 | Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the United States; an estimated 6.2 million new individuals are infected each year. HPV demonstrates no symptoms; however, persistent genital HPV infection can cause cervical cancer in women and other types of anogenital cancers (ie, vulvar, vaginal, penile, anal) and genital warts in men and women.
On October 16, 2009, the US Food and Drug Administration (FDA) approved Gardasil® (Quadrivalent Human Papillomavirus [types 6, 11, 16, 18] Recombinant Vaccine) for use among males ages 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.
On October 16, 2009, the FDA also approved Cervarix® (Bivalent Human Papillomavirus [types 16 and 18] Recombinant Vaccine) for the prevention of cervical cancer; cervical intraepithelial neoplasia (CIN) grades 1, 2, or worse; and cervical adenocarcinoma in situ (AIS), which are diseases caused by oncogenic HPV types 16 and 18. Cervarix® was approved for use among females ages 10 through 25 years of age.
Coverage Statement:
- Commercial Members
For commercial members, HPV vaccination with Gardasil® is considered medically necessary and, therefore, covered as a three-dose regimen for use in females and males ages 9 through 26 years of age.
For commercial members, HPV vaccination with Cervarix® is considered medically necessary and, therefore, covered as a three-dose regimen for use in females ages 10 through 25 years of age.
- Medicare Advantage Members
For Medicare Advantage members, HPV vaccination with Gardasil® or Cervarix® is not covered and, therefore, not eligible for reimbursement under the member's medical benefit (Part B). These vaccines are only covered under the pharmacy benefit (Part D) when such a benefit exists.
Experimental/Investigational
All other uses for HPV vaccination with Gardasil® or Cervarix®, including use in individuals outside of the FDA-approved gender or age range, are considered experimental/investigational and, therefore, not covered because their safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
Provider Reimbursement:
Primary care physicians (PCPs) who receive a monthly capitation are reimbursed in addition to capitation for Gardasil® and Cervarix®.
Indications:
Gardasil® for HPV types 6, 11, 16, and 18 is indicated in females ages 9 through 26 years of age to provide prevention of cervical cancer; vaginal cancer; vulvar cancer; genital warts (condyloma acuminata); cervical adenocarcinoma in situ (AIS); cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3; vaginal intraepithelial neoplasia (VaIN) grades 2 and 3; and vulvar intraepithelial neoplasia (VIN) grades 2 and 3.
Gardasil® is also indicated in males ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.
Cervarix® for HPV types 16 and 18 is indicated in females ages 10 through 25 years of age to provide prevention of cervical cancer; cervical intraepithelial neoplasia (CIN) grades 1, 2 or worse; and cervical adenocarcinoma in situ (AIS) caused by oncogenic HPV types 16 and 18.
Dosing and Administration:
Gardasil® and Cervarix® are each administered as a three-dose regimen over a six-month period.
Gardasil® should be administered intramuscularly as three separate 0.5-mL doses according to the following schedule:
- First dose: At elected date
- Second dose: Two months after the first dose
- Third dose: Six months after the first dose
Cervarix® should be administered intramuscularly as three separate 0.5-mL doses according to the following schedule:
- First dose: At the elected date
- Second dose: One month after the first dose
- Third dose: Six months after the first dose
Coding:
To report vaccination with Gardasil® or Cervarix®, use the appropriate Current Procedural Terminology (CPT) code below, in addition to the International Classification of Disease (ICD-9) V-code listed below.
Use the following CPT code to report Gardasil®:
90649: Human papillomavirus (HPV) vaccine, types 6, 11, 16, 18 (quadrivalent), 3 dose schedule, for intramuscular use
Use the following CPT code to report Cervarix®:
90650: Human papillomavirus (HPV) vaccine, types 16 and 18, bivalent, 3 dose schedule, for intramuscular use
The following ICD-9 code must also be reported with either of the CPT codes listed above for HPV vaccination:
V04.89: Need for prophylactic vaccination and inoculation, other viral diseases
Black Box Warnings and Contraindications:
Gardasil®
Contraindications:
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil®.
Warnings and Precautions:
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 vaccination with Gardasil®.
When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Adverse Reactions:
The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS] control or saline placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.
Cervarix®
Contraindications:
Severe allergic reactions (eg, anaphylaxis) to any component of Cervarix®.
Warnings and Precautions:
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 vaccination with Cervarix®. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. Do not use the prefilled syringes in latex-sensitive individuals.
Adverse Reactions:
Most common local adverse reactions in .20% of subjects were pain, redness, and swelling at the injection site. Most common general adverse events in .20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
About HPV:
HPV is classified as "types," and numbers are assigned in order of their discovery. Papillomaviruses initiate infection in the basal layer of the epithelium, and viral genome amplification occurs in differentiating cells by cellular reproduction. The differentiating epithelial cells remain active in the cell cycle. The result is a thickened epithelial lesion. The virus releases as cells exfoliate from the epithelium.
Quadrivalent HPV vaccine (Gardasil®, produced by Merck and Company) for HPV types 6, 11, 16, and 18 was approved by the US Food and Drug Administration (FDA) on June 8, 2006 for use among females ages 9 through 26 years of age for the prevention of HPV type-related cervical cancer; vaginal cancer; vulvar cancer; cervical cancer precursors; vaginal and vulvar cancer precursors; and anogenital warts (condyloma). As diagnoses, these include: cervical cancer; vaginal cancer; vulvar cancer; genital warts; cervical adenocarcinoma in situ (AIS); cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3; vaginal intraepithelial neoplasia (VaIN) grades 2 and 3; and vulvar intraepithelial neoplasia (VIN) grades 2 and 3.
If you have any questions, contact your Network Coordinator.
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