GARDASIL®9 FOR ADULTS

DISCUSS GARDASIL 9
WITH ADULT PATIENTS
THROUGH AGE 45.

You may be able to help protect them
from certain HPV-related cancers.

alt text

Millions of men and women aged 27–45 may still benefit from HPV vaccination1

Help protect your appropriate adult patients with GARDASIL 9 from certain HPV-related cancers and diseases caused by HPV Types to which they have not been exposed.

GARDASIL 9 helps protect against certain cancers caused by 7 HPV Typesa

  • Cervical
  • Vulvar
  • Oropharyngeal*

    *Continued approval contingent
    upon confirmatory trial.

  • Vaginal
  • Anal

*Continued approval contingent
upon confirmatory trial.

aHPV Types 16, 18, 31, 33, 45, 52, and 58.
HPV is not the only cause of these cancers.

Each year in the United States.
Tens of thousands of men and women were diagnosed with HPV-related cancers2
,b

bBased on a model of the CDC’s estimates from 2012–2016.

The most common of these HPV-attributed cancers are certain oropharyngeal cancers in men and cervical cancers in women2

Did you know?

HPV vaccination rates are low among adults aged 27453

The percentage of adults aged 2745 who reported receiving ≥1 dose of an HPV vaccine
according to 2017 NHIS3:

~4%
of men
n=116/3,272

~16%
of women
n=613/3,950

This survey was completed the year before the FDA licensure of GARDASIL 9 for adults aged 27–45.3,4

Seize the opportunity to vaccinate appropriate adults aged 2745 with GARDASIL 9.

It’s a conversation worth having

Even if your patients aged 27–45 have been exposed to one HPV type, they may still benefit from GARDASIL 9 to help protect against certain HPV-related cancers caused by HPV Types to which they haven’t been exposed.

Commercial insurance coverage for adults aged 2745
Over 99% of commercially insured 27- to 45-year-olds are covered for GARDASIL 95,c

The information reflected here is subject to change at any time.

Additionally, this information is not inclusive of all plans that have made a decision regarding coverage for GARDASIL 9. You should contact your patient’s health plan directly for information on coverage and out-of-pocket costs to ensure that you have the most timely and accurate information.

The information provided does not guarantee that a plan’s decision on coverage will result in your out-of-pocket costs being covered.

Coverage for GARDASIL 9 is dependent on the terms and conditions of your patient’s insurance benefit, including any applicable deductible or cap. Additionally, there may be a co-pay or coinsurance that applies. A pharmacist and their staff may try an alternate benefit pathway if the claim is denied, as your patient’s coverage may be unique. A health plan’s decision to cover GARDASIL 9 does not guarantee that implementation at the regional/local level has occurred or will necessarily occur.

Please note that some plans have asked not to be included in this type of resource.

cData above from Decision Resources Group reflecting data as of January 2022 covered under the commercial medical benefit.

For your appropriate adult patients, recommend GARDASIL 9 to help prevent certain HPV-related cancers

Resources Adult Section Actor Portrayal
Actor Portrayals

Share with your appropriate patients:

  • For most people, HPV clears on its own. But, for those who don’t clear the virus, it could cause certain cancers and diseases6,7,8
  • Explain the link between HPV and certain related cancers for men and women
  • Discuss GARDASIL 9 efficacy and safety profile
  • GARDASIL 9 only helps to prevent diseases caused by the HPV Types covered by the vaccine to which your patient may not have been exposed

Vaccinate appropriate adults aged 2745 with GARDASIL 9 or refer (e-prescribe) your patients to an administering pharmacy.

ref18

Reference

  1. Centers for Disease Control and Prevention (CDC). Human papillomavirus (HPV). Reasons to get vaccinated. https://www.cdc.gov/hpv/parents/vaccine/six-reasons.html. Last reviewed March 26, 2019. Accessed September 16, 2020.
ref1

Reference

  1. Objio T, Morelli V, Trimble S. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 5: Storage and handling. Centers for Disease Control and Prevention. Updated August 2021. Accessed September 16, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-storage.html

ref2

Reference

  1. Wolicki J, Miller E. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 6: Vaccine administration. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed September 21, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html
ref3

Reference

  1. Recommended child and adolescent immunization schedule for ages 18 years or younger, 2022. Centers for Disease Control and Prevention (CDC). Published February 17, 2022. Accessed September 23, 2022. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
ref12

Reference

  1. Kann L, McManus T, Harris WA, et al. Youth Risk Behavior Surveillance  — United States, 2017. MMWR Surveill Summ. 2018;67(No. SS-8):1 -114. DOI:http://dx.doi.org/10.15585/mmwr.ss6708a1
ref16

Reference

  1. Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human papillomavirus–Attributable Cancers — United States, 2012–2016. MMWR Morb Mortal Wkly Rep. 2019;68:724–728. DOI: http://dx.doi.org/10.15585/mmwr.mm6833a3.
ref17

Reference

  1. Saraiya M, Unger ER, Thompson TD, et al. US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines. JNCI J Natl Cancer Inst. (2015) 107(6): 1-12. doi: 10.1093/jnci/djv086.
ref14

Reference

  1. Centers for Disease Control and Prevention (CDC). 2015 sexually transmitted diseases treatment guidelines: human papillomavirus (HPV) infection. https://www.cdc.gov/std/tg2015/hpv.htm. Last reviewed June 4, 2015. Accessed September 16, 2020.
ref1-new

Reference

  1. Age and sex composition in the United States: 2019. Table 1. Population by age and sex: 2019. United States Census Bureau. April 2020. Accessed March 18, 2022.
    https://www.census.gov/data/tables/2019/demo/age-and-sex/2019-age-sex-composition.html
ref2-new

Reference

  1. Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human papillomavirus–attributable cancers — United States, 2012–2016. MMWR Morb Mortal Wkly Rep. 2019;68:724-728. doi:http://dx.doi.org/10.15585/mmwr.mm6833a3
ref3-new

Reference

  1. Kasting ML, Giuliano AR, Christy SM, Rouse CE, Robertson SE, Thompson EL. Human papillomavirus vaccination prevalence among adults aged 19–45 years: An analysis of the 2017 National Health Interview Survey. Am J Prev Med. 2020;59(6):837-849. doi:10.1016/j.amepre.2020.05.031
ref4-new

Reference

  1. FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. Food and Drug Administration. Published October 5, 2018. Accessed May 16, 2022.
    https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-gardasil-9-include-individuals-27-through-45-years-old
ref5-new

Reference

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-GSL-03533.
ref6-new

Reference

  1. Meites E, Gee J, Unger E, Markowitz L. Epidemiology and Prevention of Vaccine- Preventable Diseases (Pink Book). 14th edition. Chapter 11: Human Papillomavirus. Centers for Disease Control and Prevention. Updated August 2021. Accessed February 24, 2022.
    https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hpv.pdf
ref7-new

Reference

  1. Sexually transmitted infections treatment guidelines, 2021 – human papillomavirus (HPV) infection. Centers for Disease Control and Prevention. Last reviewed July 22, 2021. Accessed January 7, 2022.
    https://www.cdc.gov/std/treatment-guidelines/hpv.htm
ref8-new

Reference

  1. HPV and oropharyngeal cancer. Centers for Disease Control and Prevention (CDC). Last reviewed December 13, 2021. Accessed July 25, 2022.
    https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm
statistics-modal

Annual incidence of cancer cases per year attributed to the 7 HPV Types covered by GARDASIL 92

Based on a model of the CDC’s estimates from 2012–2016:

~31,400 cancer cases in both men and women.2

Annual Statistics Graph
Annual Statistics

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

US Cancer Statistics assessed incidence of HPV-associated cancers to estimate the annual number of cancers caused by HPV, overall, and by state in 2012–2016.2

The estimated number of cancers attributable to HPV was calculated by multiplying the average number of HPV-associated cancers by the percentage of cancers diagnosed from 1993–2005 (pre-vaccine) that were attributable to HPV.2,9

Not all cervical, vulvar, vaginal, anal, and oropharyngeal cancers are caused by HPV.2

Detection of HPV DNA in an HPV study is insufficient to indicate a causal relation with
the tumor.9

2Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human papillomavirus–attributable cancers — United States, 2012–2016. MMWR Morb Mortal Wkly Rep. 2019;68:724-728. doi:http://dx.doi.org/10.15585/mmwr.mm6833a3  9Saraiya M, Unger ER, Thompson TD, et al. US assessment of HPV Types in cancers: implications for current and 9-valent HPV vaccines. J Natl Cancer Inst. 2015;107(6):1-12, s13-s26. doi:10.1093/jnci/djv086

study-design

Study Design of 2017 National Health Interview Survey (NHIS)

The NHIS is an annual, serial, cross-sectional survey conducted in-person through a computer-assisted household interview and is nationally representative of the United States civilian, noninstitutionalized population. These analyses (n=9,744 participants) included the sample of individuals aged 19–45 years from the 2017 NHIS. In the survey, every adult respondent was asked “Have you ever received an HPV shot or vaccine?” Response options included in the analysis were yes and no.3

3Kasting ML, Giuliano AR, Christy SM, Rouse CE, Robertson SE, Thompson EL. Human papillomavirus vaccination prevalence among adults aged 19–45 years: An analysis of the 2017 National Health Interview Survey. Am J Prev Med. 2020;59(6):837-849. doi:10.1016/j.amepre.2020.05.031

Indication for GARDASIL® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

GARDASIL ®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.

The duration of immunity of GARDASIL 9 has not been established.

Dosage and Administration for GARDASIL 9

GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

  • For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Before administering GARDASIL 9, please read the Prescribing Information. The Patient Information also is available.

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

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