Human Papillomavirus (HPV) Vaccine
DESCRIPTION
More than 100 types of species-specific papillomaviruses affect humans (HPVs) and over 30 of them can be passed from person to person through sexual contact. HPVs are the most common sexually transmitted infections in the United States. The genital tract is the most common reservoir of sexually transmitted HPVs, with lesions appearing as anogenital warts (condyloma acuminata) or other epithelial vulvar, vaginal or cervical lesions.
While long noted that cervical cancer has characteristics of a sexually transmitted disease, it is now clearly established that sexually transmitted HPVs initiate the multistep process of developing invasive cervical cancer. Approximately 70% of cervical cancers contain either HPV-16 or HPV-18.
Condyloma acuminata affect both sexes. They are the most common sexually transmitted viral diseases of the vulva, vagina, rectum, and cervix caused by HPV. While generally benign and asymptomatic, some warts produce pain, itching, a tendency to bleed when friable, and an odor when secondarily infected. Over 90% of genital warts contain HPV-6 or HPV-11.
Vaccines against infection by HPVs have been developed through recombinant technology. The vaccines contain non-infectious purified virus-like particles of the major capsid proteins of the HPV types included in the vaccine. Vaccines provide protection from infection only to the specific HPV types in a particular vaccine. Commercially available vaccines include a bivalent preparation with HPV types 16 and 18 and a quadrivalent preparation with HPV types 6, 11, 16 and 18. Both are administered intramuscularly in a sequence of 3 injections at 0, 2 and 6 months.
An example of a preparation of human papillomavirus vaccine bivalent (types 16 & 18) is Cervarix®.
An example of a preparation of human papillomavirus vaccine quadrivalent (types 6, 11, 16 & 18) is Gardasil®.
REFER TO DECISION SUPPORT TREE
POLICY
Human papillomavirus (HPV) vaccine for the prevention of infection with human papillomavirus for the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
HPV types 6, 11, 16 & 18
HPV types 16 & 18
Human papillomavirus (HPV) vaccine for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Human papillomavirus (HPV) vaccine for the prevention of infection with human papillomavirus is considered medically appropriate if ANY ONE of the following criteria are met:
Gardasil® for the prevention of infection with human papillomavirus types 6, 11, 16 & 18 in individuals 9 through 26 years of age
Cervarix® for the prevention of infection with human papillomavirus types 16 & 18 infection in females 9 through 25 years of age
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
This agent is not covered under the pharmacy benefit. Medical benefits are available under the Well Care Services benefit, subject to the Well Care Services benefit maximum, if applicable.
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of presently available human papillomavirus vaccine for the treatment or prevention of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2011). AHFS DI. Human papillomavirus vaccine. Retrieved November 2, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, October). Human papillomavirus vaccine. Retrieved November 2, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration (2011, July). Center for Biologics Evaluation and Research. Cervarix® [Human papillomavirus bivalent (Types 16 and 18) vaccine, recombinant] product insert. Retrieved November 4, 2011 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf.
U. S. Food and Drug Administration (2009, October). Center for Biologics Evaluation and Research. Gardasil® [Human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, recombinant] product insert. Retrieved November 3, 2011 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf.
ORIGINAL EFFECTIVE DATE: 1/13/2007
MOST RECENT REVIEW DATE: 1/10/2012
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Human Papillomavirus (HPV) Vaccine (Gardasil®, Cervarix®)
This agent is not covered under the pharmacy benefit. Medical benefits are available under the Well Care Services benefit, subject to the Well Care Services benefit maximum, if applicable.
Is the agent being requested Gardasil®?
If yes, go to question #2
If no, go to question #3
Is Gardasil® being used to prevent infection with human papillomavirus types 6, 11, 16 & 18 in an individual 9 through 26 years of age?
If yes, satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the agent being requested Cervarix®?
If yes, go to question #4
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is Cervarix® being used to prevent infection with human papillomavirus types 16 & 18 in a female 9 through 25 years of age?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.