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Millions of men and women aged 45 and under may still benefit from vaccination16

Help protect against certain HPV-related cancers caused by HPV types to which they haven’t yet been exposed.

HPV-related cancers
Recommend GARDASIL 9

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 diseases10,11,12
  • Explain the link between HPV and certain related cancers for men and women10,12
  • 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 exposed10

Vaccinate appropriate adults aged 27-45 with GARDASIL 9 or refer (e-prescribe) your patients to an administering pharmacy.

Over 99% of commercially insured 27- to 45-year-olds are covered for GARDASIL 918,a

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.

aData above from Decision Resources Group reflecting data as of July 2023 covered under the commercial medical benefit.

Go to HPV-related cancers
ref18

Reference

  1. Data available on request from Merck Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-GSL-04591. Expires October 5, 2024
ref20

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
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 October 24, 2023. 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 October 25, 2023. 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, United States, 2024. Centers for Disease Control and Prevention. Last reviewed November 16, 2023. Accessed November 17, 2023. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
ref11

Reference

  1. HPV and oropharyngeal cancer. Centers for Disease Control and Prevention. Last reviewed November 14, 2023. Accessed May 16, 2024. https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html
ref12

Reference

  1. Human papillomavirus (HPV) infection. Centers for Disease Control and Prevention. Last reviewed July 22, 2021. Accessed May 13, 2024. https://www.cdc.gov/std/treatment-guidelines/hpv.htm
ref16

Reference

  1. 2023 population estimates by age and sex. Table 1. Population by age and sex: 2023. United States Census Bureau. May 2024. Accessed May 28, 2024. https://www.census.gov/data/tables/2023/demo/age-and-sex/2023-age-sex-composition.html
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. J Natl Cancer Inst. 2015;107(6):1-12, s13-s26. doi:10.1093/jnci/djv086
ref16

Reference

  1. 2023 population estimates by age and sex. Table 1. Population by age and sex: 2023. United States Census Bureau. May 2024. Accessed May 28, 2024. https://www.census.gov/data/tables/2023/demo/age-and-sex/2023-age-sex-composition.html
ref14

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
ref9

Reference

  1. Oh NL, Biddell CB, Rhodes BE, Brewer NT. Provider communication and HPV vaccine uptake: a meta-analysis and systematic review. Prev Med. 2021;148:106554. doi:10.1016/j.ypmed.2021.106554
ref10

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 20, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hpv.pdf
ref12

Reference

  1. Human papillomavirus (HPV) infection. Centers for Disease Control and Prevention. Last reviewed July 22, 2021. Accessed May 13, 2024. https://www.cdc.gov/std/treatment-guidelines/hpv.htm

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 a 2-dose schedule 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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