BCBST MEDICAL POLICY MANUAL

Human Papillomavirus (HPV) Vaccine

NDC CODE(S)

00006-4045-XX Gardasil SUSP (MERCK SHARP & DOHME)

 

00006-4109-XX Gardasil SUSP (MERCK SHARP & DOHME)

 

00006-4119-XX Gardasil 9 SUSP (MERCK SHARP & DOHME)

 

00006-4121-XX Gardasil 9 SUSY (MERCK SHARP & DOHME)

 

54569-5822-XX Gardasil SUSP (A-S MEDICATION SOLUTIONS)

 

54569-6671-XX Gardasil 9 SUSP (A-S MEDICATION SOLUTIONS)

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.  Cervical, vulvar, vaginal and anal cancers have been shown to be caused by HPV types 16, 18, 31, 33, 45, 52 and 58.  Causality for various precancerous or dysplastic lesions have been traced to HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.  Additionally, various precancerous or dysplastic lesions such as cervical intraepithelial neoplasia (CIN) grades 1, 2/3, cervical adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 are shown to be caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

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 to prevent HPV types 16 and 18, a quadrivalent preparation to prevent HPV types 6, 11, 16 and 18 and a vaccine to prevent HPV types 16, 18, 31, 33, 45, 52, and 58.  Both are administered intramuscularly in a sequence of 3 injections at 0, 2 and 6 months.

An example of a preparation of human papillomavirus bivalent vaccine (types 16 & 18) is Cervarix®. 

NOTE: In a business decision, the manufacturer of Cervarix®, the only available bivalent human papillomavirus vaccine, ceased shipments of to the United States after August 2016.  All licenses for sale and use of the vaccine were maintained and will be honored until supplies are exhausted.

An example of a preparation of human papillomavirus quadrivalent vaccine (types 6, 11, 16 & 18) is Gardasil®.

An example of a preparation of human papillomavirus 9-valent vaccine (types 6,11,16,18, 31, 33, 45, 52 & 58) is Gardasil® 9.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

RENEWAL CRITERIA

Human papillomavirus vaccine is NOT considered medically appropriate for renewal.

 

INDICATION(S) DOSAGE & ADMINISTRATION
Prevention of infection with Human Papillomavirus

0.5-mL suspension for injection as a single-dose vial and prefilled syringe administered as the following:

GARDASIL® should be administered intramuscularly as a 0.5-mL dose at 0, 2 months, 6 months.

 GARDASIL® 9         Age

Regimen

Schedule

  9 through 14 years

 2-dose

0, 6 to 12 months*

                             

 3-dose

0, 2, 6 months

 15 through 26 years

 3-dose

0, 2, 6 months

*If the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose.

CERVARIX® Three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months.

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 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or 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. (2017, March). AHFS DI. Human papillomavirus vaccine. Retrieved May 17, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, April). Human papillomavirus vaccine. Retrieved May 16, 2017 from MICROMEDEX Healthcare Series. 

U. S. Food and Drug Administration. (2015, April). Center for Biologics Evaluation and Research. Gardasil® [human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant]. Retrieved May 17, 2017 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf.

U. S. Food and Drug Administration. (2015, February). Center for Biologics Evaluation and Research. Cervarix® [human papillomavirus bivalent (types 16 and 18) vaccine, recombinant]. Retrieved May 17, 2017 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf.

U. S. Food and Drug Administration. (2016, October). Center for Biologics Evaluation and Research. Gardasil® 9 (human papillomavirus 9-valent vaccine, recombinant) suspension for intramuscular injection. Retrieved May 17, 2017 from https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm426457.pdf.

ORIGINAL EFFECTIVE DATE:  1/13/2007

MOST RECENT REVIEW DATE:  8/8/2017

ID_MRx

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 (Cervarix®, Gardasil®, Gardasil® 9 )

  1. Is this the initial request for human papillomavirus vaccine?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for Gardasil® 9 for prevention of infection with human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 & 58 for an individual who is ANY ONE of the following?

If yes, go to question #5

If no, go to question #3

  1. Is the request for Gardasil® for prevention of infection with human papillomavirus types 6, 11, 16 & 18 in an individual between 9 and 26 years of age?

If yes, go to question #5

If no, go to question #4

  1. Is the request for Cervarix® for prevention of infection with human papillomavirus types 16 & 18 in a female between 9 and 25 years of age?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following?

INDICATION(S) DOSAGE & ADMINISTRATION
Prevention of infection with Human Papillomavirus

0.5-mL suspension for injection as a single-dose vial and prefilled syringe administered as the following:

 

GARDASIL® should be administered intramuscularly as a 0.5-mL dose at 0, 2 months, 6 months.

 

 GARDASIL® 9         Age

Regimen

Schedule

  9 through 14 years

 2-dose

0, 6 to 12 months*

                             

 3-dose

0, 2, 6 months

 15 through 26 years

 3-dose

0, 2, 6 months

*If the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose.

 

CERVARIX® Three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months.

 

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.