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Understanding the American Cancer Society Cancer Action Networks Policy on the HPV Vaccine: Overview

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American Cancer Society Cancer Action Network's Policy. on the HPV Vaccine: ... cancer prevention vaccine in accordance with the Society's recommendations and ... – PowerPoint PPT presentation

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Title: Understanding the American Cancer Society Cancer Action Networks Policy on the HPV Vaccine: Overview


1
Understanding the American Cancer Society Cancer
Action Networks Policy on the HPV Vaccine
Overview of the IssueMona Shah, MPHCervical
Cancer ConferenceAugust 5, 2008
2
Overview
  • Overview of Principles on Administration and
    Utilization of Cancer Prevention Vaccines
  • Explanation of the ACS CANs and the Societys
    Position on School Vaccine Requirements

3
In the news
4
ACS and ACS CAN believe
  • ACS CAN and the Society is prepared to promote
    and will advocate for the widest availability and
    use of any available cancer prevention vaccine in
    accordance with the Societys recommendations
    and/or guidelines.
  • In particular, the ACS CAN will work for
    policies that have the greatest impact on
    reducing disparities in the delivery of cancer
    vaccines among the uninsured, underinsured and
    medically underserved.

5
Principles on Cancer Prevention Vaccines
  • These recommendations would create a
    successful immunization infrastructure that will
    support the delivery and use of any given cancer
    prevention vaccine
  • Sufficient evidence should exist that
    demonstrates the safety and efficacy of the
    cancer prevention vaccine and evaluates the
    effectiveness of the proposed vaccine delivery
    strategies.
  • The vaccine should be widely available and the
    administrative burden of delivery must be
    reasonable.
  • Information about the vaccine should be readily
    available to the public and the vaccine must be
    supported by the medical community.
  • Vaccine cost should not be a barrier to access.

6
  • SAFETY
  • AND EFFICACY

7
The Issues Safety
  • Vaccine safety is critical to public health
  • Pre-licensure safety testing, vaccine
    manufacturing process control, and clinical
    trials are critical foundations, but
    post-licensure monitoring is essential to ensure
    safety when vaccines are used in large numbers of
    people
  • Case study RotaShield and Intussusception
  • Good information on vaccine risks is critical
  • Urgently obtained
  • Communicated clearly

8
Recommendation 1 Safety
  • The vaccine should be tested rigorously and must
    obtain licensure by the FDA.
  • Strong evidence of vaccine safety and efficacy.
  • Sufficient post-marketing surveillance data to
    monitor any serious side effects no matter how
    rare and
  • Data tracking systems to monitor the progress of
    immunization programs and analyze vaccine uptake.
  • The vaccine should be recommended by the CDCs
    Advisory Committee on Immunization Practices
    (ACIP) and included in their recommended
    immunization schedule.

9
  • AVAILABILITY

10
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11
Availability Missing Visits and Missed
Opportunities
  • The growing number of recommended vaccines is
    making it increasingly difficult for physicians
    and other providers to fit them all into the
    available number of patient visits
  • Adolescents (the target audience for HPV vaccine)
    rarely interact with the health care system,
    especially for preventive services
  • The more visits required for a given vaccine, the
    greater the challenge (HPV vaccination requires
    three separate visits)
  • Various interventions could help increase
    vaccination rates (for example, patient/provider
    recall/reminder systems and alternative
    vaccination sites)

12
Recommendation 2 Availability
  • A stable and adequate vaccine supply to cover the
    demand for the vaccine in the recommended
    population.
  • An expanded delivery system that administers
    vaccines at venues that would be convenient for
    patients and families and that are appropriate
    for the specific immunization.
  • Targeted interventions and programs that
    eliminate any existing disparities in vaccine
    coverage rates.
  • A system where providers use any appropriate
    encounter with the health care system to
    administer missed vaccinations.

13
  • ACCEPTABILITY
  • AND
  • EDUCATION

14
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15
Recommendation 3 Information
  • The public needs to be educated about the
    vaccine.
  • Wide-scale and targeted educational campaigns by
    public and/or private entities.
  • Information about the disease, the vaccine, and
    vaccination programs must be accurate, clear, and
    presented in simple language as well as be
    culturally and ethnically appropriate.
  • Education campaigns can be used to dispel myths
    and build acceptance and understanding of both
    the vaccine and evidence regarding the benefits
    and risks.
  • Health care providers should be educated about
    the safety, efficacy and benefits of the vaccine.

16
  • COST AND
  • FINANCING

17
Vaccine Cost Coverage
  • Overall cost of the vaccine
  • List price of 120 per dose (96.75 under the
    Federal governments contract with the
    manufacturer), 360 for 3-shot series (or 290.25
    under the Federal contract)
  • Other Costs to Consumers/Parents
  • Copayments/Coinsurance for office visits
  • Charges for drug administration
  • Upfront costs of vaccine is an issue for
    physicians, others
  • Several public programs cover vaccine
    administration
  • Private insurance may cover vaccine its
    administration
  • Although a number of states have immunization
    coverage mandates for certain insurance products,
    few of these are likely to apply to HPV vaccine
    (and such mandates do not apply to the large
    segments of the population covered under
    employer, self-insured health plans)

18
U.S. Federal Contract Prices for Vaccines
Recommended Universally for Children and
Adolescents 1985, 1995, 2006
1181.60
893.60
155
45
From Rodewald L. ACIP Presentation 10/25-26/06,
available at www.cdc.gov/nip/acip/slides/mtg-slid
es-Oct06.htm
Federal contract price shown for 1985 and 1995
are averages that account for price changes
within that year. Does not include the use of
combination vaccines.
19
Vaccination The Role of Public Programs
20
Key Issues Cost and Access Barriers
  • Ensuring timely and adequate federal and state
    funding of public immunization programs
  • Increasing physician participation in public
    immunization programs, especially the Vaccines
    for Children Program
  • Increasing or improving private insurance
    coverage of vaccines and related services
    (through state insurance coverage mandates or
    other means)
  • Addressing out-of-pocket obligations (e.g.,
    cost-sharing) faced by patients/families

21
Recommendation 4 Cost
  • Public programs offering cost assistance for
    vaccines need to be fully funded. There should
    be adequate funding for the Vaccines for Children
    (VFC) program, Section 317 program, and/or state
    programs that provide vaccine financing for
    low-income families, the medically underserved,
    uninsured and underinsured.
  • Private and public health insurance policies need
    to provide full cost coverage for the vaccine.
    Deductibles, co-payments, and payment for
    non-covered services should not be a barrier to
    vaccine access.
  • Health care providers should receive adequate
    reimbursement for the purchase and administration
    of the vaccine.

22
SCHOOL MANDATES
23
School Vaccination MandatesKey Findings from
the Literature
  • School vaccination requirements are effective in
    increasing vaccination rates and decreasing
    disparities.

24
Key Issues School Vaccination Requirements
  • Whether to impose a vaccination requirement
    relating to a given vaccine
  • When to impose a vaccination requirement (for
    example, only after the new vaccine has been on
    the market for some period of time or only after
    other issues have been addressed)
  • How best to enforce a new school vaccination
    requirement
  • What options and mechanisms, if any, to provide
    for those needing or desiring an exemption from a
    school vaccination requirement
  • Will the mandate increase school absenteeism?

25
Some Factors That Could Affect State Interest in
an HPV Vaccine Mandate
  • The issue of sexual vs. non-sexual transmission
    of the target infection, and the overall risk of
    transmission in a school population
  • The lag time between infection and pathology
  • The availability of effective screening and
    treatment options for infection sequelae
  • A states budgetary situation (that is, its
    ability to cover the costs of any newly required
    vaccines).

26
School Mandates
  • At this time, the Society will not support a
    school or any other cancer prevention vaccine
    requirement1. However, as previously stated,
    the Society will support the widespread public
    acceptance and use of current and future cancer
    prevention vaccines by advocating for the four
    preceding recommendations.
  • The Society believes that a vaccine requirement
    could be considered if the following conditions
    are met
  • Sufficient progress toward achieving the four
    preceding recommendations that support the widest
    availability and use of cancer prevention
    vaccines.
  • Broad public acceptance for the vaccine.
  • Compelling evidence that a school vaccine
    requirement is the best mode of disease
    prevention.
  • 1 State laws, regulations, or rule making that
    impose vaccination requirements for obtainment of
    a driver's license or enrollment and/or
    attendance in day care, Head Start, kindergarten,
    grades 1 through 12, colleges, and universities,
    or workplaces.

27
School Mandates (contd)
  • Several years of sustained effort and investment
    of resources so there is significant uptake of
    the vaccine in the recommended population.
  • Sufficient planning for the design and
    implementation of any requirements so they do not
    undermine either the existing public health
    immunization system or the system that will carry
    out and enforce the requirement.
  • Sufficient resources and lead time available to
    implement any requirement.
  • Well-defined opt-out provisions for the
    immunization requirement laws that do not weaken
    or alter already effective vaccination
    requirements.
  • Enforcement plans that ensure any vaccine
    requirement would not be punitive.
  • School dropout rates should not increase and
    resulting school absences should be kept to a
    minimum.

28
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