Description:
According to the Centers for Disease Control and Prevention (CDC), human papillomavirus (HPV) is the most common sexually transmitted virus in the United States. At least 50 percent of sexually active people will have genital HPV at some time in their lives.

Policy: HPV vaccine is considered MEDICALLY NECESSARY in the following scenarios: 

• HPV vaccine is recommended for routine vaccination at age 11 or 12 years. (Vaccination can be started at age 9.)
• ACIP also recommends vaccination for everyone through age 26 years if not adequately vaccinated previously. HPV vaccination is given as a series of either two or three doses, depending on age at initial vaccination.
• Vaccination is not recommended for everyone older than age 26 years. However, some adults ages 27 through 45 years may decide to get the HPV vaccine based on discussion with their clinician, if they did not get adequately vaccinated when they were younger. HPV vaccination of people in this age range provides less benefit, for several reasons, including that more people in this age range have already been exposed to HPV.
• For adults ages 27 through 45 years, clinicians can consider discussing HPV vaccination with people who are most likely to benefit. HPV vaccination does not need to be discussed with most adults over age 26 years. See ACIP’s shared clinical decision-making FAQs.

HPV vaccine is considered investigational and/or unproven and therefore NOT MEDICALLY NECESSARY for all other indications.

References:

1. Markowitz LE, Dunne EF, Saraiya M, et al; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent human papillomavirus vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-2):1-24.
2. Danish Centre for Evaluation and Health Technology Assessment (DACEHTA). Reduction in the risk of cervical cancer by vaccination against human papillomavirus (HPV) – a health technology assessment [summary]. Copenhagen, Denmark: DACEHTA; 2007;9(1).
3. U.S. Food and Drug Administration (FDA). FDA approves expanded uses for Gardasil to include preventing certain vulvar and vaginal cancers. FDA News. Rockville, MD: FDA; September 12, 2008.
4. U.S. Food and Drug Administration (FDA). FDA approves new indication for Gardasil to prevent genital warts in men and boys. FDA News Release. Rockville, MD: FDA; October 16, 2009.
5. Chaudhary AK, Singh M, Sundaram S, Mehrotra R. Role of human papillomavirus and its detection in potentially malignant and malignant head and neck lesions: Updated review. Head Neck Oncol. 2009;1(1):22.
6. Paavonen J, Naud P, Salmerón J, et al; HPV PATRICIA Study Group, Greenacre M. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): Final analysis of a double-blind, randomised study in young women. Lancet. 2009;374(9686):301-314.
7. Einstein MH, Baron M, Levin MJ, et al. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18–45 years. Hum Vaccin. 2009;5(10):705-719.
8. U.S. Food and Drug Administration (FDA). FDA approves new vaccine for prevention of cervical cancer. FDA News Release. Rockville, MD: FDA; October 16, 2009.
9. Medeiros LR, Rosa DD, da Rosa MI, et al. Efficacy of human papillomavirus vaccines: A systematic quantitative review. Int J Gynecol Cancer. 2009;19(7):1166-1176.
10. Damm O, Nocon M, Roll S, et al. Human papillomavirus (HPV) vaccination for the prevention of HPV 16/18 induced cervical cancer and its precursors. Summary HTA. Cologne, Germany: German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information (DAHTA DIMDI); 2009.
11. Liddon N, Hood J, Wynn BA, Markowitz LE. Acceptability of human papillomavirus vaccine for males: A review of the literature. J Adolesc Health. 2010;46(2):113-123.
12. Palefsky JM. Human papillomavirus-related disease in men: Not just a women's issue. J Adolesc Health. 2010;46(4 Suppl):S12-S19.
13. FUTURE I/II Study Group, Dillner J, Kjaer SK, Wheeler CM, et al. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trial. BMJ. 2010;341:c3493.
14. CDC guidelines last reviewed March 17, 2020 https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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