Title: Understanding the American Cancer Society Cancer Action Networks Policy on the HPV Vaccine: Overview
1Understanding the American Cancer Society Cancer
Action Networks Policy on the HPV Vaccine
Overview of the IssueMona Shah, MPHCervical
Cancer ConferenceAugust 5, 2008
2Overview
- Overview of Principles on Administration and
Utilization of Cancer Prevention Vaccines - Explanation of the ACS CANs and the Societys
Position on School Vaccine Requirements
3In the news
4ACS 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.
5Principles 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 7The 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
8Recommendation 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.
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11Availability 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)
12Recommendation 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
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15Recommendation 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 17Vaccine 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)
18U.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
20Key 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
21Recommendation 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.
22SCHOOL MANDATES
23School Vaccination MandatesKey Findings from
the Literature
- School vaccination requirements are effective in
increasing vaccination rates and decreasing
disparities.
24Key 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?
25Some 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).
26School 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.
27School 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.
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