint PPT presentation

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Title: Emerging Issues: Challenging AntiGenerics Legislation Whats old is new again'


1
Emerging Issues Challenging Anti-Generics
LegislationWhats old is new again.
  • Bryan R. OMalley
  • Assembly Member Richard N. Gottfried
  • Chair, Assembly Committee on Health
  • New York State Assembly

2
New Yorks Generic Substitution Law
  • If a cheaper generic that is equivalent exists,
    the pharmacist must dispense that
  • One Exception If a prescriber writes DAW or
    Dispense As Written
  • Exception applies for brands and generics

3
Whats Pending
  • A.9303 (Aubry)/S.5016 (Hannon)
  • Exempts anti-epileptic drugs from the state
    mandatory generics substitution law
  • Requires practitioner permission before a generic
    is substituted for a brand name medication
    reverses the presumption for substitution
  • Creates loophole that is much larger than intent

4
What is an anti-epileptic drug
  • Any drug prescribed for the treatment of epilepsy
  • Or
  • A drug used to treat or prevent seizures

5
The Argument For
  • Patient Safety
  • Therapeutic substitution of anti-epileptic
    medication may result in an improper dosage,
    decreased efficacy, life-threatening toxicity, or
    adverse interaction with other drugs. (Memo of
    support from Harter Secrest and Emery LLP on
    behalf of GlaxoSmithKline)
  • Almost 15,000 people in New York with epilepsy
    would have a breakthrough seizure with a
    formulation change. (Epilepsy Foundation Memo of
    Support for A9303, emphasis added)

6
The Argument For
  • Cost avoidance
  • although mandatory substitution to less
    expensive drug products could cut pharmacy costs
    in the short run, in the long-term the costs of
    mandatory substitution could be far higher.
    (Memo of support from Harter Secrest and Emery
    LLP on behalf of GlaxoSmithKline)
  • Complications caused by therapeutic substitution
    can result in additional health care expenditures
    such as, (sic) added physician visits and/or
    hospitalizations. (Memo from Davidoff, Malito
    and Hutcher to Assembly Member Gottfried, dated
    3/16/2007, on need for mandatory generic
    exemption for anti-epilepsy drugs)

7
The Argument For
  • Its not even the same drug!!!
  • According to the General Pharmaceutical
    Association, When a product is therapeutically
    substituted, the patient is receiving an entirely
    different drug. (Memo from Davidoff, Malito and
    Hutcher to Assembly Member Gottfried, dated
    3/16/2007, on need for mandatory generic
    exemption for anti-epilepsy drugs)

8
History is a vast early warning system. -
Norman Cousins
9
The year was 1977
  • Mandatory generic law passed

10
The Argument Against
  • Patient Safety
  • This legislation poses a potential threat to the
    health of every New York resident who receives a
    substituted prescription. (Hoffmann LaRoche Memo
    in Opposition provided to Governor Carey while he
    considered the legislation)
  • This legislation is not a simple pro-consumer
    measureit is potential consumer health as well
    as political dynamiteand folly for the New York
    Legislature to fly in the face of overwhelming
    available evidence... (Empire State Chamber of
    Commerce in Memo of Opposition to Governor Hugh
    Carey)

11
The Argument Against
  • Its not even the same drug!!!
  • The blithe assumption of generic equivalence
    is simply wrong. (Empire State Chamber of
    Commerce Testimony on Generic Drug Substitution
    Bill, April 28, 1977)
  • It is our position that while prescribing or
    dispensing drugs by generic name neither conveys
    nor impugns product quality, it does mandate
    anonymity and that there are, in fact,
    differences in drug product quality. (Memorandum
    Requesting Executive Disapproval, American Home
    Products Council, July 19, 1977)

12
The year was 1997
  • Coumadin (DuPont-Merck) faces generic competition
    from Barr Pharmaceutical, who produces generic
    Sodium Warfarin
  • Assembly Member Steve Sanders introduces
    legislation to exempt Narrow Therapeutic Index
    (NTI) drugs from the Mandatory Generic Law

13
The Argument For
  • Patient Safety
  • The critical difference with respect to (NTI)
    drugs is that, unlike the many other drugs, a
    small change in the level of the dosage, a small
    change in the component parts of that drug can
    have a profound impact on that patient and the
    services being provided to that patient.
    (Testimony of Assembly Member Steve Sanders)
  • Our research demonstrates that the implications
    to the health of New Yorkers is large when
    considering a substitution for anti-coagulation
    drugs739 strokes, 146 deathsThats comparable
    to a major disaster like an airplane crash.
    (Testimony of Dr. Frederick Munschauer,
    Neurologist and Internist, SUNY Buffalo)

14
The Argument For
  • Cost Avoidance
  • The risks of adverse reactions, including the
    loss of seizure control and the development of
    toxic side effects associated with the mandatory
    substitution of generic anti-epileptic drugs can
    be avoided. (Testimony of Jessica Goldsmith,
    Epilepsy Society of New York)
  • When NTI drugs are switched to generics, there
    is usually an immediate cost of retitrating and
    stepped-up monitoring of the patient, and there
    may be even greater costs if there are medical
    complications because of substitution of NTI
    generics higher costs for more doctors visits,
    if not even visits to an emergency room, if not
    even hosptializations. (Testimony of Mark
    Green, Former Public Advocate for the City of New
    York)

15
The Argument For
  • It is not even the same drug!!!
  • Well, Im concerned about the FDAs statements
    that they can assure that every batch of an NTI
    drug thats manufactured by different companies
    is going to be the same. We all use different
    materials. We all use different suppliers.
    (Testimony of Richard Davis, DuPont-Merck)

16
The FDA (or) The Argument Against
  • Weve watched this closely (adverse events
    reporting of Coumadin and Sodium Warfarin), we
    are watching it closely now, and we do not see
    anything from marketplace adverse event reports
    that signals a problem with the multi-source
    products.
  • FDA does not distinguish for the benefit of the
    practitioner that some drugs should be
    distinguished based on Narrow Therapeutic Index
    for quality characteristics. Its a very
    critical distinction. We believe that all our
    approaches control the quality of the drug, so
    that the innovator and the generics may be
    exchanged under the conditions of use.
  • (Testimony of Dr. Roger Williams, Deputy
    Director, Center for Pharmaceutical Science, Food
    and Drug Administration)

17
New Evidence (or)The Argument Against
  • JAMA No difference between brand and generic
    cardiovascular drugs, including those in NTI
    classes.
  • Kesselheim, et al. Clinical equivalence of
    generic and brand-name drugs used in
    cardiovascular disease A systematic review and
    meta-analysis. Journal of the American Medical
    Association. 12/3/2008.

18
Clinical Literature
  • 11 articles studied Warfarin/Coumadin
  • 6 prospective studies the generic performed
    similar with respect to clinical endpoints such
    as number of required dose adjustments and
    adverse events
  • 5 retrospective studies - evaluated outcomes
    using pre/post test design and found no clinical
    outcome differences
  • 1 found small but clinically significant decrease
    in INR in patients, but no increase in morbidity
    or mortality
  • 1 retrospective study found increased health care
    utilization, but the comparator was not rated
    bioequivalent by FDA

19
Editorial Literature
  • 18 editorials focusing on NTI cardiovascular
  • 12 expressed negative view of substitution
  • 4 supported substitution

20
What Explains the Difference
  • Editorials reflect anecdotal evidence, not
    clinical knowledge
  • Conclusions biased by unreported financial
    relationships with brand name pharmaceutical
    companies
  • Kesselheim, et al. Clinical equivalence of
    generic and brand-name drugs used in
    cardiovascular disease A systematic review and
    meta-analysis. Journal of the American Medical
    Association. 12/3/2008.

21
Major Finding
  • Our results suggest that it is reasonable for
    physicians and patients to rely on FDA
    bioequivalence rating as a proxy for clinical
    equivalence among a number of important
    cardiovascular drugs, even in higher-risk
    contexts such as the NTI drug warfarin.
  • Kesselheim, et al. Clinical equivalence of
    generic and brand-name drugs used in
    cardiovascular disease A systematic review and
    meta-analysis. Journal of the American Medical
    Association. 12/3/2008.

22
Historys lesson
  • The same themes always arise
  • Anecdotal evidence is used in place of scientific
    evidence
  • Scientific evidence is on our side

23
Applying History to A.9303
  • Despite heart-wrenching anecdotes, patient safety
    is not at risk
  • 30 years of DAW shows generics reduce costs to
    patient and system
  • If practitioners want brand, they can write DAW

24
Bryan R. OMalleySenior Legislative
AssistantAssembly Member Richard N.
GottfriedChair, New York Assembly Committee on
Health 518-455-4941 omalleb_at_assembly.state.ny.us
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