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## Complete Summary

#### GUIDELINE TITLE

American Cancer Society guideline for human papillomavirus (HPV) vaccine
use to prevent cervical cancer and its precursors.

#### BIBLIOGRAPHIC SOURCE(S)

Saslow D, Castle PE, Cox JT, Davey DD, Einstein MH, Ferris DG, Goldie
SJ, Harper DM, Kinney W, Moscicki AB, Noller KL, Wheeler CM, Ades T,
Andrews KS, Doroshenk MK, Kahn KG, Schmidt C, Shafey O, Smith RA,
Partridge EE, Garcia F. American Cancer Society guideline for human
papillomavirus (HPV) vaccine use to prevent cervical cancer and its
precursors. CA Cancer J Clin 2007 Jan-Feb;57(1):7-28. \[169 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17237032)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Human papillomavirus (HPV) infection

-   Sequelae to HPV infection, such as cervical cancer and genital warts

#### GUIDELINE CATEGORY

Prevention\
Risk Assessment\
Screening

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Nursing\
Obstetrics and Gynecology\
Pediatrics\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Health Plans\
Managed Care Organizations\
Physician Assistants\
Physicians\
Public Health Departments

#### GUIDELINE OBJECTIVE(S)

-   To address the use of prophylactic human papillomavirus (HPV)
    vaccines, including who should be vaccinated and at what age, as
    well as provide a summary of policy and implementation issues

-   To attain the greatest impact on cervical cancer prevention

#### TARGET POPULATION

Females age 9 to 26 years

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Human papillomavirus (HPV) vaccination

2.  Pap screening for cervical intraepithelial neoplasia and cancer
    before and after HPV vaccination

3.  Education of patient and parents

#### MAJOR OUTCOMES CONSIDERED

-   Rate of age-appropriate vaccine coverage

-   Incidence of cervical intraepithelial neoplasia and cancer

-   Persistent HPV-related infections

-   Vaccine-related adverse events

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The panel reviewed published literature identified using PubMed
(National Library of Medicine) and bibliographies of identified
articles, as well as unpublished data.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The American Cancer Society (ACS) convened an expert panel to review the
existing data on human papillomavirus (HPV) vaccines and develop
recommendations specifically addressing the prevention of cervical
cancer and precancerous lesions.

The evidence and recommendations were discussed during a series of
conference calls before a July 2006 working meeting, and consensus was
reached on the key issues within the Guideline recommendations. When
evidence was insufficient or lacking, the final recommendations
incorporated the expert opinion of the panel members.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

Currently, there are several published analyses addressing the potential
impact of human papillomavirus (HPV) vaccines. In the absence of data on
vaccine effect, duration, cost, and behavior of nontargeted HPV types
over time, different assumptions were made for the base case analysis in
each. While these model-based analyses differ in their objectives, and
thus in their choice of model structure, the majority intended to be
exploratory, aiming to provide qualitative insight while awaiting better
data. The cost of the vaccine was unknown at the time these studies were
conducted; the economic analyses were based on the assumption that the
cost of the 3-dose vaccine series would be approximately \$300,
including administration (the cost of Gardasil is \$360 for 3 doses;
programmatic and administrative costs are likely to make the total cost
higher). The models are based on cervical cancer direct medical costs
only, and did not include genital warts, other HPV-related cancers or
diseases, or nonhealth care costs. None of the published studies modeled
a quadrivalent vaccine or catchup vaccination; each model assumed
vaccination of females at age 12 years.

While a range of cost-effectiveness was found across different models,
it is striking that the qualitative insights provided are complementary
and fairly consistent. Several variables were identified that are likely
to have the greatest impact on cost and benefits, including later onset
of screening and less frequent screening, age of vaccination, duration
of efficacy, and cost of vaccine. Female vaccination strategies costing
less than \$50,000 per quality adjusted life year saved (QALY) were
identified by each model. The cost-effectiveness from prevention of all
HPV6/11/16/18-associated diseases is highly dependent on the price of
the vaccine, including administration and visit costs. When genital wart
prevention is taken into account, cost-effectiveness ratios decline
(i.e., become more attractive), although the magnitude of this is
uncertain.

All models agree that a type-specific HPV vaccine will reduce, but not
eliminate, the risk of cervical cancer. In the context of existing
cervical cytology screening, a type-specific vaccine could reduce
HPV16/18-associated CIN3 and cervical cancer, although the size of the
incremental clinical benefits compared with screening alone will depend
on the underlying effectiveness of the screening program. The cost
effectiveness of vaccination will rely heavily on willingness to
initiate screening at a later age, to conduct screening less frequently,
and to adopt a conservative approach to the follow up of women with
equivocal and mildly abnormal screening test results. It appears that,
all else being equal, when vaccine coverage in women is high,
vaccinating men in addition to women provides an incremental benefit
that is relatively small compared with the incremental benefit of
vaccinating women compared with no vaccination. In addition, vaccine
benefit decreases as age at vaccination increases beyond sexual debut.
The exploratory work thus far has elucidated several data priorities,
including a better understanding of natural immunity following
type-specific HPV infection, heterogeneity of vaccine response, duration
of vaccine-induced immunity, and the effects of type-specific
vaccination on other HPV types.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The American Cancer Society Gynecologic Cancer Advisory Group members
and the National Board of Directors discussed and voted to approve the
recommendations.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The table below summarizes the American Cancer Society (ACS)
recommendations for human papillomavirus (HPV) vaccines.

**Summary of ACS Recommendations for HPV Vaccine Use to Prevent Cervical
Cancer and Its Precursors**

+-----------------------------------------------------------------------+
| -   Routine HPV vaccination is recommended for females aged 11 to 12  |
|     years.                                                            |
|                                                                       |
| -   Females as young as age 9 years may receive HPV vaccination.      |
|                                                                       |
| -   HPV vaccination is also recommended for females aged 13 to 18     |
|     years to catch up missed vaccine or complete the vaccination      |
|     series.                                                           |
|                                                                       |
| -   There are currently insufficient data\* to recommend for or       |
|     against universal vaccination of females aged 19 to 26 years in   |
|     the general population. A decision about whether a woman aged 19  |
|     to 26 years should receive the vaccine should be based on an      |
|     informed discussion between the woman and her health care         |
|     provider regarding her risk of previous HPV exposure and          |
|     potential benefit from vaccination. Ideally the vaccine should be |
|     administered prior to potential exposure to genital HPV through   |
|     sexual intercourse because the potential benefit is likely to     |
|     diminish with increasing number of lifetime sexual partners.      |
|                                                                       |
| -   HPV vaccination is not currently recommended for women over age   |
|     26 years or for males.                                            |
|                                                                       |
| -   Screening for cervical intraepithelial neoplasia and cancer       |
|     should continue in both vaccinated and unvaccinated women         |
|     according to current ACS early detection guidelines.              |
+-----------------------------------------------------------------------+

\*Insufficient evidence of benefit in women aged 19 to 26 years refers
to (1) clinical trial data in women with an average of 2, and not more
than 4, lifetime sexual partners, indicating a limited reduction in the
overall incidence of cervical intraepithelial neoplasia (CIN)2/3; (2)
the absence of efficacy data for the prevention of HPV16/18-related
CIN2/3 in women who have had more than 4 lifetime sexual partners; and
(3) the lack of cost-effectiveness analyses for vaccination in this age
group.

To attain the greatest impact on cervical cancer prevention, the ACS
provides the following supporting recommendations:

**Screening**

-   It is critical that women, whether vaccinated or not, continue
    screening according to current ACS early detection guidelines.

-   A preventive health care visit in which vaccination is discussed or
    offered represents an appropriate opportunity to offer Pap screening
    to sexually active patients.

-   HPV testing before initiating vaccination is not recommended.

**Vaccine Implementation and Utilization**

-   Public health and policy efforts are needed to ensure access and
    encourage high HPV vaccine coverage for all racial, ethnic, and
    socioeconomic groups, particularly for females of color, immigrants,
    those living in rural areas, low-income and uninsured females, and
    others who have limited access to health care services.

-   Strategies should be implemented to maximize adherence to
    vaccination recommendations, including coadministration with other
    recommended adolescent vaccines, once sufficient safety data are
    available.

-   The use of noncomprehensive visits (e.g., minor illness visits,
    camp/sports physical visits) and alternative vaccination sites for
    adolescents unable to access comprehensive preventive care is
    encouraged.

**Education**

-   There is a critical need for education of providers, policy-makers,
    parents, adolescents, and young women about cervical cancer
    prevention and early detection, including the need for regular
    screening even after vaccination.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Appropriate use of human papillomavirus (HPV) vaccine to prevent HPV
    infection, cervical cancer precursor lesions, and genital warts

-   There is potential for short-term benefit in reducing abnormal Pap
    test results, colposcopy referrals, and cervical biopsies. Use of
    procedures such as loop electrosurgical excision and cold knife
    conization can be reduced by preventing, through vaccination, cases
    of cervical intraepithelial neoplasia (CIN) likely to regress,
    thereby reducing obstetrical morbidity related to impaired cervical
    function in late pregnancy, including premature delivery, low birth
    weight, and premature rupture of membranes.

-   The potential for HPV vaccination to reduce cervical cancer
    disparities is supported by cost-effectiveness data. A recent
    analysis found that HPV 16/18 vaccination, while having very small
    incremental benefits at the population level in comparison to
    current screening, may reduce disparities substantially in terms of
    cervical cancer mortality if widespread vaccine coverage could be
    achieved in underscreened populations.

#### POTENTIAL HARMS

**Gardisil**

-   The most common injection site experiences were erythema, pain, and
    swelling, with severe intensity being reported more often in the
    vaccine recipients. The most common systemic adverse experiences,
    which were reported by a similar proportion of vaccine and placebo
    recipients (69%), were fever, headache, and nausea.

-   Vaccine-related serious adverse experiences included one case of
    bronchospasm and one case of gastroenteritis (possibly related to a
    study procedure), one case of headache with hypertension (definitely
    related), one case of injection site pain with injection site joint
    movement impairment (probably related), and one case of vaginal
    hemorrhage (probably related).

-   If prophylactic vaccine availability leads to declining
    participation in screening programs, then cancers will develop that
    may have been otherwise prevented. Benefits from HPV vaccines may be
    offset if vaccinated women acquire a false sense of protection that
    results in decreased compliance with recommended cervical cancer
    screening.

-   Although the evidence does not support that introduction of HPV
    vaccination will lead to changes in sexual behavior, postmarketing
    monitoring will be important.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

**Limitations of Human Papillomavirus (HPV) Vaccine**

-   It will be important to conduct surveillance studies to assess
    safety and identify rare adverse events, including those in pregnant
    women, as human papillomavirus (HPV) vaccines are administered to
    large populations of girls and young women. Safety surveillance for
    coadministration of HPV vaccines with other adolescent vaccines is
    also needed. Monitoring rare events and pregnancy outcomes is
    challenging because it relies on education and commitment of
    providers to identify (usually during opportunistic observation) and
    voluntarily report such events.

-   Limitations of current HPV vaccines include the following: (1) these
    vaccines do not protect against all carcinogenic HPV types; (2) the
    vaccines do not treat prevalent/existing HPV infections; (3) the
    duration of protection and the required length of protection to
    prevent cancer are unknown; (4) the cost of primary vaccination, and
    the possible need for additional booster vaccinations, will likely
    limit vaccine use among the medically underserved and the uninsured;
    and (5) a three-dose regimen for primary vaccination may not be
    achievable in population where follow up is poor, such as uninsured
    and migrant populations or those living in underserved areas.

-   There is currently insufficient evidence to recommend for or against
    universal vaccination of women aged 19 to 26 years in the general
    population.

-   It is important to note that, when subjects entered these studies
    with evidence of current or past HPV infection, there was no clear
    evidence of protection from subsequent disease demonstrated by
    administration of the prophylactic quadrivalent vaccine.

-   Actual efficacy may be even lower among the general population since
    the generalizability of the vaccine clinical trial data may be most
    applicable to women reporting on average 2 (and no more than 4)
    lifetime sexual partners at the time of vaccination.

-   At this time efficacy is unknown for younger girls and for males.

-   Even under the best of circumstances, it will be many decades before
    substantial reduction of cervical cancer risk could become a
    reality. Ultimately, cervical cancer rates will depend on (1) the
    degree of vaccination coverage of the at-risk population; (2) the
    number of carcinogenic HPV types targeted by the prophylactic
    vaccine; (3) the durability of protection; and (4) whether the
    medical community and the public continue to follow recommended
    screening guidelines.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Vaccine Implementation and Utilization**

*Adolescent Vaccination*

Vaccinating any child or adult presents immense barriers. The most
successful regimens are those required for infants. In adolescence and
beyond, the ability to immunize is limited by access. Most adolescents
do not receive annual health examinations. Hence, immunization
opportunities occur during nonroutine visits. The experience with
hepatitis B vaccines underscores the difficulty in immunizing
adolescents. Clearly, a platform for adolescent immunization similar to
that of infant immunizations is needed for the currently recommended
vaccines. The Advisory Committee on Immunization Practices, American
Medical Association, American Academy of Pediatrics, American Academy of
Family Practice, and Society of Adolescent Medicine recommend an early
adolescent health care visit at age 11 to 12 years. Vaccinations for
tetanus/diphtheria/pertussis booster, hepatitis A, and meningococcal are
recommended at this age, and other vaccines (hepatitis B, polio,
varicella, measles/mumps/rubella, pneumococcal, influenza) are
recommended as catch-up or for special risk groups. This adolescent
platform may increase the likelihood of human papillomavirus (HPV)
vaccination of girls aged 11 to 12 years. Other venues will be needed to
get adequate coverage, including sport physicals, school programs, and
acute care visits.

*HPV Vaccine Acceptability*

Several small studies on HPV vaccine acceptability among young women,
parents of adolescents and providers have suggested that overall
acceptability for a prophylactic HPV vaccine is high. Multiple factors
influenced attitudes. The most salient issues include high efficacy,
safety, severity of infection, perceived risk, physician recommendation,
and, for providers, professional society recommendation. Acceptability
by parents and providers appears to be higher for older adolescents,
although one study found that age was not a factor for parents of
adolescent children. Some parents expressed concern that a vaccine would
increase unsafe sexual behavior, while another study reported that
sexual transmission did not affect parental attitudes.

Most parents, young women, and adolescents have minimal knowledge of HPV
and its association with cervical cancer. Several studies indicate that
vaccine acceptance is improved with increased knowledge. In one study of
575 parents of 10- to 15-year-old children, brief education
significantly increased acceptance of an HPV vaccine, particularly for
parents who were initially undecided. Results from a randomized
intervention study designed to assess the impact of a brief HPV
informational brochure (such as provided in doctors\' offices) on
parental acceptability of HPV vaccines for their 8- to 12-year-old
children, however, showed that the observed increase in knowledge
related to receipt of the brochure did not result in a significant
increase in vaccine acceptability. Attitudes and life experiences
appeared to be more important factors. Findings from these acceptability
studies are limited by their small sample size and narrow
population-based sampling. Many of the authors concluded that education
of parents and providers should emphasize the risk of HPV infection in
adolescents and the importance of vaccinating children before the onset
of sexual activity. Acceptance also may be influenced by whether the
vaccine is perceived as a vaccine to reduce the risk of cervical cancer
or as a vaccine to prevent a sexually transmitted infection.

#### IMPLEMENTATION TOOLS

Patient Resources

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Saslow D, Castle PE, Cox JT, Davey DD, Einstein MH, Ferris DG, Goldie
SJ, Harper DM, Kinney W, Moscicki AB, Noller KL, Wheeler CM, Ades T,
Andrews KS, Doroshenk MK, Kahn KG, Schmidt C, Shafey O, Smith RA,
Partridge EE, Garcia F. American Cancer Society guideline for human
papillomavirus (HPV) vaccine use to prevent cervical cancer and its
precursors. CA Cancer J Clin 2007 Jan-Feb;57(1):7-28. \[169 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17237032)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007 Jan

#### GUIDELINE DEVELOPER(S)

American Cancer Society - Disease Specific Society

#### SOURCE(S) OF FUNDING

American Cancer Society

#### GUIDELINE COMMITTEE

American Cancer Society Guideline Panel

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Debbie Saslow, PhD; Philip E. Castle, PhD, MPH; J.
Thomas Cox, MD; Diane D. Davey, MD; Mark H. Einstein, MD, MS; Daron G.
Ferris, MD; Sue J. Goldie, MD, MPH; Diane M. Harper, MD, MPH, MS; Walter
Kinney, MD; Anna-Barbara Moscicki, MD; Kenneth L. Noller, MD; Cosette M.
Wheeler, PhD; Terri Ades, RN, MS, AOCN; Kimberly S. Andrews; Mary K.
Doroshenk, MA; Kelly Green Kahn; Christy Schmidt; Omar Shafey, PhD, MPH;
Robert A. Smith, PhD; Edward E. Partridge, MD (for the Gynecologic
Cancer Advisory Group); Francisco Garcia, MD, MPH

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Workgroup members were asked to disclose relationships, including
potential financial conflicts of interest, with vaccine manufacturers or
trials. The following was disclosed: F. Garcia participated in an expert
panel for GlaxoSmithKline (GSK) for an unrelated immune therapeutic
class of agents; C. Cohen is a paid speaker for Merck; T. Cox is a paid
member of the Merck Data Safety and Monitoring Committee and received an
honorarium for serving on one management advisory board for GSK; D.
Davey serves on the working group of the NCI-sponsored trial of GSK
vaccine in Costa Rica; M. Einstein has received research support from
GSK for a nonvaccine-related activity and serves on the speaker\'s
bureau for Merck, but receives no salary support or honorarium; D.
Ferris receives research support for vaccine trials from Merck and GSK
and serves as a colposcopy quality control consultant to both Merck and
GSK and on the Merck medical advisory board; D. Harper serves on the
study planning committee for Merck and GSK and is a clinical site PI for
GSK; A. Moscicki serves on Merck\'s speaker\'s bureau and adolescent
advisory board and is a local PI on the GSK vaccine trial; E. Partridge
received an honorarium for a one-day advisory meeting for Merck and is a
PI for a clinical study site for Merck; C. Wheeler receives research
support for vaccine trials from Merck and GSK; D. Solomon is a medical
monitor for the NCI-sponsored trial of GSK vaccine in Costa Rica.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Cancer Society Web
site](http://caonline.amcancersoc.org/cgi/content/full/57/1/7).

Print copies: Available from the American Cancer Society, 250 Williams
St., Suite 600, Atlanta, GA 30303; Web site:
[www.cancer.org](http://www.cancer.org/).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

The following are available:

-   From the American Cancer Society: vaccines to prevent cervical
    cancer. CA Cancer J Clin 2007 Jan-Feb;57(1):29. Available from the
    [CA A Cancer Journal for Clinicians Web
    site](http://caonline.amcancersoc.org/cgi/reprint/57/1/29).

-   Human papilloma virus (HPV). Cancer and HPV vaccines - frequently
    asked questions. Available from the [American Cancer Society (ACS)
    Web
    site](http://www.cancer.org/docroot/CRI/content/CRI_2_6x_FAQ_HPV_Vaccines.asp).

Also available by calling 1-800-ACS-2345.

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI Institute on January 31, 2008.
The information was verified by the guideline developer on February 29,
2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008